Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review

Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend homog...

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Autores principales:	Emilia Jakubowska, Natalia Ciepluch
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	blend segregation powder segregation content uniformity blend uniformity blend homogeneity tablet manufacturing Pharmacy and materia medica RS1-441
Acceso en línea:	https://doaj.org/article/8aafae956e0648439575b03461b5fd86
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spelling	oai:doaj.org-article:8aafae956e0648439575b03461b5fd862021-11-25T18:41:43ZBlend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review10.3390/pharmaceutics131119091999-4923https://doaj.org/article/8aafae956e0648439575b03461b5fd862021-11-01T00:00:00Zhttps://www.mdpi.com/1999-4923/13/11/1909https://doaj.org/toc/1999-4923Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend homogeneity, or may result from further particle segregation during storage, transfer or the compression process itself. This review presents the most relevant powder segregation mechanisms in tablet manufacturing and summarizes the currently available, up-to-date research on segregation and uniformity loss at the various stages of production process—the blend transfer from the bulk container to the tablet press, filling and discharge from the feeding hopper, as well as die filling. Formulation and processing factors affecting the occurrence of segregation and tablets’ CU are reviewed and recommendations for minimizing the risk of content uniformity failure in tablets are considered herein, including the perspective of continuous manufacturing.Emilia JakubowskaNatalia CiepluchMDPI AGarticleblend segregationpowder segregationcontent uniformityblend uniformityblend homogeneitytablet manufacturingPharmacy and materia medicaRS1-441ENPharmaceutics, Vol 13, Iss 1909, p 1909 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	blend segregation powder segregation content uniformity blend uniformity blend homogeneity tablet manufacturing Pharmacy and materia medica RS1-441
spellingShingle	blend segregation powder segregation content uniformity blend uniformity blend homogeneity tablet manufacturing Pharmacy and materia medica RS1-441 Emilia Jakubowska Natalia Ciepluch Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review
description	Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend homogeneity, or may result from further particle segregation during storage, transfer or the compression process itself. This review presents the most relevant powder segregation mechanisms in tablet manufacturing and summarizes the currently available, up-to-date research on segregation and uniformity loss at the various stages of production process—the blend transfer from the bulk container to the tablet press, filling and discharge from the feeding hopper, as well as die filling. Formulation and processing factors affecting the occurrence of segregation and tablets’ CU are reviewed and recommendations for minimizing the risk of content uniformity failure in tablets are considered herein, including the perspective of continuous manufacturing.
format	article
author	Emilia Jakubowska Natalia Ciepluch
author_facet	Emilia Jakubowska Natalia Ciepluch
author_sort	Emilia Jakubowska
title	Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review
title_short	Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review
title_full	Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review
title_fullStr	Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review
title_full_unstemmed	Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review
title_sort	blend segregation in tablets manufacturing and its effect on drug content uniformity—a review
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/8aafae956e0648439575b03461b5fd86
work_keys_str_mv	AT emiliajakubowska blendsegregationintabletsmanufacturinganditseffectondrugcontentuniformityareview AT nataliaciepluch blendsegregationintabletsmanufacturinganditseffectondrugcontentuniformityareview
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Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review

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