ABSTRACT

The aim of present investigation was formulation and development of Solifenacin Succinate Sublingual tablets. The Study started from the Preformulation study of the drug. Drug belonged to BCS class-II and had good solubility properties. The flow properties of API were found to be good enough, hence direct compression technique was used for tablet preparation. While studying IR spectrum, it was concluded that there was no interaction between drug and other excipients. Initially feasibility trials were taken to optimize three superdisintegrants namely Crospovidone, Croscarmellose sodium and Sodium starch glycollate. Tablets were found acceptable in physical parameters evaluation. After preliminary screening, it was concluded that Crospovidone showed fastest rate of drug release. Based on that P2 batch was found satisfactory and considering for further factorial screening. 32 factorial design was applied by taking Crospovidone and Mannitol as independent factors. Factorial batch F1-F9 prepared by using direct compression method. Physical and chemical evaluation was done for all batches. Finally, from overlay plot Checkpoint batch (S1) was prepared and post compression parameters were evaluated and compared with optimised factorial batch F2 and found satisfactory. F2 batch was also compared with marketed formulation for rate of drug release in phosphate buffer pH 6.8. Finally optimized factorial batch F2 was loaded for stability study for 1 month and evaluation was done and found acceptable. Hence, F2 was the optimized formulation. Keywords: Solifenacin succinate, Sublingual tablets, Crospovidone, Croscarmellose sodium and Sodium starch glycollate
Publication date: 01/08/2023

https://ijbpas.com/pdf/2023/August/MS_IJBPAS_2023_7348.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.8.7348