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WO2024220974A1 - Films à dissolution rapide de rimégépant pour administration orale - Google Patents

Films à dissolution rapide de rimégépant pour administration orale Download PDF

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Publication number
WO2024220974A1
WO2024220974A1 PCT/US2024/025673 US2024025673W WO2024220974A1 WO 2024220974 A1 WO2024220974 A1 WO 2024220974A1 US 2024025673 W US2024025673 W US 2024025673W WO 2024220974 A1 WO2024220974 A1 WO 2024220974A1
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
rimegepant
pharmaceutically acceptable
acceptable salt
film
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.)
Pending
Application number
PCT/US2024/025673
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English (en)
Inventor
Mahendra R. Patel
Venkatesh Naini
Tapaskumar Mukeshkumar SHAH
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.)
Navinta LLC
Original Assignee
Navinta LLC
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 Navinta LLC filed Critical Navinta LLC
Publication of WO2024220974A1 publication Critical patent/WO2024220974A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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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
    • A61P25/06—Antimigraine agents
    • 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
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets

Definitions

  • the present invention relates to the use of Rimegepant and salts thereof for treating calcitonin gene-related peptide (CGRP) disorders.
  • the present invention relates to an orally administered fast dissolving film compositions of Rimegepant and salts thereof and methods for preparing the same.
  • Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for treatment of migraine and other CGRP- related disorders.
  • Rimegepant has the chemical formula, C 28 H 28 F 2 N 6 O 3 and the IUPAC name [(5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro- 5H-cyclohepta[b]pyridin-9-yl] 4-(2-oxo-3H-imidazo[4,5-b]pyridin-1- yl)piperidine-1-carboxylate.
  • Rimegepant is described, for example in WO 2011/046997 published Apr. 21, 2011.
  • the structure of Rimegepant free base (Formula I) is as follows: Formula I [0004] Rimegepant is also useful in its salt forms.
  • Rimegepant is its hemi sulfate sesquihydrate salt. This salt form is described in WO 2013/130402 published Sep. 6, 2013. The chemical formula of this salt form is C 28 H 28 F 2 N 6 O 3 .0.5 H 2 SO 4 .1.5 H 2 O and the structure is as follows: Formula II [0005] Rimegepant (Brand: Nurtec®) has been approved by the FDA in 2020 for the treatment of migraine. The reference listed drug (RLD) Nurtec® is available as an orally disintegrating tablet (ODT) dosage form containing 75 mg of Rimegepant base. It is administered through oral route and can be taken without water.
  • ODT orally disintegrating tablet
  • Nurtec® OTD contains 85.7 mg Rimegepant sulfate, equivalent to 75 mg Rimegepant free base, and the following inactive ingredients: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, methyl acetate, sucralose, and vanillin.
  • the Rimegepant API is a BCS class-II compounds that has low solubility and high permeability. Rimegepant has three pKa values – 2.1, 6.5 and 9.8 (weak base) with a LogD (pH 7.4) value of 1.74. There is only one known polymorphic form of Rimegepant.
  • Solubility of Rimegepant is pH dependent – 8.5 mg/mL in pH 1.4; 1.4 mg/mL in pH 5.6; 0.09 mg/mL in pH 6.8; and 0.06 mg/mL in pH 7.6.
  • API particle size plays an important role in dissolution and solubility.
  • the Nurtec® ODT exhibits rapid dissolution at pH 1.2, 4.5 and 6.8, with more than 80% of the API released in less than 15 min.
  • T max from the ODT is 1.5 hours and is not very different from an immediate release (IR) tablet dosage form, which is around 1.9 hours, indicating that ODT does not show a faster absorption as compared to regular IR tablet.
  • Nurtec® OTD Absolute bioavailability of Nurtec® OTD is 64% and food decreases both Cmax and AUC and delays Tmax by an hour.
