Scale up of a granulation phenomenon : During the drying of an active pharmaceutical ingredient

• Published in: Pharmaceutical Technology Vol. 29; no. 10; pp. 80 - 86
• Main Authors: KUKURA, Joseph, IZZO, Bill, ORELLA, Charles
• Format: Magazine Article Trade Publication Article
• Language: English
• Published: Duluth, MN Advanstar Communications 01.10.2005; Intellisphere, LLC; MultiMedia Healthcare Inc
• Subjects: Biological and medical sciences; Crystallization; Electron microscopes; General pharmacology; Laboratories; Manufacturers; Manufacturing; Medical sciences; Moisture content; Pharmaceutical industry; Pharmaceutical technology. Pharmaceutical industry; Pharmaceuticals; Pharmacology. Drug treatments; Physical properties; Product development; R&D; Research & development; Washers & dryers; United States; United States > US; Active ingredient; Pharmaceutical technology; Granulation; Drying
• ISSN: 1543-2521

A drug product's formulation processes and dissolution rates can be sensitive to changes in the physical nature of the active pharmaceutical ingredient (API). Consequently, manufacturers must ensure that the development and scale-up of the final manufacturing step of an API maintain consistency in a product's physical properties. Granulation is conducted during many formulation processes to generate larger particles after blending an API with excipients. The evolution of granule properties during a typical granulation process is controlled by three distinct stages: wetting, growth, and attrition. Most pharmaceutical formulation granulation processes do not add liquid beyond the point where granule sizes will get smaller, but granulation during drying can start at a moisture content above this critical value. This article focuses on the effect of equipment type and size on granulation. Consistent performance upon scale-up in a rotary dryer with material that could granulate from the impact of the tumbling action was not achievable.