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Issue 22, 2011
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In-line prediction of drug release profiles for pH-sensitive coated pellets

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Abstract

A new method for the prediction of the drug release profiles during a running pellet coating process from in-line near infrared (NIR) measurements has been developed. The NIR spectra were acquired during a manufacturing process through an immersion probe. These spectra reflect the coating thickness that is inherently connected with the drug release. Pellets sampled at nine process time points from thirteen designed laboratory-scale coating batches were subjected to the dissolution testing. In the case of the pH-sensitive Acryl-EZE coating the drug release kinetics for the acidic medium has a sigmoid form with a pronounced induction period that tends to grow along with the coating thickness. In this work the autocatalytic model adopted from the chemical kinetics has been successfully applied to describe the drug release. A generalized interpretation of the kinetic constants in terms of the process and product parameters has been suggested. A combination of the kinetic model with the multivariate Partial Least Squares (PLS) regression enabled prediction of the release profiles from the process NIR data. The method can be used to monitor the final pellet quality in the course of a coating process.

Graphical abstract: In-line prediction of drug release profiles for pH-sensitive coated pellets

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Publication details

The article was received on 22 Dec 2010, accepted on 09 Aug 2011 and first published on 03 Oct 2011


Article type: Paper
DOI: 10.1039/C0AN01033B
Citation: Analyst, 2011,136, 4830-4838
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    In-line prediction of drug release profiles for pH-sensitive coated pellets

    A. L. Pomerantsev, O. Ye. Rodionova, M. Melichar, A. J. Wigmore and A. Bogomolov, Analyst, 2011, 136, 4830
    DOI: 10.1039/C0AN01033B

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