Lubrication plays a key role in successful manufacturing of pharmaceutical solid\ndosage forms; lubricants are essential ingredients in robust formulations to achieve this.\nAlthough many failures in pharmaceutical manufacturing operations are caused by issues\nrelated to lubrication, in general, lubricants do not gain adequate attention in the\ndevelopment of pharmaceutical formulations. In this paper, the fundamental background on\nlubrication is introduced, in which the relationships between lubrication and friction/adhesion\nforces are discussed. Then, the application of lubrication in the development of pharmaceutical\nproducts and manufacturing processes is discussed with an emphasis on magnesium stearate.\nIn particular, the effect of its hydration state (anhydrate, monohydrate, dihydrate, and\ntrihydrate) and its powder characteristics on lubrication efficiency, as well as product and\nprocess performance is summarized. In addition, the impact of lubrication on the dynamics\nof compaction/compression processes and on the mechanical properties of compacts/tablets\nis presented. Furthermore, the online monitoring of magnesium stearate in a blending\nprocess is briefly mentioned. Finally, the chemical compatibility of active pharmaceutical\ningredient (API) with magnesium stearate and its reactive impurities is reviewed with\nexamples from the literature illustrating the various reaction mechanisms involved.
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