Lercanidipine immediate release compositions
AssigneeForest Laboratories, Inc.
InventorsMahendra Dedhiya, Suneel Rastogi, Anil Chhettry
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Abstract
The present invention provides an immediate release composition for the low solubility drug, lercanidipine. The immediate release composition of the present invention comprises a core; a first layer, comprising lercanidipine, a surfactant and a binder, and optionally, a second layer comprising a film coating.
Claims44
An immediate release solid dosage form comprising about 1 mg to 80 mg of lercanidpine wherein the solid oral dosage form has an in vitro release rate for the lercanidipine of more than about 80% within about the first 60 minutes following entry of the solid oral dosage form into a use environment and wherein the solid oral dosage form exhibits an average Tmax within the range of about 0.5 hour to about hours 4 hours after entry of the solid dosage form into a use environment.
An immediate release pharmaceutical composition comprising:
- (a) an inert core;
- (b) a first layer substantially enveloping the core, comprising lercanidipine, a surfactant and a binder;
- and
- (c) optionally comprising a second layer comprising an additional film coating.
An immediate release oral dosage form comprising a plurality of immediate release lercanidipine beads, the immediate release beads comprising (i) lercanidipine, (ii) a core, (iii) a surfactant, (iv) a binder, and (iv) optionally, an additional film coating.
A method of treating hypertension in a patient in need thereof comprising orally administering an immediate release lercanidipine dosage form comprising (i) an inner core, (ii) a first layer comprising lercanidipine, a surfactant and a binder, and (iii) optionally, an additional film coating.
A pharmaceutical composition comprising beads, wherein each bead comprises:
- (a) a core;
- (b) a first layer substantially enveloping the core, comprising lercanidipine, a surfactant and a binder, and
- (c) optionally, a second layer comprising a film coating,
- wherein the dissolution rate of the lercanidipine in vitro is from about 50 to about 60% (by weight) dissolved within a period of about 15 minutes, from about 60 to about 70% (by weight) dissolved within a period of about 30 minutes and from about 70 to about 90% (by weight) dissolved within a period of about 45 minutes.
An immediate release oral dosage form comprising a plurality of immediate release lercanidipine beads, the immediate release beads comprising (i) lercanidipine, (ii) a core, (iii) a surfactant, (iv) a binder, and (iv) optionally, a film coating.
Dependencies are inferred from the claim text.