[go: up one dir, main page]

EP3893866A2 - Combinaison comprenant un agent de sclérose en plaques et au moins un agent anti-épileptique - Google Patents

Combinaison comprenant un agent de sclérose en plaques et au moins un agent anti-épileptique

Info

Publication number
EP3893866A2
EP3893866A2 EP19897521.1A EP19897521A EP3893866A2 EP 3893866 A2 EP3893866 A2 EP 3893866A2 EP 19897521 A EP19897521 A EP 19897521A EP 3893866 A2 EP3893866 A2 EP 3893866A2
Authority
EP
European Patent Office
Prior art keywords
pharmaceutical combination
combination according
tablets
gabapentin
pregabalin
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.)
Withdrawn
Application number
EP19897521.1A
Other languages
German (de)
English (en)
Other versions
EP3893866A4 (fr
Inventor
Zafer Toksoz
Ahmet Toksoz
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.)
Sanovel Ilac Sanayi ve Ticaret AS
Original Assignee
Sanovel Ilac Sanayi ve Ticaret AS
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
Application filed by Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Publication of EP3893866A2 publication Critical patent/EP3893866A2/fr
Publication of EP3893866A4 publication Critical patent/EP3893866A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61K31/185—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
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/275—Nitriles; Isonitriles
    • A61K31/277—Nitriles; Isonitriles having a ring, e.g. verapamil
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration

