습식 과립법을 이용한 정제 제작 시 부형제 조합 및 혼합비율이 품질 특성에 미치는 영향

초록

This study aims to evaluate the effect of excipient combinations and their mixing ratios on the quality attributes of tablets produced via wet granulation. Tablets are the most preferred pharmaceutical dosage form, and wet granulation is the commonly employed technique for tablet production. Among the diluents used in tablet formulation, lactose and corn starch were selected for this study due to their distinct properties. The objective was to determine the optimal ratio of these two excipients. The study assessed various quality characteristics of the granules and tablets, including flowability, compressibility, disintegration time, drug release rate, and mechanical strength. The experimental results revealed that the combination of lactose and starch in a 70:30 ratio (F2) showed the best performance in terms of flowability, compressibility, disintegration time, and drug release rate, which was attributed to the complementary properties of lactose’s excellent flowability and starch’s rapid swelling and disintegration. On the other hand, higher starch proportions (F3, F4) led to decreased flowability and tablet durability. The study findings align with previously reported excipient properties and demonstrate their practical implications for formulation development. The results suggest that excipient ratios significantly influence tablet quality and provide a solid foundation for optimizing wet granulation processes in tablet formulation.

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