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质量源于设计（QbD）原则在将空硬胶囊作为制剂研发和生产中的输入参数进行评估方面的应用。

Application of QbD principles for the evaluation of empty hard capsules as an input parameter in formulation development and manufacturing.

作者信息

Stegemann Sven, Connolly Paul, Matthews Wayne, Barnett Rodger, Aylott Mike, Schrooten Karin, Cadé Dominique, Taylor Anthony, Bresciani Massimo

机构信息

Capsugel, Rijksweg 11, 2880, Bornem, Belgium,

出版信息

AAPS PharmSciTech. 2014 Jun;15(3):542-9. doi: 10.1208/s12249-014-0094-y. Epub 2014 Feb 14.

DOI:10.1208/s12249-014-0094-y
PMID:24526655
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4037476/
Abstract

Understanding the product and process variable on the final product performance is an essential part of the quality-by-design (QbD) principles in pharmaceutical development. The hard capsule is an established pharmaceutical dosage form used worldwide in development and manufacturing. The empty hard capsules are supplied as an excipient that is filled by pharmaceutical manufacturers with a variety of different formulations and products. To understand the potential variations of the empty hard capsules as an input parameter and its potential impact on the finished product quality, a study was performed investigating the critical quality parameters within and in between different batches of empty hard gelatin capsules. The variability of the hard capsules showed high consistency within the specification of the critical quality parameters. This also accounts for the disintegration times, when automatic endpoint detection was used. Based on these data, hard capsules can be considered as a suitable excipient for product development using QbD principles.

摘要

了解产品和过程变量对最终产品性能的影响是药物研发中质量源于设计（QbD）原则的重要组成部分。硬胶囊是一种在全球范围内用于研发和生产的成熟药物剂型。空硬胶囊作为一种辅料提供给制药商，由其填充各种不同的制剂和产品。为了了解空硬胶囊作为输入参数的潜在变化及其对成品质量的潜在影响，开展了一项研究，调查不同批次的空硬明胶胶囊内部以及之间的关键质量参数。硬胶囊的变异性在关键质量参数的规格范围内显示出高度一致性。在使用自动终点检测时，这也适用于崩解时间。基于这些数据，硬胶囊可被视为使用QbD原则进行产品开发的合适辅料。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/70a7a659bdc3/12249_2014_94_Fig12_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/22388763a53c/12249_2014_94_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/9cb5ba12cf8a/12249_2014_94_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/137f6e4781f4/12249_2014_94_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/13da6ed48585/12249_2014_94_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/a29c60a52ec1/12249_2014_94_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/b5b2cd7359c5/12249_2014_94_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/a34eaf22961a/12249_2014_94_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/c07d4c32d226/12249_2014_94_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/08a979ba1c01/12249_2014_94_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/a021f65e9e71/12249_2014_94_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/78268dea475c/12249_2014_94_Fig11_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/70a7a659bdc3/12249_2014_94_Fig12_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/22388763a53c/12249_2014_94_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/9cb5ba12cf8a/12249_2014_94_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/137f6e4781f4/12249_2014_94_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/13da6ed48585/12249_2014_94_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/a29c60a52ec1/12249_2014_94_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/b5b2cd7359c5/12249_2014_94_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/a34eaf22961a/12249_2014_94_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/c07d4c32d226/12249_2014_94_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/08a979ba1c01/12249_2014_94_Fig9_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/a021f65e9e71/12249_2014_94_Fig10_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/78268dea475c/12249_2014_94_Fig11_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff06/4037476/70a7a659bdc3/12249_2014_94_Fig12_HTML.jpg

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