Dual drug dosage forms with improved separation of drugs
AssigneeDepomed, Inc.
InventorsJong Lim, John N. Shell, Jenny Louie-Helm
Life of this patent
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Abstract
Drug tablets that include a prolonged-release core and an immediate-release layer or shell are prepared with a thin barrier layer of drug-free polymer between the prolonged-release and immediate-release portions of the tablet. The barrier layer is penetrable by gastrointestinal fluid, thereby providing full access of the gastrointestinal fluid to the prolonged-release core, but remains intact during the application of the immediate-release layer, substantially reducing or eliminating any penetration of the immediate-release drug into the prolonged-release portion.
Claims17
A method for the manufacture of a pharmaceutical tablet which upon oral ingestion delivers a first drug by immediate release and a second drug by prolonged release defined as a release rate into gastrointestinal fluid that is slow enough to leave at least about 40% of said second drug unreleased one hour after ingestion, said method comprising:
- (a) dispersing said second drug in a solid matrix to form a unitary body which upon immersion in gastrointestinal fluid releases said second drug by prolonged release, wherein said solid matrix comprises a first polymer wherein said matrix (i) swells upon imbibition of fluid to a size that promotes retention of the dosage form in a stomach;
- (ii) releases substantially all of said second drug within about 10 hours upon immersion of the dosage form in fluid;
- and (iii) remains substantially intact until substantially all of said second drug is released;
- (b) depositing on a surface of said unitary body a polymeric film that is devoid of said first drug and said second drug, wherein said polymeric film adheres to a surface of said solid matrix and wherein said polymeric film comprises a second polymer having a molecular weight which is lower than the molecular weight of said first polymer and is dissolved in gastrointestinal fluid upon ingestion, wherein the ratio of said polymeric film to unitary body is from about 0.005:1 to about 0.2:1;
- (c) depositing over said polymeric film a fluid medium comprising said first drug and a liquid carrier that does not remove said polymeric film upon contact therewith;
- and
- (d) evaporating said liquid carrier from said fluid medium thus deposited to leave a solid layer containing said first drug over said unitary body, wherein said solid layer adheres to said polymeric film, and wherein said solid layer provides immediate release of said first drug upon immersion of the dosage form in fluid.
Dependencies are inferred from the claim text.