ABSTRACT

Solifenacin succinate is a competitive muscarinic receptor antagonist. Solifenacin succinate is used to treat overactive bladder by relaxing the muscles in the bladder which improves the ability control the urination urge, urinary incontinence and increased urinary frequency in elderly patients. Solifenacin succinate belongs to the class of drug known as antispasmodics. Solifenacin succinate 10mg immediate release tablet formulation is prepared by direct compression strategy using the suitable excipients. During formulation development study, three different grades of lactose monohydrate and two lots of drug substances having different particle size distribution have been evaluated. Different grades of lactose monohydrate and PSD of drug substance ranging from d90 – 40 ?m to 110 ?m have been evaluated to check the impact on flow ability of the blend and dissolution characteristics of drug product respectively. During formulation development study, pre-compression or lubricated blend parameters such as bulk density, tapped density, PSD by sieve analysis, compressibility index, Hausner’s ratio etc. have been evaluated. Post-compression in-process parameters such as weight of tablet, tablet dimensions, hardness, friability, disintegration time etc. have also been evaluated. Dissolution profile all the test formulations was evaluated and compared with the dissolution profile of reference product. Based on formulation development studies conducted for development of oral; immediate release tablet formulation Solifenacin Succinate Tablets, 10 mg using direct compression strategy, SuperTab 14 SD a grade of lactose monohydrate and PSD of drug substance less than 40 ?m has been finalized for better flow of lubricated blend and distribution of drug substance throughout blend which further ensured better physical and in-process properties, c and dissolution of drug product. Keywords: Solifenacin Succinate, Lactose Monohydrate Grade, Particle Size Distribution, Immediate Release Tablet, Drug Release Kinetic, Dissolution, BCS
Publication date: 01/06/21

https://ijbpas.com/pdf/2021/June/MS_IJBPAS_2021_5540.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2021/10.6.5540