Tags

Type your tag names separated by a space and hit enter

In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer.
Int J Pharm. 2015 May 15; 485(1-2):152-9.IJ

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 acid-ethyl acrylate copolymer (1:1), was applied to all commercial multiparticulate-based products, marked differences were observed between dissolution profiles of these preparations. The use of pH 6.8 physiological bicarbonate (mHanks) buffer can serve as a useful tool to provide realistic and discriminative in vitro release assessment of enteric coated PPI preparations and to assist rational formulation development of these products.

Authors+Show Affiliations

Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK. Electronic address: f.liu3@herts.ac.uk.Department of Pharmacy, School of Life and Medical Sciences, University of Hertfordshire, Hatfield AL10 9AB, UK.

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

25746736

Citation

Liu, Fang, and Honaz Shokrollahi. "In Vitro Dissolution of Proton-pump Inhibitor Products Intended for Paediatric and Geriatric Use in Physiological Bicarbonate Buffer." International Journal of Pharmaceutics, vol. 485, no. 1-2, 2015, pp. 152-9.
Liu F, Shokrollahi H. In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer. Int J Pharm. 2015;485(1-2):152-9.
Liu, F., & Shokrollahi, H. (2015). In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer. International Journal of Pharmaceutics, 485(1-2), 152-9. https://doi.org/10.1016/j.ijpharm.2015.03.008
Liu F, Shokrollahi H. In Vitro Dissolution of Proton-pump Inhibitor Products Intended for Paediatric and Geriatric Use in Physiological Bicarbonate Buffer. Int J Pharm. 2015 May 15;485(1-2):152-9. PubMed PMID: 25746736.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer. AU - Liu,Fang, AU - Shokrollahi,Honaz, Y1 - 2015/03/05/ PY - 2014/12/08/received PY - 2015/03/02/revised PY - 2015/03/04/accepted PY - 2015/3/10/entrez PY - 2015/3/10/pubmed PY - 2016/1/8/medline KW - Bicarbonate media KW - Biorelevant dissolution KW - Dysphagia KW - Modified release KW - Pellets KW - Physiological buffers SP - 152 EP - 9 JF - International journal of pharmaceutics JO - Int J Pharm VL - 485 IS - 1-2 N2 - 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 acid-ethyl acrylate copolymer (1:1), was applied to all commercial multiparticulate-based products, marked differences were observed between dissolution profiles of these preparations. The use of pH 6.8 physiological bicarbonate (mHanks) buffer can serve as a useful tool to provide realistic and discriminative in vitro release assessment of enteric coated PPI preparations and to assist rational formulation development of these products. SN - 1873-3476 UR - https://www.unboundmedicine.com/medline/citation/25746736/In_vitro_dissolution_of_proton_pump_inhibitor_products_intended_for_paediatric_and_geriatric_use_in_physiological_bicarbonate_buffer_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5173(15)00210-0 DB - PRIME DP - Unbound Medicine ER -