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预糊化改性淀粉作为新型直接压片辅料的评价。I. 压片特性。

Evaluation of Preflo modified starches as new direct compression excipients. I. Tabletting characteristics.

作者信息

Sanghvi P P, Collins C C, Shukla A J

机构信息

Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, Pennsylvania 15282.

出版信息

Pharm Res. 1993 Nov;10(11):1597-603. doi: 10.1023/a:1018968502586.

Abstract

This investigation evaluated some new (Preflo) and existing commercially available (Starch 1500, Star Tab) modified starches as direct compression excipients. Preflo corn starches (CH-10, CH-20, CH-30) and Preflo potato starches (P-250, PI-10, PJ-20) were evaluated and compared with respect to their pharmaceutical properties such as particle size, density, flowability, friability, and compression properties. Preflo starches showed a high bulk density and good flowability. Preflo corn starches and Star Tab formed harder tablets than Preflo potato starches and Starch 1500. Data from the Athy-Heckel plots indicated that the Preflo starches are soft materials and, unlike Starch 1500, undergo plastic deformation. Tablets containing acetaminophen were also compressed with the starches and disintegration and dissolution studies were conducted. Starch 1500 tablets disintegrated in 3.5 min, whereas none of the Preflo starch tablets disintegrated in 30 min. While complete acetaminophen release occurred in 25 min from Starch 1500 tablets, the drug dissolution time from Preflo starch tablets varied from 4 to 12 hr, indicating a potential use for some of these starches in solid oral modified-release dosage forms.

摘要

本研究评估了一些新型(预胶化淀粉)和市售(淀粉1500、星型片)的改性淀粉作为直接压片辅料。对预胶化玉米淀粉(CH - 10、CH - 20、CH - 30)和预胶化马铃薯淀粉(P - 250、PI - 10、PJ - 20)的粒度、密度、流动性、脆碎度和压缩性能等药学性质进行了评估和比较。预胶化淀粉表现出较高的堆密度和良好的流动性。预胶化玉米淀粉和星型片制成的片剂比预胶化马铃薯淀粉和淀粉1500制成的片剂更硬。来自阿西 - 赫克尔图的数据表明,预胶化淀粉是软质材料,与淀粉1500不同,会发生塑性变形。还使用这些淀粉压制了含对乙酰氨基酚的片剂,并进行了崩解和溶出度研究。淀粉1500片剂在3.5分钟内崩解,而预胶化淀粉片剂在30分钟内均未崩解。虽然淀粉1500片剂在25分钟内对乙酰氨基酚完全释放,但预胶化淀粉片剂的药物溶出时间为4至12小时,表明其中一些淀粉在固体口服缓释剂型中具有潜在用途。

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