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Dasharath M. Patel*, Rahul J. Patel, Hardik R. Shah and Chhagan N. Patel


Objective: Diphenhydramine hydrochloride was formulated as lozenges to provide effective release for the management of cough. Many dosage forms like syrups, tablets, capsules are available in the market but still there is a need for new dosage forms which acts effectively and locally. Present investigation was undertaken to formulate and evaluate lozenges to meet the need of improved bioavailability by avoiding hepatic first pass metabolism of the drug. Experimental Work: The lozenges were formulated using various sugars like mannitol, dextrose, sucrose and isomalt. Polyethylene glycol 200, propylene glycol and glycerine were tested as plasticizer in formulation. The prepared formulations were subjected to various evaluation parameters. After completion of stability study for a period of 1 month, the optimized formulation was subjected to evaluation parameters. Results and Discussion: Lozenges formulated using isomalt and 0.1 ml glycerine remained as hard candy, while lozenges were not formed with any other sugar. The optimized formulation showed a hardness of around 15 kg/cm²; drug content and content uniformity of 97 % and in vitro drug release of more than 99 % within 20 min. After stability study, it was found that the lozenges were not altered in terms of above parameters and were stable. Conclusion: From the present work, it was concluded that the isomalt can be successfully used as tooth friendly sugar substitute in the formulation of medicated lozenges and glycerine can be used as a plasticizer to give better appearance. The molded lozenges can provide an attractive alternative formulation in the alleviation of cough.

Keywords: Diphenhydramine hydrochloride, Lozenges, Hard candy, Cough, Isomalt

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