WO2009034431A2 - Formes posologiques à libération contrôlée de la varenicline - Google Patents

Formes posologiques à libération contrôlée de la varenicline Download PDF

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Publication number
WO2009034431A2
WO2009034431A2 PCT/IB2008/002311 IB2008002311W WO2009034431A2 WO 2009034431 A2 WO2009034431 A2 WO 2009034431A2 IB 2008002311 W IB2008002311 W IB 2008002311W WO 2009034431 A2 WO2009034431 A2 WO 2009034431A2
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
varenicline
pharmaceutically acceptable
coating
antioxidant
Prior art date
Application number
PCT/IB2008/002311
Other languages
English (en)
Other versions
WO2009034431A3 (fr
Inventor
Barbara Alic Johnson
Kenneth Craig Waterman
Original Assignee
Pfizer Inc.
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 Inc. filed Critical Pfizer Inc.
Publication of WO2009034431A2 publication Critical patent/WO2009034431A2/fr
Publication of WO2009034431A3 publication Critical patent/WO2009034431A3/fr

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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

Abstract

L'invention porte sur une composition pharmaceutique à libération contrôlée de la varenicline ou d'un sel pharmaceutiquement acceptable de cette dernière, ladite composition pharmaceutique à libération contrôlée comprenant un enrobage et un antioxydant, l'antioxydant étant présent dans une quantité égale à un pourcentage en poids compris entre environ 0,1% et 55 de la couche d'enrobage.
PCT/IB2008/002311 2007-09-10 2008-08-29 Formes posologiques à libération contrôlée de la varenicline WO2009034431A2 (fr)

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 true WO2009034431A2 (fr) 2009-03-19
WO2009034431A3 WO2009034431A3 (fr) 2009-11-19

Family

ID=40032575

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/002311 WO2009034431A2 (fr) 2007-09-10 2008-08-29 Formes posologiques à libération contrôlée de la varenicline

Country Status (1)

Country Link
WO (1) WO2009034431A2 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017119801A1 (fr) * 2016-01-08 2017-07-13 주식회사 씨티씨바이오 Préparation pharmaceutique à usage oral et goût masqué contenant de la varénicline ou un sel pharmaceutiquement acceptable de celle-ci
WO2018097629A1 (fr) * 2016-11-24 2018-05-31 에스케이케미칼 주식회사 Préparation à libération prolongée de varénicline et procédé pour sa production
WO2018149979A1 (fr) 2017-02-17 2018-08-23 Soederpalm Bo Traitement d'un trouble lié à la consommation d'alcool
WO2018154395A2 (fr) 2018-06-11 2018-08-30 Alvogen Malta Operations (Row) Ltd Composition pharmaceutique à libération contrôlée de varénicline
KR102235848B1 (ko) * 2019-11-20 2021-04-05 충북대학교 산학협력단 바레니클린 또는 이의 약학적으로 허용가능한 염의 지연 방출용 정제
CN114088843A (zh) * 2021-11-26 2022-02-25 上海皓鸿生物医药科技有限公司 一种伐伦克林中间体中亚硝胺类基因毒性杂质的检测方法
WO2022271600A1 (fr) * 2021-06-25 2022-12-29 Handa Pharma, Inc. Formes posologiques stables de varénicline
WO2023275413A3 (fr) * 2021-12-23 2023-03-09 Medichem, S.A. Formulations pharmaceutiques solides de varénicline
WO2023012376A3 (fr) * 2021-11-05 2023-03-16 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Prévention de la conversion d'agents pharmaceutiques en composés de n-nitrosamine toxiques
EP4169516A1 (fr) * 2021-11-05 2023-04-26 Alfred E. Tiefenbacher (GmbH & Co. KG) Prévention de la conversion d'agents pharmaceutiques en composés n-nitrosamine toxiques
WO2023085503A1 (fr) * 2021-11-11 2023-05-19 주식회사 아울바이오 Microsphères comprenant de la varénicline à dose élevée, leur procédé de préparation et composition pharmaceutique les comprenant

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4093105A (en) 1977-10-19 1978-06-06 N. T. Gates Company Plastic container with vent means
US4111202A (en) 1976-11-22 1978-09-05 Alza Corporation Osmotic system for the controlled and delivery of agent over time
US5612059A (en) 1988-08-30 1997-03-18 Pfizer Inc. Use of asymmetric membranes in delivery devices
WO1999001121A1 (fr) 1997-07-01 1999-01-14 Pfizer Inc. Sels de sertraline et formes posologiques de sertraline, a liberation prolongee
WO1999035131A1 (fr) 1997-12-31 1999-07-15 Pfizer Products Inc. Composes azapolycycliques fusionnes avec un aryle
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
WO2001062736A1 (fr) 2000-02-25 2001-08-30 Pfizer Products Inc. Composes azapolycycliques a fusion aryle
WO2002017918A2 (fr) 2000-08-30 2002-03-07 Pfizer Products Inc. Formulations a liberation prolongee pour les secretagogues de l'hormone de croissance
WO2003045437A1 (fr) 2001-11-30 2003-06-05 Pfizer Products Inc. Compositions pharmaceutiques de 5,7,14-triazatetracyclo[10.3.1.0(2,11).0(4,9)]-hexadeca-2(11)3,5,7,9-pentaene
US6688468B2 (en) 2001-03-16 2004-02-10 Pfizer Inc. Pharmaceutical kit for oxygen-sensitive drugs
US20040235850A1 (en) 2003-05-20 2004-11-25 Pfizer Inc Pharmaceutical compositions of varenicline

