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Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets.
J Pharm Pharmacol. 2016 Apr; 68(4):467-74.JP

Abstract

OBJECTIVES

The aim of this study was to assess the effects of buffer systems (bicarbonate or phosphate at different concentrations) on the in vitro dissolution profiles of commercially available enteric-coated tablets.

METHODS

In vitro dissolution tests were conducted using an USP apparatus II on 12 enteric-coated omeprazole and rabeprazole tablets, including innovator and generic formulations in phosphate buffers, bicarbonate buffers and a media modified Hanks (mHanks) buffer.

KEY FINDINGS

Both omeprazole and rabeprazole tablets showed similar dissolution profiles among products in the compendial phosphate buffer system. However, there were large differences between products in dissolution lag time in mHanks buffer and bicarbonate buffers. All formulations showed longer dissolution lag times at lower concentrations of bicarbonate or phosphate buffers. The dissolution rank order of each formulation differed between mHanks buffer and bicarbonate buffers. A rabeprazole formulation coated with a methacrylic acid copolymer showed the shortest lag time in the high concentration bicarbonate buffer, suggesting varied responses depending on the coating layer and buffer components.

CONCLUSION

Use of multiple dissolution media during in vitro testing, including high concentration bicarbonate buffer, would contribute to the efficient design of enteric-coated drug formulations.

Authors+Show Affiliations

National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.National Institute of Health Sciences, Setagaya-ku, Tokyo, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27019275

Citation

Shibata, Hiroko, et al. "Use of Bicarbonate Buffer Systems for Dissolution Characterization of Enteric-coated Proton Pump Inhibitor Tablets." The Journal of Pharmacy and Pharmacology, vol. 68, no. 4, 2016, pp. 467-74.
Shibata H, Yoshida H, Izutsu K, et al. Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets. J Pharm Pharmacol. 2016;68(4):467-74.
Shibata, H., Yoshida, H., Izutsu, K., & Goda, Y. (2016). Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets. The Journal of Pharmacy and Pharmacology, 68(4), 467-74. https://doi.org/10.1111/jphp.12540
Shibata H, et al. Use of Bicarbonate Buffer Systems for Dissolution Characterization of Enteric-coated Proton Pump Inhibitor Tablets. J Pharm Pharmacol. 2016;68(4):467-74. PubMed PMID: 27019275.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Use of bicarbonate buffer systems for dissolution characterization of enteric-coated proton pump inhibitor tablets. AU - Shibata,Hiroko, AU - Yoshida,Hiroyuki, AU - Izutsu,Ken-Ichi, AU - Goda,Yukihiro, Y1 - 2016/03/28/ PY - 2015/07/30/received PY - 2016/01/30/accepted PY - 2016/3/29/entrez PY - 2016/3/29/pubmed PY - 2017/5/10/medline KW - bicarbonate buffer KW - biorelevant media KW - dissolution KW - enteric-coated tablets SP - 467 EP - 74 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 68 IS - 4 N2 - OBJECTIVES: The aim of this study was to assess the effects of buffer systems (bicarbonate or phosphate at different concentrations) on the in vitro dissolution profiles of commercially available enteric-coated tablets. METHODS: In vitro dissolution tests were conducted using an USP apparatus II on 12 enteric-coated omeprazole and rabeprazole tablets, including innovator and generic formulations in phosphate buffers, bicarbonate buffers and a media modified Hanks (mHanks) buffer. KEY FINDINGS: Both omeprazole and rabeprazole tablets showed similar dissolution profiles among products in the compendial phosphate buffer system. However, there were large differences between products in dissolution lag time in mHanks buffer and bicarbonate buffers. All formulations showed longer dissolution lag times at lower concentrations of bicarbonate or phosphate buffers. The dissolution rank order of each formulation differed between mHanks buffer and bicarbonate buffers. A rabeprazole formulation coated with a methacrylic acid copolymer showed the shortest lag time in the high concentration bicarbonate buffer, suggesting varied responses depending on the coating layer and buffer components. CONCLUSION: Use of multiple dissolution media during in vitro testing, including high concentration bicarbonate buffer, would contribute to the efficient design of enteric-coated drug formulations. SN - 2042-7158 UR - https://www.unboundmedicine.com/medline/citation/27019275/Use_of_bicarbonate_buffer_systems_for_dissolution_characterization_of_enteric_coated_proton_pump_inhibitor_tablets_ DB - PRIME DP - Unbound Medicine ER -