Abstract
The requirements of the USP Content Uniformity test are translated into physical and mathematical parameters. Assuming spherical particle sizes with a log normal distribution, the mean particle size and particle size distribution required to insure a high probability of passing the content uniformity test are calculated. On the basis of these calculations it is shown that satisfactory tablets of low doses cannot be manufactured from a drug that does not meet certain particle size distribution specifications. It is recommended that particle size specifications for low dose drugs include a requirement for a limit to size distribution.
Original language | English (US) |
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Pages (from-to) | 962-966 |
Number of pages | 5 |
Journal | Pharmaceutical Research: An Official Journal of the American Association of Pharmaceutical Scientists |
Volume | 7 |
Issue number | 9 |
DOIs | |
State | Published - Sep 1990 |
Keywords
- content uniformity
- distribution
- particle size
- probability
- tablets
- uniformity
ASJC Scopus subject areas
- Biotechnology
- Molecular Medicine
- Pharmacology
- Pharmaceutical Science
- Organic Chemistry
- Pharmacology (medical)