[go: up one dir, main page]

WO2023033683A1 - Composition pharmaceutique antivirale contenant du favipiravir et un acide aminé - Google Patents

Composition pharmaceutique antivirale contenant du favipiravir et un acide aminé Download PDF

Info

Publication number
WO2023033683A1
WO2023033683A1 PCT/RU2022/050274 RU2022050274W WO2023033683A1 WO 2023033683 A1 WO2023033683 A1 WO 2023033683A1 RU 2022050274 W RU2022050274 W RU 2022050274W WO 2023033683 A1 WO2023033683 A1 WO 2023033683A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutically acceptable
acceptable salt
hydrate
solvate
amino acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/RU2022/050274
Other languages
English (en)
Russian (ru)
Inventor
Петр Александрович Белый
Эдуард Юрьевич Лопатухин
Владимир Львович КОРОЛЕВ
Кира Яковлевна ЗАСЛАВСКАЯ
Татьяна Владимировна ЛЮТОВА
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Obshestvo S Ogranichennoi Otvetstvennostiu "promomed Rus"
Original Assignee
Obshestvo S Ogranichennoi Otvetstvennostiu "promomed Rus"
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from RU2021126189A external-priority patent/RU2783282C1/ru
Application filed by Obshestvo S Ogranichennoi Otvetstvennostiu "promomed Rus" filed Critical Obshestvo S Ogranichennoi Otvetstvennostiu "promomed Rus"
Publication of WO2023033683A1 publication Critical patent/WO2023033683A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4965—Non-condensed pyrazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses

