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Tracking the physicochemical stability of teduglutide (Revestive®) clinical solutions over time in different storage containers.
Pérez-Robles, Raquel; Hermosilla, Jesús; Navas, Natalia; Clemente-Bautista, Susana; Jiménez-Lozano, Inés; Cabañas-Poy, Maria Josep; Ruiz-Travé, Julio; Hernández-García, María Amparo; Cabeza, Jose; Salmerón-García, Antonio.
Afiliación
  • Pérez-Robles R; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain; Department of Analytical Chemistry, Science Faculty, University of Granada, Granada, Spain; Fundación para la Investigación Biosanitaria de Andalucía Oriental-Alejandro Otero, Granada, Spain.
  • Hermosilla J; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain; Department of Analytical Chemistry, Science Faculty, University of Granada, Granada, Spain.
  • Navas N; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain; Department of Analytical Chemistry, Science Faculty, University of Granada, Granada, Spain. Electronic address: natalia@ugr.es.
  • Clemente-Bautista S; Maternal and Child Pharmacy Service, Vall d'Hebron Hospital, Pharmacy, Barcelona, Spain.
  • Jiménez-Lozano I; Maternal and Child Pharmacy Service, Vall d'Hebron Hospital, Pharmacy, Barcelona, Spain.
  • Cabañas-Poy MJ; Maternal and Child Pharmacy Service, Vall d'Hebron Hospital, Pharmacy, Barcelona, Spain.
  • Ruiz-Travé J; Department of Analytical Chemistry, Science Faculty, University of Granada, Granada, Spain.
  • Hernández-García MA; Department of Analytical Chemistry, Science Faculty, University of Granada, Granada, Spain.
  • Cabeza J; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain; Department of Clinical Pharmacy, San Cecilio University Hospital, Granada, Spain.
  • Salmerón-García A; Instituto de Investigación Biosanitaria de Granada (ibs.GRANADA), Granada, Spain; Department of Clinical Pharmacy, San Cecilio University Hospital, Granada, Spain.
J Pharm Biomed Anal ; 221: 115064, 2022 Nov 30.
Article en En | MEDLINE | ID: mdl-36152491
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome del Intestino Corto / Péptido 2 Similar al Glucagón Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: J Pharm Biomed Anal Año: 2022 Tipo del documento: Article País de afiliación: España

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Síndrome del Intestino Corto / Péptido 2 Similar al Glucagón Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: J Pharm Biomed Anal Año: 2022 Tipo del documento: Article País de afiliación: España