An investigation on the correlation between drug dissolution properties and the growth behaviour of granules in high shear mixer.

摘要: Objectives  The aim of this study was to investigate the correlation between growth behaviour and in-vitro dissolution rate water-insoluble drugs prepared with high-shear wet granulation. Methods  Granules containing nimodipine, microcrystalline cellulose, low-substituted hydroxypropylcellulose aqueous solution were effects independent process variables, including impeller speed liquid-to-solid ratio taken into consideration. mean granule size, granule-size distribution (GSD), porosity surface properties monitored at different kneading times identify granule-growth mechanisms simultaneously. A computer-based method applied simulate polydisperse granules based on GSD data. Key findings  drug high for early stages granulation sharply decreased when coalescence consolidation started, approaching a flat low level sufficiently consolidated. simulated results in agreement experimental observations significantly affected by GSD, during process. Moreover directly related mechanisms. Conclusions  In general, it concluded that nimodipine basically correlated mixer. simulation can be used as convenient rapid way predict formulation development optimization.