Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate - Pharmaceutical Technology

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Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate
The influence of magnesium stearate (MgSt) on powder lubrication and finished solid-dose properties presents big challenges to drug manufacturers.


Pharmaceutical Technology


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5. A. Stallings, "Approach to Understanding Immediate Release Dosage Form Dissolution Failures due to Effects of Magnesium Stearate in Pharmaceutical Formulations," AAPS poster W4332 (2005).

6. A. Alexander et al., "Characterization of the Performance of Bin Blenders: Part 3 of 3—Cohesive Powders," Pharm. Technol. 28 (9), 54–74 (2004).

7. D. Wurster, S. Likitlersuang, and Y. Chen, "The Influence of Magnesium Stearate on the Hiestand Tableting Indices and Other Related Mechanical Properties of Maltodextrins," J. Pharm. Dev. Technol. 10 (4), 461–466 (2005).

8. V. Swaminathan and D. Kildsig, "An Examination of the Moisture Sorption Characteristics of Commercial Magnesium Stearate," AAPS PharmSciTech 2 (4), article 28 (2001).

9. K. Rao et al., "Impact of Solid-State Properties on Lubrication Efficacy of Magnesium Stearate," J. Pharm. Dev. Technol. 10 (3), 423–437 (2005).

10. S. Wu, Effects of Magnesium Stearate Hydrates on Powder Flowability, Tablet Ease, and Tablet Quality, Technical Report (Tyco Healthcare–Mallinkrodt, 2006).

11. J. Kaufman et al., "Multivariate Calibration of Mixtures of Magnesium Stearate Hydrates," AAPS abstract T3288, 2006.

12. P. Okoye et al., "Understanding Scale-Up and Process Equipment Change: Case Study using Thermal Effusivity Sensor as a PAT Tool," ISPE News Magazine 3 (3), 4–8 (2006).

13. M. Emanuel and P. Okoye, "Evaluation of a Simple Fluid-bed Dryer Sampler Modification for On-line Profiling and End-Point Determination Utilizing Effusivity," AAPS abstract T3308 (2006).

14. G. Fariss, R. Kientz, and P. Okoye, "Thermal Effusivity and Power Consumption as PAT Tools for Monitoring Granulation End-Point, Pharm. Technol. 30 (6), 60–72 (2006).

15. B. Ennis and M. Emanuel, "Comparison of Shear Cell and Effusivity Methods to Determine Flow Properties of Common Excipients and Blends," AAPS abstract W5219 (2006).

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21. FDA, Guidance for Industry: Dissolution Testing for Immediate Release Solid Oral Dosage Forms, (FDA, Rockville, MD), http://www.fda.gov/cder/guidance/, 1997, accessed Aug. 10, 2007.


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