Abstract

RELEASE PATTERN STUDY OF TRAMADOL HYDROCHLORIDE DIFFERING ON FORMALDEHYDE EXPOSURE TIME FROM GELATIN-SODIUM ALGINATE BIODEGRADABLE IMPLANTS

Mukta Saha*, Sultana Mehbuba Hossain and Swarnali Islam

ABSTRACT

Implantable drug delivery systems are used to provide controlled and localized release of active substances in different medical applications. In the present work an attempt was made to formulate and evaluate Tramadol Hydrochloride implant for long term drug release, using biodegradable Gelatin and Sodium alginate polymer. Tramadol hydrochloride was chosen for this study is a synthetic, centrally acting analgesic and seen to be used in many conditions like Rheumatoid arthritis, Restless legs syndrome, Motor neuron disease, Fibromyalgia. Gelatin-Sodium Alginate implants were attempted to formulate with the incorporation of different hydrophobic excipients namely, Glyceryl monostearte, Stearyl Alcohol, Cetostearyl Alcohol, Arachis Oil and Stearic Acid. All formulations were exposed to formaldehyde vapour for different periods of time. They were evaluated for weight variation, thickness, DSC, presence of free formaldehyde and in-vitro drug release studies. The implants hardened with formaldehyde for 12hrs were found to release drug in a sustained manner for maximum days. The release kinetics was evaluated by four different kinetic models, namely, Zero order, First order, Higuchi and Korsmeyer‐Peppas. The release rate constants, the coefficients of determination and R2 values were used to calculate the accuracy of the fit. Implants were found to follow the Higuchi model in most cases. Good correlations were obtained with Korsmeyer peppas model as well.

Keywords: Tramadol Hydrochloride, DSC, TGA, Gelatin, Sodium Alginate, In-vitro Release.