Definitions

  • the present invention relates to a pharmaceutical combination comprising a multiple sclerosis agent and at least one anti-epileptic agent wherein the multiple sclerosis agent is teriflunomide or fampridine.
  • MS Multiple Sclerosis
  • CNS central nervous system
  • Myelin provides a covering or insulation for nerves, improves the conduction of impulses along the nerves and also is important for maintaining the health of the nerves.
  • inflammation causes the myelin to disappear. So, the electrical impulses become slower.
  • the nerves themselves are damaged. Patient suffers from a range of symptoms which affect their health-related quality of life such as pain, muscle spasticity and spasm, bladder problems and sleep disturbance.
  • MS Multiple sclerosis
  • MS is the most common autoimmune disorder affecting the central nervous system.
  • Multiple sclerosis also known as disseminated sclerosis or encephalomyelitis disseminata
  • MS is a demyelinating disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a wide range of signs and symptoms, including physical, mental and sometimes psychiatric problems.
  • MS takes several forms, with new symptoms either occurring in isolated attacks (relapsing forms) or building up over time (progressive forms). Between attacks, symptoms may disappear completely; however, permanent neurological problems often occur, especially as the disease advances.
  • Teriflunomide is a pirimidine synthesis inhibitor. Teriflunomide acts via the mechanism of a dihydroo rotate dehydrogenase inhibitor and it is an orally available immunomodulator used in the treatment of relapsing-remitting multiple sclerosis.
  • the chemical name of teriflunomide is (Z)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2enamide and its chemical structure is shown in Formula I.
  • Teriflunomide inhibits rapidly dividing cells including activated T cells that are believed to drive the disease process in MS and it may decrease the risk of infection thanks to its more limited effects on the immune system compared to chemotherapeutic agents.
  • EP0527736B1 is the first molecule patent that describes teriflunomide in prior art. It mentions the use of teriflunomide in the prophylaxis and/or treatment of rheumatic diseases and the possibility to administer the pharmaceuticals of the invention orally, topically, rectally and parenterally, if required.
  • Fampridine is a potassium channel blocker indicated for symptomatic improvement of walking in adults with multiple sclerosis, including relapsing remitting, secondary progressive, progressive relapsing and primary progressive.
  • the chemical name of fampridine is 1 ,4- dihydropyridin-4-imine and its chemical structure is shown in Formula II.
  • the strategy to improve the current state of MS treatment is to combine therapies.
  • a multiple sclerosis agent with at least one anti-epileptic agent, in the prior art.
  • Anti-epileptic agents are the main type of treatment for most people with epilepsy.
  • the treatment of epilepsy generally is directed toward reducing the frequency of seizures.
  • An accurate diagnosis of the form of epilepsy is critical to selection of the drug most likely to be effective.
  • the medicaments currently used for the prevention and/or treatment of epilepsy are fundamentally based on (voltage and neuronal receptor-associated) ion channel inhibitor compounds.
  • the anti-epileptic agents are selected from the group comprising gabapentin or pregabalin or phenytoin or phenobarbital or carbamazepine or oxcarbazepine or stiripentol or eslicarbazepine acetate or paramethadione or brivaracetam or etiracetam or levetiracetam or seletracetam or progabide or tiagabine or valproate or vigabatrin or combinations thereof .
  • gabapentin l-(aminomethyl)-cyclohexaneocetic acid
  • Formula III Formula III
  • Gabapentin was designed as a GABA analog that would cross the blood-brain barrier. Gabapentin was found to have anticonvulsant and anti-spasmodic activity with extremely low toxicity in human. It is used to treat partial seizures, neuropathic pain, hot flashes, and restless legs syndrome. Gabapentin is presently marketed under the trademark Neurontin as adjunctive therapy in the treatment of partial seizures in patients with epilepsy.
  • US Patent Numbers 4, 024, 175 and 4, 087, 544 disclose the use of gabapentin for the treatment of certain forms of epilepsy, faintness attacks, hypokinesia, and cranial traumas.
  • pregabalin which is an analog of gamma- aminobutyric acid (GABA). Its chemical designation is (S)-3-(aminomethyl)-5-methyl hexanoic acid, with the chemical structure illustrated below with Formula IV.
