Lubricants in Pharmaceutical Solid Dosage Forms
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, lubri...
| Main Authors: | , |
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| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2014-02-01
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| Series: | Lubricants |
| Subjects: | |
| Online Access: | http://www.mdpi.com/2075-4442/2/1/21 |
| _version_ | 1797999231906086912 |
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| author | Jinjiang Li Yongmei Wu |
| author_facet | Jinjiang Li Yongmei Wu |
| author_sort | Jinjiang Li |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T11:01:22Z |
| format | Article |
| id | doaj.art-e9fe29d42e9d42e5b5d98bd3ec6f097b |
| institution | Directory Open Access Journal |
| issn | 2075-4442 |
| language | English |
| last_indexed | 2024-04-11T11:01:22Z |
| publishDate | 2014-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Lubricants |
| spelling | doaj.art-e9fe29d42e9d42e5b5d98bd3ec6f097b2022-12-22T04:28:37ZengMDPI AGLubricants2075-44422014-02-0121214310.3390/lubricants2010021lubricants2010021Lubricants in Pharmaceutical Solid Dosage FormsJinjiang Li0Yongmei Wu1Drug Product Science & Technology, Bristol-Myers Squibb Corporation, 1 Squibb Dr., New Brunswick, NJ 08903, USADrug Product Science & Technology, Bristol-Myers Squibb Corporation, 1 Squibb Dr., New Brunswick, NJ 08903, USALubrication 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.http://www.mdpi.com/2075-4442/2/1/21lubricantsboundary lubricationmagnesium stearatefrictionadhesionthe maximum compression pressureribbon and tablet densitychemical incompatibility |
| spellingShingle | Jinjiang Li Yongmei Wu Lubricants in Pharmaceutical Solid Dosage Forms Lubricants lubricants boundary lubrication magnesium stearate friction adhesion the maximum compression pressure ribbon and tablet density chemical incompatibility |
| title | Lubricants in Pharmaceutical Solid Dosage Forms |
| title_full | Lubricants in Pharmaceutical Solid Dosage Forms |
| title_fullStr | Lubricants in Pharmaceutical Solid Dosage Forms |
| title_full_unstemmed | Lubricants in Pharmaceutical Solid Dosage Forms |
| title_short | Lubricants in Pharmaceutical Solid Dosage Forms |
| title_sort | lubricants in pharmaceutical solid dosage forms |
| topic | lubricants boundary lubrication magnesium stearate friction adhesion the maximum compression pressure ribbon and tablet density chemical incompatibility |
| url | http://www.mdpi.com/2075-4442/2/1/21 |
| work_keys_str_mv | AT jinjiangli lubricantsinpharmaceuticalsoliddosageforms AT yongmeiwu lubricantsinpharmaceuticalsoliddosageforms |