Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle
| Autor: | Robert Lionberger, Anjanette P. Smith, Laxma R. Nagavelli, Anna M. Wokovich, Lucinda F. Buhse, James F. Allgire, Vilayat A. Sayeed, Lawrence X. Yu, Benjamin J. Westenberger |
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| Rok vydání: | 2010 |
| Předmět: |
Materials science
Databases Factual Therapeutic equivalency Pharmacology toxicology Administration Oral Pharmaceutical Science Capsules Nanotechnology Aquatic Science Bead (woodworking) Drug Discovery Marketed products Drug approval Particle Size Drug Approval Brief/Technical Note Ecology Evolution Behavior and Systematics Chromatography Ecology United States Food and Drug Administration General Medicine Hydrogen-Ion Concentration United States Pharmaceutical Preparations Therapeutic Equivalency Food Delayed-Action Preparations Agronomy and Crop Science |
| Zdroj: | AAPS PharmSciTech. 11:1508-1510 |
| ISSN: | 1530-9932 |
| DOI: | 10.1208/s12249-010-9529-2 |
| Popis: | The bead sizes used in approved modified release capsules labeled for sprinkling on food was investigated to generate bead size guidelines for generic products labeled for sprinkling. The conclusions from a survey of FDA databases were corroborated with experimental data obtained by measuring the bead sizes of several reference-listed drugs on the market labeled for administration by sprinkling on food. The experimental data show that majority of the marketed products were found to have bead sizes of less than 1,500 microm (1.5 mm). Based on this information, a bead size of less than 1,500 microm should generally be considered acceptable for use in generic products labeled for sprinkling. |
| Databáze: | OpenAIRE |
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