Abstract
The aim of the research work was to formulate and evaluate Promethazine Theoclate oral fast dissolving films that offers a suitable approach for the treatment and management of nausea and vomiting. Promethazine Theoclate is an antihistamine H1 receptor antagonist. It is primarily an antihistamine with additional sedative and antiemetic actions. Twelve formulation of oral fast dissolving film of Promethazine Theoclate such as F1 to F12 were prepared by solvent casting method. The drug polymer compatibility was ruled out by FTIR studies. FTIR study revealed no interaction between the drug and excipients. A number of polymer such as PVA, HPMC, HPMC-K15, HPMC-E50 were employed as film formers for the preparation of oral fast dissolving films. All prepared films was evaluated for its weight variation, thickness, folding endurance, In-vitro disintegration time, drug content, surface pH measurement, Moisture loss studies. The physical appearance was found to be good and shows that films were transparent with smooth surface without any scratches. The folding endurance was found to vary between 29±3 to 70±4 folds indicating that films have good flexibility. In-vitro drug release for Promethazine Theoclate of all the formulations F1 to F12 was carried out using phosphate buffer PH 6.8 as dissolution media. Among the all formulations F7 was selected as the best formulation. Formulation F7 have shown (95.18%) maximum drug release at the end of 135 sec. F7 was found to be stable at (30ºC/65%RH) and (40ºC/75%RH) which was confirmed by FTIR study.