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Solid state interactions between the proton pump inhibitor omeprazole and various enteric coating polymers
A Stroyer1, J W McGinity, C S Leopold
1College of Pharmacy, University of Texas at Austin, TX, USA.
Journal of Pharmaceutical Sciences
|April 21, 2006
Summary
Acidic polymers like HP-55 and shellac accelerate omeprazole degradation in solid blends. High-performance liquid chromatography (HPLC) effectively quantified these omeprazole degradation products.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Omeprazole is an acid-labile proton pump inhibitor.
- Solid drug-polymer blends are used for drug formulation.
- Acidic polymers can potentially affect drug stability.
Purpose of the Study:
- To investigate the impact of acidic film formers on omeprazole stability.
- To evaluate the degradation of omeprazole in solid drug-polymer blends under accelerated conditions.
Main Methods:
- Solid blends of omeprazole with Eudragit L 100, HPMCAS-HF, HP-55, and shellac were prepared.
- Accelerated storage conditions (40°C/75% RH) were applied.
- Drug stability was assessed using Fourier Transform Infrared Spectroscopy (FTIR), Modulated Temperature Differential Scanning Calorimetry (MTDSC), and High-Performance Liquid Chromatography (HPLC).
Main Results:
- Acidic polymers induced omeprazole degradation, evidenced by discoloration and increased degradation products.
- HP-55 showed the highest omeprazole degradation, followed by shellac, HPMCAS-HF, and Eudragit L 100.
- HPLC was effective for quantifying degradation products, while FTIR and MTDSC lacked sensitivity for these specific analyses.
Conclusions:
- The choice of acidic polymer significantly influences omeprazole stability in solid blends.
- Melting and dissolution of acidic impurities may contribute to omeprazole decomposition, particularly with HP-55 and shellac.
- Microenvironmental pH alone did not correlate with the observed omeprazole degradation levels.
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