Definitions

  • the invention relates to the field of pharmaceutical industry and medicine, and is a new pharmaceutical composition of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate with one or more amino acids and / or their pharmaceutically acceptable salts or hydrates, and / or hydrates or solvates of their pharmaceutically acceptable salts, as well as a medicinal product containing the specified pharmaceutical composition.
  • Nucleoside analogues directly target blocking the activity of RNA-dependent RNA polymerase and block the synthesis of the viral RNA chain for a wide range of RNA viruses, including the human coronavirus family.
  • Favipiravir 6-fluoro-3-hydroxy-2-pyrazinecarboxamide
  • a guanine analogue approved in clinical practice for the treatment of influenza has been proven to effectively block the RNA-dependent RNA polymerase of influenza viruses (various types), Ebola virus, yellow fever, chikungunya , noroviruses, enteroviruses [De Clercq, E. New nucleoside analogues for the treatment of hemorrhagic fever virus infections. Chem. Asian J. 14, 3962-3968, 2019].
  • favipiravir According to the Global Substances Report, favipiravir has now entered clinical trials against COVID-19 disease based on its proven mechanism of action against viral RsRp. In a clinical study by the National Center for Clinical Research on Infectious Diseases in Shenzhen, favipiravir was administered to 340 patients (age groups and comorbidities not specified) in two doses (2 doses) of 1600 mg on the first day and two doses of 600 mg for the next 13 days in addition to an inhalation aerosol of interferon-alpha (5 million units * 2 / day).
  • This dosage resulted in more rapid disappearance of the virus to undetectable values in the blood) than in the group of patients taking the combination of anti-HIV proteases - lopinavir / ritonavir, with a median clearance of viral particles of 4 days, versus 11, respectively, and was assessed by control CT chest section.
  • the use of favipiravir reduces the number of detectable viral particles in the blood, which means that it effectively inhibits viral replication, delays the development of an aggressive course of COVID-19 or even prevents it.
  • the disease is caused by influenza virus strains of varying virulence.
  • the highly pathogenic avian influenza A(H5N1) virus caused the first outbreak in Hong Kong in 1997. and continues to cause local outbreaks of this type of influenza every year.
  • Avian influenza A(H7N9) epidemic in China in 2013 and the influenza A(H1N1) pandemic in 2009 resulted in 17,700 deaths, and influenza is still one of the major public health problems worldwide, not only in terms of incidence but also in the critical health complications it causes [Writing Committee of the WHO Consultation on Clinical Aspects of Pandemic (H1N1) 2009 Influenza. Clinical aspects of pandemic 2009 influenza A (H1N1) virus infection.- 2010,- N. Engl. J. Med.].
  • Favipiravir (T-705; 6-fluoro-3-hydroxy-2-pyrazinecarboxamide) is effective against a wide range of influenza virus strains, including A(H1N1) (pandemic 2009), A(H5N1) and A(H7N9), due to the fact that that the viral RsRn mistakenly takes the favipirovir-RTF metabolite for a purine nucleotide. Favipiravir has completed phase III trials in Japan and Poi in the US for the treatment of influenza.
  • favipiravir inhibits the replication of arenaviruses, phleboviruses (Rift Valley fever, phlebotomic fever virus and Punta Toro fever), hantaviruses (Maporal, Dobrava and Prospect Hill); flaviviruses (yellow fever and West Nile fever); enteroviruses (full and rhinoviruses); respiratory syncytium paramyxovirus and norovirus [Yousuke Furuta, Brian B. Gowen, Kazumi Takahashi, Kimiyasu Shiraki, Donald F. Smee, Dale L. Bamard. Favipiravir (T-705), a novel viral RNA polymerase inhibitor. antiviral research. -2013, - Volume 100, Issue 2].
  • favipiravir showed high antiviral activity against all strains of the influenza virus, A, B and C.
  • the effective concentration index (hereinafter referred to as EC50) ranged from 0.014 to 0.55 cg /ml [Furuta Y., Takahashi K., Fukuda Y., Kuno M., Kamiyama T., Kozaki K., Nomura N., Egawa H., Minami S., Watanabe Y., Narita H., Shiraki K. In vitro and in vivo activities of anti-influenza virus compound T-705. -2002, Antimicrob Agents Chemother; 46(4), p. 977-981].
  • Favipiravir is known to be active against 53 strains of the influenza virus, including seasonal strains A(H1N1), A(H3N2), and strains of influenza type B; A(HlNl)pdmO9 pandemic virus, highly pathogenic avian influenza A(H5N1) isolated from humans, strains A(H1N1) and A(H1N2) isolated from pigs, and A(H2N2), A(H4N2), A(H7N2) .
  • H3N2 In vivo, in mouse models of viral infection with lethal doses of H3N2 (A/Victoria/3/75), H3N2 (A/Osaka/5/70), or H5N1 (A/Duck/MN/1525/81) strains, favipiravir was administered one hour after infection. . Survival of mice at doses of 30 mg/kg/day 2 or 4 times a day was significant, while all infected mice in the control group died.
  • favipiravir When administered at 60 to 300 mg/kg/day, favipiravir has been shown to be effective in reducing the viral load in the lungs of H1N1-infected mice (A/ Califomia/04/09), as well as delayed use, up to 96 hours after infection [Takahashi K ., Furuta Y., Fukuda Y., Kuno M., Kamiyama T., Kozaki K., Nomura N., Egawa H., Minami S., Shiraki K. In vitro and in vivo activities of T-705 and oseltamivir against influenza virus. antivirus. Chem.
  • Arenaviruses cause fatal human diseases [Moraz M.L., Kunz S. Pathogenesis of arenavirus hemorrhagic fevers. - 2011, - Expert Rev. Anti infection. Ther.-9(1), p. 49-59], for which there are no antiviral drugs, except for ribavirin, which has a pronounced toxic effect.
  • favipiravir showed greater selectivity than ribavirin.
  • the EC50 values for the drug were 0.79-0.94 cg/ml for Yunin, Pichinde and Takaribe viruses.
  • the viral load during the use of favipiravir significantly decreased by the third day.
  • Viral load was also significantly reduced at the start of treatment from days 4, 5 and 6 post-infection.
  • the survival of animals significantly increased [Gowen V.V., Smee DF, Wong M.N., Hall J.O., Jung KH, Bailey KW, Stevens JR, Furuta Y., Morrey JD Treatment of late stage disease in a model of arenaviral hemorrhagic fever: T-705 efficacy and reduced toxicity suggests an alternative to ribavirin. - 2008, - PLoS One 3, e3725].
  • favipiravir demonstrated its effectiveness even after the onset of acute symptoms of the disease [Mendenhall M., Russell A., Smee D.F., Hall J.O., Skirpstunas R., Furuta Y., Gowen B.B. Effective oral favipiravir (T-705) therapy initiated after the onset of clinical disease in a model of arenavirus hemorrhagic fever. -2011,- PLoS Negl. Trop. Dis. 5, el342].
  • favpiravir When using favpiravir at a dose of 300 mg/kg/day, it showed significant effects on survival: 100% of the animals participating in the experiment survived, at a dose of 150 mg/kg/day, the indicators decreased to 50 and 25%, the animals maintained body weight, their temperature dropped to normal and all indicators were generally better than those for ribavirin at a dosage of 50 mg/kg/day.
  • Mean infectious dose viremia per ml of eluate decreased to an average of 2.1, 1.3, and 1.6 logIO SS50/ml in the high and medium dose favipiravir and ribavirin groups, respectively.
  • favipiravir The efficacy of oral administration of favipiravir has also been shown in models infected with the lethal Lassa virus in guinea pigs and mice [Safronetz D., et al. The broad-spectrum antiviral favipiravir protects guinea pigs from lethal Lassa virus infection post-disease onset.- 2015,- Sci. Rep. 5, 14775]. The therapeutic effect was observed on the 2nd day after infection. Subcutaneous administration of favipiravir at doses of 300 mg/kg/day once a day lowered the temperature, prevented weight loss, and increased the survival rate of the animals. The effects of the use of favipiravir many times over outperformed ribavirin 50 mg/kg/day.
  • Viruses of the Bunyaviride family including La Croce virus (LACV), Rift Valley fever virus (RVFV), Crimean-Congo hemorrhagic fever virus (CCHFV), acute fever with thrombocytopenia syndrome virus (SFTSV), and hantavirus, cause severe hemorrhagic fevers with concomitant pulmonary and renal complications.
  • LACV La Croce virus
  • RVV Rift Valley fever virus
  • CCHFV Crimean-Congo hemorrhagic fever virus
  • SFTSV thrombocytopenia syndrome virus
  • hantavirus cause severe hemorrhagic fevers with concomitant pulmonary and renal complications.
  • EC50 values in Plaque Forming Units (PFU) studies in cell culture started in the range of 0.9-30 cg/mL of the drug for Lassa, Punta Toro, Reef Valle, Acute Fever (SFTSV), Phlebotomy Fever, and Dobrava, Maporal, and Prospect Hill Hantaviruses [Tani H., et al. Efficacy of T-705 (Favipiravir) in the treatment of infections with lethal severe fever with thrombocytopenia syndrome virus. - 2016, - mSphere 1, e00061-15].
  • Thrombocytopenic fever virus emerged several years ago as a seasonal disease in China, Korea and Japan [Yu X., Liang M., et al. Fever with thrombocytopenia associated with a novel bunyavirus in China.- 2011,- N. Engl. J. Med, 364, pp. 523-1532].
  • Favipiravir inhibited SFTSV replication in cell culture with EC values of 0.71-1.3 cg/mL.
  • IFNAR-/- interferon-a receptor knockout
  • Favipiravir blocks the replication of viruses of the flaviviride family, including yellow fever virus (YFV) and West Nile virus (WNV) [Inlander J.G., et al. Activity of T-705 in a hamster model of yellow fever virus infection in comparison with a chemically related compound T-1106.- 2009,- Antimicrob. Agents Chemother, 53(1), p.-202-209; Morrey J.D., et al. Efficacy of orally administered T-705 pyrazine analog on lethal West Nile virus infection in rodents.- 2008,- Antiviral Res., 80(3), p. 377-379], however, at higher concentrations than needed to block influenza virus activity.
  • YFV yellow fever virus
  • WNV West Nile virus
  • the EC90 of favipiravir against YFV is 51.8 cg/ml in in vitro studies to determine the release of active viral particles on Vero cell culture.
  • YFV-infected hamsters were treated orally with favipiravir at doses ranging from 200 to 400 mg/kg/day for 8 days starting treatment 4 hours prior to infection.
  • This therapy significantly reduced the mortality rate of animals at the start of treatment [Inlander I.G., et al. Activity of T-705 in a hamster model of yellow fever virus infection in comparison with a chemically related compound T-1106.- 2009,- Antimicrob. Agents Chemother, 53(1), p. 202-209].
  • Togaviridae Favipiravir exhibits antiviral activity against Western equine encephalitis virus (WEEV) in Vero cell culture, reaching an EC90 at 49 ng/mL [Julander JG, et al. Effect of T-705 treatment on western equine encephalitis in a mouse model. Antiviral Res, 82(3), p. 169-171].
  • WEEV Western equine encephalitis virus
  • Favipiravir showed antiviral activity against Chikungunya virus (CHIKV) in Vero cell culture, reaching an EC50 at 0.3-9.4 cg/mL.
  • CHIKV-infected mice oral administration of favipiravir improved survival rates at double doses of 300 mg/kg/day starting 24 hours before or 4 hours after infection [Delang L., et al. Mutations in the chikungunya virus non-structural proteins cause resistance to favipiravir (T-705), a broad-spectrum antiviral. - 2014, - J. Antimicrob. Chemother, 69(10), p. 2770-2784].
  • Favipiravir also blocked poliovirus replication in Vero cell culture and rhinovirus in HeLa cell culture at 3K50s of 4.8 and 23 cg/ml, and with a selectivity index of 29 and >43, respectively [Furuta Y., et al. In vitro and in vivo activities of anti-influenza virus compound T-705. Antimicrob. 2002, Agents Chemother, 46(4), p. 977-981].
  • Favipiravir inhibited Enterovirus replication at EC50 at 23 cg/ml [Wang Y., et al. In vitro assessment of combinations of enterovirus inhibitors against enterovirus 71,- 2016,- Antimicrob. Agents Chemother, 60(9), p. 5357-5367].
  • Caliciviridae Favipiravir is active against murine noravirus with EC50 values of 39 cg/mL in viral plaque scoring studies in the RAW 264.7 mouse macrophage cell line. TTL? real-time revealed blocking of RNA synthesis using favipiravir with EC50 from 19 cg/ml [Rocha-Pereira J., et al. Favipiravir (T-705) inhibits in vitro norovirus replication. - 2012, - Biochem. Biophys. Res. Commun, 424(4), p. 777-780].
  • favipiravir-RTF inhibits the RNA polymerase activity of human Noraviruses [Jin Z., et al. Biochemical evaluation of the inhibition properties of Favipiravir and 2'-C-methyl-cytidine triphosphates against human and mouse norovirus RNA polymerases.- 2015 Antimicrob. Agents Chemother],
  • Favipiravir showed antiviral activity against the Zaire Ebola virus (Mayinga 1976 strain) in Vero E6 cell culture with an EC50 of 10.5 cg/ml.
  • oral administration of favipiravir avoided death and reduced viral titers in the blood after two doses of 300mg/kg/day for 8 days from day 6 post-infection, while in the placebo group all mice died [Oestereich L., et al. Successful treatment of advanced Ebola virus infection with T-705 (favipiravir) in a small animal model.- 2014,- Antiviral Res, 105, p. 17-21].
  • favipiravir against rabies virus (RABV) was detected on the cell line of mouse neuroblastoma Neuro-2a with 3K50s at 5.1-7.0 cg/ml [Yamada K., et al. Efficacy of Favipiravir (T-705) in rabies postexposure prophylaxis. - 2016, - J. Infect. Dis, 213(8), p. 1253-1261].
  • Favipiravir significantly reduced morbidity and mortality in RABV-infected mice when given orally at doses of 300 mg/kg/day twice for 7 days, starting at the loro hour post-infection.
  • Favipiravir relying on a wide spectrum and proven mechanism of its action, can also alleviate the course of viral diseases, if taken on time, and also significantly reduce the viral load in the course of diseases with complications.
  • oral forms cause difficulties in taking medications in children, elderly patients and patients with dysphagia of various nature, as well as severe patients who are on intensive care, connected to a ventilator or in a state of coma, which can significantly complicate the necessary therapy.
  • taking a large number of tablets, especially for a long time can have a negative effect on the human digestive system.
  • SARS-CoV virus-enveloped needle glycoprotein
  • ACE-2 angiotensin-converting enzyme type 2
  • the ACE-2 receptor which serves as an entry gate for SARS-CoV-2, is expressed in the cells of the lungs, epithelium of the upper esophagus, as well as in enterocytes of the ileum and colon [She J, Liu L, Liu W. COVID-19 epidemic : disease characteristics in children. Journal of Medical Virology.- 2020; 92, p. 747-754].
  • SARS-CoV-2 acting on ACE-2 receptors in the gastrointestinal tract, is able to increase the permeability of the intestinal mucosa, which leads to disruption of the absorption of fluid and electrolytes by enterocytes.
  • the organs of the gastrointestinal tract are also seriously affected by the treatment of COVID-19 with antibiotics, antiviral and hormonal drugs, which put a great burden on the organs of the gastrointestinal tract.
  • antibiotics, antiviral and hormonal drugs which put a great burden on the organs of the gastrointestinal tract.
  • there is a violation of the gastrointestinal tract including nausea, vomiting, diarrhea, dysmotility, dysbacteriosis, etc., thereby changing the absorption rate of the drug and its bioavailability.
  • the objective of the present invention was to develop a new commercially available formulation of favipiravir with improved processing characteristics, stability and bioavailability.
  • favipiravir lyophilisates with hydrates of amino acids and/or their pharmaceutically acceptable salts are also characterized by a high dissolution rate in pharmaceutically acceptable carriers, thereby reducing the time for obtaining the drug recovered from the lyophilisate, leading to the formation of more stable and safe injectables. solutions.
  • composition means a composition comprising favipiravir and at least one amino acid in an effective amount
  • a pharmaceutical composition in the context of the present invention may additionally contain one of the components selected from the group consisting of pharmaceutically acceptable and pharmacologically compatible excipients, such as , not limited to specified, fillers, solubilizers, solvents, co-solvents, antioxidants, buffering agents, cryoprotectants, diluents, preservatives, stabilizers, humectants, emulsifiers, lubricants, lubricants, suspending agents, thickeners, sweeteners, fragrances, fragrances, antibacterial agents, fungicides, delayed delivery regulators, isotonic agents, pH adjusting agents, the choice and ratio of which depends on the nature, purpose and dosage.
  • pharmaceutically acceptable and pharmacologically compatible excipients such as , not limited to specified, fillers, solubilizers, solvents, co-solvents, antioxidants, buffering agents, cryo
  • Non-limiting (illustrative) examples of suspending agents are ethoxylated isostearyl alcohol, polyoxyethylene, sorbitol and sorbitol ether, as well as mixtures of these substances.
  • the protection of the pharmaceutical composition from the action of microorganisms can be achieved by using a variety of antibacterial and antifungal agents, for example, such as sorbic acid, parabens (methylparaben, propylparaben, ethylparaben, butylparaben, isobutylparaben, isopropylparaben, benzylparaben, heptylparaben and mixtures thereof), chlorobutanol and the like. connections.
  • antibacterial and antifungal agents for example, such as sorbic acid, parabens (methylparaben, propylparaben, ethylparaben, butylparaben, isobutylparaben, isopropylparaben, benzylparaben, heptylparaben and mixtures thereof), chlorobutanol and the like. connections.
  • the pharmaceutical composition may include, but is not limited to, sugars, sodium chloride, sodium bicarbonate, etc.
  • Prolonged action of the pharmaceutical composition can be provided, but not limited to, using agents that slow down the absorption of the active agent (for example, hydrophilic and hydrophobic polymeric release inhibitors).
  • Non-limiting (illustrative) examples of suitable fillers are lactose, various types of starch, microcrystalline cellulose, calcium carbonate and phosphate, and others.
  • solvents and diluents water, suitable for parenteral forms, organic esters, ethanol, polyalcohols, and mixtures thereof can be used, but are not limited to.
  • lubricants can be magnesium or calcium stearate, talc, sodium lauryl sulfate, sodium stearyl fumarate, etc. Silicon dioxide, talc, kaolin, bentonites, etc. can be used as lubricants.
  • organic and inorganic acids or alkalis can be used to adjust the pH, such as, but not limited to, hydrochloric acid, malic, ascorbic, citric, acetic, succinic, tartaric, fumaric, lactic, aspartic, glutaric, glutamic, sorbic acids, sodium hydroxide, etc.
  • dispersing agents and spreading agents are starch, alginic acid and its salts, silicates.
  • the pharmaceutical composition can be administered to animals and humans orally, parenterally (intradermally, subcutaneously, intramuscularly, intravenously, intraarterially, in the cavity), sublingually, topically, including, but not limited to, ophthalmic, nasal administration, etc., rectally in a standard form of administration , as a mixture with traditional pharmaceutical carriers.
  • Suitable unit forms of administration include (without limitation) oral forms: tablets, capsules, pellets, granules, powders, solutions, oral and nasal spray solutions, syrups, suspensions, etc., oral: solutions, suspensions, emulsions, preparation of injection and infusion dosage forms, aerosols and powders for inhalation administration, powders and lyophilizates for the preparation of injection and infusion dosage forms; rectal: suppositories, capsules, etc.; eye drops.