Patent Citations (13)

* 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
US5698220A (en) 1988-08-30 1997-12-16 Pfizer Inc. 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 (fr) 1997-07-01 1999-01-14 Pfizer Inc. Sels de sertraline et formes posologiques de sertraline, a liberation prolongee
WO1999035131A1 (fr) 1997-12-31 1999-07-15 Pfizer Products Inc. Composes azapolycycliques fusionnes avec un aryle
US6410550B1 (en) 1997-12-31 2002-06-25 Pfizer Inc Aryl fused azapolycyclic compounds
WO2001062736A1 (fr) 2000-02-25 2001-08-30 Pfizer Products Inc. Composes azapolycycliques a fusion aryle
WO2002017918A2 (fr) 2000-08-30 2002-03-07 Pfizer Products Inc. Formulations a liberation prolongee pour les secretagogues de l'hormone de croissance
US6688468B2 (en) 2001-03-16 2004-02-10 Pfizer Inc. Pharmaceutical kit for oxygen-sensitive drugs
WO2003045437A1 (fr) 2001-11-30 2003-06-05 Pfizer Products Inc. Compositions pharmaceutiques de 5,7,14-triazatetracyclo[10.3.1.0(2,11).0(4,9)]-hexadeca-2(11)3,5,7,9-pentaene
US20040235850A1 (en) 2003-05-20 2004-11-25 Pfizer Inc Pharmaceutical compositions of varenicline

Non-Patent Citations (10)

* Cited by examiner, † Cited by third party
Title
G. SANTUS; R. W. BAKER, J. CONTROL. REL., vol. 35, 1995, pages 1 - 21
J. MARCH: "Advanced Organic Chemistry", 1992, pages: 898 - 900
J.T. CARSTENSEN: "Drug Stability: Principles and Practices", 1995, MARCEL DEKKER, pages: 449 - 452
K. WATERMAN ET AL., PHARM DEV. TECH., vol. 7, no. 2, 2002, pages 113 - 146
K. WATERMAN ET AL., PHARM. DEV. TECH., vol. 7, no. 1, 2002, pages 1 - 32
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY, vol. 1, 2005, pages 115 - 125
R. L. DOBSON, J. PACKAGING TECHNOL., vol. 1, 1987, pages 127 - 131
R. M. CAIN: "Induction Sealing Guidelines", 1995, KERR GROUP, INC.
S.M. HERBIG, J. CONTROL. REI., vol. 35, 1995, pages 127 - 136
W. F. ZITO: "Unraveling the Myths and Mysteries of Induction Sealing", J. PACKAGING TECH., 1990

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017119801A1 (fr) * 2016-01-08 2017-07-13 주식회사 씨티씨바이오 Préparation pharmaceutique à usage oral et goût masqué contenant de la varénicline ou un sel pharmaceutiquement acceptable de celle-ci
WO2018097629A1 (fr) * 2016-11-24 2018-05-31 에스케이케미칼 주식회사 Préparation à libération prolongée de varénicline et procédé pour sa production
KR20180127951A (ko) * 2016-11-24 2018-11-30 에스케이케미칼 주식회사 바레니클린 서방성 제제 및 이의 제조 방법
KR102479497B1 (ko) 2016-11-24 2022-12-20 에스케이케미칼 주식회사 바레니클린 서방성 제제 및 이의 제조 방법
WO2018149979A1 (fr) 2017-02-17 2018-08-23 Soederpalm Bo Traitement d'un trouble lié à la consommation d'alcool
WO2018154395A2 (fr) 2018-06-11 2018-08-30 Alvogen Malta Operations (Row) Ltd Composition pharmaceutique à libération contrôlée de varénicline
KR102235848B1 (ko) * 2019-11-20 2021-04-05 충북대학교 산학협력단 바레니클린 또는 이의 약학적으로 허용가능한 염의 지연 방출용 정제
WO2022271600A1 (fr) * 2021-06-25 2022-12-29 Handa Pharma, Inc. Formes posologiques stables de varénicline
EP4169516A1 (fr) * 2021-11-05 2023-04-26 Alfred E. Tiefenbacher (GmbH & Co. KG) Prévention de la conversion d'agents pharmaceutiques en composés n-nitrosamine toxiques
WO2023012376A3 (fr) * 2021-11-05 2023-03-16 Alfred E. Tiefenbacher (Gmbh & Co. Kg) Prévention de la conversion d'agents pharmaceutiques en composés de n-nitrosamine toxiques
WO2023085503A1 (fr) * 2021-11-11 2023-05-19 주식회사 아울바이오 Microsphères comprenant de la varénicline à dose élevée, leur procédé de préparation et composition pharmaceutique les comprenant
CN114088843A (zh) * 2021-11-26 2022-02-25 上海皓鸿生物医药科技有限公司 一种伐伦克林中间体中亚硝胺类基因毒性杂质的检测方法
CN114088843B (zh) * 2021-11-26 2024-01-30 上海皓鸿生物医药科技有限公司 一种伐伦克林中间体中亚硝胺类基因毒性杂质的检测方法
WO2023275413A3 (fr) * 2021-12-23 2023-03-09 Medichem, S.A. Formulations pharmaceutiques solides de varénicline

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Publication number Publication date
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