Controlled Release Dosage Form Containing Lercanidipine and a Performance-enhancing Acid
AssigneeOsmotica Corp.
InventorsEsteban A. Abalo, Marcelo A. Ricci, Glenn A. Meyer, Pablo F. A. Carraud
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Abstract
A controlled release dosage form containing lercanidipine, or a salt thereof, a performance-enhancing acid, and at least one other pharmaceutical excipient exhibits enhanced in vitro dissolution of lercanidipine, enhanced storage stability based upon the reduced degradation of lercanidipine, and/or enhanced in vivo bioavailability of lercanidipine as compared to an otherwise similar controlled release dosage form excluding the performance-enhancing acid but containing the same amount of lercanidipine.
Claims35
An osmotic device comprising:
- 1) a core comprising lercanidipine, or a pharmaceutically acceptable salt thereof, a performance-enhancing acid, and one or more other pharmaceutical excipients;
- and 2) a wall enveloping the core and comprising at least one preformed passageway, wherein the device provides a controlled release of lercanidipine over a period of 8-36 hours.
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Dependencies are inferred from the claim text.