  • excipient in the context of the present invention characterizes substances of inorganic or organic origin used in the manufacturing process, the manufacture of drugs to give them the necessary physical and chemical properties.
  • “Pharmaceutical salt” means the relatively non-toxic organic and inorganic salts of the acids and bases of the present invention.
  • a "pharmaceutically acceptable solvate” in the context of the present invention characterizes the product of addition of a solvent to solutes.
  • a "pharmaceutically acceptable hydrate” in the context of the present invention characterizes the addition product of a solvent to solutes where water is the solvent.
  • pharmaceutically acceptable in the context of the present invention means that the substance or composition to which this term is applied must be compatible from the point of view of chemistry and / or toxicology with other ingredients that make up the drug, and are safe for the person who treated with the substance or composition.
  • proteinogenic amino acids in the context of the present invention characterizes amino acids that are incorporated into proteins during biosynthesis in ribosomes under the genetic control of messenger RNA. Proteinogenic non-standard amino acids arise from standard amino acids in the process of post-translational modifications.
  • non-proteinogenic amino acids in the context of the present invention characterizes amino acids that do not take part in the formation of proteins. In some cases, there is a close structural relationship between non-proteinogenic and proteinogenic amino acids, since non-proteinogenic amino acids also include derivatives of proteinogenic amino acids.
  • isoelectric point of amino acids in the context of the present invention means the pH value at which the charge of an amino acid is zero.
  • racemate in the context of the present invention means a mixture of two enantiomers.
  • An amino acid in the form of a racemate characterizes a mixture of L- and D- isomers of an amino acid in any proportions.
  • drug in the context of the present invention characterizes substances or combinations thereof that come into contact with the human or animal body, penetrate into the organs, tissues of the human or animal body, used for the prevention, treatment of diseases, obtained by synthetic methods.
  • Medicinal products include pharmaceutical substances and drugs.
  • the drug may be presented in various formulations intended for administration to an animal or human body in various ways, for example, but not limited to, orally, sublingually, topically, rectally, parenterally.
  • lyophilizate in the context of the present invention characterizes a solid drug in the form of a powder or a porous mass, obtained by lyophilization of liquid or soft drugs. Lyophilizates can be in the form of: powder; amorphous porous mass; porous mass compacted into a tablet, and other forms. Before use, lyophilizates are dissolved (dispersed) to obtain drugs in various dosage forms: solutions; suspensions; emulsions.
  • concentrate in the context of the present invention characterizes a liquid dosage form intended for use after dilution (dilution).
  • the concentrate can be obtained, but not limited to, by dissolving the lyophilisate in a pharmaceutically acceptable solvent. If the conversion of the original dosage form into the application form is two-stage, the term "concentrate” is used to refer to the intermediate form. For example, if the lyophilisate is to be first dissolved in a small amount of solvent to form a concentrate, then the resulting solution must be further diluted in a larger amount of diluent before infusion. In this case, the solvent and the diluent may or may not be the same pharmaceutically acceptable excipient.
  • terapéuticaally effective amount in the context of the present invention means the amount of a substance (as well as a combination of substances) which, when administered to a subject for the treatment or prevention of a disease, or at least one of the clinical symptoms of a disease or disorder, is sufficient to effect such treatment (prophylaxis) to a disease, disorder, or symptom.
  • a “therapeutically effective amount” may vary depending on the form of the substance (e.g., polymorph, salt, solvate, hydrate, etc.), the disease, disorder, and/or symptoms of the disease or disorder, the severity of the disease, disorder, and/or symptoms of the disease or disorder. , as well as the age and/or weight of the subject who needs such treatment (prophylaxis).
  • Fig. 1 Dosage 100 mg favipiravir + 10 mg amino acid hydrate or salt.
  • Fig. 2 Dosage 100 mg favipiravir + 120 mg amino acid hydrate or salt.
  • Fig. 3 Dosage 1200 mg favipiravir + 120 mg amino acid hydrate or salt.
  • Fig. 4 Dosage 1200 mg favipiravir + 750 mg amino acid hydrate or its salt.
  • a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing favipiravir and at least one amino acid and/or its pharmaceutically acceptable salt in therapeutically effective amounts.
  • One of the embodiments of the invention is a pharmaceutical composition, where the mass ratio of favipiravir to amino acid is 1.0:0, 1-
  • the weight ratio of favipiravir to amino acid is 1.0:0.1, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.15, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.2, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.25, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.3, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.35, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.4, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.45, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.5, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.55, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.6, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.65, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.7, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.75, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.8, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.85, respectively. More preferably, the weight ratio of favipiravir to amino acid is 1.0:0.9, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:0.95, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:1.0, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:1.05, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:1.1, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:1.15, respectively.
  • the weight ratio of favipiravir to amino acid is 1.0:1.2, respectively.
  • a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, solvate or hydrate, and at least one amino acid hydrate and/or its a pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to at least one amino acid hydrate and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.
  • a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, solvate or hydrate, and at least one solvate or hydrate of an amino acid and/ or a solvate or hydrate of its pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to at least one solvate, amino acid hydrate and/or solvate, hydrate of its pharmaceutically acceptable salt is 1.0:0, 1- 1.0: 1.2 respectively.
  • the problem is solved, and the claimed technical result is achieved by obtaining a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing therapeutically effective amounts of favipiravir or a pharmaceutically acceptable salt, solvate or hydrate thereof, and at least one amino acid and/or a pharmaceutically acceptable salt thereof, wherein the weight ratio of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof to at least one amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2, respectively.
  • One of the embodiments of the invention is a pharmaceutical composition, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to amino acid hydrate and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:1.1, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.0, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.9, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.8, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.7, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.6, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.5, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.4, respectively. More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.3, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:0.2, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.1, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.15, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.2, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.25, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.3, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.35, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.4, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.45, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.5, respectively. More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.55, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.6, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.65, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.7, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.75, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.8, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.85, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.9, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0.95, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.0, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.05, respectively. More preferably, the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.1, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.15, respectively.
  • the weight ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:1.2, respectively.
  • a new pharmaceutical composition that exhibits prophylactic and/or therapeutic antiviral activity, containing in therapeutically effective amounts favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable an acceptable salt, hydrate or solvate, and / or one hydrate or solvate of an amino acid and / or its pharmaceutically acceptable salt, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and/or the hydrate or solvate of its pharmaceutically acceptable salt is the hydrate of the amino acid and/or its pharmaceutically acceptable salt is 1.0:0, 1-1.0:1.2, respectively.
  • the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or its pharmaceutically acceptable hydrate or solvate the acceptable salt of the amino acid hydrate and/or the pharmaceutically acceptable salt thereof is 1.0:0.1; 1.0:0.15; 1.0:0.2; 1.0:0.25; 1, 0:0.3; 1.0:0.35; 1.0:0.4; 1.0:0.45; 1.0:0.5; 1.0:0.55; 1.0:0.6; 1.0:0.65; 1.0:0.7; 1.0:0.75; 1.0:0.8; 1.0:0.85; 1.0:0.9; 1.0:0.95; 1.0: 1.0; 1.0: 1.05; 1.0: 1.1; 1.0: 1.15 or; 1.0:1.2.
  • One embodiment of the present invention is a pharmaceutical composition wherein favipiravir is in free base form.
  • One embodiment of the present invention is a pharmaceutical composition wherein the hydrate of an amino acid and/or a pharmaceutically acceptable salt thereof is a monohydrate, dihydrate or trihydrate.
  • One embodiment of the present invention is a pharmaceutical composition wherein the amino acid hydrate and/or pharmaceutically acceptable salt hydrate thereof is monohydrate, dihydrate or trihydrate.
  • All amino acids have isomerism. The bulk of natural amino acids is represented by a-isomers, but there are also -, y-amino acids. All a-amino acids, except for glycine, have an asymmetric (chiral) a-carbon atom and exist as two enantiomers (L- and D-amino acids).
  • One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid and/or a pharmaceutically acceptable salt, solvate or hydrate thereof is an a-amino acid.
  • the a-amino acid is glycine, alanine, valine, leucine, glutamine, lysine, histidine, aspartic acid, glutamic acid, isoleucine, proline, arginine, phenylalanine, tryptophan, methionine, serine, threonine, asparagine, cysteine, tyrosine.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid and/or a pharmaceutically acceptable salt thereof has an isoelectric point between 2 and 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 2.5 and 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 3.0 and 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 3.5 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 4.0 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 4.5 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 5.0 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 5.5 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 6.0 to 11. More preferably, the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 6.5 and 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 7.0 and 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point between 7.5 and 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 8.0 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 8.5 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 9.0 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 9.5 to 11.
  • the pharmaceutically acceptable amino acid and/or pharmaceutically acceptable salt thereof has an isoelectric point of 9.0 to 10.
  • One of the embodiments of the invention is a pharmaceutical composition in which the amino acid and/or its solvate, hydrate has an isoelectric point from 2 to 10.
  • One embodiment of the invention is a pharmaceutical composition wherein the amino acid has an isoelectric point between 2 and 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 2.5 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 3.0 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 3.5 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 4.0 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 4.5 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 5.0 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 5.5 to 10. More preferably, the pharmaceutically acceptable amino acid and/or solvate or hydrate thereof has an isoelectric point of 6.0 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 6.5 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 7.0 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 7.5 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 8.0 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 8.5 to 10.
  • the pharmaceutically acceptable amino acid and/or solvate, hydrate thereof has an isoelectric point of 9.0 to 10.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable solvate or hydrate of an amino acid has an isoelectric point between 2 and 10.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid is an amino acid in the L- or D-configuration, or as a racemate.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one pharmaceutically acceptable amino acid and/or a pharmaceutically acceptable salt, solvate or hydrate thereof is an amino acid in the L or D configuration, or as a racemate.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid and/or a pharmaceutically acceptable salt, hydrate or solvate thereof and/or a hydrate or solvate of its pharmaceutically acceptable salt is an amino acid and/or a pharmaceutically acceptable salt, hydrate thereof. or a solvate and/or a hydrate or solvate of a pharmaceutically acceptable salt thereof in the L- or D-configuration, or as a racemate.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid and/or a pharmaceutically acceptable salt, hydrate or solvate thereof and/or a hydrate or solvate of its pharmaceutically acceptable salt is a hydrate or solvate of an a-amino acid and/or its pharmaceutically acceptable salt.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid is a proteinogenic amino acid.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid is a proteinogenic amino acid, with the exception of arginine.
  • the proteinogenic amino acid is a non-essential or non-essential amino acid.
  • the proteinogenic amino acid is a standard or non-standard amino acid.
  • the proteinogenic standard amino acid is L-lysine.
  • the proteinogenic standard amino acid is L-glutamine.
  • the proteinogenic standard amino acid is L-histidine.
  • the proteinogenic standard amino acid is L-methionine.
  • the proteinogenic standard amino acid is L-arginine.
  • the proteinogenic standard amino acid is L-isoleucine.
  • the proteinogenic standard amino acid is L-leucine.
  • the proteinogenic standard amino acid is L-alanine.
  • the proteinogenic standard amino acid is glycine.
  • the proteinogenic standard amino acid is L-threonine.
  • the proteinogenic standard amino acid is L-tryptophan.
  • the proteinogenic standard amino acid is L-proline. More preferably, the proteinogenic standard amino acid is L-valine.
  • the proteinogenic standard amino acid is L-cysteine.
  • the proteinogenic standard amino acid is L-phenylalanine.
  • the proteinogenic standard amino acid is L-asparagine.
  • the proteinogenic standard amino acid is L-serine.
  • the proteinogenic standard amino acid is L-tyrosine.
  • the proteinogenic standard amino acid is L-glutamic acid.
  • the proteinogenic standard amino acid is L-aspartic acid.
  • the proteinogenic non-standard amino acid is L-selenocysteine.
  • the proteinogenic non-standard amino acid is L-pyrrolysine.
  • amino acids In addition to proteinogenic amino acids, other non-proteinogenic pharmaceutically acceptable amino acids that do not participate in protein synthesis can be used in the present invention. Such amino acids are often formed as intermediate metabolic pathways for standard amino acids.
  • One embodiment of the invention is a pharmaceutical composition wherein at least one amino acid is a non-proteinogenic amino acid selected from, but not limited to, N-acetyl-D-alanine, ornithine, N-acetylglycine, hydroxylysine, hydroxyproline, noarginine, homoarginine, homolysin, 2,7-diaminoheptanoic acid, 2,4-diaminobutyric acid, 3-aminoalanine, dehydroalanine, hydroxyproline, cystine, sarcosine, acetylcysteine and/or their pharmaceutically acceptable salts, solvates or hydrates.
  • N-acetyl-D-alanine, ornithine N-acetylglycine
  • hydroxylysine hydroxyproline
  • noarginine homoarginine
  • homolysin homolysin
  • 2,7-diaminoheptanoic acid 2,4-d
  • the pharmaceutical composition contains an amino acid selected from an imino acid, aliphatic, aromatic, or heterocyclic amino acids. More preferably, the aliphatic amino acids are monoamino dicarboxylic amino acid amides, monoamino monocarboxylic, oxymono amino carboxylic, monoamino dicarboxylic, diaminomonocarboxylic or sulfur containing amino acids.
  • the monoamino monocarboxylic amino acids are selected from, but not limited to, glycine, alanine, valine, isoleucine, or leucine.
  • the oxymonoaminocarboxylic amino acids are selected from, but not limited to, serine or threonine.
  • the monoaminodicarboxylic amino acids are selected from, but not limited to, aspartate or glutamate.
  • the monoaminodicarboxylic amino acid amides are selected from, but not limited to, asparagine or glutamine.
  • the diaminomonocarboxylic amino acids are selected from, but not limited to, lysine, arginine.
  • sulfur-containing amino acids are selected from, but not limited to, cysteine or methionine.
  • aromatic amino acids are selected from, but not limited to, phenylalanine, tyrosine, or tryptophan.
  • heterocyclic amino acids are selected from, but not limited to, tryptophan, histidine, or proline.
  • the pharmaceutical composition comprises an amino acid selected from polar uncharged, polar negatively charged, polar positively charged, or non-polar amino acids.
  • polar uncharged amino acids are selected from, but not limited to, serine, threonine, cysteine, asparagine, glutamine, or tyrosine.
  • polar negatively charged amino acids are selected from, but not limited to, aspartate or glutamate.
  • polar positively charged amino acids are selected from, but not limited to, lysine, arginine, or histidine.
