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不同类型乳糖的可压缩性和可压缩性。

The compressibility and compactibility of different types of lactose.

机构信息

Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia.

出版信息

Drug Dev Ind Pharm. 2009 Oct;35(10):1271-80. doi: 10.1080/03639040902932945.

Abstract

OBJECTIVE

The purpose of this study was to investigate and quantify flow properties, compressibility, and compactibility of various pharmaceutical lactose powders found on the market today (DCL-11, DCL-21, M-200, Flowlac-100, and Tablettose 70, 80, and 100).

METHODS

Flow properties were estimated by measuring flow time, angle of repose, and the Hausner ratio. Particle rearrangement was studied using Kawakita's linear model. Compressibility was studied using two 'out-of-die' methods: (i) the Heckel model and (ii) a modified Walker model. Compactibility was quantified using two methods: (i) the tensile strength profile (Cp) and (ii) the compactibility factor (Pr). Statistical approach was used to analyze the results.

RESULTS

Flow properties of all materials were passable or better, except for M-200, which has very poor flowability. Compressibility results demonstrated that the most compressible lactose is spray-dried grade of lactose (Flowlac-100) and the least compressible is milled lactose (M-200). Compactibility studies showed that beta-lactose (DCL-21) forms tablets with superior tensile strength in comparison with alpha-lactose.

CONCLUSION

Results of the compressibility study showed that the discriminative power of modified Walker model is greater in comparison with Heckel model. Compactibility methods yield similar and comparable results.

摘要

目的

本研究旨在调查和量化当今市场上各种药用乳糖粉末的流动特性、可压缩性和可压缩性(DCL-11、DCL-21、M-200、Flowlac-100 以及 Tablettose 70、80 和 100)。

方法

通过测量流动时间、休止角和 Hausner 比来估算流动特性。使用 Kawakita 的线性模型研究了颗粒的重新排列。使用两种“模外”方法研究了可压缩性:(i)Hackel 模型和(ii)改进的 Walker 模型。使用两种方法量化了可压缩性:(i)拉伸强度分布(Cp)和(ii)可压缩性因子(Pr)。使用统计方法分析了结果。

结果

除了 M-200 外,所有材料的流动性能都可以接受或更好,M-200 的流动性非常差。可压缩性结果表明,最可压缩的乳糖是喷雾干燥乳糖(Flowlac-100),而最不可压缩的乳糖是研磨乳糖(M-200)。可压缩性研究表明,β-乳糖(DCL-21)形成的片剂比α-乳糖具有更高的拉伸强度。

结论

可压缩性研究的结果表明,改进的 Walker 模型的判别能力大于 Hackel 模型。可压缩性方法产生相似且可比较的结果。

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