Characterization of direct compression grades of hydroxypropyl methylcellulose (HPMC) excipient.
Controlled release tablets remain an important dosage forms for drug delivery with hydrophilic matrix tablets utilizing hydroxypropyl methylcellulose (HPMC) being one of the most common types. Novel grades of HPMC have been developed to allow this excipient to be utilized in direct compression processes or continuous manufacturing. Three direct compression (DC) grades of HPMC (K4M, K15M and K100M) were characterized and compared to their standard grade (CR) counterparts. These materials were compared across many different physical properties with a focus on powder flow using multiple techniques. Additional evaluations with Loss-In-Weight feedering at different rates were performed to assess potential advantages of these materials for continuous manufacturing. Finally, the tablet compaction characteristics for the DC and CR grades were determined.
Carl Allenspach is an Associate Director in the Development to Launch group at Bristol-Myers Squibb responsible for Business Operations and transitioning new products into manufacturing. He has spent 22 years in solids formulation development and manufacturing at Searle/Pharmacia/Pfizer, Novartis and BMS where he has been responsible for early and late stage development, scale-up and technology transfer as well as commercial support. He has been active in AAPS since 2004 with the Manufacturing Science and Engineering section and the Content Advisory Committee where he has held leadership positions. Carl holds a B.S. in Chemistry from Roosevelt University in Chicago and is currently completing his Ph.D. in Pharmaceutical Science at Rutgers University.