期刊
ANNALES PHARMACEUTIQUES FRANCAISES
卷 80, 期 1, 页码 26-34出版社
MASSON EDITEUR
DOI: 10.1016/j.pharma.2021.05.002
关键词
Formulation; Stability; Modeling; Chemical equilibrium; Cystic fibrosis; Nasal transepithelial potential difference
This study aims to develop new formulas with improved physicochemical and microbiological stability for measuring nasal transepithelial potential difference (NPD). By using CHESS software for modeling and experimental validation, new formulas with excellent stability were identified. These new formulas can be used for harmonizing and comparing NPD measurements in different specialized centers.
Background. - One diagnosis of cystic fibrosis involves measuring the nasal transepithelial potential difference (NPD) as a complementary technique in the forms of the disease, where the sweat test is non-discriminating. The NPD is measured using solutions with and without chlorides, containing a variety of substances whose activities on nasal mucus membranes are studied or assessed. Among the solutions described in the literature and used in specialized centers, none seems to be best adapted for industrial production for reasons of stability (formulas of the international consensus of Rowe et al. and formulas of Knowles et al.) and/or potential toxicity (formulas of Middleton et al.). Objective(s). - Defining new formulas, according to those of the international consensus, with greater physicochemical and microbiological stability. Methods. - The reformulation tests were conducted on the formulas of Rowe et al., using CHESS (R) (CHemical Equilibrium of Species and Surfaces) software for modeling aqueous systems that substantially reduced the number of experiments. CHESS (R) software was first validated using models of ideal and non-ideal solutions. Thereafter, experimentation was carried out for the sake of comparison with theoretical data. Results. - CHESS (R) software using models of ideal and non-ideal solutions were validated. The experimentation confirmed the theoretical data, and new formulas were assessed based on their physicochemical (pH, content, Osmotality) and microbiological stability. Conclusion. - The new formulas defined here guarantee excellent physicochemical and microbiological stability of diagnostic solutions, indispensable criteria for harmonizing and comparing results from different specialized centers using NPD measurements. These new formulas apply to the harmonization approach of techniques for measuring the nasal transepithelial potential difference. (C) 2021 Academie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.
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