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
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here