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WO2009034431A3 - Controlled-release dosage forms for varenicline - Google Patents

Controlled-release dosage forms for varenicline Download PDF

Info

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
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2008/002311
Other languages
French (fr)
Other versions
WO2009034431A2 (en
Inventor
Barbara Alic Johnson
Kenneth Craig Waterman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pfizer Corp Belgium
Pfizer Corp SRL
Original Assignee
Pfizer Corp Belgium
Pfizer Corp SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pfizer Corp Belgium, Pfizer Corp SRL filed Critical Pfizer Corp Belgium
Publication of WO2009034431A2 publication Critical patent/WO2009034431A2/en
Publication of WO2009034431A3 publication Critical patent/WO2009034431A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (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.
PCT/IB2008/002311 2007-09-10 2008-08-29 Controlled-release dosage forms for varenicline Ceased WO2009034431A2 (en)

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 Ceased 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 (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017119801A1 (en) * 2016-01-08 2017-07-13 주식회사 씨티씨바이오 Taste-masked and orally administered pharmaceutical preparation containing varenicline or pharmaceutically acceptable salt thereof
WO2018097629A1 (en) * 2016-11-24 2018-05-31 에스케이케미칼 주식회사 Varenicline sustained-release preparation and production 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
CN115707688B (en) * 2021-08-20 2025-05-16 威智医药股份有限公司 Impurity compounds in raw materials for preparing varenicline tartrate and preparation, application and detection methods thereof
US20230056424A1 (en) * 2021-11-05 2023-02-23 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
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
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)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
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
WO1999001121A1 (en) 1997-07-01 1999-01-14 Pfizer Inc. Sertraline salts and sustained-release dosage forms of sertraline
US6605610B1 (en) 1997-12-31 2003-08-12 Pfizer Inc Aryl fused azapolycyclic compounds
HRP20050506A2 (en) 1997-12-31 2006-03-31 Pfizer Products Inc. Aryl fused azapolycyclic compounds
MXPA03001771A (en) 2000-08-30 2003-06-04 Pfizer Prod Inc SUSTAINED RELEASE FORMULATIONS FOR GROWTH HORMONE SECRETAGOGS.
EP1243524A3 (en) 2001-03-16 2004-04-07 Pfizer Products Inc. Pharmaceutical kit for oxygen-sensitive drugs
KR20040063975A (en) 2001-11-30 2004-07-15 화이자 프로덕츠 인크. Pharmaceutical compositions of 5,7,14-triazatetracyclo[10.3.1.0(2,11).0(4,9)]-hexadeca-2(11)3,5,7,9-pentaene

Patent Citations (1)

* Cited by examiner, † Cited by third party
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)

* Cited by examiner, † Cited by third party
Title
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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