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An investigation into the effects of excipient particle size blending techniques and processing parameters on the homogeneity and content uniformity of a blend containing low-dose model drug

机译：研究赋形剂粒径混合技术和加工参数对含低剂量模型药物的混合物的均质性和含量均匀性的影响

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摘要

Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contributing factors. Excipient characteristics play key role in efficient blending process and final product quality. In this work the effect of excipient type and properties, blending technique and processing time on content uniformity was investigated. Powder characteristics for three commonly used excipients (starch, pregelatinised starch and microcrystalline cellulose) were initially explored using laser diffraction particle size analyser, angle of repose for flowability, followed by thorough evaluations of surface topography employing scanning electron microscopy and interferometry. Blend homogeneity was evaluated based on content uniformity analysis of the model API, ergocalciferol, using a validated analytical technique. Flowability of powders were directly related to particle size and shape, while surface topography results revealed the relationship between surface roughness and ability of excipient with high surface roughness to lodge fine API particles within surface groves resulting in superior uniformity of content. Of the two blending techniques, geometric blending confirmed the ability to produce homogeneous blends at low dilution when processed for longer durations, whereas manual ordered blending failed to achieve compendial requirement for content uniformity despite mixing for 32 minutes. Employing the novel dry powder hybrid mixer device, developed at Aston University laboratory, results revealed the superiority of the device and enabled the production of homogenous blend irrespective of excipient type and particle size. Lower dilutions of the API (1% and 0.5% w/w) were examined using non-sieved excipients and the dry powder hybrid mixing device enabled the development of successful blends within compendial requirements and low relative standard deviation.
机译：粉末共混物的均质性是低剂量和有效活性药物成分（API）制剂开发中的关键属性，同时也是一个具有多个影响因素的复杂过程。赋形剂特性在有效的混合过程和最终产品质量中起着关键作用。在这项工作中，研究了赋形剂类型和性质，混合技术和加工时间对含量均匀性的影响。最初使用激光衍射粒度分析仪，流动性的休止角探索了三种常用赋形剂（淀粉，预糊化淀粉和微晶纤维素）的粉末特性，然后使用扫描电子显微镜和干涉术对表面形貌进行了全面评估。使用经过验证的分析技术，基于模型API麦角骨化醇的含量均匀性分析，评估掺混物的均匀性。粉末的流动性与颗粒的大小和形状直接相关，而表面形貌结果表明表面粗糙度与高表面粗糙度赋形剂将细小的API颗粒沉积在表面凹槽中的能力之间存在关系，从而导致含量均匀性高。在这两种混合技术中，几何混合确认了在长时间加工时能够以低稀释度生产均质混合物的能力，而手动混合却不能满足32分钟的含量均匀性要求。使用由阿斯顿大学实验室开发的新型干粉混合混合器设备，结果揭示了该设备的优越性，并且无论辅料类型和粒径如何，均能够生产均质的混合物。使用未过筛的赋形剂检查了API的较低稀释度（分别为1％和0.5％w / w），并且干粉混合混合装置能够在药典要求和相对标准偏差低的情况下开发出成功的混合物。

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