  • Nurtec® OTD is produced by Zydis® Technology (Catalent), which involves in situ freeze drying (lyophilizing) an aqueous solution of the active pharmaceutical ingredient (API) and excipients in preformed blister cavities. Lyophilization process can be a relatively complex process, in which several parameters must be considered to ensure the consistency of the product. Lyophilization also requires relatively expensive equipment, thus adding to the cost of manufacturing.
  • Rimegepant which is simple, easy to administer without the aid of water and cost effective to manufacture, which also provides an acceptable dissolution and solubility profile.
  • the present invention provides a fast-dissolving film formulation of Rimegepant that can be administered without water.
  • a pharmaceutical composition including a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof in combination with pharmaceutically acceptable excipients.
  • the pharmaceutical composition is in the form of a thin film, whereby Rimegepant or the pharmaceutically acceptable salt thereof is provided in a molecularly dissolved form embedded in the thin film or uniformly dispersed throughout the film in a micronized or nano milled form.
  • the Rimegepant or the pharmaceutically acceptable salt thereof dispersed in the film dosage form has a particle size of less than about 30 ⁇ m.
  • the Rimegepant or the pharmaceutically acceptable salt thereof may be provided in an amount of about 1% to about 40% by weight of the fast dissolving film.
  • the pharmaceutical composition provides an AUC 0-t of from about 80% to about 125% of 5000 (hr*ng/mL). In additional embodiments, the pharmaceutical composition provides a Cmax of from about 80% to about 125% of 835 ng/mL.
  • the Rimegepant or the pharmaceutically acceptable salt thereof is a hemi sulfate sesquihydrate salt of Rimegepant. In some of those embodiments, a particle size of the hemi sulfate sesquihydrate salt of Rimegepant is less than about 1000 nm. [0017] In some embodiments of the invention, the Rimegepant or the pharmaceutically acceptable salt thereof has a particle size in a range of about 100 nm to about 30 ⁇ m. [0018] In some embodiments of the invention, the Rimegepant or the pharmaceutically acceptable salt thereof may be molecularly dispersed uniformly within the film dosage form.
  • the Rimegepant or the pharmaceutically acceptable salt thereof may be provided in an amount of about 70 mg to about 90 mg.
  • the pharmaceutical composition further includes at least one film forming polymer such as Hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyethylene oxide, hydroxypropyl cellulose, hydroxyethyl cellulose, polyvinylpyrrolidone, polyvinyl alcohol, ethyl cellulose, Pullulan, starch, gelatin, pectin, sodium alginate, maltodextrins, polymerized rosin, polyvinyl alcohol, gelatin, copolymer of ethyl acrylate, methyl methacrylate and a low content of methacrylic acid ester with quaternary ammonium groups (Eudragit RL 100) and hydroxypropyl starch polymer, and mixtures thereof.
  • film forming polymer such as Hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyethylene oxide, hydroxypropyl cellulose, hydroxy
  • the pharmaceutical composition also includes at least one plasticizer to impart sufficient flexibility and tensile strength to the film dosage form, such as Glycerol, Propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, Citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin, castor oil, sorbitol and mannitol, and mixtures thereof.
  • the pharmaceutical composition may also include at least one saliva stimulating agent such as Citric acid, ascorbic acid, lactic acid, and tartaric acid, and mixtures thereof.
  • the pharmaceutical composition may also include at least one of a stabilizing agent and a thickening agent such as xanthan gum, locust bean gum, carrageenan and cellulosic derivatives.
  • the pharmaceutical composition may also include at least one of a flavoring agent, a sweetener, a preservative, and water retained as a residual plasticizer in the film dosage form.
  • the Rimegepant or the pharmaceutically acceptable form thereof has a particle of less than about 1 ⁇ m.
  • the method may include the steps of administering to the patient a quick dissolving film comprising a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, wherein the Rimegepant or the pharmaceutically acceptable salt thereof is provided in a micronized form or is molecularly dispersed in the film.
