WO2003047529A3 - Extended release pharmaceutical tablet of metformin - Google Patents

Extended release pharmaceutical tablet of metformin Download PDF

Info

Publication number
WO2003047529A3
WO2003047529A3 PCT/US2002/038599 US0238599W WO03047529A3 WO 2003047529 A3 WO2003047529 A3 WO 2003047529A3 US 0238599 W US0238599 W US 0238599W WO 03047529 A3 WO03047529 A3 WO 03047529A3
Authority
WO
WIPO (PCT)
Prior art keywords
metformin
extended release
release pharmaceutical
released
hours
Prior art date
Application number
PCT/US2002/038599
Other languages
French (fr)
Other versions
WO2003047529A2 (en
Inventor
Pawan Seth
Benoit Schmidtt
Original Assignee
Biovail Lab Inc
Pawan Seth
Benoit Schmidtt
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
Priority to AT02794129T priority Critical patent/ATE460157T1/en
Priority to MXPA04005667A priority patent/MXPA04005667A/en
Priority to EP02794129A priority patent/EP1460998B1/en
Priority to CA002470747A priority patent/CA2470747C/en
Priority to NZ533857A priority patent/NZ533857A/en
Priority to HU0500004A priority patent/HU229962B1/en
Application filed by Biovail Lab Inc, Pawan Seth, Benoit Schmidtt filed Critical Biovail Lab Inc
Priority to DE60235648T priority patent/DE60235648D1/en
Priority to AU2002359582A priority patent/AU2002359582C1/en
Publication of WO2003047529A2 publication Critical patent/WO2003047529A2/en
Publication of WO2003047529A3 publication Critical patent/WO2003047529A3/en
Priority to NO20042822A priority patent/NO333929B1/en
Priority to NO20130984A priority patent/NO20130984L/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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 compounds

Abstract

The invention provides an extended release pharmaceutical tablet containing: (i) a core comprising by weight, based on the core weight, about 70% to about 99% metformin and pharmaceutically acceptable excipients; and (ii) a coating permeable to metformin. The extended release tablet of the invention exhibit a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released; after about 4 hours, from about 15% to about 90% of the metformin is released; after about 8 hours, from about 50% to about 100% of the metformin is released; after about 12 hours, more than about 75% of the metformin is released.
PCT/US2002/038599 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin WO2003047529A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
MXPA04005667A MXPA04005667A (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin.
EP02794129A EP1460998B1 (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin
CA002470747A CA2470747C (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin
NZ533857A NZ533857A (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin
HU0500004A HU229962B1 (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin
AT02794129T ATE460157T1 (en) 2001-12-04 2002-12-04 EXTENDED-RELEASE PHARMACEUTICAL METFORMINT TABLET
DE60235648T DE60235648D1 (en) 2001-12-04 2002-12-04 PHARMACEUTICAL METFORMING TABLET WITH EXTENDED RELEASE
AU2002359582A AU2002359582C1 (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin
NO20042822A NO333929B1 (en) 2001-12-04 2004-07-02 Extended release - Pharmaceutical tablet of metformin
NO20130984A NO20130984L (en) 2001-12-04 2013-07-16 Extended release - Pharmaceutical tablet of metformin

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/005,387 US20030118647A1 (en) 2001-12-04 2001-12-04 Extended release tablet of metformin
US10/005,387 2001-12-04

Publications (2)

Publication Number Publication Date
WO2003047529A2 WO2003047529A2 (en) 2003-06-12
WO2003047529A3 true WO2003047529A3 (en) 2003-10-30

Family

ID=21715581

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/038599 WO2003047529A2 (en) 2001-12-04 2002-12-04 Extended release pharmaceutical tablet of metformin

Country Status (12)

Country Link
US (3) US20030118647A1 (en)
EP (1) EP1460998B1 (en)
AT (1) ATE460157T1 (en)
AU (1) AU2002359582C1 (en)
CA (1) CA2470747C (en)
DE (1) DE60235648D1 (en)
ES (1) ES2338536T3 (en)
HU (1) HU229962B1 (en)
MX (1) MXPA04005667A (en)
NO (2) NO333929B1 (en)
NZ (1) NZ533857A (en)
WO (1) WO2003047529A2 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8911781B2 (en) 2002-06-17 2014-12-16 Inventia Healthcare Private Limited Process of manufacture of novel drug delivery system: multilayer tablet composition of thiazolidinedione and biguanides
US9060941B2 (en) 2002-09-20 2015-06-23 Actavis, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1322158B1 (en) * 2000-10-02 2012-08-08 USV Ltd. Sustained release pharmaceutical compositions containing metformin and method of their production
KR200249057Y1 (en) * 2001-03-22 2001-10-19 김진환 Sewage backflow integrated into the lid and base. Odor Prevention Device
CA2476201C (en) * 2002-02-21 2009-09-01 Biovail Laboratories Incorporated Modified release formulations of at least one form of tramadol
US8323692B2 (en) 2002-02-21 2012-12-04 Valeant International Bermuda Controlled release dosage forms
US7785627B2 (en) * 2002-09-20 2010-08-31 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US8084058B2 (en) 2002-09-20 2011-12-27 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US7959946B2 (en) 2002-09-20 2011-06-14 Watson Pharmaceuticals, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
WO2005123134A2 (en) * 2004-05-14 2005-12-29 Cadila Healthcare Limited A controlled release delivery system for metformin
US20060024362A1 (en) 2004-07-29 2006-02-02 Pawan Seth Composition comprising a benzimidazole and process for its manufacture
CA2588296A1 (en) 2004-11-24 2006-06-01 Neuromolecular Pharmaceuticals, Inc. Composition comprising an nmda receptor antagonist and levodopa and use thereof for treating neurological disease
KR100780553B1 (en) * 2005-08-18 2007-11-29 한올제약주식회사 Pharmaceutical compositions and formulations of Metformin extended release tablets and its preparing method
KR100858848B1 (en) * 2006-05-23 2008-09-17 한올제약주식회사 Pharmaceutical compositions and formulations of Metformin extended release tablets
CA2706596A1 (en) * 2007-11-23 2009-05-28 Protect Pharmaceutical Corporation Tapentadol compositions
WO2010026467A2 (en) * 2008-09-04 2010-03-11 Torrent Pharmaceuticals Ltd. Controlled release dosage form of high solubility active ingredient
EP2506709B2 (en) * 2009-12-02 2019-10-09 Adamas Pharmaceuticals, Inc. Amantadine compositions and methods of use
JP5819329B2 (en) * 2010-03-09 2015-11-24 アルカーメス ファーマ アイルランド リミテッド Alcohol-resistant enteric pharmaceutical composition
WO2014204933A1 (en) 2013-06-17 2014-12-24 Adamas Pharmaceuticals, Inc. Amantadine compositions and methods of use
CN103622930B (en) * 2013-12-19 2015-06-10 石家庄市华新药业有限责任公司 Metformin hydrochloride slow release preparation and preparation method thereof
WO2016042567A1 (en) * 2014-09-16 2016-03-24 Suresh Pareek Extended release formulation of metformin

