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Accelerated stability of Ibuprofen-Eudragit RSPM sustained release tablets, IR and DSC solid stability testing
A A Abdel Rahman1, A E Aboutaleb, A Stamm
1Faculty of Pharmacy, Assiut University, Assiut, Egypt.
Journal De Pharmacie De Belgique
|November 1, 1993
Summary
Ibuprofen sustained release tablets formulated with Eudragit RSPM showed no significant degradation after six months of accelerated stability testing. Both infra-red spectroscopy and differential scanning calorimetry confirmed the drug
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Sustained release drug delivery systems are crucial for maintaining therapeutic drug levels.
- Ibuprofen is a widely used nonsteroidal anti-inflammatory drug (NSAID).
- Eudragit RSPM is a pH-dependent polymer used in controlled-release formulations.
Purpose of the Study:
- To evaluate the stability of preformulated Ibuprofen-Eudragit RSPM sustained release tablets.
- To assess drug-polymer interactions and excipient compatibility after accelerated storage.
Main Methods:
- Accelerated stability testing of tablets at 25, 37, and 45 degrees C for 6 months.
- Analysis using infra-red spectroscopy (IR) to evaluate drug integrity and interactions.
- Differential scanning calorimetry (DSC) to assess drug purity and crystalline form.
Main Results:
- IR spectra of Ibuprofen in tablets remained consistent with the standard Ibuprofen, showing no degradation or interaction with Eudragit RSPM and Avicel pH 102.
- DSC thermograms indicated that Ibuprofen maintained its highly pure (>98%) crystalline form post-storage.
- No significant degradation of Ibuprofen was observed, confirming formulation stability.
Conclusions:
- Ibuprofen-Eudragit RSPM sustained release tablets exhibit excellent stability under accelerated storage conditions.
- The formulation demonstrates good drug-polymer compatibility and excipient stability.
- The study supports the suitability of this formulation for sustained drug delivery.