  • a quick dissolving film comprising a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, wherein the Rimegepant or the pharmaceutically acceptable salt thereof is provided in a micronized form or is molecularly dispersed in the film.
  • the term does not relate to the absolute number of molecules but rather to the number of different types of said compound.
  • the term “substantially”, as used herein, means at Ieast about 80%, preferably at least about 90%, more preferably at least about 99%, for example at least about 99.9%. In some embodiments, the term substantially can mean completely, or about 100%.
  • the term “administering” refers to the physical introduction of a composition comprising a therapeutic agent to a subject, using any of the various methods and delivery systems known to those skilled in the art.
  • Administering can also be performed, for example, once, a plurality of times, and/or over one or more extended periods and can be a therapeutically effective dose or a subtherapeutic dose.
  • AUC area under the curve
  • AUC may be obtained from mathematical method in a plot of drug concentration in the subject over time until the concentration is negligible.
  • AUC could also refer to partial AUC at specified time intervals.
  • Cmax refers to a maximum concentration of a drug in blood, serum, a specified compartment or test area of a subject between administration of a first dose and administration of a second dose.
  • Cmax could also refer to dose normalized ratios, if specified.
  • pharmaceutically acceptable salt or “pharmaceutically acceptable salt form” refer to a salt form of one or more of the compounds described herein which are typically presented to increase the solubility of the compound in the gastric or gastroenteric juices of the patient’s gastrointestinal tract in order to promote dissolution and the bioavailability of the compounds.
  • Pharmaceutically acceptable salts include those derived from pharmaceutically acceptable inorganic or organic bases and acids, where applicable. Suitable salts include, for example, those derived from alkali metals such as potassium and sodium, alkaline earth metals such as calcium, magnesium and ammonium salts, among numerous other acids and bases well known in the pharmaceutical art.
  • an agent also sometimes referred to herein as a “drug” refers to any amount of the agent that, when used alone or in combination with another agent, protects a subject against the onset of a disease or promotes disease regression evidenced by a decrease in severity of disease symptoms, an increase in frequency and duration of disease symptom-free periods, or relief from impairment or disability due to the disease affliction.
  • the therapeutically effective amount of an agent can be evaluated using a variety of methods known to the skilled practitioner, such as in human subjects during clinical trials, in animal model systems predictive of efficacy in humans, or by assaying the activity of the agent in in vitro assays.
  • Tmax refers to a time or period after administration of a drug when the maximum concentration (Cmax) is reached in blood, serum, a specified compartment or test area of a subject.
  • the present invention provides a film formulation of Rimegepant free base (Formula I above) or any of its pharmaceutically acceptable salt forms, including but not limited to hemisulfate sesquihydrate form represented by Formula II above.
  • the film formulation contains active ingredient Rimegepant or a pharmaceutically acceptable salt thereof in a micronized form, whereby the average particle size of the active ingredient, represented by median diameter (D 50 ) or volume mean diameter (VMD) measured using laser diffraction, is less than about 30 ⁇ m.
  • the film formulation contains Rimegepant or the pharmaceutically acceptable salt thereof in a molecularly dissolved or dispersed form that is uniformly distributed throughout the film.
  • the terms “molecularly dispersed” and “molecularly dissolved” means that the active ingredient is essentially “dissolved” or dissociated from other compounds or molecules.
  • the film dosage form is designed to provide Rimegepant, or the pharmaceutically acceptable salt thereof, in an amount of about 50 mg to about 100 mg, or about 70 mg to about 90 mg, by adjusting the surface area and thickness of the final film dosage form.
  • the film composition of the present invention may be prepared using any suitable excipients and processing known in the art.
  • a solvent casting method may be used whereby the drug and other excipients are dissolved in water and or solvent mixtures and then are poured over a substrate and dried to produce a film of a predetermined thickness.
  • the dried film is then separated from the substrate and cut to required dimensions and packaged in pouches or blisters to further protect it from the environment.