Citations (2)

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US6099859A (en) * 1998-03-20 2000-08-08 Andrx Pharmaceuticals, Inc. Controlled release oral tablet having a unitary core
US6350471B1 (en) * 2000-05-31 2002-02-26 Pharma Pass Llc Tablet comprising a delayed release coating

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US2001A (en) * 1841-03-12 Sawmill
US4721709A (en) * 1984-07-26 1988-01-26 Pyare Seth Novel pharmaceutical compositions containing hydrophobic practically water-insoluble drugs adsorbed on pharmaceutical excipients as carrier; process for their preparation and the use of said compositions
US4892742A (en) * 1985-11-18 1990-01-09 Hoffmann-La Roche Inc. Controlled release compositions with zero order release
CH672888A5 (en) * 1986-11-07 1990-01-15 Mepha Ag
CH668553A5 (en) * 1987-02-02 1989-01-13 Mepha Ag MEDICINAL PRODUCTS WITH DELAYED RELEASE OF THE ACTIVE SUBSTANCE.
US5202128A (en) * 1989-01-06 1993-04-13 F. H. Faulding & Co. Limited Sustained release pharmaceutical composition
US5472712A (en) * 1991-12-24 1995-12-05 Euroceltique, S.A. Controlled-release formulations coated with aqueous dispersions of ethylcellulose
US5451409A (en) * 1993-11-22 1995-09-19 Rencher; William F. Sustained release matrix system using hydroxyethyl cellulose and hydroxypropyl cellulose polymer blends
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DE4432757A1 (en) * 1994-09-14 1996-03-21 Boehringer Mannheim Gmbh Pharmaceutical preparation containing metformin and process for its preparation
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US6096341A (en) * 1998-10-30 2000-08-01 Pharma Pass Llc Delayed release tablet of bupropion hydrochloride
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US6338857B1 (en) * 2000-05-26 2002-01-15 Pharma Pass Llc Sustained release carbamazepine pharmaceutical composition free of food effect and a method for alleviating food effect in drug release
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Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6099859A (en) * 1998-03-20 2000-08-08 Andrx Pharmaceuticals, Inc. Controlled release oral tablet having a unitary core
US6350471B1 (en) * 2000-05-31 2002-02-26 Pharma Pass Llc Tablet comprising a delayed release coating

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8911781B2 (en) 2002-06-17 2014-12-16 Inventia Healthcare Private Limited Process of manufacture of novel drug delivery system: multilayer tablet composition of thiazolidinedione and biguanides
US9060941B2 (en) 2002-09-20 2015-06-23 Actavis, Inc. Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative

Also Published As

Publication number Publication date
WO2003047529A2 (en) 2003-06-12
AU2002359582B2 (en) 2007-01-18
ES2338536T3 (en) 2010-05-10
NO20042822L (en) 2004-08-26
US20040161461A1 (en) 2004-08-19
EP1460998B1 (en) 2010-03-10
HU229962B1 (en) 2015-03-30
HUP0500004A3 (en) 2012-09-28
CA2470747C (en) 2009-07-28
NO20130984L (en) 2004-08-26
NO333929B1 (en) 2013-10-21
HUP0500004A2 (en) 2005-04-28
AU2002359582A1 (en) 2003-06-17
US20030118647A1 (en) 2003-06-26
EP1460998A4 (en) 2005-09-14
DE60235648D1 (en) 2010-04-22
NZ533857A (en) 2007-05-31
ATE460157T1 (en) 2010-03-15
EP1460998A2 (en) 2004-09-29
CA2470747A1 (en) 2003-06-12
MXPA04005667A (en) 2005-06-17
AU2002359582C1 (en) 2008-11-13
US20030170302A1 (en) 2003-09-11

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