  • non-polar amino acids are selected from, but not limited to, glycine, alanine, valine, isoleucine, leucine, proline, methionine, phenylalanine, or tryptophan.
  • the pharmaceutical composition comprises an amino acid selected from, but not limited to, glucogenic, ketogenic, or glucoketogenic amino acids.
  • the glucogenic amino acids are selected from, but not limited to, glycine, alanine, valine, proline, serine, threonine, cysteine, methionine, aspartate, asparagine, glutamate, glutamine, arginine, or histidine.
  • ketogenic amino acids are selected from, but not limited to, leucine or lysine.
  • the glucoketogenic amino acids are selected from, but not limited to, isoleucine, phenylalanine, tyrosine, or tryptophan.
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 100,000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 50,000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 25,000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 10,000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 5000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 4000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 100 to 3700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 110 to 3300 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 120 to 3000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 130 to 2700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 140 to 2400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 150 to 2100 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 160 to 1800 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 170 to 1500 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 180 to 1200 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 190 to 900 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 200 to 600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 200 to 400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 200 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 300 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is 800 mg.
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 90 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 5 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 10 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 15 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 20 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 25 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 30 to 90 wt.% of the total pharmaceutical composition. More preferably, the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 45 to 90 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 50 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 55 to 90% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 60 to 90 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 65 to 90 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 70 to 90 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 15 to 85% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 40 to 85 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 20 to 80% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 45 to 80 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 25 to 75% by weight of the entire pharmaceutical composition. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 50 to 75% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 30 to 70 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 35 to 70% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 40 to 70% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in the pharmaceutical composition is from 45 to 70 wt.% of the total pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 50 to 70% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 55 to 70% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 55 to 65% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 85% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 80% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 75% by weight of the entire pharmaceutical composition. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 70% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 65% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 60% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 55% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 50% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 45% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 35% by weight of the entire pharmaceutical composition.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the pharmaceutical composition is from 1 to 25% by weight of the entire pharmaceutical composition.
  • One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 100,000 mg.
  • One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or hydrate or solvate of its pharmaceutically acceptable salt is from 10 to 100,000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 10,000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 9000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 8000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 7000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 6500 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt a is from 10 to 6000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 5500 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 5000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 4500 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 4000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 3000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 2000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 900 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10 to 800 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 20 to 730 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 30 to 710 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 40 to 690 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 50 to 670 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 60 to 650 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 70 to 630 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 80 to 610 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 90 to 590 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 100 to 570 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 110 to 550 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 120 to 530 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 130 to 510 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 140 to 490 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 150 to 470 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 160 to 450 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 170 to 430 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 180 to 410 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 190 to 390 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 200 to 370 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 210 to 350 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 220 to 330 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 230 to 310 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 240 to 290 mg.
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • One of the embodiments of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire pharmaceutical composition .
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 53.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 53.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable acceptable salt is from 1.0 to 49.5 wt.% by weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 49.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 47.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 45.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 40.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 35.0 wt.% of the total pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 30.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 25.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 25.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 20.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 54.5 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 55 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 54.5 wt.% by weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 54.5 wt.% by weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 15.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 20.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 25.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 30.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 35.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 45.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 50.0 to 55.0 wt.% of the weight of the entire pharmaceutical composition.
  • One embodiment of the invention is a pharmaceutical composition further comprising at least one pharmaceutically acceptable excipient.
  • the pharmaceutically acceptable excipient is selected from the group including, but not limited to, a stabilizer, a buffering agent, or a pH adjusting agent.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 0 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 90% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 85% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 80% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 75% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 70% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 65% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 60% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 55% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 50% by weight of the entire pharmaceutical composition. More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 45% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 40% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 35% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 30% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 25% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 25% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 15% by weight of the total pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 10% by weight of the total pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 1 to 5% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of from 10% to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 15 to 98% by weight of the entire pharmaceutical composition. More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 20 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 25 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 30 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 35 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 40 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 45 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 50 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 55 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 60 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 65 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 70 to 98% by weight of the entire pharmaceutical composition. More preferably, the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 75 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient of the present invention may be present in the pharmaceutical composition in an amount of 80 to 98% by weight of the entire pharmaceutical composition.
  • the pharmaceutically acceptable excipient in the pharmaceutical composition of the present invention is sodium hydroxide or hydrochloric acid.
  • the sodium hydroxide of the present invention may be present in the pharmaceutical composition in an amount of 100 to 2000 mg.
  • One embodiment of the invention is a pharmaceutical composition exhibiting prophylactic and/or therapeutic antiviral activity, wherein the virus is an RNA-containing virus.
  • One of the embodiments of the invention is a pharmaceutical composition exhibiting prophylactic and/or therapeutic antiviral activity, where the virus is a virus whose genome is encoded by a single-stranded sense (+)-strand, as well as an antisense (-)-strand of RNA and which use viral RNA- dependent-RNA polymerase for its replication.
  • the virus of the present invention is an influenza virus, coronavirus, picornavirus, arenavirus, flavivirus, bunyavirus, filovirus, phlebovirus, hantavirus, enterovirus, togavirus, calicivirus, respiratory syncytial virus, parainfluenza virus, rhinoviruses, metapneumoviruses, rotavirus, or noravirus.
  • the virus of the present invention is a highly virulent or low virulent virus.
  • the virus of the present invention is SARS-CoV, SARS-CoV-2, MERS-CoV or Influenza A, B, C.
  • influenza virus of the present invention is, but not limited to, influenza A virus, including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2) , A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).
  • influenza A virus including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2) , A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).
  • One embodiment of the invention is a pharmaceutical composition characterized in that it is a pharmaceutical composition in solid form.
  • One embodiment of the invention is a pharmaceutical composition characterized in that it is a pharmaceutical composition in liquid form.
  • One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or a pharmaceutically acceptable salt, solvate or hydrate thereof is from 0.1 to 20% w/v.
  • One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or solvate or hydrate of its pharmaceutically acceptable salt is from 0.1 to 20 w/v%.
  • One embodiment of the invention is a pharmaceutical composition in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 0.1 to 20% w/v.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.2 to 17% w/v.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.3 to 15% w/v.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.4 to 13% w/v.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.5 to 10% w/v.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.6 to 7 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.7 to 5 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.8 to 5% w/v. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 0.9 to 4 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the pharmaceutical composition is from 1.0 to 3% w/v.
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, MES or hydrate is from 0.1 to 20 w/v%.
  • One of the embodiments of the invention is a pharmaceutical composition, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, MES or hydrate is from 0.1 to 20 w/v%.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.2 to 17% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.3 to 15% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.4 to 13% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.5 to 10% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.6 to 7% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.7 to 5% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.8 to 5% w/v. More preferably, the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 0.9 to 4% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the pharmaceutical composition is from 1.0 to 3% w/v.
  • One of the embodiments of the invention is a pharmaceutical composition consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and an amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2 respectively.
  • One of the embodiments of the invention is a pharmaceutical composition consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts and sodium hydroxide , where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1 ,2 respectively.
  • One of the embodiments of the invention is a pharmaceutical composition consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, sodium hydroxide and injection water, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1, 0:1.2 respectively.
  • the problem is solved, and the claimed technical result is achieved by obtaining a medicinal product that exhibits prophylactic and/or therapeutic antiviral activity, containing pharmaceutical a composition of the present invention; and at least one pharmaceutically acceptable excipient.
  • the problem is solved, and the claimed technical result is achieved by obtaining a drug that exhibits prophylactic and/or therapeutic antiviral activity, containing a pharmaceutical composition of the present invention.
  • One of the embodiments of the invention is a medicinal product, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 4000 mg.
  • One of the embodiments of the invention is a medicinal product, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 100 to 2000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 100 and 3900 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1900 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1800 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 110 to 1500 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 120 to 1400 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 130 and 1300 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 140 to 1200 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 150 and 1100 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 160 to 1000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 170 to 900 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 180 to 800 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 190 to 700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 200 and 600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 3800 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 3700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 110 to 3300 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 120 to 3000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 130 and 2700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 140 and 2400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 150 and 2100 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 160 to 1800 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 170 to 1500 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 180 to 1200 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 190 to 900 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 200 and 600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 200 to 400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1900 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1800 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 100 to 1600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 110 to 1500 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 120 to 1400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 130 and 1300 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 140 to 1200 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 150 and 1100 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 160 to 1000 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 170 to 900 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 180 to 800 mg. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 190 to 700 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 200 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 300 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 400 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 600 mg.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 800 mg.
