Formulation and Evaluation of Poly Herbal formulations for Aphthous Stomatitis

Abstract

The currently available locally acting formulations to treat recurrent aphthous stomatitis newline(RAS) are either less efficacious or they are not comfortable for the use in the patients. newlineLozenges are one of the locally acting palatable oral formulations that may be used for the newlinetreatment of RAS. The aim of the present research work was to formulate locally acting newlineefficacious herbal lozenges for the treatment of RAS which can provide a good patient newlinecompliance. As the part of preformulation study, estimation of secondary plant metabolites newline(Total phenolics and flavanoids) and compatibility study was carried out to formulate newlinelozenges by moulding method. In in- vitro study on LC demonstrated the depression of newlineinflammation. Prior to the initiation of human clinical trials of novel drugs, the safety of their newlineapplication is to be proved. Generally this is accomplished by the implementation of general newlinepreclinical toxicity experiments to uncover potential poisonous effects of any drug in newlineanimals. So, the third part of the study was to evaluate the animal safety of a Glycyrrhiza newlineglabra and Acacia catechu as anew phytotherapeutic candidate for Aphthous Stomatitis. newlineTrial batches were prepared for the optimization of bases (Isomalt, Liquid glucose and newlineHoney) to formulate lozenges. The evaluation tests i.e. moulding time, hardness, friability, newlineweight variation, in vitro drug release were carried out for the optimization of the batch. newlineEvaluation of batches LC-LOZ 1 to LC-LOZ 9 was carried out. The diameter, thickness and newlinehardness of lozenges were found to be 14.87±0.077mm, 7.15±0.005mm and147±0.16 N newlinerespectively. The weight uniformity was found to be 1.1±0.11 gm. The friability of lozenges newlinewas found to be less than 1% .The weight variation of all the formulations was found to be newlineclose to 1 gm which complied with the official standards. In clinical study the patients were newlinedivided into two groups and the number and size of ulcers were measured at baseline. After newlinethe treatment, follow up was taken after 24 hours, 48 hours and 72 hours.