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Mechanistic Insights into Propylparaben Sorption on Polyvinyl Chloride.
Correa-Soto, Clara E; Sengupta, Rajarshi; Gonzales, Isaiah; Schupp, Sydney; Bejgum, Bhanu; Alvarez-Nunez, Fernando; Kiang, Y-H.
Afiliação
  • Correa-Soto CE; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
  • Sengupta R; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. Electronic address: rsengu03@amgen.com.
  • Gonzales I; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
  • Schupp S; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
  • Bejgum B; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. Electronic address: bbejgum@amgen.com.
  • Alvarez-Nunez F; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
  • Kiang YH; Drug Product Technologies, Process Development, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
J Pharm Sci ; 2024 Apr 04.
Article em En | MEDLINE | ID: mdl-38580143
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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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article