CA2417686A1 - Manufacture of oral dosage forms delivering both immediate release and sustained release drugs - Google Patents

Manufacture of oral dosage forms delivering both immediate release and sustained release drugs Download PDF

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Publication number
CA2417686A1
CA2417686A1 CA002417686A CA2417686A CA2417686A1 CA 2417686 A1 CA2417686 A1 CA 2417686A1 CA 002417686 A CA002417686 A CA 002417686A CA 2417686 A CA2417686 A CA 2417686A CA 2417686 A1 CA2417686 A1 CA 2417686A1
Authority
CA
Canada
Prior art keywords
release
drug
immediate
prolonged
manufacture
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
CA002417686A
Other languages
French (fr)
Other versions
CA2417686C (en
Inventor
Jong Lim
John N. Shell
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.)
Assertio Therapeutics Inc
Original Assignee
Depomed 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 Depomed Inc filed Critical Depomed Inc
Publication of CA2417686A1 publication Critical patent/CA2417686A1/en
Application granted granted Critical
Publication of CA2417686C publication Critical patent/CA2417686C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Abstract

A method is disclosed for manufacturing a pharmaceutical tablet for oral administration, the tablet combining both immediate-release and prolonged-release modes of drug delivery and using an immediate-release drug that is either insoluble in water or only sparingly soluble and is present in a very small amount compared to the prolonged-release drug. The method involves the use of particles of the immediate-release drug that are equal to or less than 10 microns in diameter, applied as a layer or coating over a core of the prolonged-release drug, the layer or coating being either the drug particles themselves, applied as an aqueous suspension, or a solid mixture containing the drug in admixture with a material that disintegrates rapidly in gastric fluid. The result in both cases is a high degree of uniformity in the proportions of the immediate-release and prolonged-release drugs, uniformity that is otherwise difficult to achieve in view of the insolubility of the immediate-release drug and its relatively small amount compared to the prolonged-released drug.
CA002417686A 2002-02-01 2003-01-30 Manufacture of oral dosage forms delivering both immediate release and sustained release drugs Expired - Fee Related CA2417686C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/066,146 US6682759B2 (en) 2002-02-01 2002-02-01 Manufacture of oral dosage forms delivering both immediate-release and sustained-release drugs
US10/066,146 2002-02-01

Publications (2)

Publication Number Publication Date
CA2417686A1 true CA2417686A1 (en) 2003-08-01
CA2417686C CA2417686C (en) 2006-06-06

Family

ID=27658647

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002417686A Expired - Fee Related CA2417686C (en) 2002-02-01 2003-01-30 Manufacture of oral dosage forms delivering both immediate release and sustained release drugs

Country Status (11)

Country Link
US (1) US6682759B2 (en)
EP (1) EP1469838A4 (en)
JP (1) JP2005521674A (en)
KR (1) KR100680574B1 (en)
AU (1) AU2003207755B2 (en)
CA (1) CA2417686C (en)
IL (1) IL163205A (en)
MX (1) MXPA04007371A (en)
NZ (1) NZ534312A (en)
TW (1) TWI280141B (en)
WO (1) WO2003066028A1 (en)

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