AR107392A1 - Formulaciones / composiciones que comprenden un inhibidor de btk - Google Patents
Formulaciones / composiciones que comprenden un inhibidor de btkInfo
- Publication number
- AR107392A1 AR107392A1 ARP170100142A ARP170100142A AR107392A1 AR 107392 A1 AR107392 A1 AR 107392A1 AR P170100142 A ARP170100142 A AR P170100142A AR P170100142 A ARP170100142 A AR P170100142A AR 107392 A1 AR107392 A1 AR 107392A1
- Authority
- AR
- Argentina
- Prior art keywords
- ibrutinib
- formulations
- compositions
- pharmaceutical composition
- preparing
- Prior art date
Links
Classifications
-
- 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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
-
- 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
-
- 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
- A61K9/2009—Inorganic 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
- A61K9/2013—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
- A61K9/2013—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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
-
- 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
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Immunology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Inorganic Chemistry (AREA)
- Oncology (AREA)
- Pain & Pain Management (AREA)
- Child & Adolescent Psychology (AREA)
- Obesity (AREA)
- Diabetes (AREA)
- Transplantation (AREA)
- Dermatology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Se divulgan formulaciones / composiciones que comprenden un inhibidor de BTK, especialmente ibrutinib de fórmula (1), así como los procesos para preparar dichas formulaciones / composiciones y métodos para el tratamiento de una enfermedad o dolencia que comprende el uso de dichas formulaciones / composiciones. Reivindicación 1: Una composición farmacéutica que comprende ibrutinib, en la que ibrutinib es un compuesto con la estructura del compuesto de fórmula (1); y en la que la composición farmacéutica comprende i) al menos un 60% p/p de ibrutinib, y ii) excipientes que comprenden aproximadamente un 4 - 7% p/p de manitol, y aproximadamente un 13 - 16% p/p de crospovidona del peso total de la composición farmacéutica. Reivindicación 52: El método de la reivindicación 51, en el que el trastorno proliferativo de linfocitos B es un linfoma difuso de linfocitos B grandes, linfoma folicular o leucemia linfocítica crónica. Reivindicación 62: Un proceso para preparar la composición farmacéutica de una cualquiera de las reivindicaciones 1 - 15 o la formulación en forma de comprimido de una cualquiera de las reivindicaciones 16 - 45, comprendiendo el proceso preparar gránulos húmedos que comprenden ibrutinib y al menos un excipiente mediante un método de granulación por vía húmeda. Reivindicación 63: El proceso de la reivindicación 62, en el que los gránulos húmedos comprenden ibrutinib, manitol, crospovidona y laurilsulfato de sodio.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201621001987 | 2016-01-19 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR107392A1 true AR107392A1 (es) | 2018-04-25 |
Family
ID=57851068
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP170100142A AR107392A1 (es) | 2016-01-19 | 2017-01-19 | Formulaciones / composiciones que comprenden un inhibidor de btk |
Country Status (15)
| Country | Link |
|---|---|
| US (3) | US20190290650A1 (es) |
| EP (1) | EP3405178A1 (es) |
