Author: Navas, Natalia ; Clemente-Bautista, Susana ; Pérez-Robles, Raquel ; Jiménez-Lozano, Inés ; Cabeza, Jose ; Cabañas-Poy, María Josep ; Hermosilla, Jesus ; Torrente-López, Anabel ; Salmerón-García, Antonio

Teduglutide (Revestive®) is a glucagon-like peptide-2 analogue used for the treatment of short bowel syndrome, a rare life-threatening condition in which the amount of functional gut is too short to enable proper absorption of nutrients and fluids. During handling prior to administration to the patient in hospital, it is possible that peptide-based medicines may be exposed to environmental stress conditions that could affect their quality. It is therefore essential to carry out stress testing studies to evaluate how such medicines respond to these stresses. For this reason, in this paper we present a strategy for a comprehensive analytical characterization of a peptide and a stress testing study in which it was subjected to various stress conditions: heating at 40 °C and 60 °C, light exposure and shaking. Several complementary analytical techniques were used throughout this study: Far UV circular dichroism, intrinsic protein fluorescence spectroscopy, dynamic light scattering, size-exclusion chromatography and intact and peptide mapping reverse-phase chromatography coupled to mass spectrometry. To the best of our knowledge, this is the first study to offer an in-depth description of the chemical structure of teduglutide peptide and its physicochemical characteristics after stress stimuli were applied to the reconstituted medicine Revestive®.

01 Aug 2019·DMW - Deutsche Medizinische WochenschriftQ4 · MEDICINE

Intestinale Rehabilitation bei Kurzdarmsyndrom und chronischem Darmversagen

Q4 · MEDICINE

Article

Author: Maasberg, Sebastian ; Pape, Ulrich-Frank

01 Mar 2013·Expert Review of Gastroenterology & Hepatology

The novel use of peptide analogs in short bowel syndrome

Author: Palle Bekker Jeppesen

The approval of the peptide analog, tedu -glutide, by the US FDA and EMA in 2012 for the treatment of short bowel syndrome (SBS) is anticipated to increase the aware -ness of this rare, serious, potentially life-threatening, orphan condition. SBS results from surgical resection, congenital defect or disease-associated loss of absorption. Patients with intestinal insufficiency main -tain their metabolic balances though oral compensation, pharmacologic or physi-ologic adaptation, whereas supplemental parenteral support (PS; parenteral nutri-tion and/or intravenous fluids) through a central catheter is required to maintain fluid, electrolytes, trace elements, vita-mins, nutrient balances and ultimately life in patients with SBS with intestinal failure (SBS-IF)

100 Deals associated with Teduglutide (Prolynx)

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Indication	Highest Phase	Country/Location	Organization	Date
Blind Loop Syndrome	Preclinical	United States	Prolynx LLC	10 Aug 2022

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