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环境湿度变化对粉末滚压成型行为以及对后磨碎颗粒所制得片剂特性的影响。

Effect of the variation in the ambient moisture on the compaction behavior of powder undergoing roller-compaction and on the characteristics of tablets produced from the post-milled granules.

作者信息

Gupta Abhay, Peck Garnet E, Miller Ronald W, Morris Kenneth R

机构信息

Department of Industrial and Physical Pharmacy, Purdue University School of Pharmacy, West Lafayette, Indiana 47907-2091, USA.

出版信息

J Pharm Sci. 2005 Oct;94(10):2314-26. doi: 10.1002/jps.20414.

DOI:10.1002/jps.20414
PMID:16136545
Abstract

Effect of variation in the ambient moisture levels on the compaction behavior of a 10% acetaminophen (APAP) powder blend in microcrystalline cellulose (MCC) powder was studied by comparing the physical and mechanical properties of ribbons prepared by roller compaction with those of simulated ribbons, i.e., tablets prepared under uni-axial compression. Relative density, moisture content, tensile strength, and Young's modulus were used as key compact properties for comparison. Moisture was found to facilitate the particle rearrangement of both, the APAP and the MCC particles, as well as the deformation of the MCC particles. The tensile strength of the simulated ribbons also showed an increase with increasing moisture content. An interesting observation was that the tensile strength of the roller compacted samples first increased and then decreased with increasing moisture content. Variation in the ambient moisture during roller compaction was also found to influence the characteristics of tablets produced from the granules obtained post-milling the ribbons. A method to study this influence is also reported.

摘要

通过比较滚压法制得的条带与模拟条带(即单轴压缩制备的片剂)的物理和机械性能,研究了环境湿度水平变化对10%对乙酰氨基酚(APAP)与微晶纤维素(MCC)粉末混合粉末压实行为的影响。相对密度、水分含量、拉伸强度和杨氏模量用作比较的关键压实性能。发现水分有助于APAP和MCC颗粒的颗粒重排以及MCC颗粒的变形。模拟条带的拉伸强度也随水分含量增加而增加。一个有趣的观察结果是,滚压压实样品的拉伸强度随着水分含量的增加先增加后降低。还发现滚压过程中环境湿度的变化会影响由条带研磨后得到的颗粒制备的片剂的特性。还报道了一种研究这种影响的方法。

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