SOLID STABILITY TESTING OF IBUPROFEN - EUDRAGIT RESPM SUSTAINED RELEASE TABLETS

Abdel Rahman, Aly A.; Aboutaleb, A. E.; Stamm, A.; Abdel Rahman, S. I.; Samy, E. M.

doi:10.21608/bfsa.1993.70025

SOLID STABILITY TESTING OF IBUPROFEN - EUDRAGIT RESPM SUSTAINED RELEASE TABLETS

Document Type : Original Article

Authors

¹ Department of Industrial Pharmacy, Faculty of Pharmacy, Assiut University, Assiut, Egypt

² Faculty of Pharmacy, Louis Pasteur University, France

10.21608/bfsa.1993.70025

Abstract

Preformulated ibuprofen-Eudragit RSPM sustained release tablets were subjected to accelerated stability testing at 25, ·37 and 45°C for 6 months. The stored tablets were evaluated for the intact drug in the formula, drug-polymer interaction and compatibility of the drug with the formulated excipients using infra red spectroscopy (I.R.) and differential scanning calorimetry (DSC).
The IR spectrum of ibuprofen in the tablets prepared by 15% w/v Eudragit RSPM as a granulating agent and containing 23% w/w Avicel pH 102 as an excipient was similar to the IR of standard ibuprofen. There was no change in the IR spectra of the tablet components before and after storage of those tablets at the different investigated temperatures for 1, 3 and 6 months.
The DSC thermograms of ibuprofen stored tablets showed that the drug was still in the highly pure (>98%) crystalline form and there was no significant degradation after storage indicating the stability of the drug on storage.
In detecting ibuprofen purity in the stored tablets, plotting of the sample temperature versus the reciprocal of the fraction of ibuprofen melted showed deviation from Van't Hoff linear plot.