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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.

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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).

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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.