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

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...

Full description

Saved in:
Bibliographic Details
Published inPharmaceutical Technology Vol. 29; no. 10; pp. 80 - 86
Main Authors KUKURA, Joseph, IZZO, Bill, ORELLA, Charles
Format Magazine Article Trade Publication Article
LanguageEnglish
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
Online AccessGet full text

Cover

More Information
Summary: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.
ISSN:1543-2521
2150-7376