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Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers by Raquel Pérez-Robles; Jesús Hermosilla; Natalia Navas; Susana Clemente-Bautista; Inés Jiménez-Lozano; Maria Josep Cabañas-Poy; Julio Ruiz-Travé; María Amparo Hernández-García; Jose Cabeza; Antonio Salmerón-García is a Chemistry article available to read on EtoBox.
What is Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers about?
Teduglutide, the active ingredient of the medicine Revestive® (5 mg), is a recombinant therapeutic peptide that mimics the effects of the endogenous glucagon-like peptide 2 (GLP-2). It stimulates intestinal growth, adaptation and function in patients with Short Bowel Syndrome who are dependent on parenteral nutrition. The Summary of Product Characteristics recommends immediate use of the reconstituted solutions and the discarding of any subsequent surplus. This study aims to carry out a long-term stability study that reproduces hospital conditions of use which provide sound evidence regarding the use of teduglutide surplus beyond the Summary Product Characteristics recommendations. We conducted a stability study of teduglutide solutions prepared from a 5 mg vial of Revestive®. Some of the solutions were stored in their original vial after reconstitution, while others were repackaged in plastic syringes to evaluate their physicochemical stability over time. For this purpose, we applied a set of previously validated analytical methodologies to evaluate the main critical quality attributes of teduglutide, i.e., primary (including post-tralational modifications), secondary and tertiary
Who reads Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers?
It is typically read by researchers, students, and practitioners in Chemistry.
- Author
- Raquel Pérez-Robles; Jesús Hermosilla; Natalia Navas; Susana Clemente-Bautista; Inés Jiménez-Lozano; Maria Josep Cabañas-Poy; Julio Ruiz-Travé; María Amparo Hernández-García; Jose Cabeza; Antonio Salmerón-García
- Publisher
- Elsevier BV
- Published
- 2022
- Language
- EN
- Field
- Chemistry (Physical Sciences)