Abstract
Although many therapeutically active peptides and proteins have been developed there is a lack of topical pharmaceutical products on the market containing these sensitive molecules. The main reasons may be lack of stability and a limitation of larger molecules to penetrate into the skin. In this study we investigated the possibility to develop a peptide formulation which enables follicular permeation of peptides and passes the following criteria: 1) The formulation should be chemically and physically stable, 2) The formulation should have appealing cosmetical properties and 3) The formulation should be compatible with skin as well as sebum. The hypothesis was that increased stability of the peptide could be obtained by keeping the peptide in solid form and in a water-free environment, and that permeation into skin could be facilitated by reducing the particle size to < 10 µm and by formulating the peptide in sebum compatible excipients. By this method a safe and a cosmetically attractive formulation, facilitating the local distribution of the model peptide FOL-005 into the skin and at the same time securing chemical and physical stability, was successfully developed.
Highlights
Today, a vast number of different topical cosmetic and pharmaceutical products are commercially available indicated for a considerable number of different applications
We developed a topical formulation where the stability problems were handled by maintaining the peptide in non-dissolved, solid form, and without presence of water, which significantly increased the stability of the peptide at room temperature as has previously been shown.[10,16,17]
In this study we investigated the possibility to form a stable formulation of a pharmaceutical peptide FOL-005 by ensuring that the peptide was maintained in solid form throughout the storage period
Summary
A vast number of different topical cosmetic and pharmaceutical products are commercially available indicated for a considerable number of different applications. Most of these products are based on delivering small molecules to the skin or deeper into the body. Using peptides or proteins as topical drug molecules comes with difficulties regarding stabilization of the molecule in the formulation and ensuring homogeneity of the product. Formulating such molecules into an attractive formulation with targeted delivery into skin while maintaining sufficient stability is a huge challenge. Healthy skin is an efficient barrier to the external environment, protecting the body from
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