Development, Optimization And Evaluation Of Medicated Lozenges For Management Of Oral Lichen Planus

Abstract

Oral lichen planus is a chronic inflammatory condition affecting the mucous membrane of oral cavity. It appears as white lacy patches and may lead to oral cancer if not treated early. Oral pills, capsules, tablets, syrups are the popular marketed dosage forms for the treatment of oral cancer. The main drawback related to this conventional dosage form is there limited stay in the oral cavity and hence reduced effects. The objective of our study was to formulate and evaluate clobetasol propionate medicated lozenges for the management of oral lichen planus. The selection of lozenges as the dosage form resolved the issue of limited stay and hence the drug is exposed to the oral cavity for a longer period of time. Medicated lozenges were prepared by heat and congealing method. Sucrose and Dextrose were selected as base for the formulation. The melting point was found to be in range of 196-197 ⁰C. In the DSC studies the enthalpy of heat was found to be 196.73 ⁰C. The optimized formulation of lozenge showed friability (0.798%), hardness (8.7±0.5%) and thickness (4.85±0.07). The moisture content was found to be 0.3% in Dessicator, and 0% in gravimetery method and Azeotropic distillation method and drug content was found to be 98%. The drug release study shows that the 50% drug was released in 2 min and 96% in 12 min. The lozenges were found to be stable during stability study and there is no change in colour after completion of study period. The formulation can be further explored using systematic optimization studies.