"Formulation and In Vitro Evaluation of Sustained-Release Tramadol HCl by Melt Granulation"

ABSTRACTThe present study aimed to formulate and evaluate sustained-release matrix tablets ofTramadol Hydrochloride using the melt granulation technique to achieve prolonged drugrelease and improve patient compliance. Preformulation studies were carried out to determinethe physicochemical properties of Tramadol Hydrochloride, including potency, melting point,UV spectroscopic analysis, FTIR spectroscopy, and DSC studies. The drug exhibited amelting point in the range of 180–184°C and showed a λmax of 271 nm in water, 0.1 N HCl,and phosphate buffer pH 6.8, indicating suitability for analytical estimation. FTIR and DSCstudies confirmed drug identity, purity, and compatibility with the selected excipients.Nine formulations (F1–F9) of sustained-release tablets were prepared and evaluated formicromeritic properties and post-compression characteristics. The powder blendsdemonstrated good flow properties with angle of repose values ranging from 23.92° to28.99°, Carr’s index from 9.73% to 20.00%, and acceptable bulk and tapped densities. Thecompressed tablets exhibited satisfactory physical characteristics, including uniform weightvariation, hardness, thickness, friability below 1%, and drug content ranging from 96.24% to99.66%.In vitro dissolution studies were performed using USP Type II dissolution apparatus. Amongall formulations, formulation F7 exhibited the most desirable sustained-release profile,releasing approximately 95.56% of drug over 12 hours while maintaining acceptablephysicochemical properties. The study demonstrated that melt granulation is an effectivetechnique for developing sustained-release Tramadol Hydrochloride tablets with controlleddrug release characteristics.