In-line monitoring of granule moisture in fluidized-bed dryers using microwave resonance technology
| Autor: | Wolfgang Wiedey, Caroline Buschmüller, Jörg Breitkreutz, Claas Döscher, Jochen Dressler |
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| Rok vydání: | 2008 |
| Předmět: |
Time Factors
Chemistry Pharmaceutical Drug Compounding Process analytical technology Analytical chemistry Pharmaceutical Science Placebos Granulation Drug Stability Technology Pharmaceutical Cellulose Microwaves Process engineering Water content Dosage Forms Moisture business.industry Chemistry Granule (cell biology) Water Humidity Equipment Design General Medicine Pharmaceutical Preparations Solubility Fluidized bed Crystallization business Biotechnology Karl Fischer titration |
| Zdroj: | European Journal of Pharmaceutics and Biopharmaceutics. 69:380-387 |
| ISSN: | 0939-6411 |
| DOI: | 10.1016/j.ejpb.2007.09.014 |
| Popis: | This is the first report on in-line moisture measurement of pharmaceutical products by microwave resonance technology. In order to meet the FDA's PAT approach, a microwave resonance sensor appropriate for pharmaceutical use was developed and implemented into two different fluidized-bed dryers. The novel sensor enables a continuous moisture measurement independent from the product density. Hence, for the first time precise real time determination of the moisture in pharmaceutical granules becomes possible. The qualification of the newly developed sensor was performed by drying placebo granules under experimental conditions and the validation using drug loaded granules under real process conditions. The results of the investigations show good correlations between water content of the granules determined by the microwave resonance sensor and both reference methods, loss on drying by infrared light exposure and Karl Fischer titration. Furthermore, a considerable time saving in the drying process was achieved through monitoring the residual water content continuously by microwave resonance technology instead of the formerly used discontinuous methods. |
| Databáze: | OpenAIRE |
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