難溶藥物在?即釋放之劑型設計上，除了須考慮複雜的處方設計外，尚須使用適當的製程??，為達處方設計之最佳化，所以需要控制的變因種?則?多，本研究則?用實驗設計法（Experimental Design），進而達到處方設計之最佳化。在處方設計上主要探討活性成分的粉末顆?大小、黏合劑Polyvinylpyrrolidonek30（PVP k30）的配方含?及崩散劑Croscamellose（CROS）的配方含?等三個因子，製劑設計乃以乾式造粒法的方式?使其活性成份分散均勻，使藥物在預定的時間內?達到完全的釋放與溶解。實驗設計法之方式為田口氏直交表（Orthogonal Arrays）。採用直交表L9（34）的方式，以三個因子各以三個水準?設計處方。經過實驗得知，影響藥物溶?最大之因子為活性成分的崩散劑CROS，其次為Particle Size，而黏合劑PVP k30對溶離結果在統計上沒有影響。最後再利用此依據再做調整達到處方的最佳化，而實驗溶?結果與預定之溶?目標以f 2值比對，得到第二個處方（L2）為最適化處方：處方中活性成分顆?大小為0.1-2.8μm、CROS配方百分比含?為2%、PVP k30配方百分比含?為4%。 When designed the content of formulation excipients, process of manufacture shoild be considered, therefore many factors need to be considered to design a formulation. This study used experimental design to assess the main factor of dissolution and perform dissolution studies. There are three factors to be discussed in this study, they are, Particle size of API, content of Binder and content of Disintegrant. Process of manufacture is based on blending technique, and dry granulation method (one of dispersion technique) to homogenize API and make sure drug to dissolve and release completely in the short time. There are several steps in experimental design. Experimental design is performed on formulation by Taguchi Method (Orthogonal Arrays: L9(3)4)(4 factors, 3 levels). After experiment, second formulation(L2) found to be the optimizing formulation, the optimal formulation is particle size of API: 0.1-2.8μm, binder: 2%, disintegrant: 4%. There showed thatthe content of disintegrant is main effect in this study, the second factor is particle size of API, binder content has the smallest influence on tablet dissolution.
