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2 Citations 163 References 7 Figures
An IQ Consortium Review
Article (PDF Available) in Journal of Pharmaceutical Sciences 107(9) · May 2018 with 2,784 Reads
DOI: 10.1016/j.xphs.2018.04.029
Cite this publication
Sayantan Chattoraj
Patrick Daugherity
18.15 · GlaxoSmithKline plc. Upper Providence
Abstract
Sticking and picking during tablet manufacture has received increasing interest recently, as it causes tablet defects, downtime in
manufacturing and yield losses. The capricious nature of the problem means that it can appear at any stage of the development
cycle, even when it has been deemed as low risk by models, tests and previous experience. In many cases, the problem manifests
when transferring the process from one manufacturing site to another. Site transfers are more common than in previous times due
to the multinational nature of drug product manufacture and the need for redundancy in manufacturing networks.
+4
Picking in a tablet logo. The disastrous effects of tablet sticking Photomicrograps of tools with steel
when observed in manufacturing process. inclusions.
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a r t i c l e i n f o a b s t r a c t
Article history: Sticking and picking during tablet manufacture has received increasing interest recently, as it causes
Received 6 March 2018 tablet defects, downtime in manufacturing, and yield losses. The capricious nature of the problem means
Revised 23 April 2018 that it can appear at any stage of the development cycle, even when it has been deemed as low risk by
Accepted 27 April 2018
models, tests, and previous experience. In many cases, the problem manifests when transferring the
process from one manufacturing site to another. Site transfers are more common now than in previous
times because of the multinational nature of drug product manufacturing and the need for redundancy
Keywords:
tableting in manufacturing networks. Sticking is a multifactorial problem, so one single “fix” is unlikely to solve it
tablet(s) completely, and “solutions” addressing one problem may exacerbate another. A broad-based strategy
physical characterization involving the API, formulation, tablet tooling, and the manufacturing process is the most likely approach
excipient(s)
to provide a robust and lasting solution. When faced with a sticking problem for the first or subsequent
process analytical technology (PAT)
processing time, the formulator should address, in a structured way, a range of possible causes and remedies. In this
article, we focus on current research and practice; on some of the common causes of sticking; mitigation
and resolution strategies and solutions; and possible future directions in research.
© 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.xphs.2018.04.029
0022-3549/© 2018 American Pharmacists Association ®. Published by Elsevier Inc. All rights reserved.
Manufacture of Tablet Tooling of the punches. If the steel has been refined, then the carbide
structures within the steel will be more homogeneous, and the
Steel Selection surface will be polished to a more consistent finish.
There are thousands of types of steels available in the market
The manufacture of tablet tooling starts with selection of the today. However, because of the nature of the cyclic loading placed on
correct steel. The steel needs to have the ability to be conditioned to the tooling during powder compaction and manufacturing pro-
allow the correct tensile strength and toughness. These 2 properties cesses, such as cold forming, the number of steel options is reduced
are key as they will together improve the ability of the punches and to only a handful. In general, tooling manufacturers will maintain a
dies to resist fracture and allow the maximum possible compres- number of steels, with specific properties, that may have specifically
sion force to be applied. Some tooling manufacturers offer steel that advantageous properties in some situations, taking into account tip
have undertaken a secondary refining process as standard. This wear, strength, and suitability for common processes, such as wash
process not only increases the steel's ability to withstand fracture in place, among other characteristics. Consultation with a tooling
but also has a great effect on the structure of the compression faces manufacturer to identify the most suitable steel for the tooling for a
specific application is a key step in development.13,14
Although other materials have been investigated as possible
bases for tooling,15 it is likely that steel tooling will remain the only
viable option for the foreseeable future.
Finishing of Tooling
API Properties
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Article Article
This main aim of the current review article is to provide a complete overview on Purpose The objective of this article is to review the critical material attributes of
recent development in excipient technology and the approaches involved in pharmaceutical excipients employed in solid dosage manufacturing and link
development of such excipients. Formulation scientists recognized that single them to critical quality attributes (CQAs). Material attributes can have a profound
component excipients do not always provide the requisite performance to allow impact on CQAs of product. Methods The importance of particle size, particle
certain active pharmaceutical ingredients to be formulated or manufactured morphology, density, moisture content, and polymorphism to product CQAs is ...
adequately ... [Show full abstract] [Show full abstract]
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