Formulation development and evaluation of Tamsulosin Hydrochloride and Dutasteride in tablet dosage form

The purpose of the study was to develop tablet in tablet (compression – coated tablets) having different release pattern, which is indicated for the treatment of Benign Prostate Hyperplasia. The study was planned in three stages. In the first stage, five batches (T₁,T₂,T₃,T₄,T₅) of matrix tablet of Tamsulosin hydrochloride were prepared by wet granulation method, enteric coated and evaluated. Among the five batches, batch T₃ was taken up for further studies. In the second stage, three batches (T₆,T₇,T₈) of Dutasteride granules were prepared and evaluated. All three batches showed good flow property and drug content and taken up for further studies. In the third stage, three batches (T₉,T₁₀,T₁₁) of compression – coated tablets were prepared, film coated and evaluated. Among three batches, batch T₁₁ showed desirable properties and drug release. Hence batch T₁₁ was considered as an optimized batch. The stability studies was determined for the optimized batch. This design of dosage form will open a new era for repeat action tablets.

Author(s): V. Ravichandiran, K. Masilamani, K. Punitha, S. Sureshkumar, B. Senthilnathan

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