DESIGN AND CHARACTERIZATION OF BUCCAL FILMS OF TRAMADOL HYDROCHLORIDE
Opioid analgesics are important in both acute and chronic pain management. Tramadol Hydrochloride is a centrally acting analgesic having both opioid and non opioid effects, which is associated with little respiratory depression. Tramadol Hydrochloride is a water soluble drug. It is having relatively short duration of action it requires repeated dosage for therapeutic action. And it is having extensive first pass metabolism. Controlled released buccal films of Tramadol Hydrochloride were prepared and investigated using polymers HPMC K4M, sodium carboxy methyl cellulose, carbopol 934 in different ratios. Compatibility studies were done by using Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry techniques (DSC). FTIR spectra and DSC thermograph of Tramadol Hydrochloride, polymers, and all formulations indicates that there is no chemical interaction and confirmed the stability of the drug. The films were evaluated for their physical characteristics like weight variation, Thickness, folding endurance, surface pH, drug content uniformity, swelling index, Ex vivo bioadhesion time. In vitro drug release studies reveal that all films exhibited controlled release in the range of 75.87 to 91.22% for a period of 8 hours. Ex vivo permeation studies through sheep buccal mucosa indicate that films showed good controlled drug release in the range of 80.95 to 93.12% over a period of 10 hours.