Composition and in-vitro Analyzation of Taste-Masked Fast-Dissolving Ambroxol Hydrochloride Tablets

The purpose of the present work was to mask the taste of Ambroxol hydrochloride and to formulate its patient- friendly dosage form. Solid dosage forms also present significant administration challenges in children, mentally challenged and uncooperative patients. Moreover, patients travelling with little or no access to water, limit utility to orally administered conventional tablets or capsules. 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). FT-IR spectroscopy was employed to ascertain the compatibility between Ambroxol, hydrochloride and the selected polymers. The pure drug and drug with excipient were scanned separately. 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.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. The data obtained of post-compression parameters such as weight variation, hardness, friability, wetting time, water absorption ratio, content uniformity, disintegration time and dissolution and was found superior over conventional formulation. 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.