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WO2024211881A1 - Suspension de rimégépant - Google Patents

Suspension de rimégépant Download PDF

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Publication number
WO2024211881A1
WO2024211881A1 PCT/US2024/023559 US2024023559W WO2024211881A1 WO 2024211881 A1 WO2024211881 A1 WO 2024211881A1 US 2024023559 W US2024023559 W US 2024023559W WO 2024211881 A1 WO2024211881 A1 WO 2024211881A1
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WO
WIPO (PCT)
Prior art keywords
rimegepant
pharmaceutically acceptable
pharmaceutical composition
acceptable salt
composition
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/US2024/023559
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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 WO2024211881A1 publication Critical patent/WO2024211881A1/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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/10—Dispersions; Emulsions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
    • C07D471/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains two hetero rings
    • C07D471/04—Ortho-condensed systems

Definitions

  • the present invention relates to Rimegepant and salts thereof for use in treating calcitonin gene-related peptide (CGRP) disorders.
  • the present invention relates to a liquid suspension formulation and a composition in the form of a reconstitutable powder for an oral suspension of Rimegepant and salts thereof.
  • Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist indicated for treatment of migraine and other CGRP-related disorders.
  • CGRP calcitonin gene-related peptide
  • Rimegepant is C 28 H 28 F 2 N 6 O 3 and its IUPAC name is [(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 -y l)piperid ine-1 - carboxylate.
  • Rimegepant is described, for example in WO 2011/046997.
  • the structure of Rimegepant free base (Formula I) is as follows:
  • Rimegepant is also useful in its salt forms.
  • One particularly useful form of Rimegepant is its hemi sulfate sesquihydrate salt. This salt form is described in WO 2013/130402. 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:
  • 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.
  • Nurtec® ODT 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 active pharmaceutical ingredient is a BCS class-ll compound 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.
  • Absolute bioavailability of Nurtec® ODT is 64% and food decreases both C max and AUC and delays T max by an hour.
  • Nurtec® ODT is produced by Zydis® Technology (Catalent), which involves in situ freeze drying (lyophilizing) an aqueous solution of the 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.
  • the present invention provides a liquid suspension formulation and a reconstitutable powder formulation for an oral suspension of Rimegepant.
  • a pharmaceutical composition including a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.
  • the pharmaceutical composition is in a form of a liquid suspension, and the Rimegepant or the pharmaceutically acceptable salt thereof is provided in a micronized form or nano milled form.
  • the Rimegepant or the pharmaceutically acceptable salt thereof has a particle size of less than about 30 ⁇ m.
  • the liquid suspension has a pH in a range from about 3 to about 7.5.
  • the Rimegepant or the pharmaceutically acceptable salt thereof may be provided in an amount of about 2% to about 20% by volume and/or by weight of the liquid suspension.
  • 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 C max 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.
  • a particle size of the hemi sulfate sesquihydrate salt of Rimegepant is less than about 1000 nm.
  • the Rimegepant or the pharmaceutically acceptable salt thereof has a particle size in a range of about 100 nm to about 30 ⁇ m.
  • the Rimegepant or the pharmaceutically acceptable salt thereof may be provided in an amount of about 70 mg to about 80 mg.
  • the pharmaceutical composition further includes at least one suspension stabilizer, at least one viscosity enhancer, at least one buffer to adjust a pH of the liquid suspension to about 3 to about 7.5 and at least one preservative.
  • the at least one suspension stabilizer is selected from crospovidone, microcrystalline cellulose, starch, alginates, cellulose derivatives, potassium chloride, and sodium chloride, or mixture thereof.
  • the at least one viscosity enhancer is selected from xantham gum, Acacia gum, tragacanth gum, sodium alginate, methylcellulose, sodium carboxymethylcellulose, and hydroxypropyl methylcellulose, or mixture thereof.
  • the pharmaceutical composition also includes at least one ionic surfactant, at least one steric stabilizer, and at least one polymeric stabilizer.
  • the at least one ionic surfactant is selected from sodium lauryl sulfate, sodium dodecyl sulfate, dioctyl sulfosuccinate sodium salt, and benzethonium chloride, or mixture thereof.
  • the at least one steric stabilizer is selected from poloxamers, cellulose derivatives, polysorbates, and povidones, or mixture thereof.
  • the at least one polymeric stabilizer is selected from Poloxamers, hydroxypropyl methylcellulose, hydroxypropyl cellulose, methylcellulose, hydroxyethyl cellulose, carboxymethylcellulose sodium salt, alginic acid sodium salt, and povidones, or mixture thereof.
  • the pharmaceutical composition may also include at least one of a flavoring agent, a sweetener, a preservative, and water.
  • a reconstitutable powder composition including a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, and at least one excipient, wherein the Rimegepant or the pharmaceutically acceptable form thereof has a particle of less than about 30 ⁇ m.
  • the Rimegepant or the pharmaceutically acceptable form thereof has a particle of less than about 1 ⁇ m.
