Compatibility studies between nebicapone, a novel COMT inhibitor, and excipients using stepwise isothermal high sensitivity DSC method

Study of excipients incompatibility with drugs in an early phase of pharmaceutical development is still a persistent difficulty within the pharmaceutical industry. We examine here the compatibility between an experimental drug (nebicapone) and common excipients using differential scanning calorimetr...

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Bibliographic Details
Published in:Journal of thermal analysis and calorimetry 2010-10, Vol.102 (1), p.317-321
Main Authors: Sousa e Silva, J. P., Sousa Lobo, J. M.
Format: Article
Language:English
Subjects:
Analysis
Analytical Chemistry
Antiparkinsonian agents
Biological and medical sciences
Calorimetry
Chemistry
Chemistry and Materials Science
Differential scanning calorimetry
Drugs
Excipients
General pharmacology
Incompatibility
Inhibitors
Inorganic Chemistry
Lactose
Magnesium compounds
Measurement Science and Instrumentation
Medical sciences
Methods
Pharmaceutical technology. Pharmaceutical industry
Pharmaceuticals
Pharmacology. Drug treatments
Physical Chemistry
Polymer Sciences
Sodium
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Summary:Study of excipients incompatibility with drugs in an early phase of pharmaceutical development is still a persistent difficulty within the pharmaceutical industry. We examine here the compatibility between an experimental drug (nebicapone) and common excipients using differential scanning calorimetry (DSC), high sensitivity DSC (HSDSC) and a conventional heat stress test. The results obtained indicate that nebicapone may be compatible with lactose monohydrate and sodium croscarmellose but is incompatible with magnesium stearate. This study concludes that HSDSC, in stepwise isothermal mode, may be used as a potential tool for detecting excipient incompatibilities.
ISSN:1388-6150
1588-2926
1572-8943
DOI:10.1007/s10973-010-0807-8