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一种可直接压缩的预胶化西米淀粉:药物片剂制剂中的新型辅料。

A Directly Compressible Pregelatinised Sago Starch: A New Excipient in the Pharmaceutical Tablet Formulations.

作者信息

Widodo Riyanto Teguh, Hassan Aziz, Liew Kai Bin, Ming Long Chiau

机构信息

Department of Pharmaceutical Technology, Faculty of Pharmacy, Universiti Malaya, Kuala Lumpur 50603, Malaysia.

Department of Chemistry, Faculty of Science, Universiti Malaya, Kuala Lumpur 50603, Malaysia.

出版信息

Polymers (Basel). 2022 Jul 28;14(15):3050. doi: 10.3390/polym14153050.

Abstract

An excipient intended for direct compression in pharmaceutical tableting must show important features of flowability and compactibility. This study investigated pregelatinised sago starch as an excipient for direct compression tablets. Pregelatinised sago starch was prepared and characterised. Its powder bulk properties and performance in the tablet formulations with paracetamol as a model drug were compared against two commercial, directly compressible excipients, namely Avicel PH 101 and Spress B820. The results showed that pregelatinisation did not affect the chemical structure of sago starch, but its degree of crystallinity reduced, and X-ray diffraction pattern changed from C-type to A-type. Powder bulk properties of pregelatinised sago starch and Spress B820 were comparable, exhibiting better flowability but lower compactibility than Avicel PH 101. In the formulation of paracetamol tablets, pregelatinised sago starch and Spress B820 performed equally well, followed by Avicel PH 101 as indicated in Formulations 3, 2 and 1, respectively.

摘要

用于药物压片直接压片的辅料必须具备良好的流动性和可压性等重要特性。本研究考察了预胶化西米淀粉作为直接压片辅料的性能。制备并表征了预胶化西米淀粉。以对乙酰氨基酚为模型药物,将其粉体性质及在片剂配方中的性能与两种市售直接压片辅料即微晶纤维素PH 101和Spress B820进行了比较。结果表明,预胶化处理未影响西米淀粉的化学结构,但结晶度降低,X射线衍射图谱由C型转变为A型。预胶化西米淀粉和Spress B820的粉体性质相当,流动性优于微晶纤维素PH 101,但可压性低于微晶纤维素PH 101。在对乙酰氨基酚片剂配方中,预胶化西米淀粉和Spress B820表现相当,微晶纤维素PH 101依次次之,分别对应配方3、2和1。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e22b/9370636/eb42234049b7/polymers-14-03050-g001.jpg

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