DELAYED RELEASE RASAGILINE FORMULATION

摘要

PROBLEM TO BE SOLVED: To provide formulations of rasagiline base which are designed to delay release of rasagiline while maintaining specific pharmacokinetic properties on R(+)-N-propargyl-1-aminoindan (rasagiline) known as a selective inhibitor of the B-form of the enzyme monoamine oxidase.SOLUTION: The invention provides a stable oral dosage form containing a core having a rasagiline base in a form derived from a production process and at least one kind of pharmaceutically acceptable excipient, and an acid resistant pharmaceutically acceptable coating. The production process comprises a) preparing the core by mixing rasagiline base, citric acid and/or malic acid, and a pharmaceutically acceptable excipient; and b) coating the core with the acid resistant pharmaceutically acceptable coating.