Publication:
Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers.

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Date

2022-09-15

Authors

Perez-Robles, Raquel
Hermosilla, Jesus
Navas, Natalia
Clemente-Bautista, Susana
Jimenez-Lozano, Ines
Cabañas-Poy, Maria Josep
Ruiz-Trave, Julio
Hernandez-Garcia, Maria Amparo
Cabeza, Jose
Salmeron-Garcia Antonio

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Elsevier BV
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Abstract

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 structures, aggregates, particulate, concentration and pH. The results indicate that the solutions maintain high physicochemical stability over time, regardless of the storage temperature (4ºC or -20ºC) or the storage container (vials or syringes). This research provides new data on the stability of Revestive® that will be of great value to hospital pharmacists. This comprehensive assessment of the physicochemical long-term stability of TGT has demonstrated that under the storage conditions and over the period studied here, the medicine maintains its quality, efficacy and safety profiles.

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MeSH Terms

Gastrointestinal Agents
Glucagon-Like Peptide 2
Humans
Peptides
Plastics
Short Bowel Syndrome

DeCS Terms

Fármacos gastrointestinales
Péptido 2 similar al glucagón
Síndrome del intestino corto
Péptidos
Plásticos

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Keywords

Hospital condition, Long-term stability study, Revestive®, Teduglutide

Citation

Pérez-Robles R, Hermosilla J, Navas N, Clemente-Bautista S, Jiménez-Lozano I, Cabañas-Poy MJ, et al. Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers. J Pharm Biomed Anal. 2022 Nov 30;221:115064.