Stability characterization of controlled release coprecipitates and solid dispersions

The present study was conducted to determine the effects of ageing at exaggerated storage conditions on controlled release tablets prepared with indomethacin–Eudragit® coprecipitates (CPs) and solid dispersions (SDs). CPs and SDs compressed as tablets were stored at −20, 4, 37, 45, 55, 37°C/11% RH,...

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Bibliographic Details
Published in:Journal of controlled release 2000-01, Vol.63 (1-2), p.1-6
Main Authors: Khan, Mansoor A, Karnachi, Anees A, Agarwal, Vikas, Vaithiyalingam, Sivakumar R, Nazzal, Sami, Reddy, Indra K
Format: Article
Language:English
Subjects:
Acrylic Resins - chemistry
Anti-Inflammatory Agents, Non-Steroidal - chemistry
Biological and medical sciences
Bones, joints and connective tissue. Antiinflammatory agents
Calorimetry, Differential Scanning
Chemical Precipitation
Coprecipitates
Delayed-Action Preparations - chemistry
Drug Stability
Drug Storage
DSC
General pharmacology
Indomethacin
Indomethacin - chemistry
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Polymethacrylic Acids - chemistry
Solid dispersions
Solubility
Stability
Tablets
Temperature
X-Ray Diffraction
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Summary:The present study was conducted to determine the effects of ageing at exaggerated storage conditions on controlled release tablets prepared with indomethacin–Eudragit® coprecipitates (CPs) and solid dispersions (SDs). CPs and SDs compressed as tablets were stored at −20, 4, 37, 45, 55, 37°C/11% RH, 37°C/51% RH and 37°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°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°C) and Form II (mp 153–154°C). CPs showed an endotherm of Form I, whereas SDs showed a mixture of Form I and II.
ISSN:0168-3659
1873-4995
DOI:10.1016/S0168-3659(99)00172-8