Zealand Pharma A/S
FORMULATIONS OF GLUCAGON-LIKE-PEPTIDE-2 (GLP-2) ANALOGUES

Abstract:

Liquid formulations of GLP-2 analogues are described that make it possible to include a preservative while allowing the formulation to be stabilised for long term storage as liquids and/or as multi-dose liquid formulations. The development of these formulations is base on the finding that that reducing the pH of the formulation to below 7.0, e.g. to a pH between about pH 5.0 and about 6.8, was able to offset the effect that the addition of a preservative such as meta-cresol has on the physical stability of the formulation. Additionally, the addition of an excipient such as propylene glycol was shown to be able to offset the effect that the addition of a preservative, such as meta-cresol, has on the physical stability of the formulation. This opens up the possibility of being able to deliver the GLP-2 analogues as multi-dose formulations, for example allowing the use of the formulations in a drug delivery device.