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DESIGN, DEVELOPMENT AND EVALUATION OF BI LAYERED TABLET OF PREGABALIN
Author Name

Smriti Kumari, Ankita Shukla, Dharmendra Singh Rajput, Naveen Gupta and Neeraj K Sharma

Abstract

Tablets containing Hydralazine HCl and Pregabalin by Direct compression technology was to formulate a stable, safe and convenience dosage form for the better management of most common cardiovascular disorders or blood pressure. The formulations of bilayer tablets showed good results in case of Hydralazine HCl immediate release layer physicochemical parameters and prepared using concentration of superdisintegrant sodium starch glycolate and ac-di-sol® for the fast release layer and sustained release layer of pregabalin containing HPMC K100 M and polyoxtm WSR 303 for the delay the drug release up to 10-12 hrs. The FTIR and DSC analysis indicates that there were no drug-drug and drug-excipients interactions. Pre compression and post compression parameters were found to be within the satisfactory limits and hence suitable to formulate Bilayer tablets. Formulation batch HDID was finally optimize in which HD9 (Hydralazine HCl) batch is selected as immediate release layer and ID9 (pregabalin) batch is selected as sustained release layer as final selected formulation. Batch HDID provides better drug release profile. The data obtained from in vitro release study were fitted to various mathematical models like Higuchi and Peppas model exponential coefficient ‘n’ < 0.5 indicates that the release was governed by Fickian diffusion..

Keyword: Hydralazine HCl, In vitro release, Preformulation and Pregabalin



Published On :
2022-12-16

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