PROCESS OPTIMIZATION AND INVITRO EVALUATION OF RISEDRONATE SODIUM IMMEDIATE RELEASE TABLETS
Journal Title: Mintage journal of pharmaceutical and medical sciences - Year 2017, Vol 6, Issue 6
Abstract
Objective: Present project aims to process optimize and evaluate 150mg of Risedronate Sodium tablets. Objective of the process optimization plan is to monitor the manufacturing process of Risedronate sodium tablets 150mg to facilitate the evaluation, optimization, and confirmation of the critical product/process parameter identified during the developmental stage of the formulation so that the final product at pilot scale/test batch will produce a consistent result. Methods: All parameters optimization was carried out and post compression parameters were observed. All parameters in satisfactory conditions. Results: Then dissolution profile of trial RST09 is compared with the innovator product, and it meets the market specifications. Conclusion: From the above results obtained, it can be concluded that the optimized trial 9 achieved the objective drug release. The “n” value obtained from formulation RST09 is 0.472 which is between >0.45 and < 0.89 hence it follows the non fickian release. Also, the drug release was best explained by the first order equation as the plot showed the highest linearity with (r2 value = 0.982) followed by Higuchi equation (r2=0.906).Stability studies are conducted for two months. There is no change of the previous product was observed.
Authors and Affiliations
kagithala gopi, suryakanta swain, manohar babu s
Keywords
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