  • pregabalin binds to the auxiliary sub-unit of voltage-sensitive calcium channels in the central nervous system, thereby replacing the [3H]-gabapentin. It also reduces the release of many neurotransmitters, including pregabalin glutamate, noradrenaline and the substance P. It is used for the treatment of epilepsy, simple or complex partial convulsion, either accompanied or not by secondary generalized convulsions, and of neuropathic pain, fibromyalgia, and generalized anxiety disorder.
  • Pregabalin is currently marketed as a capsule for oral administration with brand name LYRIC A® by Pfizer.
  • the capsule is filled by a powder blend comprising free base of pregabalin as the active moiety (25, 50, 75, 100, 150, 200, 225 or 300 mg per capsule), lactose monohydrate, maize starch and talc.
  • combining more than one molecule in one dosage form increases the patient’s compliance.
  • this combination increases the patients’ quality of life, combining more than one molecule in one dosage form also reduces undesired multiple sclerosis symptoms which can be muscle spasticity.
  • a multiple sclerosis agent, teriflunomide or fampridine with at least one anti-epileptic agent, preferably the antiepileptic agents are gabapentin or pregabalin or mixtures thereof.
  • the main object of the present invention is to combine a multiple sclerosis agent with at least one anti-epileptic agent to eliminate multiple sclerosis symptoms, to provide rapid and effective treatment and to bring additional advantages over the relevant prior art.
  • the multiple sclerosis agent is teriflunomide or fampridine.
  • Another object of the present invention is to obtain a stable combination formulation with synergistic effect for use in multiple sclerosis.
  • This invention also provides a pharmaceutical combination comprising an effective amount of teriflunomide and an effective amount of an anti-epileptic agent, especially gabapentin or pregabalin, for use in treating a human afflicted with multiple sclerosis, wherein teriflunomide and an anti-epileptic agent are administered simultaneously, separately or sequentially.
  • an anti-epileptic agent especially gabapentin or pregabalin
  • This invention also provides a pharmaceutical combination comprising an effective amount of fampridine and an effective amount of an anti-epileptic agent, especially gabapentin or pregabalin, for use in treating a human afflicted with multiple sclerosis, wherein fampridine and an anti-epileptic agent are administered simultaneously, separately or sequentially.
  • an anti-epileptic agent especially gabapentin or pregabalin
  • gabapentin refers to gabapentin in the form of the free base or in the form of pharmaceutically acceptable salts, crystalline polymorph, solvates, hydrates, esters or mixture thereof.
  • pregabalin refers to pregabalin in the form of the free base or in the form of pharmaceutically acceptable salts, crystalline polymorph, solvates, hydrates, esters or mixture thereof.
  • the pharmaceutical combination comprises a multiple sclerosis agent and at least one anti-epileptic agent.
  • the anti-epileptic agent is selected from the group comprising gabapentin or pregabalin or phenytoin or phenobarbital or carbamazepine or oxcarbazepine or stiripentol or eslicarbazepine acetate or paramethadione or brivaracetam or etiracetam or levetiracetam or seletracetam or progabide or tiagabine or valproate or vigabatrin or combinations thereof.
  • the anti-epileptic agent is gabapentin or pregabalin or combinations thereof which is used as adjunctive therapy in pain control and muscle spasticity.
  • an embodiment of this present invention is to combine a multiple sclerosis agent, teriflunomide or fampridine, with gabapentin or pregabalin in a same and stable dosage form with desired dissolution profiles.
  • This invention provides a method of treating a human afflicted with multiple sclerosis comprising periodical administration of an effective amount of a multiple sclerosis agent and an effective amount of anti-epileptic agent to the subject together, wherein these effective amounts described below are effective to treat a human.
  • the pharmaceutical combination comprises teriflunomide and gabapentin.
  • the pharmaceutical combination comprises teriflunomide in an amount of between 10 mg and 30 mg and gabapentin in an amount of between 80 mg and 900 mg.
  • the weight ratio of teriflunomide to gabapentin is between 0.01 - 4.0, preferably 0.01 -2.0, preferably 0.01 - 1 .0.
  • the pharmaceutical combination comprises teriflunomide and pregabalin.
  • the pharmaceutical combination comprises teriflunomide in an amount of between 10 mg and 30 mg and pregabalin in an amount of between 20 to 400 mg.
  • the weight ratio of teriflunomide to pregabalin is between 0.01 - 4.0, preferably 0.01 -2.0.