  • One of the embodiments of the invention is a drug, in which the amount of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 1 to 90 wt.% of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 5 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 10 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 15 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 20 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 25 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 30 to 90% by weight of the total drug. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 35 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 40 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 45 and 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 50 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 55 and 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 60 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 65 and 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is 70 to 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 75 and 90% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is between 55 and 85% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 85% by weight of the total drug. More preferably, the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 80% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 75% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 70% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 65% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 60% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 55% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 50% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 45% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 35% by weight of the total drug.
  • the amount of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the drug is from 1 to 25% by weight of the total drug.
  • One embodiment of the invention is a medicinal product in which the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate is from 10 to 1000 mg.
  • One of the embodiments of the invention is a drug, in which the amount of amino acid and/or its pharmaceutically acceptable salt, solvate or a hydrate, solvate or hydrate of an amino acid and/or a pharmaceutically acceptable salt thereof is from 10 to 1000 mg.
  • One embodiment of the invention is a medicinal product in which the amount of an amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or solvate or hydrate of its pharmaceutically acceptable salt is from 10 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 950 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 900 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 850 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 800 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 750 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 710 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 700 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 650 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 600 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 550 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 500 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 450 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 400 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 350 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 300 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 250 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 200 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 150 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 20 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 50 to 1000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 100 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 150 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 200 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 250 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 300 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 350 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 400 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 450 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 500 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 550 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 600 to 1000 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 650 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 700 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 750 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 800 to 1000 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 10 to 900 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 10 to 800 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 20 to 750 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 30 to 710 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 40 to 690 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 50 to 670 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 60 to 650 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 70 to 630 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 80 to 610 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 90 to 590 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the medicament is from 100 to 570 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 110 to 550 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 120 to 530 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 130 to 510 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 140 to 490 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 150 to 470 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 160 to 450 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 170 to 430 mg. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 180 to 410 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 190 to 390 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 200 to 370 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 210 to 350 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 220 to 330 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 230 to 310 mg.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 240 to 290 mg.
  • One of the embodiments of the invention is a drug, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the weight of the entire drug.
  • One of the embodiments of the invention is a drug, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or hydrate or solvate of its pharmaceutically acceptable salt is from 1 to 55.0 wt.% of the mass of the entire drug .
  • One of the embodiments of the invention is a drug, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 55.0 wt.% of the total drug.
  • One of the embodiments of the invention is a drug, in which the amount of amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.5 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 54.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 53.5% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 53.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.5 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 52.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.5 wt.% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 51.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.5 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 50.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 49.5 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 49.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.5 wt.% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 48.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 47.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 45.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 40.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 35.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 30.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 25.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1 to 25.0% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 20.0 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 1.0 to 54.5 wt.% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 55.0 wt.% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 5.0 to 54.5 wt.% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 54.5% by weight of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 10.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 15.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 20.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 25.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 30.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 35.0 to 55.0 wt.% of the total drug. More preferably, the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 45.0 to 55.0 wt.% of the total drug.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 50.0 to 55.0 wt.% of the total drug.
  • One embodiment of the invention is a drug that is a solid drug.
  • the solid drug of the present invention is, but not limited to, a tablet, capsule, pellet, sachet, dragee, powder, or lyophilisate.
  • Lyophilization is a process of removing a solvent from a frozen material by sublimation (sublimation) of solvent crystals under vacuum, i.e. converting it to vapor without going through the liquid phase.
  • the drug in the form of a lyophilizate fully retains its pharmacological activity.
  • the removal of the solvent during freeze-drying is carried out mainly by sublimation.
  • Sublimation is the removal of a solvent from a frozen object without the formation of a liquid phase, it is carried out under vacuum or much less often in an inert gas.
  • the freezing step is one of the determining steps for obtaining a quality drug in the form of a lyophilisate.
  • the dissolution of favipiravir or its pharmaceutically acceptable salts, hydrates or solvates in an aqueous solution of the solvates or hydrates of amino acids specified in the application and / or their pharmaceutically acceptable salts allows to obtain transparent, stable solutions with a concentration of favipiravir or its pharmaceutically acceptable salts, hydrates or solvates, without being limited to the specified , 10-150 mg/ml.
  • the obtained solutions of favipiravir or its pharmaceutically acceptable salts, hydrates or solvates can be subjected to freeze drying to obtain the corresponding solid lyophilisates, which provide the best stability of the drug components during storage. Lyophilizates can be reconstituted into stable solutions with a favipiravir concentration of 10-150 mg/ml.
  • auxiliary excipients used in freeze-dried medicinal preparations of the present invention include: solvents, solubilizers (EDTA, a-cyclodextrin, etc.), fillers (mannitol, glycine, glucose, sucrose, lactose, etc.), preservatives (benzyl alcohol, ethyl and methyl parahydroxybenzoate, etc.), pH regulators (buffer solutions, sodium chloride hydroxide, hydrochloric acid), stabilizers, cryoprotectants (dextran, gelatin, hydroxyethyl starch, etc.), tween, poloxamers.
  • solvents solubilizers (EDTA, a-cyclodextrin, etc.)
  • fillers mannitol, glycine, glucose, sucrose, lactose, etc.
  • preservatives benzyl alcohol, ethyl and methyl parahydroxybenzoate, etc.
  • pH regulators buffer solutions, sodium chloride hydroxide,
  • the lyophilizate may be presented in the form of two or more components, in which favipiravir or its pharmaceutically acceptable salts, hydrates or solvates are packaged separately from other components.
  • the first component eg in unit dosage form, eg sachet, vial or container
  • the second component for example, a unit dosage form, for example, a sachet (packaged form) or vial containing an amino acid.
  • the inventors have unexpectedly found that when using at least one amino acid and/or its pharmaceutically acceptable salt, or solvates, or hydrates of amino acids and/or their pharmaceutically acceptable salts in a solid dosage form containing favipiravir or its pharmaceutically acceptable salt, hydrate or solvate avoids all the disadvantages mentioned above.
  • One embodiment of the invention is a drug in liquid form.
  • One of the embodiments of the invention is a medicinal product, in which the amount of amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate is from 0.1 to 20 w/v%.
  • One embodiment of the invention is a medicinal product in which the amount of an amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or solvate or hydrate of its pharmaceutically acceptable salt is from 0.1 to 20 w/v%.
  • One of the embodiments of the invention is a medicinal product, in which the amount of an amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate of the amino acid and/or its pharmaceutically acceptable salt is from 0.1 to 20 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.2 to 17 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.3 to 15 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.4 to 13 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.5 to 10% w/v.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.6 to 7 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.7 to 5 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.8 to 5 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 0.9 to 4 w/v%.
  • the amount of the amino acid and/or its pharmaceutically acceptable salt, solvate or hydrate of the amino acid and/or its pharmaceutically acceptable salt in the drug is from 1.0 to 3 w/v%.
  • One of the embodiments of the invention is a drug, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, solvate or hydrate is from 0.1 to 20 w/v%.
  • One of the embodiments of the invention is a drug, in which the amount of favipiravir and/or its pharmaceutically acceptable salt, solvate or hydrate is from 0.1 to 20 w/v%.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.2 to 17% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.3 to 15% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.4 to 13% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.5 to 10% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.6 to 7% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.7 to 5% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.8 to 5% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 0.9 to 4% w/v.
  • the amount of favipiravir and/or a pharmaceutically acceptable salt, solvate or hydrate thereof in the drug is from 1.0 to 3% w/v.
  • One of the embodiments of the invention is a medicinal product, which is a concentrate.
  • One of the embodiments of the invention is a medicinal product, which is a concentrate, in which the concentration of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate is from 10 to 150 mg/ml. More preferably, the concentration of favipiravir in the concentrate of the present invention is from 10 to 140 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 130 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is between 10 and 120 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 110 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 100 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 90 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 80 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 70 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 60 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is 10 to 50 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is from 10 to 40 mg/ml.
  • the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the concentrate of the present invention is 10 to 30 mg/ml. More preferably, the concentrate of the present invention has a pH of 6.5 to 8.5.
  • the concentrate of the present invention has a pH of 7.0 to 7.5.
  • the concentrate of the present invention also obtained by reconstitution of the lyophilisate, is in turn diluted to a solution suitable for injection or infusion into the patient.
  • the volume of aqueous material used for reconstitution is dictated by the concentration of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the final pharmaceutical composition. Reconstitution using a smaller volume of reductant than the prelyophilization volume results in a composition that is more concentrated than before lyophilization.
  • One embodiment of the invention is a drug that is a parenteral drug.
  • Parenteral drug administration is a way of introducing drugs into the body, in which they bypass the gastrointestinal tract, in contrast to the oral route of drug administration.
  • Parenteral medicinal products are sterile preparations intended for administration by injection, infusion, inhalation or implantation into the human or animal body. These include solutions, emulsions, suspensions, aerosols, powders and tablets for the preparation of solutions and implantation, powders for inhalation, lyophilized preparations for the preparation of dosage forms administered parenterally (subcutaneously, intramuscularly, intravenously, intraarterially, into various cavities).
  • Parenteral routes of administration include administration into tissues (intradermally, subcutaneously, intramuscularly, intraosseously), into vessels (intravenously, intraarterially, into lymphatic vessels), into cavities (into the pleural, abdominal, cardiac and articular cavities), into the subarachnoid space, as well as inhalation , intranasal and subconjunctival administration.
  • the parenteral drug of the present invention is, but not limited to, an infusion solution, an injection solution, an inhalation drug, including an aerosol, spray, or powder.
  • the parenteral drug of the present invention is an infusion solution. More preferably, the parenteral drug of the present invention is an injectable solution.
  • the parenteral drug of the present invention is an inhalation drug.
  • One of the embodiments of the invention is a drug, which is a drug for topical administration.
  • Local administration of drugs refers to the application of a drug to mucous membranes (including ophthalmic, nasal, rectal, vaginal application, application to the gums, oral mucosa, etc.), as well as the introduction into the external auditory canal.
  • the topical drug of the present invention is an ophthalmic, nasal, and rectal drug.
  • One embodiment of the invention is a drug that is a drug for rectal administration.
  • the rectal drug of the present invention is, but not limited to, suppositories or capsules.
  • One embodiment of the invention is a medicament wherein the pharmaceutically acceptable excipients are selected from the group including, but not limited to, excipients, stabilizers, solubilizers, solvents, humectants, lubricants, lubricants, thickeners, sweeteners, fragrances, fragrances, fungicides, sustained release regulators, co-solvents, diluents, fillers, emulsifiers, preservatives, antioxidants, buffering agents, cryoprotectants, pH adjusting agents, isotonicity or corrective agents.
  • the pharmaceutically acceptable excipients are selected from the group including, but not limited to, excipients, stabilizers, solubilizers, solvents, humectants, lubricants, lubricants, thickeners, sweeteners, fragrances, fragrances, fungicides, sustained release regulators, co-solvents, diluents, fillers, emulsifiers, preservatives,
  • the solvent of the present invention is, but is not limited to, saline, injection water, pyrogen-free water, distilled water, Ringer's solution, Hartman's solution, or glucose solution.
