Study On Preparation Technics And Quality Of Solifenacin Succinate Tablets

Solifenacin succinate is a highly selective muscarinic M3 receptor antagonist,indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence,urgency,and urinary frequency.The preparation technics and quality of solifenacin succinate tablets were studied in the dissertation.HPLC methods were established to detect solifenacin and the related substances in the studies of the formulation,preparation technics,and stability of solifenacin succinate tabletsThe direct compression method was selected to prepare solifenacin succinate tablets.Pre-blend,dispersion and final belend process was useed to ensure the blending uniformity.Solifenacin succinate tablets were prepared according to the determined process.The dissolution profiles in 4 disperse medium of water,pH 1.2 HCl solution,pH4.5 acetate buffer,and pH6.8 phosphate buffer,were similar to those of the reference product,respectively.There similarity factor f2 values were all greater than 50.The related substances and stability including heat stability,humidity stability,light stability and accelerated stability were tested.The results showed that the quality of the solifenacin succinate tablets was satisfactory and its related substances and stability were in accordance with the reference product.