P-015?–?Formulation development of nifedipine controlled-release coated tablets

摘要

Due to frequent administration of oral nifedipine tablet, controlledor sustained release of the drug will improve patientcompliance, stable blood level and side effect decrement [1,2].Various extended release nifedipine products have been commerciallyavailable. In this study, extended release tabletsof this drug were formulated using sodium alginate,hydroxypropylmethylcellulose (HPMC) as controlled releasematrix materials. Small scale production of 200 tablets andscale-up production to 5000 tablets were performed by manualand electrical single punch tableting machines. The tabletswere then film coated. Physicochemical evaluation wasfollowed USP 32 including assay, content uniformity and impuritiesanalyzed by high performance liquid chromatography.The effect of amount of the polymers and lactose on drugrelease was compared. Moreover, stability study of the selectedformulation was performed at room temperature(25 °C).