Lubricants 2014, 2(1), 21-43; doi:10.3390/lubricants2010021

Lubricants in Pharmaceutical Solid Dosage Forms

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Received: 18 December 2013; in revised form: 21 January 2014 / Accepted: 24 January 2014 / Published: 25 February 2014
(This article belongs to the Special Issue Additives for Lubricants)
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract: Lubrication plays a key role in successful manufacturing of pharmaceutical solid dosage forms; lubricants are essential ingredients in robust formulations to achieve this. Although many failures in pharmaceutical manufacturing operations are caused by issues related to lubrication, in general, lubricants do not gain adequate attention in the development of pharmaceutical formulations. In this paper, the fundamental background on lubrication is introduced, in which the relationships between lubrication and friction/adhesion forces are discussed. Then, the application of lubrication in the development of pharmaceutical products and manufacturing processes is discussed with an emphasis on magnesium stearate. In particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and trihydrate) and its powder characteristics on lubrication efficiency, as well as product and process performance is summarized. In addition, the impact of lubrication on the dynamics of compaction/compression processes and on the mechanical properties of compacts/tablets is presented. Furthermore, the online monitoring of magnesium stearate in a blending process is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical ingredient (API) with magnesium stearate and its reactive impurities is reviewed with examples from the literature illustrating the various reaction mechanisms involved.
Keywords: lubricants; boundary lubrication; magnesium stearate; friction; adhesion; the maximum compression pressure; ribbon and tablet density; chemical incompatibility
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MDPI and ACS Style

Li, J.; Wu, Y. Lubricants in Pharmaceutical Solid Dosage Forms. Lubricants 2014, 2, 21-43.

AMA Style

Li J, Wu Y. Lubricants in Pharmaceutical Solid Dosage Forms. Lubricants. 2014; 2(1):21-43.

Chicago/Turabian Style

Li, Jinjiang; Wu, Yongmei. 2014. "Lubricants in Pharmaceutical Solid Dosage Forms." Lubricants 2, no. 1: 21-43.

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