WO2009034431A3 - Controlled-release dosage forms for varenicline - Google Patents
Controlled-release dosage forms for varenicline Download PDFInfo
- Publication number
- WO2009034431A3 WO2009034431A3 PCT/IB2008/002311 IB2008002311W WO2009034431A3 WO 2009034431 A3 WO2009034431 A3 WO 2009034431A3 IB 2008002311 W IB2008002311 W IB 2008002311W WO 2009034431 A3 WO2009034431 A3 WO 2009034431A3
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- varenicline
- controlled
- dosage forms
- release dosage
- antioxidant
- Prior art date
Links
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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
Abstract
A controlled release pharmaceutical composition of varenicline or a pharmaceutically acceptable salt thereof wherein said controlled release pharmaceutical composition comprises a coating and an antioxidant wherein said antioxidant is present in an amount equal to a weight percent greater than about 0.1 % but less than 5% of the coating layer.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US97101707P | 2007-09-10 | 2007-09-10 | |
US60/971,017 | 2007-09-10 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2009034431A2 WO2009034431A2 (en) | 2009-03-19 |
WO2009034431A3 true WO2009034431A3 (en) | 2009-11-19 |
Family
ID=40032575
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IB2008/002311 WO2009034431A2 (en) | 2007-09-10 | 2008-08-29 | Controlled-release dosage forms for varenicline |
Country Status (1)
Country | Link |
---|---|
WO (1) | WO2009034431A2 (en) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20200276113A1 (en) * | 2016-01-08 | 2020-09-03 | Ctc Bio, Inc. | Taste-masked and orally administered pharmaceutical preparation containing varenicline or pharmaceutically acceptable salt thereof |
KR20180058644A (en) * | 2016-11-24 | 2018-06-01 | 에스케이케미칼 주식회사 | Sustained release pharmaceutical formulation of varenicline and preparation method thereof |
GB2561333B (en) | 2017-02-17 | 2020-06-03 | Bo Soederpalm | Treatment of alcohol use disorder |
WO2018154395A2 (en) | 2018-06-11 | 2018-08-30 | Alvogen Malta Operations (Row) Ltd | Controlled release pharmaceutical composition of varenicline |
KR102235848B1 (en) * | 2019-11-20 | 2021-04-05 | 충북대학교 산학협력단 | Tablet for delayed release of varenicline or pharmaceutically acceptable salts thereof |
WO2022271600A1 (en) * | 2021-06-25 | 2022-12-29 | Handa Pharma, Inc. | Stable varenicline dosage forms |
EP4169516A1 (en) * | 2021-11-05 | 2023-04-26 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Prevention of the conversion of pharmaceutical agents into toxic n-nitrosamine compounds |
WO2023012376A2 (en) * | 2021-11-05 | 2023-02-09 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Prevention of the conversion of pharmaceutical agents into toxic n-nitrosamine compounds |
KR20230068877A (en) * | 2021-11-11 | 2023-05-18 | 주식회사 아울바이오 | Microspheres containing high-dose varenicline, method for preparing the same, and pharmaceutical composition comprising the same |
CN114088843B (en) * | 2021-11-26 | 2024-01-30 | 上海皓鸿生物医药科技有限公司 | Detection method for nitrosamine genotoxic impurities in valance intermediate |
WO2023275413A2 (en) * | 2021-12-23 | 2023-01-05 | Medichem, S.A. | Solid pharmaceutical formulations of varenicline |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20040235850A1 (en) * | 2003-05-20 | 2004-11-25 | Pfizer Inc | Pharmaceutical compositions of varenicline |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4111202A (en) | 1976-11-22 | 1978-09-05 | Alza Corporation | Osmotic system for the controlled and delivery of agent over time |
US4093105A (en) | 1977-10-19 | 1978-06-06 | N. T. Gates Company | Plastic container with vent means |
US5612059A (en) | 1988-08-30 | 1997-03-18 | Pfizer Inc. | Use of asymmetric membranes in delivery devices |
US6133361A (en) | 1996-02-03 | 2000-10-17 | Mitsubishi Gas Chemical Company, Inc. | Oxygen-absorbing composition, oxygen-absorbing resin composition, packing material, multi-layered packing, oxygen absorber packet, packing method and preservation method |
BR9810403A (en) | 1997-07-01 | 2000-08-29 | Pfizer | Sertraline salts and sustained release dosage forms of sertraline |
IL136727A0 (en) | 1997-12-31 | 2001-06-14 | Pfizer Prod Inc | Aryl fused azapolycyclic compounds |
US6605610B1 (en) | 1997-12-31 | 2003-08-12 | Pfizer Inc | Aryl fused azapolycyclic compounds |
AU2001276608A1 (en) | 2000-08-30 | 2002-03-13 | Pfizer Products Inc. | Sustained release formulations for growth hormone secretagogues |
EP1243524A3 (en) | 2001-03-16 | 2004-04-07 | Pfizer Products Inc. | Pharmaceutical kit for oxygen-sensitive drugs |
JP2005528330A (en) | 2001-11-30 | 2005-09-22 | ファイザー・プロダクツ・インク | Pharmaceutical composition of 5,7,14-triazatetracyclo [10.3.1.02, 11.04,9] -hexadeca-2 (11) 3,5,7,9-pentaene |
-
2008
- 2008-08-29 WO PCT/IB2008/002311 patent/WO2009034431A2/en active Application Filing
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20040235850A1 (en) * | 2003-05-20 | 2004-11-25 | Pfizer Inc | Pharmaceutical compositions of varenicline |
Non-Patent Citations (3)
Title |
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KENNETH C WATERMAN ET AL: "N-methylation and N-formylation of a secondary amine drug (varenicline) in an osmotic tablet", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN PHARMACEUTICAL ASSOCIATION, WASHINGTON, US, vol. 97, no. 4, 1 April 2008 (2008-04-01), pages 1499 - 1507, XP008111696, ISSN: 0022-3549 * |
PUZ MICHAEL J ET AL: "Use of the antioxidant BHT in asymmetric membrane tablet coatings to stabilize the core to the acid catalyzed peroxide oxidation of a thioether drug.", PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY 2005, vol. 10, no. 1, 2005, pages 115 - 125, XP002546552, ISSN: 1083-7450 * |
WATERMAN ET AL.: "N-methylation and N-formylation of a secondary amine drug (varenicline) in an osmotic tablet", J PHARM SCI, vol. 97, no. 4, 21 August 2007 (2007-08-21), pages 1499 - 1507, XP002546561, Retrieved from the Internet <URL:http://www3.interscience.wiley.com/journal/115805949/abstract?CRETRY=1&SRETRY=0> [retrieved on 20090909] * |
Also Published As
Publication number | Publication date |
---|---|
WO2009034431A2 (en) | 2009-03-19 |
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