In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer

International Journal of Pharmaceutics
Fang Liu, Honaz Shokrollahi

Abstract

Proton-pump inhibitor (PPI) products based on enteric coated multiparticulates are design to meet the needs of patients who cannot swallow tablets such as children and older adults. Enteric coated PPI preparations exhibit delays in in vivo absorption and onset of antisecretory effects, which is not reflected by the rapid in vitro dissolution in compendial pH 6.8 phosphate buffer commonly used for assessment of these products. A more representative and physiological medium, pH 6.8 mHanks bicarbonate buffer, was used in this study to evaluate the in vitro dissolution of enteric coated multiparticulate-based PPI products. Commercially available omeprazole, lansoprazole and esomeprazole products were subject to dissolution tests using USP-II apparatus in pH 4.5 phosphate buffer saline for 45 min (acid stage) followed by pH 6.8 phosphate buffer or pH 6.8 mHanks bicarbonate buffer. In pH 6.8 phosphate buffer, all nine tested products displayed rapid and comparable dissolution profiles meeting the pharmacopeia requirements for delayed release preparations. In pH 6.8 mHanks buffer, drug release was delayed and failed the pharmacopeia requirements from most enteric coated preparations. Despite that the same enteric polymer, methacrylic ...Continue Reading

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Citations

Mar 29, 2016·The Journal of Pharmacy and Pharmacology·Hiroko ShibataYukihiro Goda
Apr 14, 2016·Drug Development and Industrial Pharmacy·Yinhe TanChuanbin Wu
Jun 21, 2019·Drug Development and Industrial Pharmacy·Harilal PatelNuggehally R Srinivas
Nov 14, 2020·Scientific Reports·Heran C BhaktaWilliam H Grover

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