Development, Characterization And Optimization Of Lozenges Of Clobetasol Propionate

Abstract

Oral lichen planus is a chronic T-cell mediated mucocutaneous disease. Oral lichen planus is a chronic inflammatory condition that affects the mucous membranes inside the mouth. Oral lichen planus is a disease that affects the skin, intraorally the buccal mucosa, tongue, and gingiva. Oral lichen planus can appear as a white lacy, red swollen tissue, or open sore patches on the skin. These injuries may lead to burning, pain, or other discomforts. If this oral lichen planus was not treated with time, then it may lead to oral cancer. Capsules, tablets, syrups were the popular dosage forms available in the market for the treatment of oral cancer. But the major disadvantage of these marketed formulations was that their limited stay in the oral cavity and hence display more systemic adverse effects. The objective of this study was the management of oral lichen planus with an appropriate dosage form even suitable for pediatrics as well as geriatrics. The selection of lozenges as a dosage form also solves the issue of limited stay. The lozenges remain in the oral cavity for a longer time in comparison to tablets, capsules and syrups and hence the drug will be exposed to the oral cavity for a longer period of time. Moulded lozenges were prepared with the heat and congealing method and compressed lozenges by the wet granulation method. Sucrose and corn syrup was selected as the main base of the formulation. All formulations possess the satisfactory values of different parameter such as the melting point was found in the range of 196 ºC-197 ºC. The moulded lozenges and compressed lozenges show friability of 1.4 % and 0.1 %. The moisture content was found to be 0.3 % and 1.8 % in a desiccator. The drug content was found to be 91 % and 87 %. The drug release study shows complete release in 30 min for moulded lozenges and 89 % release in 30 min for compressed lozenges. In conclusion, all formulations met the acceptance criteria of the physicochemical tests and quality control tests for the clobetasol lozenges.