Design, Development and Optimization of Natural Gum Based Matrix Tablet of Tramadol Hydrochloride

The objective of this research was to develop and optimize a sustained release matrix tablet of freely soluble drug, tramadol hydrochloride using natural gums (Gum copal and Xanthan Gum) as cheap, non-toxic, easily available polymers for matrixing. Sustained release tablet of Tramadol HCl (dose 100mg) were produced by the help of wet granulation method. The prepared batches of tablets were evaluated for hardness, weight variation, friability, drug content, and in-vitro dissolution profile and found satisfactory. A 32 full factorial design was used for optimization by taking the Gum copal (X1) and Xanthan Gum (X2) as an independent variables. Tramadol hydrochloride is a centrally acting analgesic easily available. It has dual opioid and non-opioid mechanisms of action, favorable efficacy, safety clinical profiles and non-controlled regulatory status in most markets contribute to its worldwide use. A major drawback of the immediate-release formulation of tramadol four- times-a-day dosing is due to its short elimination half-life 5.5 hr. and hence, it is necessary for the drug to develop a sustained release dosage form with reduced risk of drug administration, side effects and improved patient compliance. The formulations were found to have good pre-formulation characteristics. FTIR spectroscopy indicated the no chemical interaction within drug and excipients.