RU2020109948A - EXTRUDED ENZALUTAMIDE COMPOSITIONS - Google Patents

EXTRUDED ENZALUTAMIDE COMPOSITIONS Download PDF

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Publication number
RU2020109948A
RU2020109948A RU2020109948A RU2020109948A RU2020109948A RU 2020109948 A RU2020109948 A RU 2020109948A RU 2020109948 A RU2020109948 A RU 2020109948A RU 2020109948 A RU2020109948 A RU 2020109948A RU 2020109948 A RU2020109948 A RU 2020109948A
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RU
Russia
Prior art keywords
acetate
polymer
methyl cellulose
composition
polyvinyl
Prior art date
Application number
RU2020109948A
Other languages
Russian (ru)
Inventor
ХариХаран ВЕНУГОПАЛ
Манджунатха Хосахалли РАМАЧАНДРА
Original Assignee
Др. Редди'З Лабораториз Лимитед
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Application filed by Др. Редди'З Лабораториз Лимитед filed Critical Др. Редди'З Лабораториз Лимитед
Publication of RU2020109948A publication Critical patent/RU2020109948A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/41641,3-Diazoles
    • A61K31/41661,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D233/00Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings
    • C07D233/54Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members
    • C07D233/66Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D233/86Oxygen and sulfur atoms, e.g. thiohydantoin

Claims (14)

