Stability characterization of controlled release coprecipitates and solid dispersions
| Autor: | Indra K. Reddy, Sami Nazzal, S R Vaithiyalingam, Anees Abdulquadar Karnachi, Mansoor A. Khan, Vikas Agarwal |
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| Rok vydání: | 2000 |
| Předmět: |
Calorimetry
Differential Scanning Stereochemistry Coprecipitation Chemistry Drug Storage Anti-Inflammatory Agents Non-Steroidal Indomethacin Acrylic Resins Temperature Pharmaceutical Science Humidity Controlled release Dosage form Crystallinity Differential scanning calorimetry Drug Stability Polymethacrylic Acids Solubility X-Ray Diffraction Delayed-Action Preparations Chemical Precipitation Endotherm Dissolution Tablets Nuclear chemistry |
| Zdroj: | Journal of Controlled Release. 63:1-6 |
| ISSN: | 0168-3659 |
| Popis: | The present study was conducted to determine the effects of ageing at exaggerated storage conditions on controlled release tablets prepared with indomethacin-Eudragit((R)) coprecipitates (CPs) and solid dispersions (SDs). CPs and SDs compressed as tablets were stored at -20, 4, 37, 45, 55, 37 degrees C/11% RH, 37 degrees C/51% RH and 37 degrees C/91% RH. The samples were analyzed over a period of six months for their dissolution, crystalline reversion and thermal changes. Samples stored at extremely low temperatures, higher temperatures and humidity conditions exhibited a significant decrease in dissolution rates. However, no significant change in the release rates was observed for samples stored at 4 degrees C. The degree of crystallinity increased over a period of time as confirmed by X-ray diffractometry. DSC data demonstrated that indomethacin exists in two polymorphic forms, Form I (mp 160-161 degrees C) and Form II (mp 153-154 degrees C). CPs showed an endotherm of Form I, whereas SDs showed a mixture of Form I and II. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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