  • the pharmaceutical combination comprises fampridine and gabapentin. According to this embodiment of the present invention, the pharmaceutical combination comprises fampridine in an amount of between 5 mg and 20 mg and gabapentin in an amount of between 80 mg and 900 mg.
  • the weight ratio of fampridine to gabapentin is between 0.005 - 4.0, preferably 0.01 -2.0, preferably 0.01 - 1.0.
  • the pharmaceutical combination comprises fampridine and pregabalin.
  • the pharmaceutical combination comprises fampridine in an amount of between 5 mg and 20 mg and pregabalin in an amount of between 20 to 400 mg.
  • the weight ratio of fampridine to pregabalin is between 0.01 - 3.0, preferably 0.01 -2.0, more preferably 0.01 -1 .0.
  • said combination further comprises at least one pharmaceutically acceptable excipient which is selected from fillers, binders, disintegrants, solvents and co-solvents, rate controlling polymers, direct compression agent, surfactants, lubricants, glidants, sweeteners, stabilizers, coating agents, colouring agents, inert agents or mixtures thereof.
  • at least one pharmaceutically acceptable excipient which is selected from fillers, binders, disintegrants, solvents and co-solvents, rate controlling polymers, direct compression agent, surfactants, lubricants, glidants, sweeteners, stabilizers, coating agents, colouring agents, inert agents or mixtures thereof.
  • Suitable fillers are selected from the group comprising microcrystalline cellulose, mannitol, spray-dried mannitol, lactose, lactose monohydrate, starch, dextrose, sucrose, fructose, maltose, sorbitol, xylitol, inositol, kaolin, inorganic salts, calcium salts, polysaccharides, dicalcium phosphate, sodium chloride, dextrates, lactitol, maltodextrin, sucrose-maltodextrin mixture, trehalose, sodium carbonate, sodium bicarbonate, calcium carbonate or mixtures thereof.
  • Suitable binders are selected from the group comprising polyvinylpyrrolidone, polyethylene glycol, polyvinyl alcohol, starch, pregelatinized starch, glucose, glucose syrup, natural gums, sucrose, sodium alginate, cellulose derivatives such as hydroxypropyl methyl cellulose, hydroxypropyl cellulose, carboxy methyl cellulose, methyl cellulose, gelatin, carrageenan, guar gum, carbomer, polymethacrylates, methacrylate polymers, collagens, proteins like gelatin, agar, alginate, alginic acid, xanthan gum, hyaluronic acid, pectin, polysaccharides, carbomer, poloxamer, polyacrylamide, aluminium hydroxide, laponit, bentonit, polyoxyethylene-alkyl ether, polydextrose, polyethylene oxide or mixtures thereof.
  • Suitable disintegrants are selected from the group comprising polyvinyl pyrrolidone (crospovidone), povidone, cross-linked carboxymethyl cellulose (croscarmellose sodium), low-substituted hydroxypropyl cellulose, pregelatinized starch, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, carboxymethyl cellulose, docusate sodium, guar gum, low substituted hydroxypropyl cellulose, polyacryline potassium, sodium alginate, corn starch, sodium starch glycolate, alginic acid, alginates, ion-exchange resins, magnesium aluminium silica, sodium dodesyl sulphate, poloxamer, sodium glycine carbonate, sodium lauryl sulphate or mixtures thereof.
  • polyvinyl pyrrolidone crospovidone
  • povidone povidone
  • carboxymethyl cellulose croscarmellose sodium
  • low-substituted hydroxypropyl cellulose pregelatinized star
  • Suitable solvents or co-solvents are selected from the group comprising water, propylene glycol, glycerin, ethanol, polyethylene glycol or mixtures thereof.
  • Suitable rate controlling polymers are selected from the group comprising ethyl acrylate, ethyl methacrylate copolymer, ethylcellulose, methylcellulose, hypromellose phthalate, polydextrose, polyvinylacetate phthalate, zein, polyvinylpyrrolidone, polyvinyl alcohol, polyvinyl acetate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose E4M, hydroxypropyl methylcellulose K100MCR, hydroxyethyl cellulose, hydroxymethyl cellulose, gelatin, polyethylene oxide, acacia, dextrin, starch, polyhydroxyethylmethacrylate, sodium carboxymethylcellulose, carboxymethyl cellulose, sodium alginate, alginic acid, pectin, polyglucoronic acid, polygalacturonic acid, chondroitic sulfate, carrageenan, lambda carregeenan, io
  • Suitable direct compression agents are selected from the group comprising calcium hydrogen phosphate sodium alginate, pregelatinized starch, calcium citrate or mixtures thereof.
  • Suitable surfactants are selected from the group comprising sodium docusate, glyceryl monooleate, polyethylene alkyl ether, polyoxyethylene sorbitan fatty acid ester, sodium lauryl sulfate, sorbic acid, sorbitan fatty acid ester, nonoxynol, polyoxyethylene stearates, polyethylene glycol, leucine, poloxamer 407, sodium benzoate, docusate sodium, alpha tocopherol, ascorbyl palmitate, citric acid, polyethoxylated fatty acid esters, polyoxyethylene hydrogenated castor oil or mixtures thereof.
