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Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release From Nifedipine Extended-Release Tablets.
J Pharm Sci. 2019 03; 108(3):1189-1194.JP

Abstract

In contrast to nifedipine matrix-based extended-release dosage forms, the osmotic pump drug delivery systems have a zero-order drug release independent of external variables such as pH, agitation rate, and dissolution media. The objective of this study focuses on the in vitro evaluation of the mechanical properties of osmotic pump and polymer matrix-based formulations in dissolution media, and the potential impacts that media pH and simulated gastrointestinal contraction have on drug release. Two strengths of osmotic pump product A and polymer matrix-based product B were used in this study. An in-house system was developed with the capability of applying mechanical compression and monitoring mechanical properties of sample during dissolution testing. A United States Pharmacopeia or an in-house apparatus was used for dissolution testing under various conditions. Compared to the product A, the mechanical properties of the product B change significantly at various pHs and mechanical compressions. The results suggest that polymer matrix-based products bear a risk of formulation-related interactions with the gastrointestinal tract during in vivo drug dissolution, especially in the case of concomitant pH and gastric contractile changes. Modified dissolution testing devices may help formulation scientists in product development and provide regulatory agencies with an additional metric for quality assurance of drug products.

Authors+Show Affiliations

Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri 63110. Electronic address: zongming.gao@fda.hhs.gov.Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri 63110.Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri 63110.Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri 63110.Division of Pharmaceutical Analysis, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, St. Louis, Missouri 63110.Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland 20993.Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland 20993.Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland 20993.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30343136

Citation

Gao, Zongming, et al. "Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction On Drug Release From Nifedipine Extended-Release Tablets." Journal of Pharmaceutical Sciences, vol. 108, no. 3, 2019, pp. 1189-1194.
Gao Z, Ngo C, Ye W, et al. Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release From Nifedipine Extended-Release Tablets. J Pharm Sci. 2019;108(3):1189-1194.
Gao, Z., Ngo, C., Ye, W., Rodriguez, J. D., Keire, D., Sun, D., Wen, H., & Jiang, W. (2019). Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release From Nifedipine Extended-Release Tablets. Journal of Pharmaceutical Sciences, 108(3), 1189-1194. https://doi.org/10.1016/j.xphs.2018.10.014
Gao Z, et al. Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction On Drug Release From Nifedipine Extended-Release Tablets. J Pharm Sci. 2019;108(3):1189-1194. PubMed PMID: 30343136.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release From Nifedipine Extended-Release Tablets. AU - Gao,Zongming, AU - Ngo,Cindy, AU - Ye,Wei, AU - Rodriguez,Jason D, AU - Keire,David, AU - Sun,Dajun, AU - Wen,Hong, AU - Jiang,Wenlei, Y1 - 2018/10/19/ PY - 2018/07/19/received PY - 2018/09/17/revised PY - 2018/10/11/accepted PY - 2018/10/22/pubmed PY - 2020/5/12/medline PY - 2018/10/22/entrez KW - US Pharmacopeia (USP) KW - controlled release KW - dissolution KW - gastrointestinal tract KW - in vitro model(s) KW - oral drug delivery KW - osmotic pump(s) KW - pH KW - physiological model(s) KW - polymeric drug delivery system(s) SP - 1189 EP - 1194 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 108 IS - 3 N2 - In contrast to nifedipine matrix-based extended-release dosage forms, the osmotic pump drug delivery systems have a zero-order drug release independent of external variables such as pH, agitation rate, and dissolution media. The objective of this study focuses on the in vitro evaluation of the mechanical properties of osmotic pump and polymer matrix-based formulations in dissolution media, and the potential impacts that media pH and simulated gastrointestinal contraction have on drug release. Two strengths of osmotic pump product A and polymer matrix-based product B were used in this study. An in-house system was developed with the capability of applying mechanical compression and monitoring mechanical properties of sample during dissolution testing. A United States Pharmacopeia or an in-house apparatus was used for dissolution testing under various conditions. Compared to the product A, the mechanical properties of the product B change significantly at various pHs and mechanical compressions. The results suggest that polymer matrix-based products bear a risk of formulation-related interactions with the gastrointestinal tract during in vivo drug dissolution, especially in the case of concomitant pH and gastric contractile changes. Modified dissolution testing devices may help formulation scientists in product development and provide regulatory agencies with an additional metric for quality assurance of drug products. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/30343136/Effects_of_Dissolution_Medium_pH_and_Simulated_Gastrointestinal_Contraction_on_Drug_Release_From_Nifedipine_Extended_Release_Tablets_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(18)30614-2 DB - PRIME DP - Unbound Medicine ER -