| JP (3) | JP7336195B2 (es) |
| KR (1) | KR20180102150A (es) |
| CN (2) | CN108472258B (es) |
| AR (1) | AR107392A1 (es) |
| AU (1) | AU2017208473B2 (es) |
| BR (1) | BR112018014540B1 (es) |
| CA (1) | CA3008576A1 (es) |
| EA (1) | EA201891664A1 (es) |
| HK (2) | HK1259433A1 (es) |
| MA (1) | MA43650A (es) |
| MX (2) | MX2018008772A (es) |
| TW (1) | TWI794153B (es) |
| WO (1) | WO2017125424A1 (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104736178A (zh) | 2012-06-04 | 2015-06-24 | 药品循环公司 | 布鲁顿酪氨酸激酶抑制剂的晶形 |
| IL315294A (en) | 2015-03-03 | 2024-10-01 | Pharmacyclics Llc | Pharmaceutical formulations of proton tyrosine kinase inhibitor |
| WO2017125424A1 (en) * | 2016-01-19 | 2017-07-27 | Janssen Pharmaceutica Nv | Formulations/compositions comprising a btk inhibitor |
| CA3089537A1 (en) | 2018-01-20 | 2019-07-25 | Natco Pharma Limited | Pharmaceutical compositions comprising ibrutinib |
| EP3575300A1 (en) | 2018-05-31 | 2019-12-04 | Apotex Inc. | Novel crystalline forms of ibrutinib |
| EA202190045A1 (ru) | 2018-06-15 | 2021-03-17 | Янссен Фармацевтика Нв | Составы/композиции, содержащие ибрутиниб |
| US10688050B1 (en) * | 2018-12-21 | 2020-06-23 | Synthon B.V. | Pharmaceutical composition comprising ibrutinib |
Family Cites Families (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4327725A (en) | 1980-11-25 | 1982-05-04 | Alza Corporation | Osmotic device with hydrogel driving member |
| US4624848A (en) | 1984-05-10 | 1986-11-25 | Ciba-Geigy Corporation | Active agent containing hydrogel devices wherein the active agent concentration profile contains a sigmoidal concentration gradient for improved constant release, their manufacture and use |
| US4968509A (en) | 1987-07-27 | 1990-11-06 | Mcneilab, Inc. | Oral sustained release acetaminophen formulation and process |
| IL92966A (en) | 1989-01-12 | 1995-07-31 | Pfizer | Hydrogel-operated release devices |
| KR0182801B1 (ko) | 1991-04-16 | 1999-05-01 | 아만 히데아키 | 고체 분산체의 제조방법 |
| WO1993009785A1 (en) | 1991-11-22 | 1993-05-27 | Procter & Gamble Pharmaceuticals, Inc. | Risedronate delayed-release compositions |
| US5461140A (en) | 1992-04-30 | 1995-10-24 | Pharmaceutical Delivery Systems | Bioerodible polymers for solid controlled release pharmaceutical compositions |
| US5323907A (en) | 1992-06-23 | 1994-06-28 | Multi-Comp, Inc. | Child resistant package assembly for dispensing pharmaceutical medications |
| US5700410A (en) | 1992-10-16 | 1997-12-23 | Nippon Shinyaku Co., Ltd. | Method of manufacturing wax matrices |
| US5686105A (en) | 1993-10-19 | 1997-11-11 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery |
| US6326469B1 (en) | 1994-04-22 | 2001-12-04 | Sugen, Inc. | Megakaryocytic protein tyrosine kinases |
| CA2220451A1 (en) | 1995-05-17 | 1996-11-21 | Cedars-Sinai Medical Center | Methods and compositions for improving digestion and absorption in the small intestine |
| US6395300B1 (en) | 1999-05-27 | 2002-05-28 | Acusphere, Inc. | Porous drug matrices and methods of manufacture thereof |
| US6465014B1 (en) | 2001-03-21 | 2002-10-15 | Isp Investments Inc. | pH-dependent sustained release, drug-delivery composition |
| US7711492B2 (en) | 2003-09-03 | 2010-05-04 | The United States Of America As Represented By The Department Of Health And Human Services | Methods for diagnosing lymphoma types |
| EP2532235A1 (en) | 2006-09-22 | 2012-12-12 | Pharmacyclics, Inc. | Inhibitors of bruton's tyrosine kinase |
