ValiStab®, a new tool to help carry out a physicochemical stability study
5 October 2022
D’Huart E.1,2, Vigneron J.1,2, Demore B.1,2,3.1 Pharmacie à Usage Intérieur, Hôpitaux de Brabois, 54511 Vandœuvre-lès-Nancy, France.
2 Infostab, non-profit association, Heillecourt, France
3 Université de Lorraine, EA 4360 APEMAC, Nancy, France.
Introduction
Carrying out a physicochemical stability study is one of the scientific missions of the hospital pharmacist. According to the French text about the Good Preparation Practices, “stability times established from analyzes are preferred”. In the absence of drug stability data available in the literature, the pharmacist must perform stability studies. This work is complex and requires the study of several elements such as physical stability with visual and subvisual examination and chemical stability with a validated separative analytical method.
Objectives
To create a tool accessible online for hospital pharmacists and research teams to study the stability of a single molecule under several conditions: concentrations, solvents, containers, storage conditions.
Materials and methods
This tool was created based on the recommendations of the methodological guide for stability studies of preparations by the SFPC/GERPAC, the ICH Guidelines and the publication “Guidelines for the practical stability studies of anticancer drugs: a European consensus conference”.
Results
ValiStab® is a tool allowing to integrate all the steps necessary to carry out a stability study in the same document: presentation of the different study conditions, presentation of the analytical method and its validation to study the chemical stability of a molecule (linearity, precision, forced degradation, specificity) as well as the results obtained and presentation of the methods used to study the physical stability and the results obtained. In addition to the high performance liquid chromatography method, each researcher can choose the methods used according to their stability study (measurement of pH, osmolality, organoleptic criteria for drinkable forms), respecting all the necessary steps. This software allows you to open an account with a username and password, to access these stability studies in progress, completed, or to start a new stability study.
Discussion - Conclusion
This new tool was created to facilitate the performance of a stability study of a single molecule and to bring together in a single document all the results obtained at each stage of the study. It also facilitates the writing of a publication to promote and disseminate the results of the stability study. It is not designed for the study of the stability of a protein or a monoclonal antibody, which requires a set of complementary analytical methods. ValiStab® will soon be available free of charge on the Stabilis® stability and drug compatibility database (www.stabilis.org).