  • the pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 0 to 98% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 1 to 98% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 95 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 90 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 85 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 80 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 75 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 70 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 65 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 60 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 55 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 50 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 45 wt.% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 40 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 35 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 30 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 25 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 1 to 20% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 1 to 15 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be present in the drug in an amount of 1 to 10% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 10 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 15 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 20 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 25 to 98 wt.% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 30 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 35 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 40 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 45 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 50 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 55 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 60 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 65 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 70 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 75 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 80 to 98 wt.% by weight of the total drug. More preferably, the pharmaceutically acceptable excipient of the present invention may be in the drug in an amount of from 85 to 98 wt.% by weight of the total drug.
  • the pharmaceutically acceptable excipient in the medicament of the present invention is, but is not limited to, sodium hydroxide or hydrochloric acid.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 5 to 200 mg.
  • the sodium hydroxide of the present invention may be present in the drug in an amount of 10 to 200 mg.
  • the sodium hydroxide of the present invention may be present in the drug in an amount of 10 to 190 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 15 to 180 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 20 to 170 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 25 to 160 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 30 to 150 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 35 to 140 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 40 to 130 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 45 to 120 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 50 to 110 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 55 to 100 mg.
  • the sodium hydroxide of the present invention may be present in the medicament in an amount of 60 to 90 mg.
  • the sodium hydroxide of the present invention may be present in the drug in an amount of 65 to 80 mg. More preferably, the sodium hydroxide of the present invention may be present in the medicament in an amount of 50 to 150 mg.
  • One of the embodiments of the present invention is a medicinal product consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, and sodium hydroxide, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to an amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt is 1, 0:0, 1-1.0: 1.2 respectively.
  • One of the embodiments of the present invention is a medicinal product consisting of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate, and at least one amino acid and/or its pharmaceutically acceptable salt, hydrate or solvate, and/or hydrate or solvate of its pharmaceutically acceptable salt in therapeutically effective amounts, sodium hydroxide and injection water, where the mass ratio of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate to the amino acid and / or its pharmaceutically acceptable salt, hydrate or solvate, and / or hydrate or solvate of its pharmaceutically acceptable salt is 1.0:0, 1-1.0: 1.2 respectively.
  • One embodiment of the invention is a drug exhibiting prophylactic and/or therapeutic antiviral activity, wherein the virus is an RNA-containing virus.
  • One of the embodiments of the invention is a drug exhibiting prophylactic and/or therapeutic antiviral activity, where the virus is a virus whose genome is encoded by a single-stranded sense (+)-strand, as well as an antisense (-)-strand of RNA and which use viral RNA- dependent-RNA polymerase for its replication.
  • the virus of the present invention is an influenza virus, coronavirus, picornavirus, arenavirus, flavivirus, bunyavirus, filovirus, phlebovirus, hantavirus, enterovirus, togavirus, calicivirus, respiratory syncytial virus, parainfluenza virus, rhinoviruses, metapneumoviruses, rotavirus, or noravirus.
  • the virus of the present invention is a highly virulent or low virulent virus. More preferably, the virus of the present invention is SARS-CoV, SARS-CoV-2, MERS-CoV or Influenza A, B, C.
  • influenza virus of the present invention is, but not limited to, influenza A virus, including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2) , A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).
  • influenza A virus including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2) , A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).
  • Medicines of the present invention are used in human treatment, including the course.
  • the duration of the course, the daily dose, as well as the dosage form are determined by the task, the complexity of the disease and the individual characteristics of the patient and can be adjusted during therapy.
  • the duration of the prophylactic course can be from four days to four weeks and include, but is not limited to, one to five doses per day, which corresponds to 100-2000 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form).
  • One of the options for performing therapy is the following dosing regimen: 1600 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 2 times on the 1st day of therapy, then 800 mg 2 times a day in within 10 days.
  • One of the options for performing therapy is the following dosing regimen: 1600 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 2 times on the 1st day of therapy, then 600 mg 2 times a day in within 10 days.
  • One of the options for performing therapy is the following dosing regimen: 1800 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) 2 times on the 1st day of therapy, then 800 mg 2 times a day in within 10 days.
  • Dosages may be changed depending on the individual characteristics of the patient (including age and body weight).
  • favipiravir for the administration of a single dose of 1600 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form), according to the present invention, 4 x 10 ml vials or 2 x 20 ml vials of the concentrate are used according to the present invention.
  • favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in terms of favipiravir in free form
  • concentration 40 mg favipiravir / ml concentration 40 mg favipiravir / ml
  • 800 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in terms of favipiravir in free form
  • use 2 vials of 10 ml or 1 vial of 20 ml of favipiravir concentrate or its pharmaceutically acceptable salt, hydrate or solvate in terms of favipiravir in free form
  • the introduction is carried out intravenously or intramuscularly.
  • favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in the form of a powder (including a lyophilisate) for the preparation of a parenteral solution of the present invention
  • a dosage of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof in terms of favipiravir in free form
  • 1600 mg should be used, but not limited to 4 vials of the drug of the present invention, 400 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each or 2 vial of 800 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each.
  • favipiravir To administer a dosage of favipiravir in the amount of 800 mg, it is necessary to use, but not limited to, 2 vials of the drug, 400 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each or 1 vial of 800 mg of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof (in terms of free form favipiravir) in each.
  • 2 vials of the drug 400 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form) in each or 1 vial of 800 mg of favipiravir or a pharmaceutically acceptable salt, hydrate or solvate thereof (in terms of free form favipiravir) in each.
  • favipiravir or its pharmaceutically acceptable salt, hydrate or solvate in terms of favipiravir in free form
  • 4 tablets of 400 mg of favipiravir or its pharmaceutically acceptable salt can be used, without limitation, hydrate or solvate (in terms of favipiravir in free form) (or 8 tablets of 200 mg of favipiravir) according to the present invention
  • hydrate or solvate in terms of favipiravir in free form
  • hydrate or solvate in terms of favipiravir in free form
  • hydrate or solvate in terms of favipiravir in free form
  • the duration of the therapeutic course can be from one to four weeks and include taking from two to ten dosage forms per day, which corresponds to 400-4000 mg of favipiravir or its pharmaceutically acceptable salt, hydrate or solvate (in terms of favipiravir in free form).
  • the viral infection to be treated and/or prevented by the pharmaceutical composition or medicament of the present invention is an RNA-containing virus.
  • the viral infection for the treatment and/or prevention of which the pharmaceutical composition or medicament of the present invention is used is a virus whose genome is encoded by a single-stranded sense (+)-strand as well as an antisense (-)-strand RNA and which use the viral RNA-dependent-RNA polymerase for its replication.
  • the viral infection to be treated and/or prevented by the pharmaceutical composition or medicament of the present invention is influenza virus, coronavirus, picornavirus, arenavirus, flavivirus, bunyavirus, filovirus, phlebovirus, hantavirus, enterovirus, togavirus, calicivirus, respiratory -syncytial virus, parainfluenza virus, rhinoviruses, metapneumoviruses, rotavirus or noravirus.
  • the virus of the present invention is a highly virulent or low virulent virus.
  • the virus of the present invention is SARS-CoV, SARS-CoV-2, MERS-CoV or Influenza A, B, C.
  • influenza virus of the present invention is, but not limited to, influenza A virus, including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2), A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).
  • influenza A virus including strains A (H1N1), A (H1N1) pdm09, A (H1N2), A (H3N2), A (H2N2), A (H4N2), A (H7N2), swine influenza type A, avian influenza type A, including highly pathogenic strains (including H5N1 and H7N9).
  • Example 1 Preparation of a pharmaceutical composition of favipiravir with amino acids in the form of a solution.
  • compositions of favipiravir with hydrates of amino acids or their salts are provided.
  • compositions listed in the table. 1 was obtained as follows. Previously, 50% of the calculated amount of favipiravir powder was mixed in a separate container with the calculated amount of amino acid hydrate powder (or its salt). Water for injection was placed in a container for preparing solutions and heated to 60-70°C, then it was alkalized, and pre-mixed powders of favipiravir with hydrates of amino acids or their salts were added to the resulting solution with stirring. Stirring was continued until complete dissolution of the components. The remaining amount of favipiravir was added to the resulting solution and stirring was continued at a temperature of 60-70°C until a transparent pharmaceutical composition was obtained in the form of a solution.
  • the pH of the solution was measured, and, if necessary, its value was corrected by adding a solution of sodium hydroxide or hydrochloric acid.
  • the solution was adjusted with water for injection to a predetermined volume and filtered through a membrane filter, the filtrate was poured into a container and hermetically sealed.
  • compositions of favipiravir with other hydrates and/or solvates of amino acids and/or their pharmaceutically acceptable salts were prepared in a similar manner.
  • Table 1 Compositions of pharmaceutical compositions of favipiravir with amino acid hydrates or their salts in the form of solutions.
  • favipiravir powder 50% of the calculated amount of favipiravir powder was mixed in a separate container with the calculated amount of lysine powder.
  • a container for preparing solutions was placed with water for injection and heated to 60-70 ° C, then it was alkalized and pre-mixed powders of favipiravir with lysine were added to the resulting solution with stirring. Stirring was continued until complete dissolution of the components. The remaining amount of favipiravir was added to the resulting solution and stirring was continued at a temperature of 60-70°C until a transparent pharmaceutical composition was obtained in the form of a solution.
  • the pH of the solution was measured, and, if necessary, its value was corrected by adding a solution of sodium hydroxide or hydrochloric acid. When the required pH value was reached, the solution was adjusted with water for injection to a predetermined volume and filtered through a membrane filter, the filtrate was poured into a container and hermetically sealed.
  • compositions of favipiravir with other amino acids and/or their pharmaceutically acceptable salts were prepared in a similar manner.
  • compositions of favipiravir (total volume 50 ml) with sodium hydroxide solutions of various concentrations were prepared as follows. Water for injection was placed in a container for preparing solutions and heated to 60-70°C, then the calculated amount of sodium hydroxide solution was added with continuous stirring. The calculated amount of favipiravir was added to the resulting solution with stirring. Stirring was continued until complete dissolution of the components. Next, the solution was adjusted with water for injection to a predetermined volume and filtered through a membrane filter, the filtrate was poured into a container and hermetically sealed. Some of the results are presented in Table 2.
  • Composition 16 was a turbid solution with multiple inclusions of suspension. After 3 days of storage in the resulting solutions (compositions 14-16), the formation of a white cloudy precipitate was observed at the bottom of the vial. These solutions were filtered. After 4 days of storage, the solutions became cloudy, a pronounced suspension formed. In the compositions 18-19 on the next day of storage after shaking, single hairy inclusions could be seen. Two days later, a pronounced suspension formed in solutions 18–19.
  • Example 2 Preparation of favipiravir drugs with amino acids in the form of a lyophilisate and a concentrate.
  • Lyophilizates and concentrates of favipiravir with other amino acids and/or their pharmaceutically acceptable salts, hydrates or solvates and/or hydrates or solvates of their pharmaceutically acceptable salts were prepared in a similar manner.
  • Example 3 Study of the therapeutic effect of favipiravir salts with amino acids against the influenza virus.
  • the experiment was carried out on 85 adult mice. The animals were kept under standard vivarium conditions and received sterile rodent food and sterile water.
  • Modeling of viral infection in mice was carried out by intranasal administration of the calculated number of viral units of the highly pathogenic H3N2 avian influenza virus during anesthesia. During the experiment, the condition of the animals was recorded every day (changes in weight and clinical symptoms: fever, mucous secretions, activity level, breathing). Animals were randomly divided into seventeen groups of 5 individuals.
  • favipiravir drug lysine hydrate
  • 2nd group favipiravir preparation: asparagine sodium salt hydrate
  • group 3 favipiravir: proline hydrate
  • group 5 favipiravir: lysine hydrate
  • favipiravir preparation asparagine sodium salt hydrate
  • group 7 favipiravir: proline hydrate
  • 11th group favipiravir preparation: proline hydrate
  • group 12 favipiravir: histidine hydrate
  • group 15 favipiravir: proline hydrate
  • Virus titers were determined using the standard plaque formation method [Stroganova, I.Ya. Use in cell culture virology: method, indications / I.Ya. Stroganova, A. A. Trukhonenko; Krasnoyar. state agrarian un-t. - Krasnoyarsk, 2013. - 48 p.].
  • Example 4 Study of the antiviral activity of favipiravir compositions with amino acids against the SARS-CoV-2 virus.
  • compositions of favipiravir with the amino acids of the compositions listed in table. 3 against the SARS-CoV-2 virus was carried out on a permanent culture of African green monkey kidney cells. Hank's saline medium containing fetal calf serum was used as a growth and maintenance medium.
  • compositions 1a-3a, 5a-7a, 9a-11a The study used nine formulations of favipiravir with amino acids with different qualitative and quantitative characteristics (compositions 1a-3a, 5a-7a, 9a-11a) and three formulations containing an amount of favipiravir identical to its group (composition 4a: the amount of favipiravir identical to formulations 1a-3a; formulation 8a: identical amount of favipiravir to formulations 5a-7a, formulation 12a: identical amount of favipiravir to formulations 9a-11a) (Table 3).
  • Saline solution composition 13a was used as a control.
  • the growth medium was removed from the cell monolayer and the SARS-CoV-2 virus was introduced, incubated for 60 min at a temperature of 37 ⁇ 0.5°C, then the inoculum was removed, washed, fresh medium containing the studied samples of compositions 1-13, respectively, was introduced into the cell samples. The samples were incubated at a temperature of 37 ⁇ 0.5°C for 48 hours. The biological activity was assessed by titrating the resulting cell suspension according to the cytopathic effect of the virus 24 and 48 hours after infection. The research results are presented in table. 3.
  • the main criterion for evaluating the effectiveness of la-12a formulations in vitro was the coefficient of inhibition of the cytopathogenic effect of the virus (CI, %).
  • the inhibition coefficient (CI, %) was calculated by the formula:
  • ⁇ kontr the biological activity of the virus, determined in cells without the introduction of the drug (using the control composition);
  • Aop is the biological activity of the virus, determined in cells with the introduction of the drug.
  • compositions of favipiravir with various amino acids in mass ratios of 1.0:0, 1-1.0: 1.2.
  • these compositions exhibit a synergistic effect in relation to antiviral activity compared with favipiravir monotherapy in identical amounts.
  • the “accelerated aging” method (storage at elevated temperature) is based on the dependence of the chemical reaction rate on temperature in accordance with the van’t Hoff rule: when the temperature rises by 10 ° C, the chemical reaction rate increases by 2-4 times. Testing the stability of the solutions was carried out by the method of accelerated aging at 40 ⁇ 2°C for 71 days, which corresponds to 3 years of storage under standard conditions (no more than 10°C).
  • favipiravir drugs with amino acids in the form of lyophilisates obtained by the method described in example 1 was evaluated by the "accelerated aging" method according to the content of favipiravir and compared with the stability of lyophilisates containing only favipiravir.
  • the “accelerated aging” method (storage at elevated temperature) is based on the dependence of the chemical reaction rate on temperature in accordance with the Van’t Hoff rule: when the temperature rises by 10 ° C the rate of a chemical reaction increases by 2-4 times.
  • Stability tests of lyophilizates were carried out by the method of accelerated aging at 40 ⁇ 2°C for 457 days, which corresponds to 5 years of storage under standard conditions (not more than 25°C). The experiment was carried out on 3 series of each drug. The quantitative content of favipiravir was expressed in average values.
  • the content of favipiravir was determined by HPLC using standards.
  • the favipiravir amino acid lyophilisate formulations of the present invention (formulations 1a-3a; 5a-7a; 9a-11a) have a statistically significant improved storage stability compared to formulations (4a; 8a; 12a).

