FORMULATION AND EVALUATION OF TRAMADOL HYDROCHLORIDE ORAL THIN FILMS

Oral films are a novel approach for the development of orally disintegrating dosage forms. They are thin, elegant in appearance and can be made into various sizes and shapes like rectangular or circular. The strips may be flexible or brittle, opaque or transparent. Oral films are made up of various hydrophilic and hydrophobic polymers to provide rapid disintegration on the tongue without the need for water. The aim of the present study is to develop fast dissolving films of tramadol Hydrochloride by enhancing drug dissolution in the oral cavity. The development of the films decreases the analgesic effect in less time and increases the patient’s compliance. Tramadol HCl films were prepared using Hydroxy propyl methyl cellulose-E5, Hydroxy propyl methyl cellulose-E6, Hydroxy propyl methyl cellulose-E15 and sodium alginate as polymers. Therefore the prepared films were evaluated for various parameters like physical appearance and surface texture of the film, thickness of the film, folding endurance, moisture uptake, uniformity of weight and drug content, swelling index, in vitro disintegration studies, and in vitro dissolution studies. Stability studies were also performed. Though all the formulations equally passed the evaluation parameters, it is concluded that oral thin films containing 400 mg of sodium alginate as the polymer because of better dissolution profile.