Comparison of Co-Processed Superdisintegrants with Superdisintegrants in Drug Release for Palatable Fast Disintegrating Oral Films of Metolazone

Abstract

The present study was aimed to compare co-proceesed superdisentigrant with superdisentigrants in drug release and formulate a palatable fast disintegrating oral films of metolazone and compare with standard market solid oral dosage forms. The drug was incorporated as solid dispersion to mask the bitter taste of the drug with different polymers in different ratios (PEG 4000 & Poloxomer 407) and was assessed for its taste. Metalazone with Poloxomer 407 (M-SD 5) in the ratio of 1:2 was better masked. The films were prepared by solvent casting method. HPMC E15 & Pullulan were chosen as the film forming polymers and sodium starch glycolate and crosscaramellose sodium were chosen as superdisentigrant for formulation. Pullulan (80mg) and crosscaramellose sodium (0.6%) showed the highest % drug release (99.49±0.15 within 15 min.). Therefore, this composition was chosen to prepare the film having co-processed superdisintegrants (SSG+CCS in 1:1) MF-10. MF-10 showed better disintegration (10 sec) and dissolution rate (99.12% drug release within 10 minutes.) when compared with the best formulation of superdisintigrant. All the evaluations of the optimized formulation were found to be satisfactory and within limits. MF-10 was subjected to stability studies and compared with marketed oral formulation and was found to be satisfactory.
 Keywords: Metolazone, Fast disintegrating oral films (FDOFs), patient compliance, taste mask, rapidly disintegrate, co-processed superdisintegrants.