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Pharmaceutics. 2020 Aug 04;12(8). doi: 10.3390/pharmaceutics12080729.

Effects of Formulation Excipients on Skin Barrier Function in Creams Used in Pediatric Care.

Pharmaceutics

Anita Kovács, Dóra Péter-Héderi, Katalin Perei, Mária Budai-Szűcs, Attila Léber, Attila Gácsi, Erzsébet Csányi, Szilvia Berkó

Affiliations

  1. Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6, 6720 Szeged, Hungary.
  2. Department of Biotechnology, University of Szeged, Közép fasor 52, 6726 Szeged, Hungary.

PMID: 32759663 PMCID: PMC7465361 DOI: 10.3390/pharmaceutics12080729

Abstract

Semisolid dosage forms are recommended for the dermal care of babies and children. If we look at the ingredients of these preparations, there are still many cases in which there are substances (occlusive agents, preservatives) that no longer meet certain requirements of the modern age, so it is timely to replace them with other substances. The aim of this work was to formulate a science-based formulation with new components that keep or improve its moisturizing properties, rheological parameters, and microbiological stability. Occlusive oils, like white petrolatum and liquid paraffin and the preservative parabens are traditional ingredients in oil in water creams, were replaced with white beeswax, sunflower oil, and phenoxyethanol, respectively. Cocoa butter, urea, and glycerol were added to improve long-lasting hydration and support the barrier function of the reformulated creams. The rheological properties of the formulations were determined. The effects of the preparations on skin hydration and on the barrier function of the skin were tested. Furthermore, microbiological stability was investigated. The result of the reformulation was an o/w cream that provided a good longer-lasting hydration effect; supported the barrier function of the baby skin without occlusion; and had adequate consistency, easy spreading, a pleasant skin feeling, proper pH, and good microbiological stability.

Keywords: excipients; formulation; microbiological stability; o/w cream; pediatric care; skin barrier; skin hydration

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