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首页> 美国卫生研究院文献>AAPS PharmSciTech >Effect of Particle Size on In-die and Out-of-die Compaction Behavior of Ranitidine Hydrochloride Polymorphs
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Effect of Particle Size on In-die and Out-of-die Compaction Behavior of Ranitidine Hydrochloride Polymorphs

机译：粒度对盐酸雷尼替丁多晶型的模内和模外压实行为的影响

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摘要

The present study investigates the effect of particle size on compaction behavior of forms I and II of ranitidine hydrochloride. Compaction studies were performed using three particle size ranges [450–600 (A), 300–400 (B), and 150–180 (C) μm] of both the forms, using a fully instrumented rotary tableting machine. Compaction data were analyzed for out-of-die compressibility, tabletability, and compactibility profiles and in-die Heckel and Kawakita analysis. Tabletability of the studied size fractions followed the order; IB > IA > > IIC > IIB > IIA at all the compaction pressures. In both the polymorphs, decrease in particle size improved the tabletability. Form I showed greater tabletability over form II at a given compaction pressure and sized fraction. Compressibility plot and Heckel and Kawakita analysis revealed greater compressibility and deformation behavior of form II over form I at a given compaction pressure and sized fraction. Decrease in particle size increased the compressibility and plastic deformation of both the forms. For a given polymorph, improved tabletability of smaller sized particles was attributed to their increased compressibility. However, IA and IB, despite poor compressibility and deformation, showed increased tabletability over IIA, IIB, and IIC by virtue of their greater compactibility. Microtensile testing also revealed higher nominal fracture strength of form I particles over form II, thus, supporting greater compactibility of form I. Taken as a whole, though particle size exhibited a trend on tabletability of individual forms, better compactibility of form I over form II has an overwhelming impact on tabletability.
机译：本研究调查了粒径对盐酸雷尼替丁晶型I和II压实行为的影响。使用设备齐全的旋转压片机，使用两种形式的三种粒径范围[450–600（A），300–400（B）和150–180（C）μm]进行压实研究。分析压实数据的模头外可压缩性，压片性和可压实性曲线以及模内Heckel和Kawakita分析。研究的大小部分的可压片性遵循该顺序。在所有压实压力下，IB> IA IIC> IIB> IIA。在两种多晶型物中，粒径的减小都改善了可压片性。在给定的压实压力和施胶比例下，I型比II型具有更好的压片性。可压缩性图以及Heckel和Kawakita分析显示，在给定的压实压力和尺寸分数下，II型比I型具有更大的可压缩性和变形行为。颗粒尺寸的减小增加了两种形式的可压缩性和塑性变形。对于给定的多晶型物，较小尺寸颗粒的改进的可压片性归因于其增加的可压缩性。但是，尽管IA和IB的可压缩性和变形性较差，但它们具有更高的可压实性，与IIA，IIB和IIC相比，其可压片性更高。微拉伸试验还显示，形式I的颗粒比形式II的标称断裂强度更高，因此，支持形式I的更高的可压缩性。总的来说，尽管粒度显示出单个形式的可压片性趋势，形式I的可压缩性优于形式II对压片性产生了压倒性的影响。

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