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

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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).


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