  • suitable manufacturing techniques known in the art include hot-melt extrusion, semisolid casting and film formation using 3D printing.
  • the active ingredient in the film dosage from is dispersed or dissolved in the molecular form, which is further stabilized using anti-oxidants, pH adjusting agents and polymers to decrease molecular mobility, thereby imparting superior chemical stability throughout the formulation shelf life.
  • the active ingredient dispersed in the film dosage form may be prepared using air-jet milling, pearl or media milling, high-pressure homogenization, micro fluidization or high-energy sonication.
  • the film formulation may utilize suitable excipients, such as viscosity modifiers and/or dispersion stabilizers.
  • suitable excipients such as viscosity modifiers and/or dispersion stabilizers.
  • the formulation may include crospovidone, microcrystalline cellulose and carboxymethylcellulose sodium (e.g., Avicel® RC-591), starch, alginates, cellulose derivatives, potassium chloride, sodium chloride or combinations thereof as dispersion stabilizers.
  • steric stabilizers include, but are not limited to, cellulose derivatives, poloxamers (which may also act as polymeric surfactants), polysorbates, povidones, and mixtures thereof.
  • polymeric stabilizers include, but are not limited to, HPMC, HPC, MC, HEC, carboxymethylcellulose sodium salt (NaCMC), and alginic acid sodium salt (NaAlg), PVP K30, PVP K90, and mixtures thereof.
  • the formulation may include xanthan gum, acacia gum, xanthan gum, tragacanth gum, sodium alginate, methylcellulose, sodium carboxymethylcellulose, hydroxypropyl methylcellulose and combinations thereof as viscosity modifiers.
  • the formulation may include xanthan gum, acacia gum, xanthan gum, tragacanth gum, sodium alginate, methylcellulose, sodium carboxymethylcellulose, hydroxypropyl methylcellulose and combinations thereof as viscosity modifiers.
  • xanthan gum acacia gum
  • xanthan gum tragacanth gum
  • sodium alginate sodium carboxymethylcellulose
  • hydroxypropyl methylcellulose hydroxypropyl methylcellulose and combinations thereof as viscosity modifiers.
  • Exemplary compositions of film formulations in accordance with the present invention are provided below.
  • Example 1 Film Formulation of Rimegepant and/or Its Salt Forms 1 D50 ⁇ 30 ⁇ m
  • an aqueous dispersion of Rimegepant or its salt form with the film forming polymers is prepared in water and solvent mixture such as ethanol or isopropyl alcohol.
  • Suitable film forming polymers include hydrophilic polymers or a blend of a hydrophilic polymer and a plasticizer, e.g., a complementary oligomer capable of noncovalent bonding to the hydrophilic polymer and optionally capable of ionic or covalent bonding to the hydrophilic polymer as well.
  • the hydrophilic polymer is generally a relatively high molecular weight polymer
  • the plasticizer is generally an oligomer of substantially lower molecular weight.
  • the complementary oligomer is not required, its inclusion may facilitate precise tailoring of the film properties.
  • Suitable hydrophilic polymers may include repeating units derived from one or more monomers such as an N-vinyl lactam monomer, a carboxy vinyl monomer, a vinyl ester monomer, an ester of a carboxy vinyl monomer, a vinyl amide monomer, and a hydroxy vinyl monomer.
  • the film forming polymer may be one of Hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyethylene oxide, hydroxypropyl cellulose, hydroxyethyl cellulose, polyvinylpyrrolidone, polyvinyl alcohol, ethyl cellulose, Pullulan, starch, gelatin, pectin, sodium alginate, maltodextrins, polymerized rosin, polyvinyl alcohol, gelatin, copolymer of ethyl acrylate, methyl methacrylate and a low content of methacrylic acid ester with quaternary ammonium groups (Eudragit RL 100) and hydroxypropyl starch polymer, or mixtures thereof.
