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18.97.14.81

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

By Jakubowska, E; Ciepluch, N

Published on

Abstract

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 Article 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.

Journal

Pharmaceutics. Volume 13, 2021, 1909

DOI

10.3390/pharmaceutics13111909

Type of publication

Peer-reviewed journal

Affiliations

  • Poznan University of Medical Sciences

Article Classification

Review article

Classification Areas

  • API

Tags