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Virology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oncology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention se rapporte au domaine de l'industrie chimique et pharmaceutique et de la médecine, et concerne une nouvelle composition pharmaceutique de Favipiravir et son sel, son hydrate et son soluté pharmaceutiquement acceptables avec un ou plusieurs acides aminés et/ou leurs sels, hydrates et/ou solutés pharmaceutiquement acceptables, et/ou hydrates ou solutés d'acides aminés et/ou leur sel pharmceutiquement acceptables; l'invention concerne également un médicament contenant ladite composition pharmaceutique. L'invention permet d'améliorer les propriétés pharmaceutiques de la composition et du médicament, ainsi que la biodiversité, la stabilité et la sécurité.
PCT/RU2022/050274 2021-09-06 2022-09-02 Composition pharmaceutique antivirale contenant du favipiravir et un acide aminé Ceased WO2023033683A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
RU2021126189A RU2783282C1 (ru) 2021-09-06 Противовирусная фармацевтическая композиция, содержащая фавипиравир и аминокислоту, лекарственное средство, ее содержащее, а также их применение для лечения и/или профилактики вирусных инфекций
RU2021126189 2021-09-06
RU2021140069A RU2789612C1 (ru) 2021-12-30 Противовирусная фармацевтическая композиция, содержащая фавипиравир и гидрат аминокислоты и/или ее фармацевтически приемлемой соли
RU2021140069 2021-12-30