  • Suitable plasticizers may include glycerol, propylene glycol, low molecular weight polyethylene glycols, phthalate derivatives such as like dimethyl, diethyl and dibutyl phthalate, citrate derivatives such as tributyl, triethyl, acetyl citrate, triacetin, castor oil, sorbitol and mannitol, and mixtures thereof.
  • the film formulation may include at least one saliva stimulating excipient such as citric acid, ascorbic acid, lactic acid, and tartaric acid, and mixtures thereof
  • the film formulation may further comprise at least one at least one rapidly dissolving polymeric material.
  • Exemplary rapidly dissolving polymeric materials include water-soluble sugars, semi-synthetic and synthetic polymers, and commercially available disintegrants.
  • the film formulations of the present invention may also include one or more sweeteners and/or flavoring agents.
  • sweeteners may include sorbitol, sucrose, aspartame, corn syrup, glycerin, sodium saccharin, mannitol, and mixtures thereof.
  • the formulations may include one or more surfactants, preferably ionic surfactants.
  • Exemplary surfactants include, but are not limited to, sodium lauryl sulfate, sodium dodecyl sulfate, dioctyl sulfosuccinate sodium salt, benzethonium chloride, and mixtures thereof.
  • Other excipients are then added to the mixture and homogenized to a uniform dispersion which is then spread uniformly over a substrate and dried in ovens to yield a film with uniform thickness.
  • the film is separated from the substrate and cut to desired size providing about 70 mg to up to about 90 mg of Rimegepant per unit dose of the film.
  • the films are packaged into individual pouches or blisters for further protection against moisture and oxygen.
  • the film formulation is preferably non-tacky during application and thus easily removed from packaging material and placed within a designated area, for example, under the tongue.
  • the ratio of components is selected so that the film is not mucoadhesive, i.e., it does not stick to any mucosal surface.
  • the fast dissolving action may also serve to prevent adhesion from taking place.
  • the present invention also provides a method of treating migraine in a patient in need thereof.
  • the method includes the steps of administering to the patient a film composition including a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein the Rimegepant or the pharmaceutically acceptable salt thereof is provided in a micronized form or molecularly dispersed in the film.
  • the film can be administered to the patient by placing the dosage on the tongue or in any of the oral cavities, such as buccal, gingival and sublingual.
  • the terms “fast dissolving” or “rapidly dissolving” mean that the film dissolves in less than about 10 minutes after being applied, preferably within about 5 seconds to 10 minutes after application, optimally within about 30 seconds to 10 minutes after application.
  • the film is designed to release the active agent within the time frame of the dissolution of the film.
  • the film begins to release drug within about 30 seconds to 10 minutes after being placed within a moist environment such as the oral cavity. In other embodiments, the film releases the drug in less than about 30 seconds after administration.
  • CGRP related disorders that may be treated by the pharmaceutical compositions and methods of the present invention include, for example, cluster headache; chronic tension type headache; chronic pain; neurogenic inflammation and inflammatory pain; eye pain; tooth pain; non-insulin dependent diabetes mellitus; vascular disorders; inflammation; arthritis; bronchial hyperreactivity; asthma; shock; sepsis; opiate withdrawal syndrome; morphine tolerance; hot flashes in men and women; allergic dermatitis; psoriasis; encephalitis, brain trauma, ischaemia, stroke, epilepsy, and neurodegenerative diseases; skin diseases; neurogenic cutaneous redness, skin rosaceousness and erythema; tinnitus; obesity; inflammatory bowel disease; irritable bowel syndrome; and cystitis.
  • the method provides an AUC 0-t of from about 80-125% of 5000 (hr*ng/mL). In additional embodiments, the method provides an AUC 0-t of from about 85-115% of 5000 (hr*ng/mL). In further embodiments, the method provides an AUC 0-t of from about 90-105% of 5000 (hr*ng/mL). [0064] In some embodiments, the method provides a C max of from about 80-125% of 835 (ng/mL). In further embodiments, the method provides a C max of from about 85-120% of 835 (ng/mL). In yet further embodiments, the method provides a C max of from about 95-115% of 835 (ng/mL).

