Solid state interactions between the proton pump inhibitor omeprazole and various enteric coating polymers

Journal of Pharmaceutical Sciences
A StroyerC S Leopold

Abstract

The influence of the acidic film formers Eudragit L 100, HPMCAS-HF, HP-55, and shellac on the stability of the acid-labile proton pump inhibitor omeprazole in solid drug-polymer blends at accelerated storage conditions (40 degrees C/75% RH) was determined by fourier transform infrared spectroscopy (FTIR), modulated temperature differential scanning calorimetry (MTDSC), and high performance liquid chromatography (HPLC). As expected, acidic polymers caused a degradation of omeprazole which was manifested by discolorations and increasing amounts of degradation products. However, MTDSC curves and FTIR spectra did not show additional peaks resulting from the omeprazole degradation products. These methods appeared to be not sensitive enough to separate analytically the drug and polymer signals from those of the decomposition products. With HPLC a sufficient quantification of the degradation products was possible. HP-55 caused the highest degree of omeprazole degradation, followed by shellac, HPMCAS-HF, and Eudragit L 100. No correlation with the microenvironmental pH values generated by the acidic polymers at the applied storage conditions was found. The melting process and the dissolution of acidic impurities were figured out as pos...Continue Reading

References

Jan 1, 1985·Scandinavian Journal of Gastroenterology. Supplement·A Pilbrant, C Cederberg
Jan 7, 1999·Drug Development and Industrial Pharmacy·S Storpirtis, D Rodrigues
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Mar 19, 2005·Drug Development and Industrial Pharmacy·A Riedel, C S Leopold

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Citations

Mar 30, 2013·Colloids and Surfaces. B, Biointerfaces·Shilei HaoTingwang Guo
May 28, 2014·Materials Science & Engineering. C, Materials for Biological Applications·Shilei HaoYang Cao
Feb 6, 2010·AAPS PharmSciTech·Ana FigueirasJ Francisco Veiga
Dec 1, 2010·AAPS PharmSciTech·Ana FigueirasFrancisco J B Veiga
Feb 3, 2009·Chemical & Pharmaceutical Bulletin·Wei HeDe-Ying Cao
Feb 14, 2014·Drug Development and Industrial Pharmacy·Bo LangRobert O Williams
Apr 7, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Jaywant PawarPurnima Amin
Dec 28, 2017·Drug Development and Industrial Pharmacy·Panagiotis Barmpalexis, Agni Grypioti
Sep 4, 2018·Pharmaceutical Development and Technology·Rahul V HawareWilliam C Stagner
Sep 13, 2017·AAPS PharmSciTech·Mittal A DarjiS Narasimha Murthy
Jun 19, 2021·AAPS PharmSciTech·Marta F SimõesSérgio Simões

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