Abstract

FORMULATION AND IN-VITRO EVALUATION OF TASTE MASKED FAST DISSOLVING TABLETS OF AMBROXOL HYDROCHLORIDE

Bimal Debbarma* and Sunaina Benedict

ABSTRACT

Purpose: The purpose of the present work was to mask the taste of Ambroxol hydrochloride and to formulate its patient-friendly dosage form. Approach: Complexation technique using KYRON -T-114 an ion-exchange resin was used to mask the bitter taste and the drug loading onto the ion-exchange resin was optimized for ratio of drug to resin, effect of pH and effect on soaking time. The resinate was evaluated for taste masking and characterized by FT-IR and DSC. Then the taste-masked drug was formulated into a fast dissolving tablet (FDT). The developed tablets were evaluated for hardness, friability, drug content, weight variation, content uniformity, friability, water absorption ratio, in-vitro disintegration time and in-vitro drug release studies. Results: IR and DSC spectra revealed that there were no possible interactions between the drug and polymer. Maximum loading was obtained at drug–resin ratio 1:2, pH 7, and soaking time 30 min. A successful taste masking of resinate was confirmed by time intensity method. The values of pre-compression parameters evaluated and were within prescribed limits and indicated good free flowing properties. The data obtained of post-compression parameters found superior over conventional formulation. The F3 batch with disintegration time 30.4±0.64 sec and dissolution 98.4±2.69 was selected as optimized formulation, This was compared with conventional marketed formulation and was found superior. Conclusion: The obtained results revealed that Ambroxol hydrochloride has been successfully taste masked and formulated into an FDT as a suitable alternative to the conventional tablets.

Keywords: Ambroxol hydrochloride, KYRON -T-114, taste masking, sodium starch glycolate, crospovidone.