A Correlative Model to Predict In Vivo AUC for Nanosystem Drug Delivery with Release Rate-Limited Absorption

Mohammad Barzegar-Jalali1, Kaivan Mohammadi2, Ghobad Mohammadi3, Hadi Valizadeh1, Azim Barzegar-Jalali4, Khosro Adibkia5, Ali Nokhodchi6

1Drug Applied Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran
2Mechanical Engineering School, Sharif University of Technology, Tehran, Iran
3Faculty of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran
4Faculty of Medicine, Islamic Azad University Ardabil Branch, Ardabil, Iran
5Biotechnology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
6Medway School of Pharmacy, Universities of Kent, Chatham, Kent, England


Purpose. Drug release from nanosystems at the sites of either absorption or effect biophase is a major determinant of its biological action. Thus, in vitro drug release is of paramount importance in gaining insight for the systems performance in vivo. Methods. A novel in vitro in vivo correlation, IVIVC, model denoted as double reciprocal area method was presented and applied to 19 drugs from 55 nano formulations with total 336 data, gathered from literature. Results. The proposed model correlated the in vitro with in vivo parameters with overall error of 12.4 ± 3.9%. Also the trained version of the model predicted the test formulations with overall error of 15.8 ± 3.7% indicating the suitability of the approach. A theoretical justification was provided for the model considering the unified classical release laws. Conclusion. The model does not necessitate bolus intravenous drug data and seems to be suitable for IVIVC of drugs with release rate-limited absorption.

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J Pharm Pharm Sci, 15 (4): 583-591, 2012

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DOI: http://dx.doi.org/10.18433/J3NP5N