RU2019115672A - Диспергируемые композиции - Google Patents
Диспергируемые композиции Download PDFInfo
- Publication number
- RU2019115672A RU2019115672A RU2019115672A RU2019115672A RU2019115672A RU 2019115672 A RU2019115672 A RU 2019115672A RU 2019115672 A RU2019115672 A RU 2019115672A RU 2019115672 A RU2019115672 A RU 2019115672A RU 2019115672 A RU2019115672 A RU 2019115672A
- Authority
- RU
- Russia
- Prior art keywords
- composition according
- pharmaceutically acceptable
- diluent
- composition
- fraction
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 17
- 239000008187 granular material Substances 0.000 claims 5
- 239000003085 diluting agent Substances 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims 4
- 208000031886 HIV Infections Diseases 0.000 claims 3
- 208000037357 HIV infectious disease Diseases 0.000 claims 3
- 239000013543 active substance Substances 0.000 claims 3
- 208000033519 human immunodeficiency virus infectious disease Diseases 0.000 claims 3
- YIBOMRUWOWDFLG-ONEGZZNKSA-N rilpivirine Chemical compound CC1=CC(\C=C\C#N)=CC(C)=C1NC1=CC=NC(NC=2C=CC(=CC=2)C#N)=N1 YIBOMRUWOWDFLG-ONEGZZNKSA-N 0.000 claims 3
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 229960002814 rilpivirine Drugs 0.000 claims 2
- 229940124597 therapeutic agent Drugs 0.000 claims 2
- 239000000080 wetting agent Substances 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
Classifications
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
-
- 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
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Virology (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Communicable Diseases (AREA)
- Tropical Medicine & Parasitology (AREA)
- AIDS & HIV (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Zoology (AREA)
- Oncology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Cosmetics (AREA)
- Other In-Based Heterocyclic Compounds (AREA)
- Plural Heterocyclic Compounds (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)
- Saccharide Compounds (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Thiazole And Isothizaole Compounds (AREA)
- Furan Compounds (AREA)
Claims (14)
1. Диспергируемая композиция, содержащая E-4-[[4-[[4-(2-цианоэтенил)-2,6-диметилфенил]амино]-2-пиримидинил]амино]бензонитрил (рилпивирин) или его фармацевтически приемлемую соль присоединения кислоты в качестве активной субстанции, где указанная активная субстанция присутствует в диспергируемой композиции в форме гранул, причем указанные гранулы дополнительно содержат фармацевтически приемлемое формообразующее (гранулярная фракция).
2. Композиция согласно п. 1, где фармацевтически приемлемое формообразующее гранул содержит смачивающий агент.
3. Композиция согласно п. 1 или 2, где фармацевтически приемлемое формообразующее гранул содержит разрыхлитель.
4. Композиция согласно любому из предыдущих пунктов, где фармацевтически приемлемое формообразующее гранул содержит разбавитель.
5. Композиция согласно любому из предыдущих пунктов, содержащая разбавитель во внегранулярной фракции.
6. Композиция согласно п. 5, где разбавитель во внегранулярной фракции представляет собой нерастворимый разбавитель.
7. Композиция согласно любому из предыдущих пунктов, содержащая смачивающий агент во внегранулярной фракции.
8. Композиция согласно любому из предыдущих пунктов, содержащая разрыхлитель во внегранулярной фракции.
9. Композиция согласно любому из предыдущих пунктов, где композиция представляет собой таблетку.
10. Композиция согласно любому из предыдущих пунктов, где активной субстанцией является рилпивирин HCl.
11. Композиция согласно любому из предыдущих пунктов для применения в лечении ВИЧ-инфекции.
12. Композиция согласно п. 11 для применения в педиатрической и/или гериатрической популяциях.
13. Композиция согласно любому одному из предыдущих пунктов для применения в комбинации с одним или несколькими другими терапевтическими средствами, применимыми в лечении ВИЧ-инфекции.
