This new oral formulation has been

This new oral formulation has been mainly developed for patients who have difficulties or dislike swallowing tablets, this being of particular importance considering the debilitated patient population experiencing serious fungal infections.
A dry powder formulation to be reconstituted has been chosen over a “ready-to-use” liquid
formulation based on the active substance properties: low solubility and instability in aqueous environments, and good stability in the solid state.
It has been demonstrated that the particle size of the active substance has no influence on
manufacturing process, suspension properties and stability of the finished product. However, an apparent relationship between this parameter and in vitro dissolution was observed, but batches with a wide range of particle size distribution have been shown to be clinically acceptable. Based on these data, an appropriate particle size specification for voriconazole drug substance has been established (see active substance).

結果 (中文) 1:

这种新的口服制剂主要针对有困难或不喜欢吞咽药片，这是特别重要，考虑到衰弱的病人人口经历严重真菌感染的患者。在一种"现成"液体选择了干粉配方需要重组制订基于活性物质属性: 低溶解性和在水环境中，不稳定和良好的稳定性，在固体状态。表现出的活性物质的粒子大小有没有影响制造工艺、 悬浮性能和成品的稳定性。然而，观察此参数和体外溶出度明显关系，但与粒径分布的种类繁多的批次已被证明是临床上可以接受。基于这些数据，建立合适的粒度大小规格为伏立康唑原料药 (见活性物质)。

結果 (中文) 3:

这种新的口服制剂，主要是为那些有困难或不喜欢吞咽药片的病人，这是特别重要的考虑虚弱病人人口经历严重的真菌感染。
干粉制剂是重组已经选择了一个“准备使用”液体
制定基于活性物质的性质：在水溶液中溶解度低和不稳定，并在固体状态下稳定性好。
证明了活性物质的颗粒尺寸对
制造过程无影响，悬浮性能和成品的稳定性。然而，这个参数与之间的明显关系的体外溶出度的观察，但与范围广泛的粒径分布批次已被证明是临床上可接受的。在这些数据的基础上，适当的粒度规格伏立康唑原料药已建立（见活性物质）。