Gastric retentive dosage forms for extended release of acamprosate into the upper gastrointestinal tract
AssigneeDepomed, Inc.
InventorsBret Berner, Cuiping Chen
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Abstract
Gastric retentive dosage forms for sustained release of acamprosate are described which may allow once- or twice-daily dosing for both acute and long-term treatment of a disorder including alcohol dependence, tinnitus, sleep apnea, Parkinson's disease, levodopa-induced dyskinesias in Parkinson's disease, Alzheimer's disease, Huntington's disease, Amyotrophic lateral sclerosis, Cortical spreading depression, migraine, schizophrenia, anxiety, tardive dyskinesia, spasticity, multiple sclerosis, various types pain, or binge eating. Methods of treatment using the dosage forms and methods of making the dosage forms are also described.
Claims15
A method for treating a subject in need thereof comprising administering to the subject a total daily dose of about 300 mg to 2500 mg acamprosate or a pharmaceutically acceptable salt thereof dispersed in a polymeric matrix wherein the polymeric matrix comprises one or more polymers that upon imbibition of fluid swells to a size sufficient to promote gastric retention, wherein upon administration to the subject, the gastric retentive dosage form provides a mean AUC of plasma acamprosate which is at least 50% greater than the mean AUC of plasma acamprosate provided by an immediate release (IR) dosage form which contains a dose of acamprosate or pharmaceutically acceptable salt thereof equal to or more than the dose of acamprosate in the gastric retentive dosage form;
- wherein the subject is suffering from a disorder selected from the group consisting of alcohol dependence, tinnitus, levodopa-induced dyskinesias in Parkinson's disease, Huntington's disease, and tardive dyskinesia.
Dependencies are inferred from the claim text.