Taste masking of Promethazine Hydrochloride using Eudragit E100 via solid dispersion technique to develop fast disintegrating tablets
By Gaurav Sharma, Vivek Kumar Pawar, Garima Garg, Rajendra Awasthi and Giriraj T. Kulkarni
The purpose of present study was to mask the intensely bitter taste of promethazine HCl and to formulate fast disintegrating tablets (FDTs) of the taste masked drug. The taste masking was done via solid dispersion (SD) technique using Eudragit E100 (amino-alkyl methacrylate copolymer) in different ratios. The drug-polymer compatibility and their compatibility with process condition were evaluated on the basis of FTIR spectroscopy and there was no sign of any interaction between drug and polymer and within the prepared system. The SD prepared with different ratio of drug and polymer was evaluated for drug release in phosphate buffer (pH 6.2), and for in vivo taste. The SD with drug polymer ratio of 1:4 did not give any taste and shows minimum release in phosphate buffer (pH 6.2); therefore that ratio was selected as best candidate for development of FDTs. The nine batches were prepared using crospovidone and croscarmellose to find out effect of both the polymers on in vitro and in vivo disintegration time. The prepared batches were also evaluated for different parameters such as hardness, friability, wetting time, in vitro dispersion time, and for in vivo taste. Crospovidone 20% w/w gave the minimum disintegration time. The tablets of the final formulation containing 38.16 % mannitol and 9.14 % of microcrystalline cellulose showed the minimum disintegration time of 23 sec. The taste evaluation of the tablets in comparison to quinine sulfate in human volunteers revealed a considerable taste masking. Thus results conclusively demonstrated successful masking of taste and fast disintegration of the developed formulation in the oral cavity.
Key Words : fast disintegrating tablets, taste masking, solid dispersion, promethazine HCl, Eudragit E100.
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