RT Journal Article
T1 Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers.
A1 Perez-Robles, Raquel
A1 Hermosilla, Jesus
A1 Navas, Natalia
A1 Clemente-Bautista, Susana
A1 Jimenez-Lozano, Ines
A1 Cabañas-Poy, Maria Josep
A1 Ruiz-Trave, Julio
A1 Hernandez-Garcia, Maria Amparo
A1 Cabeza, Jose
A1 Salmeron-Garcia Antonio, 
K1 Hospital condition
K1 Long-term stability study
K1 Revestive®
K1 Teduglutide
AB 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.
PB Elsevier BV
YR 2022
FD 2022-09-15
LK http://hdl.handle.net/10668/22329
UL http://hdl.handle.net/10668/22329
LA en
NO 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.
NO Fundaci´on Andaluza de Farmacia Hospitalaria (Spain); HospitalPaediatrics Pharmacy Unit of the Hospital Vall d′ Hebron (Barcelona,Spain); Junta de Andalucia (Spain), Universidad de Granada (Spain).
DS RISalud
RD Apr 20, 2025