FORMULATION AND IN VITRO EVALUATION OF TAMSULOSIN HCL SUSTAINED RELEASE PELLETS IN CAPSULES
Lavanya Pitta, Damu Umashankar, Madhuri Latha Thadanki* and Pavan Kumar Chadalawada
ABSTRACT
Tamsulosin HCl is used for the treatment of benign prostatic hyperplasia (BPH). As it acts as an antagonist of alpha 1A adrenoceptor in the prostate. Its plasma half life is 2-4 hours. The present work was aimed to develop the sustained release Tamsulosin Hcl pellets loaded capsules using Ethylcellulose N45 as a sustained release polymer and Eudragit L100-55 as an enteric coating polymer in different formulations and polyvinyl pyrrolidone used as a pore former, Tri ethyl citrate as a plasticizer, Iso propyl alcohol and purified water used as solvents in solution layering technique by coating technology, should release the drug equivalent to the innovator product. The prepared Tamsulosin Hcl pellets were characterized by various evaluation studies and compare with the marketed innovator product drug release profile and further performed the stability test for selected or optimized formulation. It was finally brought down that the optimized formulation TC8 follows zero order release whose regression value was found to be 0.890. It was also found that the drug was released by diffusion as the regression in Higuchi’s plot was 0.858. All formulations are determined for similarity factor, formulation TC8 drug release profile was very close to the innovator drug dissolution profiles and whose f2 values was found to be 88.3. It was concluded that stability studies of the optimized TC8 was carried out to the sample at temperatures 400C / 75% RH for a period one month. The capsules are checked and there is no indicative change in the release pattern.
Keywords: Tamsulosin HCl, Benign prostatic hyperplasia, Sustained release capsule, Innovator product.
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