PE20212107A1 - SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATOR - Google Patents
SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATORInfo
- Publication number
- PE20212107A1 PE20212107A1 PE2021001464A PE2021001464A PE20212107A1 PE 20212107 A1 PE20212107 A1 PE 20212107A1 PE 2021001464 A PE2021001464 A PE 2021001464A PE 2021001464 A PE2021001464 A PE 2021001464A PE 20212107 A1 PE20212107 A1 PE 20212107A1
- Authority
- PE
- Peru
- Prior art keywords
- solid formulation
- solid
- assembly modulator
- hpmc
- ratio
- Prior art date
Links
- 239000007787 solid Substances 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- ZUAAPNNKRHMPKG-UHFFFAOYSA-N acetic acid;butanedioic acid;methanol;propane-1,2-diol Chemical compound OC.CC(O)=O.CC(O)CO.OC(=O)CCC(O)=O ZUAAPNNKRHMPKG-UHFFFAOYSA-N 0.000 abstract 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 2
- 239000007962 solid dispersion Substances 0.000 abstract 2
- 229940126062 Compound A Drugs 0.000 abstract 1
- 241000700721 Hepatitis B virus Species 0.000 abstract 1
- NLDMNSXOCDLTTB-UHFFFAOYSA-N Heterophylliin A Natural products O1C2COC(=O)C3=CC(O)=C(O)C(O)=C3C3=C(O)C(O)=C(O)C=C3C(=O)OC2C(OC(=O)C=2C=C(O)C(O)=C(O)C=2)C(O)C1OC(=O)C1=CC(O)=C(O)C(O)=C1 NLDMNSXOCDLTTB-UHFFFAOYSA-N 0.000 abstract 1
- 210000000234 capsid Anatomy 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 229960003943 hypromellose Drugs 0.000 abstract 1
- 208000015181 infectious disease Diseases 0.000 abstract 1
- 230000002401 inhibitory effect Effects 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 239000006186 oral dosage form Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000012453 solvate Substances 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate 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
- A61K9/146—Intimate 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- 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
- A61P31/20—Antivirals for DNA viruses
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Communicable Diseases (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Virology (AREA)
- Molecular Biology (AREA)
- Biotechnology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Referido a una dispersion solida que comprende el compuesto A, o un solvato o sal farmaceuticamente aceptable del mismo, y un estabilizador seleccionado de al menos uno de Hipromelosa (HPMC) y Acetato-succinato de hipromelosa (HPMC-AS) a una razon de 1:1 a menos de 1:3 en peso, con la condicion de que la razon no sea 1:2 en peso. Esta formulacion solida tiene actividad inhibidora de ensamblaje de la capside para el tratamiento de la infeccion por el virus de la hepatitis B (VHB). Tambien se refiere a una forma farmaceutica oral solida, que comprende dicha dispersion solida, y un procedimiento para preparar dicha forma farmaceutica.Referred to a solid dispersion comprising compound A, or a pharmaceutically acceptable salt or solvate thereof, and a stabilizer selected from at least one of Hypromellose (HPMC) and Hypromellose Acetate-succinate (HPMC-AS) at a ratio of 1 :1 to less than 1:3 by weight, provided that the ratio is not 1:2 by weight. This solid formulation has capsid assembly inhibitory activity for the treatment of hepatitis B virus (HBV) infection. It also relates to a solid oral dosage form, comprising said solid dispersion, and a process for preparing said dosage form.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US16/352,754 US10973801B2 (en) | 2018-03-14 | 2019-03-13 | Capsid assembly modulator dosing regimen |
