Abstract

FORMULATION AND IN-VITRO EVALUATION OF SUSTAINED RELEASE TABLETS OF TRAMADOL HYDROCHLORIDE

Abhishek Shrestha*, Emi Maharjan, Nistha Amatya and Rajendra Ayer

Abstract

Sustained release provides the most desirable dosing regimens with effective pharmacokinetic profile and pharmacodynamic response. This is potentially useful to overcome problems associated with conventional dose and has advantage of patient compliance. In present investigation, the study was aimed to formulate and in- vitro evaluation of sustained release tablets of Tramadol hydrochloride using polymeric matrix system. The matrix system adopted in this study had Hydroxy Propyl Methyl Cellulose K100M and Ethyl cellulose as rate retarding polymers individually as well as in combinations and in varying concentration of polymers in order to investigate the effect on drug release. Matrix tablets of Tramadol HCl were prepared by direct compression method. Various formulation with different concentration of polymers were tried to optimize the process and release of the drug. The pre-compression parameters were characterized for flow properties, compressibility index and other physical proprieties. The prepared tablets were evaluated for different parameter such as weight variation, diameter, hardness, friability, disintegration, swelling index and drug content. The in-vitro drug release profiles were studied in two media (0.1N HCl and Phosphate buffer pH 6.8). All the tablets prepared possess a weight variation below ±5%, hardness of (6.77 to 8.05) kg/cm2, percentage friability of (0.33 to 0.94%), diameter (10.10 to 10.19 mm. The drug content was in between 98.01% to 105.74%. Among all the formulations, sustained release tablets (F7) were considered to be the successful formulation which showed drug release upto 95.32%, and showed very close to release profile of the marketed sample which suggests the release the mechanism of drug from diffusion coupled with erosion. Increased concentration of polymers revealed the decreased release rate due to increase in diffusional path length and decreased concentration showed increase in release rate due to insufficient concentration of the polymer. Similarly the swelling index of higher concentration of polymer was found high and also the swelling index increased with increase in concentration of polymer. Dissolution data are fitted to Zero order Model, First order model and Krosmeyer- Peppas Model and Higuchi model.

Keywords: Tramadol hydrochloride, Sustained Release, Matrix Tablet, Hydroxypropyl Methyl Cellulose (HPMC K100M), Ethyl cellulose.