Effects of Manufacturing Process Variables on In Vitro Dissolution Characteristics of Extended-Release Tablets Formulated with Hydroxypropyl Methylcellulose

摘要: The purpose of this study was to investigate the effect three process variables: distribution hydroxypropyl methylcellulose (HPMC) within tablet matrix, amount water for granulation, and hardness on drug release from hydrophilic matrix tablets. Tablets were made both by direct compression as well wet granulation method. Three formulations all having exact same composition but differing in intragranular:intergranular HPMC matrix. Further, each formulation using two different amounts granulation. All tablets then compressed at levels. Dissolution studies performed USP dissolution apparatus I (basket). parameters obtained statistically analyzed a multilevel factorial-design approach influence various variables Results indicated that change manufacturing could yield significantly dissimilar profiles formulation, especially low-hardness level. Overgranulation lead showing hardness-dependent drug-release characteristics. Studies showed intergranular addition partial (i.e., outside granules) provided significant advantage making more robust over intragranular which entire added granules). these relatively less dependent irrespective during