  • a method of treating migraine in a patient in need thereof may include the steps of administering to the patient a liquid suspension composition comprising 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.
  • contacting includes mixing, adding, slurring, stirring clear solution or a combination thereof.
  • contacting means that one or more reagent(s) are mixed or added with each other and I or solvent(s) in any sequences and further slurried as an insoluble solid mixture or stirred as a clear solution.
  • At least one relates to one or more, i.e. , 1 , 2, 3, 4, 5, 6, 7, 8, 9, or more. If used in combination with a compound, the term does not relate to the absolute number of molecules but rather to the number of different types of said compound.
  • substantially means at least 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%.
  • 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 refers to a total amount of drug absorbed or exposed to a subject. Generally, AUC may be obtained from mathematical method in a plot of drug concentration in the subject over time until the concentration is negligible. The term “AUC” could also refer to partial AUC at specified time intervals.
  • C max 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.
  • the term C max 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.
  • T max refers to a time or period after administration of a drug when the maximum concentration (C max ) is reached in blood, serum, a specified compartment or test area of a subject.
  • the present invention provides a liquid suspension 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 liquid suspension formulation contains active ingredient Rimegepant or a pharmaceutically acceptable salt thereof in a micronized form, whereby the average particle size of the Rimegepant active ingredient, represented by a median diameter (D50) or volume median diameter (VMD) measured using laser diffraction, is less than about 30 ⁇ m.
  • the liquid suspension contains Rimegepant or the pharmaceutically acceptable salt thereof in a nano milled form, whereby the average particle size of the Rimegepant active ingredient in the suspension is less than about 1 ⁇ m, represented by D90 or DV(0.9) measured using laser diffraction or photon correlation spectroscopy (PCS).
  • D90 or DV(0.9) means that about 90% of the total particles are smaller than this size.
  • the liquid suspension compositions of the present invention may be in a unit dosage range of about 1 mg/mL to about 100 mg/mL.
  • Some exemplary liquid dosage units of the present invention include, but are not limited to, 0.1 mg/mL, 1 mg/mL, 10 mg/mL, 25 mg/mL, 50 mg/mL, and 100 mg/mL.
  • liquid suspension composition of the present invention may be prepared using any suitable excipients and processing known in the art.
  • the micronized form of the Rimegepant active ingredient may be prepared using air-jet milling or similar milling technique.
  • the active ingredient particles for a nano suspension may be prepared using pearl or media milling, high-pressure homogenization, micro fluidization or high-energy sonication.
  • the suspension is preferably stabilized for both chemical stability and physical stability to provide uniform distribution of the active ingredient particles in suspension to facilitate uniformity of dosing throughout shelf-life.
  • the suspension formulation may utilize any suitable anti-caking agents, viscosity modifiers and/or suspension stabilizers. These excipients may be provided in an amount of about 0.1 to about 2.0 by weight of the suspension formulation, or about 0.5 to about 1 .5 by weight of the suspension formulation.
  • 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 suspension 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 (NaAIg), 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 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.
  • the one or more surfactants may be provided in an amount of about 0.005 to about 0.015 by weight of the suspension formulation.
  • the formulations of the present invention may also include one or more sweeteners and/or flavoring agents.
  • sweeteners may include sorbitol, sucrose, aspartame, com syrup, glycerin, sodium saccharin, mannitol, and mixtures thereof.
  • the one or more sweeteners and/or flavoring agents may be provided in an amount of about 0.01 to about 0.03 by weight of the suspension formulation.
  • compositions of micro- and nano- suspension formulations in accordance with the present invention are provided below.
  • Example 1 Micronized Suspension of Rimegepant and/or Its Salt Forms
  • exemplary suspension stabilizers include, but are not limited to, Avicel® RC-591, starch, alginates, cellulose derivatives, potassium chloride, and sodium chloride.
  • exemplary viscosity modifiers include, but are not limited to, acacia gum, xanthan gum, tragacanth gum, sodium alginate, methylcellulose, sodium carboxymethylcellulose, and hydroxypropyl methylcellulose.
  • exemplary sweeteners include, but are not limited to, sucrose, sorbitol, aspartame, corn syrup, glycerin, sodium saccharin, and mannitol.
  • Example 2 Nanomilled Suspension of Rimegepant and/or
  • exemplary ionic surfactants include, but are not limited to, sodium dodecyl sulfate (SDS), dioctyl sulfosuccinate sodium salt (DOSS) and benzethonium chloride (BKC).
  • SDS sodium dodecyl sulfate
  • DOSS dioctyl sulfosuccinate sodium salt
  • BKC benzethonium chloride
  • exemplary steric stabilizers include, but are not limited to, cellulose derivatives, poloxamers (also considered as polymeric surfactants), polysorbates, and povidones.
  • polymeric stabilizers include, but are not limited to, HPMC, HPC, MC, HEC, carboxymethylcellulose sodium salt (NaCMC), and alginic acid sodium salt (NaAIg) PVP K30 and PVP K90.
