Glp-1-Analogzusammensetzungen und Herstellungsverfahren

Details

Veröffentlichungs-Nr.

EP4656182

Aktenzeichen

EP25155776

Anmeldetag

4. Februar 2025

Veröffentlichung

3. Dezember 2025

Rechtsraum

EP

IPC

A61K9/00A61K9/08A61K9/19A61K38/26// A61K47/02A61K47/18A61K47/26

Abstract

The invention relates to a method for the preparation of a pharmaceutical composition comprising a GLP-1 agonist, a tonicity modifier, a buffering agent and a preservative which comprises the following steps: preparing a final solution comprising the tonicity modifier, the buffering agent, the preservative, the GLP-1 agonist and water for injection; and adjusting the pH of the final solution between 6.5-8.5 with a pH adjuster; wherein the final solution is prepared at a temperature between 2-15°C, preferably 2-10°C, more preferably 2-8 °C, most preferably 3-6°C.

Anmelder

Firma

Galenicum Health S.L.U.

Land

🇪🇸 Spanien

Fachgebiete