Physico-mechanical Characterization and Evaluation of Directly Compressible Grades of Hypromellose
Jan. 1, 2011, midnight
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A new variant of HPMC, Benecel™ PH DC HPMC, has been developed to facilitate the creation of robust, scalable, and directly compressible matrix tablet formulations. HPMC K100M DC exhibits notably enhanced powder flow characteristics, as assessed by Johanson Indicizer and Brookfield powder flow testing procedures. This improved flow is attributed to significantly reduced cohesion forces compared to the standard controlled-release grade of Benecel™ PH HPMC K100M CR. The decreased cohesiveness also translates into improved powder flow for directly compressible formulations containing metformin HCl and quetiapine fumarate, incorporating HPMC at levels ranging from 25% to 60%.
In typical metformin matrix tablet formulations, those comprising HPMC K100M DC demonstrate a 30% increase in tablet strength when compressed at commercial tablet production rates. The content uniformity of these tablets consistently meets the USP-mandated threshold acceptance value of 15. Dissolution profiles and tablet strengths for quetiapine formulations prepared via wet granulation using standard HPMC K100M CR and through direct compression using HPMC K100M DC were similar. However, the HPMC K100M DC powder blend exhibited significantly enhanced powder flow compared to the wet granulated formulation.