Volume :
5
Issue :
4
Abstract :
The currently available locally acting formulations to treat recurrent aphthous stomatitis (RAS) are either less efficacious or they are not comfortable for the use in the patients. Lozenges are one of the locally acting palatable oral formulations that may be used for the treatment of RAS. The aim of the present research work was to formulate locally acting efficacious herbal lozenges for the treatment of RAS which can provide a good patient compliance. As the part of preformulation study, estimation of secondary plant metabolites (Total phenolics and flavanoids) and compatibility study was carried out to formulate lozenges by moulding method. Trial batches were prepared for the optimization of bases (Isomalt, Liquid glucose and Honey) to formulate lozenges. The evaluation tests i.e. moulding time, hardness, friability, weight variation, in vitro drug release were carried out for the optimization of the batch. Evaluation of batches LC-LOZ 1 to LC-LOZ 9 was carried out. The diameter, thickness and hardness of lozenges were found to be 14.87±0.077mm, 7.15±0.005mm and147±0.16 N respectively. The weight uniformity was found to be 1.1±0.11 gm. The friability of lozenges was found to be less than 1% .The weight variation of all the formulations was found to be close to 1 gm which complied with the official standards. In clinical study the patients were divided into two groups and the number and size of ulcers were measured at baseline. After the treatment, follow up was taken after 24 hours, 48 hours and 72 hours. LC-LOZ was found to be more effective than Alarsin, a routinely used marketed formulation.