  • an aqueous dispersion of Rimegepant or its salt form with the surfactant may be nano milled using media mill, high- pressure homogenizer or microfluidizer.
  • the nano milled suspension may be further diluted in an aqueous solution of steric and polymeric stabilizers with one or more flavoring agents, sweeteners, and preservatives added.
  • Experimental observations and results of inventive formulations prepared as per Example 1 and Example 2 are presented in below Table 1 and Table 2, respectively.
  • Table 1 Results of pharmaceutically acceptable formulation of Micronized Suspension of Rimegepant Base or Salt Form as per Example 1:
  • the suspensions prepared using the inventive formulation(s) exhibit acceptable physical properties. As mentioned in above tables, the prepared suspensions were uniform and easily redisperse upon shaking. The suspension formulation was prepared by simple and easy method and is cost effective to manufacture. [0055]
  • a reconstitutable powder composition for an oral suspension including a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, together with one or more suitable excipients.
  • the solid powder composition may be used to prepare a reconstituted oral suspension.
  • the reconstitutable solid composition according to the invention can comprise Rimegepant or its salt in a solid micronized form with at least one other pharmaceutical excipient.
  • the composition can comprise Rimegepant or its salt in a solid nano milled with at least one pharmaceutical excipient.
  • the reconstitutable powder formulation can include one or more pharmaceutical excipients such as preservatives, antifoaming agents, antioxidants, buffering agents, acidifying agents, alkalizing agents, bulking agents, colorants, complexation-enhancing agents, cryoprotectants, electrolytes, glucose, emulsifying agents, oils, plasticizers, solubility- enhancing agents, stabilizers, tonicity modifiers, flavors, sweeteners, adsorbents, antiadherents, binders, diluents, direct compression excipients, disintegrants, glidants, lubricants, opaquants, polishing agents, complexing agents, fragrances, and other excipients known to persons of ordinary skill in the art for use in formulations.
  • the powder formulation may include one or more excipients referenced in Examples 1 and 2 above.
  • a reconstitutable powder composition may be prepared according to any of the following processes.
  • a liquid formulation of the invention is first prepared, then a solid is formed by lyophilization (freeze- drying), spray-drying, spray freeze-drying, antisolvent precipitation, aseptic spray drying, various processes utilizing supercritical or near supercritical fluids, or other methods known to those of ordinary skill in the art to make a solid for reconstitution.
  • a liquid vehicle included in the formulations of the present invention may include an aqueous liquid carrier (e.g., water), an aqueous alcohol, an aqueous organic solvent, a non-aqueous liquid carrier, and combinations thereof.
  • a kit may be provided including the reconstitutable powder composition and instructions for reconstituting the composition to prepare an oral suspension formulation, and an optional reconstitution container.
  • the powder composition described herein may be packaged into suitable containers, e.g., HDPE bottles, each containing a suitable dose of reconstitutable powder composition. Each dose is reconstituted with a certain amount of water or another suitable liquid carrier to obtain an oral suspension formulation containing the specified concentration of API.
  • suitable containers e.g., HDPE bottles
  • Each dose is reconstituted with a certain amount of water or another suitable liquid carrier to obtain an oral suspension formulation containing the specified concentration of API.
  • a 6.4 wt/vol% powder formulation provides 64 mg/mL oral suspension
  • a 3.2 wt/vol% powder formulation provides 32 mg/mL oral suspension.
  • 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 liquid suspension 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 a nanomilled form.
  • the method includes the steps of providing a reconstitutable powder composition comprising a therapeutically effective amount of Rimegepant or a pharmaceutically acceptable salt thereof, reconstituting the powder composition with water or another suitable liquid carrier to obtain a liquid suspension formulation, and administering the liquid suspension formulation to the patient via an oral route.
  • 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 about 80-125% of 5000 (hr*ng/mL). In additional embodiments, the method provides an AUC 0-t of about 85-115% of 5000 (hr*ng/mL). In further embodiments, the method provides an AUC 0-t of about 90-105% of 5000 (hr*ng/mL).
  • the method provides a C max of about 80- 125% of 835 (ng/mL). In further embodiments, the method provides a C max of about 85-120% of 835 (ng/mL). In yet further embodiments, the method provides a C max of 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 un support pharmaceutiquement acceptable, la composition pharmaceutique se présentant sous la forme d'une suspension liquide ou d'une composition de poudre reconstituable, et le rimégépant ou son sel pharmaceutiquement acceptable étant fourni sous une forme micronisée ou nano-broyée.
PCT/US2024/023559 2023-04-06 2024-04-08 Suspension de rimégépant Pending WO2024211881A1 (fr)

Applications Claiming Priority (2)

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US202363457729P 2023-04-06 2023-04-06
US63/457,729 2023-04-06

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WO2024211881A1 true WO2024211881A1 (fr) 2024-10-10

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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 (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

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