Volume : 13, Issue : 06, June – 2026
Title:
DEVELOPMENT AND IN VITRO EVALUATION OF TRAMADOL HYDROCHLORIDE BUCCAL FILM
Authors :
R. Bhavya, Dr. B.Swathi*
Abstract :
The present study was aimed at the formulation and evaluation of Tramadol hydrochloride buccal films for sustained drug delivery using different polymers by solvent casting technique. Buccal drug delivery systems offer several advantages, including improved bioavailability, avoidance of first-pass metabolism, prolonged drug release, and enhanced patient compliance. Preformulation studies such as organoleptic evaluation, solubility studies, melting point determination, UV spectrophotometric analysis, and FTIR compatibility studies were carried out to characterise the drug and evaluate its compatibility with excipients. Buccal films were prepared using Ethyl cellulose and HPMC K15M as film-forming polymers, PEG as plasticizer, Aspartame as a sweetening agent, and DMSO as a permeation enhancer. The prepared films were evaluated for various physicochemical parameters, including thickness, weight variation, folding endurance, drug content uniformity, moisture absorption, moisture loss, swelling index, and surface appearance. All formulations showed satisfactory physicochemical characteristics with good flexibility and uniformity. In vitro drug release studies were performed using a Franz diffusion cell apparatus in phosphate buffer pH 6.8 for 8 hours. Among all formulations, formulation F8 exhibited the highest cumulative drug release of 99.4% and showed satisfactory mechanical and physicochemical properties. Drug release kinetic studies revealed that the optimised formulation followed Higuchi diffusion kinetics, indicating diffusion-controlled drug release mechanism. Accelerated stability studies conducted for 90 days under different storage conditions showed no significant changes in physical appearance or drug release profile, confirming good stability of the optimised formulation. The study concluded that Tramadol hydrochloride buccal films prepared by solvent casting method can be considered a promising approach for sustained buccal drug delivery with improved therapeutic efficacy and patient compliance.
Keywords: Tramadol hydrochloride, Ethyl cellulose, HPMC K15M, Buccal films, Solvent casting technique, In vitro drug release studies.
Cite This Article:
Please cite this article in press R. Bhavya et al., Advanced Screening Development And In Vitro Evaluation Of Tramadol Hydrochloride Buccal Film.., Indo Am. J. P. Sci, 2026; 13(06).
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