CA2306103A1 - Novel once-a-day controlled release sulfonylurea formulation - Google Patents

Novel once-a-day controlled release sulfonylurea formulation Download PDF

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Publication number
CA2306103A1
CA2306103A1 CA002306103A CA2306103A CA2306103A1 CA 2306103 A1 CA2306103 A1 CA 2306103A1 CA 002306103 A CA002306103 A CA 002306103A CA 2306103 A CA2306103 A CA 2306103A CA 2306103 A1 CA2306103 A1 CA 2306103A1
Authority
CA
Canada
Prior art keywords
controlled release
matrix
day controlled
dosage form
formulation
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.)
Granted
Application number
CA002306103A
Other languages
French (fr)
Other versions
CA2306103C (en
Inventor
Dileep Bhagwat
Donald Ii Diehl
Anand R. Baichwal
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.)
Penwest Pharmaceuticals Co
Original Assignee
Edward Mendell Co., Inc.
Dileep Bhagwat
Donald Ii Diehl
Anand R. Baichwal
Penwest Pharmaceuticals Co.
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 Edward Mendell Co., Inc., Dileep Bhagwat, Donald Ii Diehl, Anand R. Baichwal, Penwest Pharmaceuticals Co. filed Critical Edward Mendell Co., Inc.
Publication of CA2306103A1 publication Critical patent/CA2306103A1/en
Application granted granted Critical
Publication of CA2306103C publication Critical patent/CA2306103C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/64Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30Oestrogens
    • 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
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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

Abstract

This invention is directed to a novel solid matrixed controlled release, oral dosage form where the dosage form contains a therapeutically effective amount of a sulfonylurea or a salt or derivative thereof in the matrix. Further, the use of an aqueous alkalizing medium affords substantially complete bioavailability of the drug from the matrix of the tablet. The core tablets may optionally be coated with a coating material in the range of 2 % to 10 %
with an enteric material or with a water insoluble material like ethyl cellulose.
CA002306103A 1997-10-15 1998-10-15 Novel once-a-day controlled release sulfonylurea formulation Expired - Fee Related CA2306103C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/950,732 US6056977A (en) 1997-10-15 1997-10-15 Once-a-day controlled release sulfonylurea formulation
US08/950,732 1997-10-15
PCT/US1998/021752 WO1999018932A1 (en) 1997-10-15 1998-10-15 Novel once-a-day controlled release sulfonylurea formulation

Publications (2)

Publication Number Publication Date
CA2306103A1 true CA2306103A1 (en) 1999-04-22
CA2306103C CA2306103C (en) 2003-12-09

Family

ID=25490807

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002306103A Expired - Fee Related CA2306103C (en) 1997-10-15 1998-10-15 Novel once-a-day controlled release sulfonylurea formulation

Country Status (6)

Country Link
US (3) US6056977A (en)
EP (1) EP1028709A4 (en)
JP (1) JP2001519377A (en)
AU (1) AU1087799A (en)
CA (1) CA2306103C (en)
WO (1) WO1999018932A1 (en)

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EP1028709A1 (en) 2000-08-23
US20030219481A1 (en) 2003-11-27
CA2306103C (en) 2003-12-09
WO1999018932A1 (en) 1999-04-22
AU1087799A (en) 1999-05-03
US6875793B2 (en) 2005-04-05
JP2001519377A (en) 2001-10-23
US6056977A (en) 2000-05-02
US6537578B1 (en) 2003-03-25

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