Prediction of the effect of taste masking on disintegration behavior, mechanical strength and rheological characteristics of highly water soluble drug (itopride HCl); an application of SeDeM-ODT expert system

Abstract

Polymeric excipients are commonly applied for taste masking of bitter tasting drugs, to get a palatable dosage form, due to wide spectra of characteristics like safety, availability and cost effectiveness. Taste masking changes nature of powder material and affects rheological characteristics, mechanical strength and disintegration behavior which are mandatory for preparation of a pharmaceutical product meeting the official specifications. Extensive experimentation is carried out to get the optimum rheological characteristics; mechanical strength and disintegration behavior are required for a product. In the present study SeDeM-ODT expert system has been applied for prediction of effect of taste masking on various characteristics of powder material at pre-formulation level. Bitter taste of itopride HCl powder was masked by granulation technique using hydroxy propyl methyl cellulose as taste masking polymer. According to SeDeM-ODT expert system, itopride HCl powder was evaluated for 15 basic parameters, before and after taste masking and results were compared.Taste masking was achieved at 1:3 (drug to HPMC ratio by weight) and panel of healthy male volunteers ranked the composition completely taste masked. Comparison of results before and after taste masking showed that taste masking significantly improved mechanical strength and rheological characteristics and decreased disintegration behavior of powder. From the study it is concluded that the effect of taste masking on rheological characteristics, mechanical strength and disintegration behavior can be successfully predicted by SeDeM-ODT expert system at pre-formulation level avoiding extra experimentation and facilitating the process of formulation development.