| US20140303191A1 (en) * | 2011-10-19 | 2014-10-09 | Pharmacyclics, Inc. | Use of inhibitors of bruton's tyrosine kinase (btk) |
| CN104736178A (zh) * | 2012-06-04 | 2015-06-24 | 药品循环公司 | 布鲁顿酪氨酸激酶抑制剂的晶形 |
| WO2014004707A1 (en) | 2012-06-29 | 2014-01-03 | Principia Biopharma Inc. | Formulations comprising ibrutinib |
| BR112015021995A2 (pt) * | 2013-03-14 | 2017-07-18 | Pharmacyclics Llc | combinações de inibidores de tirosina quinase de bruton e inibidores de cyp3a4 |
| WO2015071432A1 (en) * | 2013-11-14 | 2015-05-21 | Sandoz Ag | Pharmaceutical compositions of ibrutinib |
| CN104523695A (zh) * | 2014-11-12 | 2015-04-22 | 广东东阳光药业有限公司 | 一种治疗过度增生性疾病的药物组合物 |
| WO2017125424A1 (en) * | 2016-01-19 | 2017-07-27 | Janssen Pharmaceutica Nv | Formulations/compositions comprising a btk inhibitor |
-
2017
- 2017-01-18 WO PCT/EP2017/050964 patent/WO2017125424A1/en active Application Filing
- 2017-01-18 BR BR112018014540-8A patent/BR112018014540B1/pt active IP Right Grant
- 2017-01-18 MX MX2018008772A patent/MX2018008772A/es unknown
- 2017-01-18 CN CN201780006739.5A patent/CN108472258B/zh active Active
- 2017-01-18 CA CA3008576A patent/CA3008576A1/en active Pending
- 2017-01-18 AU AU2017208473A patent/AU2017208473B2/en active Active
- 2017-01-18 CN CN202210154359.9A patent/CN114681462A/zh active Pending
- 2017-01-18 MA MA043650A patent/MA43650A/fr unknown
- 2017-01-18 JP JP2018556012A patent/JP7336195B2/ja active Active
- 2017-01-18 EP EP17700821.6A patent/EP3405178A1/en active Pending
- 2017-01-18 US US16/071,453 patent/US20190290650A1/en not_active Abandoned
- 2017-01-18 EA EA201891664A patent/EA201891664A1/ru unknown
- 2017-01-18 KR KR1020187023229A patent/KR20180102150A/ko not_active Application Discontinuation
- 2017-01-19 AR ARP170100142A patent/AR107392A1/es unknown
- 2017-01-19 TW TW106101787A patent/TWI794153B/zh active
-
2018
- 2018-07-17 MX MX2022006817A patent/MX2022006817A/es unknown
-
2019
- 2019-02-01 HK HK19101837.4A patent/HK1259433A1/zh unknown
- 2019-02-01 HK HK19101845.4A patent/HK1259441A1/zh unknown
-
2021
- 2021-02-11 US US17/174,305 patent/US20210169888A1/en not_active Abandoned
-
2022
- 2022-04-07 JP JP2022063752A patent/JP7565971B2/ja active Active
- 2022-11-22 US US17/992,348 patent/US20230364090A1/en active Pending
-
2024
- 2024-06-05 JP JP2024091441A patent/JP2024138243A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| BR112018014540B1 (pt) | 2024-02-27 |
| JP7336195B2 (ja) | 2023-08-31 |
| HK1259433A1 (zh) | 2019-11-29 |
| CN114681462A (zh) | 2022-07-01 |
| JP2022105006A (ja) | 2022-07-12 |
| HK1259441A1 (zh) | 2019-11-29 |
| AU2017208473B2 (en) | 2022-04-21 |
| MA43650A (fr) | 2018-11-28 |
| US20210169888A1 (en) | 2021-06-10 |
| EA201891664A1 (ru) | 2019-02-28 |
| JP7565971B2 (ja) | 2024-10-11 |
| CN108472258B (zh) | 2024-05-24 |
| CA3008576A1 (en) | 2017-07-27 |
| TWI794153B (zh) | 2023-03-01 |
| AU2017208473A1 (en) | 2018-07-12 |
| CN108472258A (zh) | 2018-08-31 |
| MX2022006817A (es) | 2022-07-11 |
| US20190290650A1 (en) | 2019-09-26 |
| TW201737918A (zh) | 2017-11-01 |
| KR20180102150A (ko) | 2018-09-14 |
| JP2024138243A (ja) | 2024-10-08 |
| BR112018014540A2 (pt) | 2018-12-11 |
| MX2018008772A (es) | 2018-11-09 |
| JP2019506450A (ja) | 2019-03-07 |
| US20230364090A1 (en) | 2023-11-16 |
| WO2017125424A1 (en) | 2017-07-27 |
| EP3405178A1 (en) | 2018-11-28 |
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