Moisture-Activated Dry Granulation Part II: The Effects of Formulation Ingredients and Manufacturing-Process Variables on Granulation Quality Attributes - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Moisture-Activated Dry Granulation Part II: The Effects of Formulation Ingredients and Manufacturing-Process Variables on Granulation Quality Attributes
In this article, the authors evaluated the effects of the granulating binder level, binder type, water amount, and water-droplet size on the MADG process.


Pharmaceutical Technology
Volume 33, Issue 12, pp. 42-51

Conclusions

The MADG is a simple, clean, lean, and robust process for particle-size enlargement. The results from the evaluation of the effects of the granulating binder level, binder type, water amount, and water-droplet size suggest that the MADG process is robust and creates granulation with good physical properties and finished products with satisfactory quality attributes. The process is applicable to most of the granulation needs for solid dosage-form development as practiced in the pharmaceutical industry. It is essentially a one-pot granulation process. It is also an economical, energy-saving, green, and efficient manufacturing process. The MADG process has advantages such as short manufacturing time and few critical formulation and process variables. These advantages make the MADG process a better candidate than conventional wet- or dry-granulation processes for QbD concepts. Because the MADG process does not require drying or milling, it is suited for use as a continuous process.

Acknowledgements

The authors are grateful to FMC BioPolymer and Evonik Degussa for providing samples of micro crystalline cellulose (Avicel PH200 Low Moisture) and silicon dioxide (Aeroperl 300), respectively.

The authors also sincerely thank their colleagues in the biopharmaceutics research and development department at BMS for their help in executing various experiments and for their constant support and encouragement. In particular, we appreciate Maurice Lobo's and Jeffrey Hemenway's thoughtful comments and tablet-content uniformity data of various compounds.

Ismat Ullah is president of Simple Pharma Solutions (Cranbury, NJ). Jennifer Wang* is a senior research investigator, Shih-Ying Chang is a principal scientist, Hang Guo is a research scientist, San Kiang is a research fellow, and Nemichand B. Jain is director of biopharmaceutics research and development, all at Bristol-Myers Squibb, One Squibb Dr., New Brunswick, NJ 08903, tel. 732.227.5684,

*To whom all correspondence should be addressed.

Submitted: Feb. 23, 2009. Accepted: Apr. 21, 2009.

References

1. I. Ullah et al., Pharm. Technol. 11 (9), 48–54 (1987).

2. C. Chen et al., DrugDev. Ind. Pharm. 16 (3), 379–394 (1990).

3. L.H. Christensen, H.E. Johansen, and T.Schaefer, Drug Dev. Ind. Pharm. 20 (14), 2195–2213 (1994).

4. I. Ullah etal., Pharm. Technol. 33 (11), 62–70 (2009).

5. W. Chen et al., J. Pharm. Innov. 3 (1), 3–14 (2008).


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.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here