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Using the Internal Stress Concept to Assess the Importance of Moisture Sorption-induced Swelling on the Moisture Transport through the Glassy HPMC Films
Authors:Fesia L Laksmana  Paul J A Hartman Kok  Henderik W Frijlink  Herman Vromans  Kees Van der Voort Maarschalk
Institution:(1) Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, The Netherlands;(2) Department of Pharmaceutics, Schering–Plough Corporation, Oss, The Netherlands;(3) Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands;(4) PO BOX 20, Room RP2130, 5340 BH Oss, The Netherlands
Abstract:The purpose of this research was to elucidate the significance of the changes in the mechanical and the volumetric properties on the moisture diffusivity through the polymer films. The internal stress concept was adapted and applied to estimate the relative impact of these property changes on the total stress experienced by a polymer film during storage. Hydroxypropyl Methylcellulose free films were used as a model material prepared at various conditions and stored at different relative humidities. The changes in the internal stress of these films due to the moisture sorption were studied. It was demonstrated that the stress-relaxation of the films increases at increasing moisture content. At the point when there is a definite loss of stress in the film, which is at moisture content higher than 6%, was shown to correlate with the significant increase of the moisture diffusivity. Further investigations revealed that the loss of stress is especially due to the swelling of the polymer rather than the changes in the inherent strain (the quotient between the tensile strength and the modulus of elasticity) of the HPMC films. This implies that the impact of the moisture sorption on the diffusivity is predominantly via volume addition rather than via altering the mechanical properties. Additionally, the approach presented here also brings up a new application of the internal stress concept, which in essence suggests the possibility to estimate the diffusion coefficient from the sorption isotherm and the mechanical analysis data.
Keywords:HPMC  internal stress  mechanical properties  moisture diffusion  swelling
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