Publications (1)

Publication Number Publication Date
WO2023033683A1 true WO2023033683A1 (fr) 2023-03-09

Family

ID=85412978

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU2022/050274 Ceased WO2023033683A1 (fr) 2021-09-06 2022-09-02 Composition pharmaceutique antivirale contenant du favipiravir et un acide aminé

Country Status (1)

Country Link
WO (1) WO2023033683A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150266831A1 (en) * 2010-09-30 2015-09-24 Toyama Chemical Co., Ltd. Sodium salt of 6-fluor0-3-hydroxy-2-pyrazine carboxamide
WO2017179683A1 (fr) * 2016-04-15 2017-10-19 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 Composition pharmaceutique contenant de la micafungine dans un état stabilisé
CN111214446A (zh) * 2020-03-07 2020-06-02 瑞阳制药有限公司 一种供注射用法匹拉韦l-精氨酸盐冻干制剂
CN112624985A (zh) * 2020-12-31 2021-04-09 北京石油化工学院 一种复合物晶体、制备方法及应用

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150266831A1 (en) * 2010-09-30 2015-09-24 Toyama Chemical Co., Ltd. Sodium salt of 6-fluor0-3-hydroxy-2-pyrazine carboxamide
WO2017179683A1 (fr) * 2016-04-15 2017-10-19 Ｍｅｉｊｉ Ｓｅｉｋａファルマ株式会社 Composition pharmaceutique contenant de la micafungine dans un état stabilisé
CN111214446A (zh) * 2020-03-07 2020-06-02 瑞阳制药有限公司 一种供注射用法匹拉韦l-精氨酸盐冻干制剂
CN112624985A (zh) * 2020-12-31 2021-04-09 北京石油化工学院 一种复合物晶体、制备方法及应用

Similar Documents

Publication Publication Date Title
KR102233826B1 (ko) 바이러스 감염을 치료하기 위한 티아졸리드 화합물
RU2789612C1 (ru) Противовирусная фармацевтическая композиция, содержащая фавипиравир и гидрат аминокислоты и/или ее фармацевтически приемлемой соли
RU2783282C1 (ru) Противовирусная фармацевтическая композиция, содержащая фавипиравир и аминокислоту, лекарственное средство, ее содержащее, а также их применение для лечения и/или профилактики вирусных инфекций
RU2814927C1 (ru) Противовирусная фармацевтическая композиция, содержащая фавипиравир и аминокислоту, лекарственное средство, ее содержащее, а также их применение для лечения и/или профилактики вирусных инфекций
RU2839470C2 (ru) Противовирусная фармацевтическая композиция, содержащая фавипиравир и аминокислоту, лекарственное средство, ее содержащее, а также их применение для лечения и/или профилактики вирусных инфекций
WO2023085979A1 (fr) Nouveaux dérivés de favipiravine
WO2023033683A1 (fr) Composition pharmaceutique antivirale contenant du favipiravir et un acide aminé
TW202203946A (zh) 用於人或動物之慢性或急性之病毒感染症及/或敗血症之預防或治療的組成物
RU2832326C1 (ru) Фармацевтическая композиция и лекарственное средство, содержащие новые производные фавипиравира
RU2828875C1 (ru) Способ получения новых производных фавипиравира
US20210315968A1 (en) Prevention and Treatment of Viral Infection and Viral Infection-Induced Organ Failure
US20230270709A1 (en) Antiviral pharmaceutical composition for topical administration
US8193152B2 (en) Treatment or prevention of hemorrhagic viral infections with immunomodulator compounds
CN112794807B (zh) 九氨胍及其制备方法和防治冠状病毒感染的应用
WO2021195763A1 (fr) Agents thérapeutiques antiviraux de type ruthénate(iii)
WO2021205053A1 (fr) Composition injectable de mélatonine pour le traitement de maladies virales
CN100364975C (zh) 一种抗呼吸道病毒的药物及用途
NL2027924B1 (en) Antimicrobial peptide for prevention and treatment of virusinfections
RU2435606C1 (ru) Лекарственное средство, обладающее противовирусными свойствами
US20230226027A1 (en) Thienopyridine derivatives for use in the treatment of coronavirus infection
ES2221641T3 (es) Utilizacion de acido 2-metil-tiazolidin-2,4-diacarboxilico para la produccion de un medicamento para el tratamiento de enfermedades infecciosas.
CN105920004B (zh) 1，2，4-三取代哌嗪化合物在制备抗流感病毒药物中的用途
EP4132501A1 (fr) Nouvelle utilisation du n,n-bis-2-mercaptoéthyl-isophtalamide
EA047936B1 (ru) Противовирусная композиция
CN101084893A (zh) 一种抗呼吸道病毒的药物及用途

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22865160

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 202490277

Country of ref document: EA

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22865160

Country of ref document: EP

Kind code of ref document: A1