Mechanistic Insights into Propylparaben Sorption on Polyvinyl Chloride.

J Pharm Sci

Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.

Published: August 2024

AI Article Synopsis

  • * The adsorption process is analyzed using a pseudo-second order model, indicating that the rate of adsorption increases with higher concentrations of propylparaben.
  • * The adsorption isotherm data is best represented by the Freundlich and Temkin models, suggesting a multi-layer process, which helps in understanding compatibility between pharmaceutical components and their packaging materials.

Article Abstract

The mechanism of loss of propylparaben potency from formulations when in contact with polyvinyl chloride has been determined. It is caused by the adsorption of propylparaben onto polyvinyl chloride surfaces. The adsorption kinetics is best described using a pseudo-second order model based on non-linear fit. The rate of adsorption increases with increasing bulk concentration of propylparaben. Adsorption equilibrium isotherm was fitted to three isotherm models: Langmuir, Freundlich, and Temkin, using non-linear fit. The Freundlich and Temkin models show the best fit, indicating a multi-layer adsorption. Using this case study, we present a methodology to provide mechanistic insights into the compatibility data between pharmaceutical ingredients and product contact materials when sorption is involved.

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Source
http://dx.doi.org/10.1016/j.xphs.2024.03.025DOI Listing

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