Modified release composition of at least one form of venlafaxine
AssigneeBiovail Laboratories International S.R.L.
InventorsFang Zhou, Paul Maes, Steven Frisbee
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Abstract
The present invention relates to a modified release composition of at least one form of venlafaxine, which is an enhanced absorption delayed controlled release composition. The composition comprises a core comprising at least one form of venlafaxine, less than 10% of a gelling agent and a pharmaceutically acceptable excipient. The composition further comprises a modified release coating which substantially surrounds the core which provides a delayed controlled release of the at least one form of venlafaxine.
Claims20
An enhanced absorption delayed controlled release pharmaceutical composition for oral administration suitable for once daily dosing comprising:
- a) a core comprising by weight of the core dry weight from about 10% to about 90% of at least one form of venlafaxine, less than 10% of a gelling agent, and optional conventional excipients;
- wherein the gelling agent comprises hydroxypropylmethylcellulose and polyvinyl alcohol;
- and
- b) a modified release coat substantially surrounding the core, the coat comprising at least one water-insoluble, water-permeable, film-forming polymer, at least one water-soluble polymer or substance and at least one plasticizer;
- wherein the composition provides a delayed controlled release of the at least one form of venlafaxine such that no more that 25% of the at least one form of venlafaxine is released after about 2 hours, about 15% to about 45% of the at least one form of venlafaxine is released after about 4 hours, about 50% to about 90% of the at least one form of venlafaxine is released after about 8 hours, no less than about 70% of the at least one form of venlafaxine is released after about 12 hours and no less than about 80% of the at least one form of venlafaxine is released after about 16 hours when tested using USP Apparatus 1 in 1000 ml of pH 6.8 phosphate buffer at 75 rpm at 37° C.±0.5° C.
An enhanced absorption delayed controlled release pharmaceutical composition for oral administration suitable for once daily dosing comprising:
- a) a core comprising by weight of the core dry weight from about 10% to about 90% of at least one form of venlafaxine, less than 10% of a gelling agent, and optional conventional excipients;
- and
- b) a modified release coat substantially surrounding the core, the coat comprising at least one water-insoluble, water-permeable, film-forming polymer, at least one water-soluble polymer or substance and at least one plasticizer;
- wherein the composition provides a delayed controlled release of the at least one form of venlafaxine such that no more that 25% of the at least one form of venlafaxine is released after about 2 hours, about 15% to about 45% of the at least one form of venlafaxine is released after about 4 hours, about 50% to about 90% of the at least one form of venlafaxine is released after about 8 hours, no less than about 70% of the at least one form of venlafaxine is released after about 12 hours and no less than about 80% of the at least one form of venlafaxine is released after about 16 hours when tested using USP Apparatus 1 in 1000 ml of pH 6.8 phosphate buffer at 75 rpm at 37° C.±0.5° C.;
- and
- wherein the composition shows a reduced ethanol-induced dose dumping effect compared to a reference composition, wherein the reference composition is a commercially available extended release formulation of venlafaxine.
Dependencies are inferred from the claim text.