Modified release dosage form comprising desvenlafaxine or salts thereof

摘要

The present invention refers to a modified release pharmaceutical composition comprising desvenlafaxine or salts thereof, a release rate modifying system that controls the release of active agent(s) in both acidic and basic environments. A process of making and method of using the above-described composition is also disclosed.

主权项

1. A monolayered modified release pharmaceutical comprising:Ingredient% w/wDesvenlafaxine succinate monohydrate 20-50%Hypromellose 25-60%Sodium carboxy methylcellulose  1-10%Microcrystalline cellulose 11-20%Talc 0.5-2%Magnesium stearate 0.5-5% wherein the monolayered pharmaceutical composition is devoid of any functional coating; and wherein the composition exhibits a dissolution profile such that at least 75% of the Desvenlafaxine is released within 20 hours, wherein the release rate is measure in Apparatus-I (USP, Dissolution, Basket, 100 rpm) using 900 ml, 0.9% NaCl in water at 37° C.±0.5° C.