Development of a predictive model for the long term stability assessment of drug-in-adhesive transdermal films using polar pressure sensitive adhesives as carrier/matrix.

Chenevas-Paule, Clemence, Wolff, Hans, Ashton, Mark, Schubert, Martin and Dodou, Kalliopi (2017) Development of a predictive model for the long term stability assessment of drug-in-adhesive transdermal films using polar pressure sensitive adhesives as carrier/matrix. Journal of Pharmaceutical Sciences, 106 (5). pp. 1293-1301. ISSN 0022-3549

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Abstract

Drug crystallization in transdermal drug delivery systems is a critical quality defect. The impact of drug load and hydration on the physical stability of polar (acrylic) drug-in-adhesive (DIA) films was investigated with the objective to identify predictive formulation parameters with respect to drug solubility and long-term stability. Medicated acrylic films were prepared over a range of drug concentrations below and above saturation solubility and were characterized by Fourier transform infrared spectroscopy, differential scanning calorimetry, polarized microscopy, and dynamic vapor sorption (DVS) analysis. Physical stability of medicated films was monitored over 4 months under different storage conditions and was dependent on solubility parameters, Gibbs free energy for drug phase transition from the amorphous to the crystalline state, and relative humidity. DVS data, for assessing H-bonding capacity experimentally, were essential to predict physical stability at different humidities and were used together with Gibbs free energy change and the Hoffman equation to develop a new predictive thermodynamic model to estimate drug solubility and stability in DIA films taking into account relative humidity.

Item Type: Article
Subjects: Sciences > Pharmacy and Pharmacology
Divisions: Faculty of Health Sciences and Wellbeing
Faculty of Health Sciences and Wellbeing > School of Pharmacy and Pharmaceutical Sciences
Depositing User: Barry Hall
Date Deposited: 25 Jan 2017 11:35
Last Modified: 20 Feb 2020 10:49
URI: http://sure.sunderland.ac.uk/id/eprint/6895
ORCID for Kalliopi Dodou: ORCID iD orcid.org/0000-0002-2822-3543

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