1. Экструдированная фармацевтическая композиция для перорального приема, содержащая:1. Extruded pharmaceutical composition for oral administration, containing: (i) 160 мг или 80 мг энзалутамида, и(i) 160 mg or 80 mg of enzalutamide, and (ii) один или больше полимеров.(ii) one or more polymers. 2. Композиция по п. 1, где количества энзалутамида и полимера находятся в весовом соотношении от примерно 1:0,5 до примерно 1:5.2. The composition of claim 1, wherein the amounts of enzalutamide and polymer are in a weight ratio of from about 1: 0.5 to about 1: 5. 3. Композиция по п. 1, где количества энзалутамида и полимера находятся в весовом соотношении от 1:0,7 до 1:2.3. A composition according to claim 1, wherein the amounts of enzalutamide and polymer are in a weight ratio from 1: 0.7 to 1: 2. 4. Композиция по п. 1, где полимер выбран из одного или больше целлюлозных полимеров или нецеллюлозных полимеров или их смесей.4. The composition of claim 1, wherein the polymer is selected from one or more cellulosic polymers or non-cellulosic polymers, or mixtures thereof. 5. Композиция по п. 4, где целлюлозный полимер выбран из одного или более из следующих: гидроксипропилметилцеллюлозы ацетат, гидроксипропилметилцеллюлоза, гидроксипропилцеллюлоза, метилцеллюлоза, гидроксиэтилметилцеллюлоза, гидроксиэтилцеллюлозы ацетат, гидроксиэтилэтилцеллюлоза, гидроксипропилметилцеллюлозы ацетат-сукцинат, гидроксипропилметилцеллюлозы сукцинат, гидроксипропилцеллюлозы ацетат-сукцинат, гидроксиэтилметилцеллюлозы сукцинат, гидроксиэтилцеллюлозы ацетат-сукцинат, гидроксипропилметилцеллюлозы фталат, гидроксиэтилметилцеллюлозы ацетат-сукцинат, гидроксиэтилметилцеллюлозы ацетат-фталат и любые их смеси.5. The composition of claim 4, wherein the cellulose polymer is selected from one or more of the following: hydroxypropyl methylcellulose acetate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, methyl cellulose, hydroxyethyl methyl cellulose, hydroxyethyl cellulose acetate, hydroxyethyl ethyl cellulose, hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose acetate, hydroxypropyl methyl cellulose acetate , hydroxyethyl cellulose acetate succinate, hydroxypropyl methyl cellulose phthalate, hydroxyethyl methyl cellulose acetate succinate, hydroxyethyl methyl cellulose acetate phthalate, and any mixtures thereof. 6. Композиция по п. 4, где нецеллюлозный полимер выбран из одного или более из следующих: винильные полимеры и сополимеры, сополимеры поливинилового спирта и поливинилацетата; поливинилпирролидон; поливинилпирролидон-винилацетат, сополимеры полиэтилена и поливинилового спирта, карбоксил-содержащие винильные полимеры, сополимеры метакрилатов и акрилатов, привитые сополимеры полиэтиленгликоля, поливинилкапролактама и поливинилацетата, и любые их смеси.6. The composition according to claim 4, where the non-cellulosic polymer is selected from one or more of the following: vinyl polymers and copolymers, copolymers of polyvinyl alcohol and polyvinyl acetate; polyvinylpyrrolidone; polyvinylpyrrolidone-vinyl acetate, copolymers of polyethylene and polyvinyl alcohol, carboxyl-containing vinyl polymers, copolymers of methacrylates and acrylates, graft copolymers of polyethylene glycol, polyvinyl caprolactam and polyvinyl acetate, and any mixtures thereof. 7. Композиция по п. 4, где полимер представляет собой привитые сополимеры полиэтиленгликоля, поливинилкапролактама и поливинилацетата.7. A composition according to claim 4, wherein the polymer is graft copolymers of polyethylene glycol, polyvinyl caprolactam and polyvinyl acetate. 8. Композиция по п. 4, где полимер представляет собой гидроксипропилметилцеллюлозы ацетат-сукцинат.8. The composition of claim 4, wherein the polymer is hydroxypropyl methylcellulose acetate succinate. 9. Композиция по п. 4, где композиция дополнительно содержит одно или более фармацевтически приемлемых вспомогательных веществ.9. The composition of claim 4, wherein the composition further comprises one or more pharmaceutically acceptable excipients. 10. Экструдированная фармацевтическая композиция для перорального приема, содержащая:10. Extruded pharmaceutical composition for oral administration, containing: (i) 160 мг энзалутамида, и(i) 160 mg of enzalutamide, and (ii) один или более полимеров, выбранных из гидроксипропилметилцеллюлозы ацетата-сукцината, привитых сополимеров полиэтиленгликоля, поливинилкапролактама и поливинилацетата, где энзалутамид и полимер находятся в весовом соотношении 1:2 или 1:1.(ii) one or more polymers selected from hydroxypropyl methylcellulose acetate succinate, graft copolymers of polyethylene glycol, polyvinyl caprolactam and polyvinyl acetate, wherein the enzalutamide and the polymer are in a 1: 2 or 1: 1 weight ratio.
RU2020109948A 2017-08-08 2018-08-08 EXTRUDED ENZALUTAMIDE COMPOSITIONS RU2020109948A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201741028199 2017-08-08
IN201741028199 2017-08-08
PCT/IB2018/055968 WO2019030691A1 (en) 2017-08-08 2018-08-08 Extrudate enzalutamide compositions

Publications (1)

Publication Number Publication Date
RU2020109948A true RU2020109948A (en) 2021-09-10

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RU2020109948A RU2020109948A (en) 2017-08-08 2018-08-08 EXTRUDED ENZALUTAMIDE COMPOSITIONS

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BR (1) BR112020002705A2 (en)
RU (1) RU2020109948A (en)
WO (1) WO2019030691A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021240206A1 (en) * 2020-05-24 2021-12-02 Lotus International Pte. Ltd. Enzalutamide formulation

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7709517B2 (en) * 2005-05-13 2010-05-04 The Regents Of The University Of California Diarylhydantoin compounds
EP4169908A1 (en) * 2012-09-11 2023-04-26 Medivation Prostate Therapeutics LLC Formulations of enzalutamide
CN106102716A (en) * 2014-02-05 2016-11-09 斯洛文尼亚莱柯制药股份有限公司 The solid composite medicament of androgen receptor antagonists

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BR112020002705A2 (en) 2020-07-28
WO2019030691A1 (en) 2019-02-14

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Effective date: 20210809