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US 8,945,619 B2Granted
Shell-and-core dosage form approaching zero-order drug release
AssigneeDepomed, Inc.
InventorsBret Berner, Jenny Louie-Helm, Gloria Gusler, John N. Shell
Life of this patent
Estimating the term…
Abstract
Drugs are formulated as oral dosage forms for controlled release in which the release rate limiting portion is a shell surrounding the drug-containing core. The shell releases drug from the core by permitting diffusion of the drug from the core. The shell also motes gastric retention of the dosage form by swelling upon imbibition of gastric fluid to size that is retained in the stomach during the postprandial or fed mode.
Claims23
A controlled-release oral drug dosage form for releasing a drug, comprising:
- (a) a core comprising a first polymeric matrix with said drug dispersed therein, and
- (b) a shell encasing said core, said shell comprising a second polymeric matrix having a drug:polymer weight ratio that is less than that of said core, the second matrix being a material and thickness relative to the core such that when the dosage form is immersed in gastric fluid, the drug is released from the dosage form into the gastric fluid at a controlled rate by diffusion of the drug through the shell during substantially the entire period of drug release such that at least about 40% of said drug remains unreleased one hour after such immersion has begun, said shell remaining intact during substantially the entire period of drug release.
Dependencies are inferred from the claim text.