Fgf-18 formulation in xyloglucan gels

A technology of FGF-18 and xyloglucan, applied in the field of pharmaceutical preparations

Active Publication Date: 2016-10-12
ARES TRADING SA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Therefore, the resulting product may not be pharmaceutically acceptable

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  • Fgf-18 formulation in xyloglucan gels
  • Fgf-18 formulation in xyloglucan gels
  • Fgf-18 formulation in xyloglucan gels

Examples

Experimental program
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Effect test

Embodiment 1

[0135] Example 1: Temperature-responsive gelling system based on DEG-XG

[0136] Deg-XG solutions were prepared at 1, 2, 3, 4, 5% by weight in water. Deg-XG was prepared at 3.3 wt% and 4.4 wt% in D-PBS, and it was also loaded with 54 μg / ml of FGF-18. All systems were tested for injectability after overnight storage at 5°C (time=0) and after further incubation at 37°C for 1, 2 and 3 hours.

[0137] Injectability (Tables 1 and 2). The time to inject a given volume (1 ml) of polymer solution increased with increasing polymer concentration. The amount remaining in the syringe was between 5-8% at concentrations up to 4% by weight, although it increased significantly to about 15% at 5% by weight. The presence of FGF-18 did not significantly affect the performance of the two systems characterized (3 and 4 wt%). After storage at 25°C, for the 3 wt% system, the amount remaining in the syringe increased only after 4 h, while for the 4 wt% system, the amount remaining in the syringe ...

Embodiment 2

[0144] Example 2: Dynamic mechanical properties of DEG-XG based temperature-responsive gelling systems.

[0145] The dynamic mechanical properties of the gels incubated at 37°C for different times were investigated by stress and frequency sweep tests.

[0146] For the water-based gel system, the G’ curves of the strain sweep at a frequency of 1 Hz after incubation at 37 °C for 5 and 30 min are shown in Figure 7 . G' increases dramatically with increasing concentration, although the more elastic-like the material becomes, the lower the strain it can withstand before losing integrity (a condition detected by a sudden decrease in G'). Strain sweep testing after 30 minutes at 37°C showed a general further increase in storage modulus and showed a difference between the 4 and 5 wt% Deg-XG / water systems. Similar tests were performed on D-PBS gels loaded with 540 and 54 μg / ml GF and a "placebo" system (D-PBS gel without GF) ( Figure 8 a-c).

[0147] The combined effect of diluti...

Embodiment 3

[0151] Embodiment 3: Study on gelation kinetics

[0152] Gelation kinetic studies were performed by repeating frequency sweeps of the Deg-XG / water system at 37°C at given time intervals. Plot storage modulus and loss modulus values ​​versus time at 1 Hz ( Figure 11 ).

[0153] While the 1 wt% Deg-XG system shows a steady increase over time of G' and G", which first increase and then decrease, all other systems show nearly constant values ​​for the two components of the complex modulus over the time range studied .These results are in agreement with qualitative preliminary studies of flow behavior using tilt tests.

[0154] Given the observed similarities between D-PBS and aqueous systems, we can assume that these two types of gels have the same qualitative properties.

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Abstract

The invention relates to the field of pharmaceutical formulations. More particularly it is directed to xyloglucan hydrogels comprising Fibroblast Growth Factor 18 (FGF-18) compound and to methods of producing such hydrogels. The hydrogels of the invention can be used, once formed in situ, for the treatment of cartilage disorders such as osteoarthritis or cartilage injury.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations. More specifically, it relates to fibroblast growth factor 18 (FGF-18) protein formulations in xyloglucan gels, and methods of producing said formulations. Background technique [0002] Fibroblast growth factor 18 (FGF-18) is a member of the fibroblast growth factor (FGF) protein family that is closely related to FGF-8 and FGF-17. Members of the FGF family are characterized by: a heparin binding domain. This putative heparin binding domain has been identified for FGF-18. It is hypothesized that receptor-mediated signal transduction is initiated following the binding of FGF ligands complexed with cell surface heparin sulfate proteoglycans. [0003] FGF-18 has been shown to be a proliferation agent of chondrocytes and osteoblasts (Ellsworth et al., 2002; Shimoaka et al., 2002). FGF-18 has been proposed to treat cartilage diseases such as osteoarthritis (OA) and cartilage injury (CI) ei...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61L27/52A61K9/00A61K47/36A61P19/02
CPCA61L27/52A61K38/1825A61L2430/06A61K9/0019A61K9/0024A61L27/54A61L2300/414A61K47/36A61P19/02A61P19/08A61P43/00A61K9/00A61K38/18A61K47/02A61K9/06
Inventor C·洛普莱斯蒂D·布龙C·迪斯潘萨
Owner ARES TRADING SA
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