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Critical factors in manufacturing multi-layer tablets--assessing material attributes, in-process controls, manufacturing process and product performance.

Abstract：

:Advancement in the fields of material science, analytical methodologies, instrumentation, automation, continuous monitoring, feed forward/feed back control and comprehensive data collection have led to continual improvement of pharmaceutical tablet manufacturing technology, notably the multi-layer tablets. This review highlights the material attributes, formulation design, process parameters that impact the performance, and manufacturability of the multi-layer tablets. It also highlights on critical-to-quality elements that needs to be addressed in the regulatory submission.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Vaithiyalingam SR,Sayeed VA

doi

10.1016/j.ijpharm.2010.07.025

subject

Has Abstract

pub_date

2010-10-15 00:00:00

pages

9-13

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(10)00552-1

journal_volume

398

pub_type

杂志文章,评审

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