Stable formulations of insulinoptropic peptides

A technology of insulin-stimulating peptides and preservatives, applied in the field of pharmaceutical preparations

Inactive Publication Date: 2007-10-17
NOVO NORDISK AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

GLP-2 may be effective in the treatment of gastrointestinal diseases

Method used

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  • Stable formulations of insulinoptropic peptides
  • Stable formulations of insulinoptropic peptides
  • Stable formulations of insulinoptropic peptides

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0162] The ThT fibril formation assay of the pharmaceutical composition of the acylated GLP-1 analog liraglutide is shown in Figure 1 (the experiment was performed according to the method described in "General Methods"). ThT fluorescence emission increased after approximately 10 hours, indicating the onset of fibril formation. The signal increased steadily and reached a plateau before the assay was terminated. However, in the presence of 200 ppm poloxamer 188, the ThT fluorescence signal remained at background levels. This indicates that no fibril formation occurs and thus the pharmaceutical composition is physically stable under these conditions. The pharmaceutical composition used in Example 1 (Fig. 1) had no added buffer.

Embodiment 2

[0164] The effect of poloxamer 188 in liraglutide pharmaceutical compositions comprising sodium phosphate as buffer is shown in Figure 2 (experiments were performed as described in "General Methods"). Here the presence of 50 ppm poloxamer 188 prolongs the lag time before the onset of fibril formation, whereas 100 ppm poloxamer 188 completely inhibits fibril formation during the assay.

Embodiment 3

[0166] Polysorbate 20 also stabilized formulations of liraglutide. One such example is shown in Figure 3 (experiments were performed as described in "General Methods"). The presence of 200 ppm polysorbate 20 attenuated fibril formation, which was observed as a slower growth rate of the ThT fluorescent signal. Thus, significantly less ThT fluorescence signal was observed in the polysorbate 20 samples than in the reference after 40 hours of incubation.

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Abstract

The present invention provides a stable pharmaceutical composition comprising insulinotropic peptide.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations. More specifically, the present invention relates to shelf-stable pharmaceutical formulations comprising insulinotropic peptides. Background technique [0002] Therapeutic peptides are widely used in medical practice. Pharmaceutical compositions of such therapeutic peptides are required to have a shelf life of several years for common use. However, peptide compositions are inherently unstable due to susceptibility to chemical and physical degradation. Chemical degradation involves changes in covalent bonds such as oxidation, hydrolysis, racemization or cross-linking. Physical degradation involves conformational changes relative to the peptide's native structure, which can cause aggregation, precipitation, or adsorption to surfaces. [0003] Glucagon has been used in diabetic medical practice for decades, and several glucagon-like peptides are being developed for various therapeutic i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/26A61K47/26A61K47/10A61P3/10
CPCA61K9/0019A61K9/08A61K47/02A61K38/26A61K9/19A61K47/10A61K47/34C07K14/605A61P3/08A61P3/10
Inventor S·路德维希森M·施莱因T·E·G·博芬C·邦德A-M·利莱奥雷D·K·恩格伦德B·R·尼尔森
Owner NOVO NORDISK AS
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