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((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.
Khan
M A
MA
Department of Pharmaceutical Sciences, Texas Tech University Health Sciences Center, Amarillo, TX 79106, USA. Khan@cortex.ama.ttuhsc.edu
Karnachi
A A
AA
Agarwal
V
V
Vaithiyalingam
S R
SR
Nazzal
S
S
Reddy
I K
IK
D000180:Acrylic Resins / Q000737:chemistry; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000737:chemistry; D002152:Calorimetry, Differential Scanning; D011232:Chemical Precipitation; D003692:Delayed-Action Preparations / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage; D007213:Indomethacin / Q000737:chemistry; D011109:Polymethacrylic Acids / Q000737:chemistry; D012995:Solubility; D013607:Tablets; D013696:Temperature; D014961:X-Ray Diffraction
D000180:Acrylic Resins; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D011109:Polymethacrylic Acids; D013607:Tablets; C038300:methylmethacrylate-methacrylic acid copolymer; D007213:Indomethacin