  • Suitable lubricants are selected from the group comprising from magnesium stearate, colloidal silicon dioxide, calcium stearate, zinc stearate, talc, waxes, boric acid, hydrogenated vegetable oil, sodium chlorate, magnesium lauryl sulfate, sodium oleate, sodium acetate, sodium benzoate, polyethylene glycol, stearic acid, fatty acid, fumaric acid, glyseryl palmito sulphate, sodium stearyl fumarate, sodium lauryl sulphate or mixtures thereof.
  • Suitable glidants are selected from the group comprising colloidal silicon dioxide, corn starch, talc or mixtures thereof.
  • Suitable sweeteners are selected from the group comprising aspartame, potassium acesulfame, sodium saccharinate, neohesperidine dihydrochalcone, sucralose, saccharin, sugars such as sucrose, glucose, lactose, fructose or sugar alcohols such as mannitol, sorbitol, xylitol, erythritol or mixtures thereof.
  • Suitable stabilizers are selected from the group comprising citric acid, fumaric acid, tartaric acid, sodium citrate, sodium benzoate, sodium dihydrogen phosphate, calcium carbonate, magnesium carbonate, arginine, lysine, meglumine, ascorbic acid, gallic acid esters or the mixtures thereof, and preferably, citric acid, fumaric acid, arginine or mixtures thereof.
  • Suitable coating agents are selected from the group comprising polymethacrylates, polyalkylacrylates copolymers, hydroxyl propyl methyl cellulose, lactose monohydrate, hydroxypropyl cellulose, polyvinyl alcohol, polyethylene glycol, talc, polyvinyl alcohol- polyethylene glycol copolymers (Kollicoat® IR), ethylcellulose dispersions (Surelease®), polyvinylpyrrolidone, polyvinylpyrrolidone-vinyl acetate copolymer (PVP-VA), all kinds of Opadry®, pigments, dyes, titanium dioxide, iron oxide or mixtures thereof.
  • Suitable colouring agents are selected from the group comprising ferric oxide, titanium dioxide, Food, Drug & Cosmetic (FD&C) dyes (such as; FD&C blue, FD&C green, FD&C red, FD&C yellow, FD&C lakes), poncau, indigo Drug & Cosmetic (D&C) blue, indigotine FD&C blue, carmoisine indigotine (indigo Carmine); iron oxides (such as; iron oxide red, yellow, black), quinoline yellow, flaming red, carmine, carmoisine, sunset yellow or mixtures thereof.
  • FD&C Food, Drug & Cosmetic
  • Suitable inert agents between the two molecules are selected from starch, lactose, sugar alcohol like D-mannitol, erythritol; low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, methylcellulose, hydroxyethyl methylcellulose or mixtures thereof.
  • the pharmaceutical combination is administered orally.
  • the pharmaceutical combination is in the form of tablets, capsules, strips, syrups, powders, pastilles, sachets, effervescent compositions, pills, coated bead systems, granules, microspheres, dragees, films, orally administrable films, solutions, solids, suspensions or emulsions.
  • the pharmaceutical combination is in the form of tablets or capsules.
  • the pharmaceutical combination is in the form of a tablet.
  • the pharmaceutical combination is formulated as tablets comprising film-coated tablets, bilayer tablets, inlay tablets, orally disintegrating tablets, compressed tablets, coated or uncoated tablets, multilayer tablets, mini tablets, buccal tablets, sublingual tablets, effervescent tablets, gastric disintegrating tablets, chewable tablets, dispersing tablets or lozenges.
  • the pharmaceutical combination is in the form of a capsule.
  • modified release dosage form is selected from the group comprising controlled release, sustained release, delayed release, extended release, repeat action system or mixtures thereof.
  • modified release dosage form is prepared using rate controlling polymers.
  • the combination is prepared using direct compression, wet or dry granulation, hot melt granulation, hot melt extrusion, fluidized bed granulation, extrusion, spheronization, slugging, spray drying or solvent evaporation.
  • the combination is for use in the treatment of multiple sclerosis in human.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une combinaison pharmaceutique qui comprend un agent de sclérose en plaques et au moins un agent anti-épileptique, l'agent de sclérose en plaques étant le tériflunomide ou la fampridine.
EP19897521.1A 2018-12-12 2019-11-15 Combinaison comprenant un agent de sclérose en plaques et au moins un agent anti-épileptique Withdrawn EP3893866A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2018/19197A TR201819197A2 (tr) 2018-12-12 2018-12-12 Bi̇r multi̇pl skleroz ajani ve en az bi̇r anti̇-epi̇lepti̇k ajan i̇çeren bi̇r kombi̇nasyon
PCT/TR2019/050958 WO2020122838A2 (fr) 2018-12-12 2019-11-15 Combinaison comprenant un agent de sclérose en plaques et au moins un agent anti-épileptique