14. Комбинация, содержащая композицию согласно любому одному из пп. 1-10 и одно или несколько других терапевтических средств, применимых в лечении ВИЧ-инфекции.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201621036404 | 2016-10-24 | ||
| IN201621036404 | 2016-10-24 | ||
| PCT/EP2017/077030 WO2018077815A1 (en) | 2016-10-24 | 2017-10-23 | Dispersible compositions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2019115672A true RU2019115672A (ru) | 2020-11-24 |
| RU2019115672A3 RU2019115672A3 (ru) | 2021-01-21 |
Family
ID=60262899
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2019115672A RU2019115672A (ru) | 2016-10-24 | 2017-10-23 | Диспергируемые композиции |
Country Status (22)
| Country | Link |
|---|---|
| US (2) | US11065198B2 (ru) |
| EP (2) | EP3528791B1 (ru) |
| JP (2) | JP7197474B2 (ru) |
| KR (2) | KR20240011873A (ru) |
| CN (1) | CN110191704A (ru) |
| BR (1) | BR112019007564A2 (ru) |
| CA (1) | CA3039562A1 (ru) |
| DK (1) | DK3528791T3 (ru) |
| ES (1) | ES2970870T3 (ru) |
| FI (1) | FI3528791T3 (ru) |
| HR (1) | HRP20240118T1 (ru) |
| HU (1) | HUE064823T2 (ru) |
| LT (1) | LT3528791T (ru) |
| MA (1) | MA46563B1 (ru) |
| MX (1) | MX2019004767A (ru) |
| PL (1) | PL3528791T3 (ru) |
| PT (1) | PT3528791T (ru) |
| RS (1) | RS65159B1 (ru) |
| RU (1) | RU2019115672A (ru) |
| SI (1) | SI3528791T1 (ru) |
| TW (1) | TWI821163B (ru) |
| WO (1) | WO2018077815A1 (ru) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021104487A1 (en) | 2019-11-29 | 2021-06-03 | Aptorum Therapeutics Limited | Composition including rilpivirine and use thereof for treating tumors or cancer |
| CN114392241B (zh) * | 2022-01-10 | 2023-07-25 | 安徽贝克生物制药有限公司 | 一种利匹韦林片及其制备方法 |
| GB202211231D0 (en) * | 2022-08-02 | 2022-09-14 | Glaxosmithkline Ip No 2 Ltd | Novel formulation |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0181966A1 (en) * | 1984-11-13 | 1986-05-28 | Gist-Brocades N.V. | Compression-coated dispersible tablets |
| GB9109862D0 (en) * | 1991-05-08 | 1991-07-03 | Beecham Lab Sa | Pharmaceutical formulations |
| JO3429B1 (ar) | 2001-08-13 | 2019-10-20 | Janssen Pharmaceutica Nv | مشتقات برميدينات مثبطة فيروس الايدز |
| MY169670A (en) | 2003-09-03 | 2019-05-08 | Tibotec Pharm Ltd | Combinations of a pyrimidine containing nnrti with rt inhibitors |
| AU2003266413B2 (en) | 2002-08-09 | 2009-04-02 | Janssen Pharmaceutica N.V. | Processes for the preparation of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile |
| KR101284361B1 (ko) | 2004-09-02 | 2013-07-15 | 얀센 파마슈티카 엔.브이. | 4-((4-((4-(2-시아노에텐일)-2,6-디메틸페닐)아미노-2-피리미딘일)아미노)벤조니트릴의 하이드로클로라이드 |
| UA92469C2 (en) * | 2004-09-02 | 2010-11-10 | Янссен Фармацевтика Н.В. | Fumarate of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl amino benzonitrile |
| PT1632232E (pt) * | 2004-09-02 | 2011-08-02 | Janssen Pharmaceutica Nv | Sal de 4-[[4-[[4-(2-cianoetenil)-2,6-dimetilfenil]amino]- 2-pirimidinil]amino]benzonitrilo |
| TWI413521B (zh) | 2006-06-23 | 2013-11-01 | Tibotec Pharm Ltd | Ｔｍｃ２７８之水性懸浮液 |
| WO2015120014A1 (en) | 2014-02-05 | 2015-08-13 | Merck Sharp & Dohme Corp. | Novel disintegration systems for pharmaceutical dosage forms |
| WO2015136294A1 (en) | 2014-03-13 | 2015-09-17 | Cipla Limited | Pharmaceutical composittion comprising rilpivirine |
