DEXAMETHASONE UNIDIRECTIONAL AQUEOUS BI-LAYERED BUCCAL MUCOADHESHIVE PATCH WITH SODIUM SACCHARINE AS RELEASE ENHANCER; A NON-INVASIVE TREATMENT APPROACH OF ORAL SUB-MUCOUS FIBROSIS

摘要

The main objective of this invention is to provide a non- invasive method of treatment for Oral sub mucous fibrosis (OSF) which is a chronic, progressive, potentially malignant condition affecting the oral cavity and frequently involving the upper part of the aero digestive tract which leads to fibrotic lesions and severe inflammation to the buccal mucosa occurs ¡n patients chewing tob¡ceo produets. As the patient compliance was poor due to the unwillingness for the invasive treatment with intralesional injections, the present invention discloses the convenient non invasive dosage form i.e., a unidirectional bi-layered aqueous buccal mucoadhesive patch of dexamethasone, which includes a placebo outer layer of ethyl cellulose and drug (Dexamethasone) containing polymer layer. Sodium saccharine was used as relase enhancer to relase the active ingredient faster in to buccal mucosa. Solvent casting method was used to prepare the patches. The formulations were subjected to in vitro drug permeation studies along with all the required evaluation parameters. Clinical studies were conducted on OSF patients to evalºate the clinical efficacy of dexamethasone mucosal patch. Results showed that the formulation gave faster drug relase within 20 minutes and showed good bioadhesion. The clinical study showed that there was a significant improvement in the condition of OSF patients with unidirectional bilayered patch of dexamethasone compared to intralesional injection. It can be concluded that the unidirectional bilayered dexamethasone mucosal patch is the best substitute to intralesional injection in the treatment of oral submucous fibrosis.