Comment
Author: Admin | 2025-04-28
The composition is at least 1:40. In a preferred embodiment, the ratio of riociguat:release controlling material:diluent in the composition is at least 1:20:40. the present invention relates to, a glidant free extended release pharmaceutical tablet composition a glidant free extended release pharmaceutical tablet composition comprising: a) riociguat in an amount of about 0.01% to about 10% by weight, b) hydroxypropyl methylcellulose and/or ethyl cellulose in an amount of about 25% to about 35% by weight, c) microcrystalline cellulose in an amount of at least about 25% by weight, d) polyvinylpyrrolidone in an amount of at least about 1% by weight; and e) magnesium stearate in an amount of at least about 0.1% by weight, wherein the composition exhibits at least 10% drug release in 4 hours, at least 15% drug release in 6 hours, at least 20% drug release in 8 hours, and at least 40% drug release in 12 hours when measured in 900 ml of 6.8 phosphate buffer and 0.1% sodium lauryl sulfate (SLS) using a USP II apparatus (Paddle) at a temperature of 37 ⁇ 0.5° C. the present invention relates to an extended release solid oral pharmaceutical composition of riociguat comprising: the inner core is an inert non-pareil sugar sphere. the core is devoid of any cellulose-based excipients. the core is devoid of microcrystalline cellulose. the drug and binder is present in a ratio less than 1:3 or less than 1:2. the drug and binder is in a ratio of 1:1. the controlled release polymer has a viscosity of less than 10 cps. the controlled release polymer has a viscosity of less than 10 cps. the controlled release polymer is ethyl cellulose having a viscosity of 7 cps. the controlled release polymer is used in about 20% weight gain or less, about 10% weight gain or less by the total weight of the core or drug layered composition. In a preferred embodiment, the controlled release polymer is used in about 5% weight gain or less by the total weight of core or drug layered composition. In a preferred embodiment, the composition is free of any glidant. In a preferred embodiment, the multi-particulate delivery system contains particles having a mean diameter of about 400 to about 1200 microns. the oral pharmaceutical composition is in the form of a tablet or capsule, wherein the ratio of riociguat to a release controlling polymer in the composition ranges from about 1:1 to about 1:50. In particular, the ratio of riociguat to release modifying polymer in the composition is about 1:1 to about 1:40. the ratio of riociguat to release modifying polymer in the composition is about 1:1 to about 1:20. the ratio of riociguat to binder in the composition ranges
Add Comment