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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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


3. H. Lieberman, L. Lachman, and J. Schwartz, Pharmaceutical Dosage Forms: Tablets Vol. 1 (Marcel Dekker, New York, 2d ed., 1989), pp. 195–246.

4. P. Arratia et al., "Characterizing Mixing and Lubrication in the Bohle Bin Blender," Powder Technol. 161 , 202–208 (2006).

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).

16. P. Sheskey, R. Rowe, and P. Weller, Handbook of Pharmaceutical Excipients, (Pharmaceutical Press, London, 4th ed., 2003).

17. Minitab: Data Analysis and Quality Tools (Minitab Inc., State College, PA), 2000.

18. N. Mathis, "Monitoring Blend Uniformity with Effusivity," Pharm. Technol. 26 (4), 80–84 (2002).

19. R. Hwang, Y. Huang, and G. Peck, "Evaluation of Blend Sampling Errors: A Statistical Approach," Pharm. Technol. 23 (6), 56–65 (1999).

20. FDA. Generic Drug Draft: Blend Uniformity Analysis (FDA, Rockville, MD), http://www.fda.gov/cder/guidance/, 05/17/2002, accessed Aug. 10, 2007.

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here