EFFECT OF CO-PROCESSED SUPERDISINTIGRANT ON NIMODIPINE ORODISPERSIBLE TABLETS USING 23 FACTORIAL DESIGN APPROACH

Sagar Kothawade*, Shubham Biyani, Chetan Harne, Rutuja Wakure, Udhhav Bagul and Surendra Gattani

ABSTRACT

In present research work, Orodispersible tablets of Nimodipine drug were formulated by using direct compression method. Nimodipine is belonging to BCS class-II, therefore the solubility of Nimodipine was enhanced by complex with Beta-Cyclodextrins. The drug-excipient’s compatibility was carried out by using FTIR spectrometry. The four preliminary trial of formulation were taken with three different superdisintegrants Viz. Sodium starch glycolate, Crospovidone and co-processed sodium starch glycolate with crospovidone. The prepared batches were evaluated for weight variation, hardness, thickness, mechanical strength, wetting ability, disintegration time and in-vitro drug release. The batch A4 Containing co-processed superdisintegrants 5 mg, mannitol 30 mg and MCC 61 mg has shown disintegration time of 21 seconds along with 100% drug release within 45 min. Among all preliminary trials batches the Batch A4 was selected for optimization by using 23 factorial design. The software generated 10 formulations were developed and evaluated for nature and concentration of superdisintegrants in tablets with respective to disintegration time, wetting time and in-vitro drug release. Optimised batch F4 was further subjected for stability studies & kinetic studies and found to be stable and followed first order release kinetics model.

Keywords: Nimodipine, Beta-cyclodextrins complex, Superdisintegrants, Factorial Design, Kinetic Study, 23 factorial design.