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Abstract

Une composition pharmaceutique comprend une quantité thérapeutiquement efficace de rimégépant ou d'un sel pharmaceutiquement acceptable de celui-ci, et au moins un polymère filmogène, la composition pharmaceutique se présentant sous la forme d'un film à dissolution rapide, le rimégépant ou le sel pharmaceutiquement acceptable de celui-ci étant fourni sous une forme micronisée ou nano-broyée ou sous une forme de dispersion moléculaire.
PCT/US2024/025673 2023-04-21 2024-04-22 Films à dissolution rapide de rimégépant pour administration orale Pending WO2024220974A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363461133P 2023-04-21 2023-04-21
US63/461,133 2023-04-21

Publications (1)

Publication Number Publication Date
WO2024220974A1 true WO2024220974A1 (fr) 2024-10-24

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117414352A (zh) * 2023-11-22 2024-01-19 湖北广济医药科技有限公司 一种瑞美吉泮口溶膜剂及其制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4136145A (en) * 1974-07-05 1979-01-23 Schering Aktiengesellschaft Medicament carriers in the form of film having active substance incorporated therein
WO2005018609A1 (fr) * 2003-08-18 2005-03-03 Boehringer Ingelheim International Gmbh Microparticules contenant l'antagoniste de cgrp 1-[n2-[3,5-dibromo-n-[[4-(3,4-dihydro-2(1h)-oxoquinazolin-3-yl)-1-piperidinyl]carbonyl]-d-tyrosyl]-l-lysyl]-4-(4-pyridinyl)-piperazine, procede de production desdites particules ainsi que leur utilisation en tant que poudre d'inhalation
US20210000814A1 (en) * 2018-03-25 2021-01-07 Biohaven Pharmaceutical Holding Company Ltd. Rimegepant for cgrp related disorders
WO2022155352A1 (fr) * 2021-01-13 2022-07-21 Dyve Biosciences, Inc. Formulations d'agents pénétrants transdermiques pour l'administration de médicaments
WO2022178279A1 (fr) * 2021-02-19 2022-08-25 Nova Thin Film Pharmaceuticals Llc Procédé et système de fabrication de films solubles oraux, compositions de films solubles oraux, films solubles oraux préparer par ce procédé, et leurs méthodes d'utilisation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4136145A (en) * 1974-07-05 1979-01-23 Schering Aktiengesellschaft Medicament carriers in the form of film having active substance incorporated therein
WO2005018609A1 (fr) * 2003-08-18 2005-03-03 Boehringer Ingelheim International Gmbh Microparticules contenant l'antagoniste de cgrp 1-[n2-[3,5-dibromo-n-[[4-(3,4-dihydro-2(1h)-oxoquinazolin-3-yl)-1-piperidinyl]carbonyl]-d-tyrosyl]-l-lysyl]-4-(4-pyridinyl)-piperazine, procede de production desdites particules ainsi que leur utilisation en tant que poudre d'inhalation
US20210000814A1 (en) * 2018-03-25 2021-01-07 Biohaven Pharmaceutical Holding Company Ltd. Rimegepant for cgrp related disorders
WO2022155352A1 (fr) * 2021-01-13 2022-07-21 Dyve Biosciences, Inc. Formulations d'agents pénétrants transdermiques pour l'administration de médicaments
WO2022178279A1 (fr) * 2021-02-19 2022-08-25 Nova Thin Film Pharmaceuticals Llc Procédé et système de fabrication de films solubles oraux, compositions de films solubles oraux, films solubles oraux préparer par ce procédé, et leurs méthodes d'utilisation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117414352A (zh) * 2023-11-22 2024-01-19 湖北广济医药科技有限公司 一种瑞美吉泮口溶膜剂及其制备方法

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