Formulation and evaluation of tramadol hydrochloride extended release tablet by using hydrophilic and hydrophobic polymers


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Volume :

3

Issue :

3

Abstract :

The purpose of the study is to prepare extended release tablet of tramadol hydrochloride by using combination of hydrophilic polymer and wax. The hydrophilic polymers like Carbopol 934 P, polyox N 80 & HPMC K200 M & the waxes like compritol 888 ATO, cutina HR, spherizol, lubritab Type A were used. Tablets were prepared by using the wet granulation and melt granulation method. Polyox N80 & lubritab type A were selected as most promising release retarding agents in their respective groups. The drug release from only hydrophilic matrix tablet is achieved by rapid diffusion through its gel network and use of only wax is also limited due to its compression hardening and stability problems. Hence combination of hydrophilic polymer and wax has been used in the formulation of extended release tablet of tramadol hydrochloride. The two methods were selected for preparation of tablets i.e. wet granulation of hydrophilic polymer followed by wax addition method and melt granulation of wax followed by polymer addition method. All the formulations were compared with marketed formulation Ultram. Based on the comparison of similarity factor 2nd method was found to be the most promising method for the preparation of extended release tablet. The results indicated the dissolution rate was found to be directly proportional to concentration of wax as well as to concentration of hydrophilic polymer when studied at lower and higher wax levels.
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