| RU2740903C2 (ru) | 2014-05-16 | 2021-01-21 | Вивус, Инк. | Пероральная рассыпающаяся лекарственная форма для введения аванафила и связанные с ней способы получения и применения |
-
2017
- 2017-10-23 LT LTEPPCT/EP2017/077030T patent/LT3528791T/lt unknown
- 2017-10-23 HU HUE17794275A patent/HUE064823T2/hu unknown
- 2017-10-23 US US16/344,143 patent/US11065198B2/en active Active
- 2017-10-23 DK DK17794275.2T patent/DK3528791T3/da active
- 2017-10-23 MA MA46563A patent/MA46563B1/fr unknown
- 2017-10-23 KR KR1020247001197A patent/KR20240011873A/ko not_active Application Discontinuation
- 2017-10-23 KR KR1020197014202A patent/KR20190073450A/ko not_active IP Right Cessation
- 2017-10-23 MX MX2019004767A patent/MX2019004767A/es unknown
- 2017-10-23 EP EP17794275.2A patent/EP3528791B1/en active Active
- 2017-10-23 SI SI201731486T patent/SI3528791T1/sl unknown
- 2017-10-23 EP EP23169649.3A patent/EP4248947A3/en active Pending
- 2017-10-23 FI FIEP17794275.2T patent/FI3528791T3/fi active
- 2017-10-23 CA CA3039562A patent/CA3039562A1/en active Pending
- 2017-10-23 ES ES17794275T patent/ES2970870T3/es active Active
- 2017-10-23 CN CN201780065671.8A patent/CN110191704A/zh active Pending
- 2017-10-23 HR HRP20240118TT patent/HRP20240118T1/hr unknown
- 2017-10-23 WO PCT/EP2017/077030 patent/WO2018077815A1/en active Application Filing
- 2017-10-23 JP JP2019521720A patent/JP7197474B2/ja active Active
- 2017-10-23 BR BR112019007564A patent/BR112019007564A2/pt active Search and Examination
- 2017-10-23 PT PT177942752T patent/PT3528791T/pt unknown
- 2017-10-23 PL PL17794275.2T patent/PL3528791T3/pl unknown
- 2017-10-23 RU RU2019115672A patent/RU2019115672A/ru unknown
- 2017-10-23 RS RS20240158A patent/RS65159B1/sr unknown
- 2017-10-24 TW TW106136552A patent/TWI821163B/zh active
-
2021
- 2021-06-15 US US17/347,929 patent/US20220008333A1/en not_active Abandoned
-
2022
- 2022-10-14 JP JP2022165319A patent/JP2023011659A/ja not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| US11065198B2 (en) | 2021-07-20 |
| PT3528791T (pt) | 2024-02-19 |
| CN110191704A (zh) | 2019-08-30 |
| PL3528791T3 (pl) | 2024-04-02 |
| SI3528791T1 (sl) | 2024-04-30 |
| MA46563A (fr) | 2019-08-28 |
| DK3528791T3 (da) | 2024-01-29 |
| FI3528791T3 (fi) | 2024-01-30 |
| WO2018077815A1 (en) | 2018-05-03 |
| CA3039562A1 (en) | 2018-05-03 |
| MX2019004767A (es) | 2019-07-01 |
| TW201828927A (zh) | 2018-08-16 |
| EP3528791B1 (en) | 2023-12-06 |
| KR20190073450A (ko) | 2019-06-26 |
| LT3528791T (lt) | 2024-05-27 |
| MA46563B1 (fr) | 2024-01-31 |
| EP4248947A3 (en) | 2023-11-22 |
| JP2023011659A (ja) | 2023-01-24 |
| US20220008333A1 (en) | 2022-01-13 |
| HUE064823T2 (hu) | 2024-04-28 |
| KR20240011873A (ko) | 2024-01-26 |
| RS65159B1 (sr) | 2024-02-29 |
| BR112019007564A2 (pt) | 2019-07-02 |
| EP3528791A1 (en) | 2019-08-28 |
| TWI821163B (zh) | 2023-11-11 |
| ES2970870T3 (es) | 2024-05-31 |
| JP7197474B2 (ja) | 2022-12-27 |
| RU2019115672A3 (ru) | 2021-01-21 |
| HRP20240118T1 (hr) | 2024-04-12 |
| US20200069579A1 (en) | 2020-03-05 |
| JP2020500168A (ja) | 2020-01-09 |
| EP4248947A2 (en) | 2023-09-27 |
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