Publications (2)

Publication Number Publication Date
EP3893866A2 true EP3893866A2 (fr) 2021-10-20
EP3893866A4 EP3893866A4 (fr) 2022-08-03

Family

ID=71076152

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19897521.1A Withdrawn EP3893866A4 (fr) 2018-12-12 2019-11-15 Combinaison comprenant un agent de sclérose en plaques et au moins un agent anti-épileptique

Country Status (3)

Country Link
EP (1) EP3893866A4 (fr)
TR (1) TR201819197A2 (fr)
WO (1) WO2020122838A2 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114146062B (zh) * 2021-03-17 2023-07-28 长沙晶易医药科技有限公司 一种组合物及其制备方法和用途
CN114732797B (zh) * 2022-03-31 2023-03-17 海南钧华医疗科技有限公司 一种加巴喷丁和普瑞巴林复方胶囊及其制备方法
WO2025128058A1 (fr) * 2023-12-13 2025-06-19 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Formulation de comprimé effervescent de brivaracétam

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090041806A1 (en) 2007-06-15 2009-02-12 Xenoport, Inc. Use of prodrugs of gaba analogs, antispasticity agents, and prodrugs of gaba b receptor agonists for treating spasticity
EP2274042A4 (fr) * 2008-04-11 2012-03-14 Epiphany Biosciences Inc Traitement et/ou prévention de la sclérose en plaques
WO2018071537A1 (fr) * 2016-10-11 2018-04-19 Crestovo Holdings Llc Compositions et méthodes pour traiter la sclérose en plaques et des troubles associés
US11007192B2 (en) * 2016-11-07 2021-05-18 Metriopharm Ag Use of 5-amino-2,3-dihydro-1,4-phthalazinedione in the treatment of chronic progressive multiple sclerosis

Also Published As

Publication number Publication date
EP3893866A4 (fr) 2022-08-03
TR201819197A2 (tr) 2020-06-22
WO2020122838A3 (fr) 2020-08-13
WO2020122838A2 (fr) 2020-06-18

Similar Documents

Publication Publication Date Title
EP2575798B1 (fr) Formes galéniques gastrorétentives d'analogues de gaba
US20080014271A1 (en) Novel pharmaceutical compositions comprising levetiracetam
US12161758B2 (en) Modified release formulations and uses thereof
EP3893866A2 (fr) Combinaison comprenant un agent de sclérose en plaques et au moins un agent anti-épileptique
US20030147957A1 (en) Dual release formulation comprising levodopa ethyl ester and a decarboxylase inhibitor in immediate release layer with levodopa ethyl ester and a decarboxylase inhibitor in a controlled release core
US20110171302A1 (en) Method for treating neurodegenerative disorders with oral dosage formulation containing both immediate-release and sustained-release drugs
US20090175938A1 (en) Controlled Release Flurbiprofen and Muscle Relaxant Combinations
WO2019203752A2 (fr) Combinaisons comprenant un agent de relaxation des muscles squelettiques et un agent de traitement de la sclérose en plaques
EP3103444A1 (fr) Compositions pharmaceutiques de lacosamide et d'eslicarbazépine
WO2010086868A1 (fr) Compositions pharmaceutiques de trimétazidine
EP3810274A2 (fr) Combinaison comprenant du fingolimod et au moins un agent anti-épileptique
EP3893855A2 (fr) Association comprenant un agent contre la sclérose en plaques et au moins un agent relaxant musculaire
EP3810112A2 (fr) Association comprenant du fingolimod et du modafinil
EP2977045A1 (fr) Zaltoprofène et combinaisons pour le relâchement musculaire
WO2020117161A1 (fr) Combinaison comprenant du fumarate de diméthyle et au moins un agent de relaxation musculaire
EP3810110A2 (fr) Combinaison comprenant du fingolimod et de l'amantadine
TR2022010905A2 (tr) Fampi̇ri̇di̇n ve bi̇r korti̇kosteroi̇d ajani i̇çeren bi̇r kombi̇nasyon
TR2021021540A2 (tr) A combination comprising ibuprofen and at least one atypical antipsychotic agent
US20040175423A1 (en) Sustained release formulation of N- (2-propylpentanoyl) glycinamide and related compounds
EP3902531A2 (fr) Combinaisons pharmaceutiques comprenant du fingolimod et un spasmolytique
TR2021021538A2 (tr) İbuprofen ve en az bi̇r ati̇pi̇k anti̇psi̇koti̇k ajan i̇çeren bi̇r farmasöti̇k kombi̇nasyon
WO2023031755A1 (fr) Formulations, compositions et méthodes pour l'administration de médicaments neurodégénératifs associés
WO2025250110A1 (fr) Comprimé à libération prolongée comprenant de la fampridine
EP4659744A1 (fr) Comprimé à libération prolongée comprenant de la fampridine
JP2022087834A (ja) 放出調節製剤およびその使用

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20210712

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20220706

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 45/06 20060101ALI20220630BHEP

Ipc: A61K 9/00 20060101ALI20220630BHEP

Ipc: A61P 25/28 20060101ALI20220630BHEP

Ipc: A61P 25/08 20060101ALI20220630BHEP

Ipc: A61P 25/00 20060101ALI20220630BHEP

Ipc: A61K 31/4409 20060101ALI20220630BHEP

Ipc: A61K 31/44 20060101ALI20220630BHEP

Ipc: A61K 31/277 20060101ALI20220630BHEP

Ipc: A61K 31/195 20060101ALI20220630BHEP

Ipc: A61K 31/197 20060101AFI20220630BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20230207