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Understanding the interaction between Soluplus® and biorelevant media components.

Juliana Munari Oliveira Pinto1, Andrés Felipe Chamorro Rengifo2, Cassiana Mendes3

  • 1Laboratório de Controle de Qualidade de Fármacos e Medicamentos (LabCQ), Programa de Pós-Graduação em Farmácia, Departamento de Ciências Farmacêuticas, Universidade Federal de Santa Catarina, 88040-900, Florianópolis, SC, Brazil.

Colloids and Surfaces. B, Biointerfaces
|December 9, 2019
PubMed
Summary

Soluplus®, a polymer carrier, can unexpectedly lower drug solubility in simulated intestinal fluid due to interactions with lecithin. This highlights the importance of selecting appropriate media for in vitro drug solubility studies.

Keywords:
Biorelevant mediumCandesartan cilexetilLecithinSodium taurocholateSoluplus®Supersaturation

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Soluplus® (polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer) is a widely used carrier in solid dispersions for poorly soluble drugs.
  • It enhances drug solubility and absorption by increasing apparent solubility in the gastrointestinal tract.

Purpose of the Study:

  • To investigate the interaction of Soluplus® with components of biorelevant media during in vitro supersaturation studies.
  • To understand the impact of these interactions on the apparent solubility of candesartan cilexetil.

Main Methods:

  • In vitro supersaturation studies using different dissolution media.
  • Dynamic Light Scattering (DLS) and Transmission Electron Microscopy (TEM) for characterizing interactions.
  • Fluorescence measurements to determine microenvironment polarity.

Main Results:

  • Soluplus® interacted with lecithin in Fasted State Simulated Intestinal Fluid (FSIF).
  • These interactions formed mixed micelles with a more polar microenvironment.
  • This resulted in reduced solubilization capacity and lower apparent solubility of candesartan cilexetil.

Conclusions:

  • The selection of dissolution media is critical for in vitro solubility-supersaturation studies.
  • Biorelevant media that mimic the gastrointestinal environment are recommended to accurately predict drug behavior.
  • Soluplus®'s performance as a carrier can be influenced by excipient interactions within the chosen medium.