Formulation and Evaluation of Taste Masked Fast Disintegrating Tablet of Promethazine Hydrochloride

Abstract

Purpose: To mask the bitter taste of the widely used antiallegic drug, Promethazine Hydrochloride(PMZ HCL), and to formulate it into patient-compliant and convenient fast disintegrating tablets. Methods: Taste masking of Promethazine Hydrochloride was achieved by microencapsulation using amino alkyl methacrylate copolymers (Eudragit E100) employing the solvent evaporation technique. Taste assessment was carried out by time intensity metod. Sublimation method was used, using camphor as subliming agent, sodium starch glycolate and crosspovidone as a super-disintegrant was used to prepare fast disintegrating tablets. Tablets were evaluated with regard to a variety of pharmacopoeial tests, drug release, and disintegration time in the oral cavity. Results: The time intensity method confirmed tasteless nature of the optimized microspheres. In vitro dissolution studies at pH 6.8 showed that no significant amount of drug is released while tablet is in mouth and approximately 92.3% of the release takes place in 15 min at gastric pH of 0.1N HCl indicating that taste-masking the drug with the pH-sensitive polymer does not affect the release of the drug in the stomach. Conclusions: Sensory evaluation for taste by a time inetensity method on 6 healthy volunteers confirms the successful formulation of the oral palatable fast disintegrating tablets which disintegrates in the oral cavity in 15±0.4 s.