| EP2019056348 | 2019-03-13 | ||
| PCT/IB2019/000231 WO2019175657A1 (en) | 2018-03-14 | 2019-03-13 | Capsid assembly modulator dosing regimen |
| EP19197566 | 2019-09-16 | ||
| PCT/EP2020/056991 WO2020183020A1 (en) | 2019-03-13 | 2020-03-13 | Capsid assembly modulator solid formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20212107A1 true PE20212107A1 (en) | 2021-11-04 |
Family
ID=72427202
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2021001464A PE20212107A1 (en) | 2019-03-13 | 2020-03-13 | SOLID FORMULATION OF CAPSIDE ASSEMBLY MODULATOR |
Country Status (16)
| Country | Link |
|---|---|
| EP (1) | EP3937928A1 (en) |
| JP (1) | JP2022524819A (en) |
| KR (1) | KR20210137484A (en) |
| CN (1) | CN113557016A (en) |
| AU (1) | AU2020235442A1 (en) |
| BR (1) | BR112021017525A2 (en) |
| CA (1) | CA3132095A1 (en) |
| CR (1) | CR20210481A (en) |
| EC (1) | ECSP21067052A (en) |
| IL (1) | IL286209A (en) |
| JO (1) | JOP20210250A1 (en) |
| MA (1) | MA55280A (en) |
| MX (1) | MX2021011030A (en) |
| PE (1) | PE20212107A1 (en) |
| SG (1) | SG11202109710QA (en) |
| WO (1) | WO2020183020A1 (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112018071048A2 (en) | 2016-04-15 | 2019-05-07 | Janssen Sciences Ireland Uc | combinations and methods comprising a capsid assembly inhibitor |
| MA52019A (en) * | 2018-03-14 | 2021-01-20 | Janssen Sciences Ireland Unlimited Co | CAPSIDE ASSEMBLY MODULATOR DOSAGE SCHEDULE |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JO3603B1 (en) | 2013-05-17 | 2020-07-05 | Janssen Sciences Ireland Uc | Sulfamoyl pyrolamide derivatives and their use as medicines to treat hepatitis B |
| MA52019A (en) * | 2018-03-14 | 2021-01-20 | Janssen Sciences Ireland Unlimited Co | CAPSIDE ASSEMBLY MODULATOR DOSAGE SCHEDULE |
-
2020
- 2020-03-13 KR KR1020217031285A patent/KR20210137484A/en not_active Withdrawn
- 2020-03-13 CR CR20210481A patent/CR20210481A/en unknown
- 2020-03-13 JO JOP/2021/0250A patent/JOP20210250A1/en unknown
- 2020-03-13 SG SG11202109710Q patent/SG11202109710QA/en unknown
- 2020-03-13 WO PCT/EP2020/056991 patent/WO2020183020A1/en not_active Ceased
- 2020-03-13 JP JP2021554750A patent/JP2022524819A/en active Pending
- 2020-03-13 BR BR112021017525A patent/BR112021017525A2/en not_active IP Right Cessation
- 2020-03-13 MX MX2021011030A patent/MX2021011030A/en unknown
- 2020-03-13 PE PE2021001464A patent/PE20212107A1/en unknown
- 2020-03-13 MA MA055280A patent/MA55280A/en unknown
- 2020-03-13 CN CN202080020501.XA patent/CN113557016A/en active Pending
- 2020-03-13 EP EP20709618.1A patent/EP3937928A1/en not_active Withdrawn
- 2020-03-13 AU AU2020235442A patent/AU2020235442A1/en not_active Abandoned
- 2020-03-13 CA CA3132095A patent/CA3132095A1/en not_active Abandoned
-
2021
- 2021-09-09 IL IL286209A patent/IL286209A/en unknown
- 2021-09-10 EC ECSENADI202167052A patent/ECSP21067052A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2020235442A1 (en) | 2021-08-12 |
| SG11202109710QA (en) | 2021-10-28 |
| CR20210481A (en) | 2021-10-25 |
| ECSP21067052A (en) | 2021-11-18 |
| CN113557016A (en) | 2021-10-26 |
| IL286209A (en) | 2021-10-31 |
| JP2022524819A (en) | 2022-05-10 |
| MA55280A (en) | 2022-01-19 |
| EP3937928A1 (en) | 2022-01-19 |
| KR20210137484A (en) | 2021-11-17 |
| WO2020183020A1 (en) | 2020-09-17 |
| JOP20210250A1 (en) | 2023-01-30 |
| CA3132095A1 (en) | 2020-09-17 |
| BR112021017525A2 (en) | 2021-11-23 |
| MX2021011030A (en) | 2021-10-13 |
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