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A composition comprising a protein and a polyalkoxy fatty acyl surfactant

A polyalkoxy fatty acyl and surfactant technology, which is applied in the field of compositions containing proteins and polyalkoxy fatty acyl surfactants, and can solve problems such as surfactant degradation

Active Publication Date: 2021-04-16
DOW GLOBAL TECH LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although polysorbate and poloxamer 188 are used for their safety in injectable formulations, they still have significant disadvantages, especially due to surfactant degradation

Method used

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  • A composition comprising a protein and a polyalkoxy fatty acyl surfactant
  • A composition comprising a protein and a polyalkoxy fatty acyl surfactant
  • A composition comprising a protein and a polyalkoxy fatty acyl surfactant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0022] In the polyalkoxyaliphatic compound of formula I, R 1 A substituted or unsubstituted aliphatic group is preferred. Among substituted aliphatic groups, the preferred substituent is hydroxyl. More preferably, R 1 is an unsubstituted aliphatic group; more preferably, R 1 is an unsubstituted alkyl group. Preferably, R 1 is a linear alkyl group having 9-22 carbon atoms, preferably 10-18 carbon atoms, more preferably 10-16 carbon atoms.

[0023] Preferably, X 1 It's NH. Preferably, X 2 It's NH.

[0024] Preferably, n is 0 or 1, 2, 3, 4 or 5. More preferably, n is 0 or 1.

[0025] Preferably, R 2 Has 20 or fewer atoms; more preferably 15 or fewer atoms. Preferably, if R 2 is not hydrogen, then R 2 Contains one or more carbon atoms. Preferably, R 2 is hydrogen or unsubstituted hydrocarbyl; more preferably, R 2 is hydrogen, an unsubstituted alkyl group, or an alkyl group whose only substituent is an unsubstituted arene group. Among unsubstituted alkyl groups, m...

example 1

[0060] Prepare 600 μL of formulation in 1 mL glass vials. 100 μL was removed for t=0 analysis, and samples were then shaken sideways overnight at 200 rpm at 35°C. Measure the phase clarity of each vial and measure the size of a 100 μL aliquot by DLS. The data are shown in the table below:

[0061] Phase Transparency:

[0062]

[0063] Light scattering data, mean size (nm)

[0064]

[0065] From the light scattering data, the concentration required to keep the mean radius smaller than a certain size can be calculated:

[0066]

example 2

[0067] Example 2: Aggregation Kinetics

[0068] Experiments were performed as in Example 1, but with a set concentration of surfactant: 0.05 mg / mL (ratio 400:1). At each time point, samples were removed from the shaker and analyzed for hydrodynamic radius by light scattering. For Unreadable data, enter a value of 100.

[0069] Hydrodynamic radius.

[0070] Shaking time (hours) PS80 PS20 PO188 FM1000 control 0 7.7 7.9 7.8 8 100 0 7.7 8 7.9 7.9 100 0 8 7.9 8 8.1 100 1 7.7 7.7 9.4 7.8 7.9 1 7.4 7.7 9 7.7 8.2 1 7.6 7.4 8.9 7.6 100 2 10.3 8.2 20.8 7.6 10.3 2 8.7 8.2 14.1 7.9 9.1 2 8.6 7.9 11.7 7.9 100 4 14.5 8.6 100 8.2 12.1 4 11.9 9.4 100 8 11.7 4 14.4 8.8 100 8.1 100 6 100 10 100 9.2 13.9 6 21.3 11.3 100 8.4 16.2 6 11.5 10 100 10.4 100

[0071] This data can be fitted and used to calculate the time to reach a given radius...

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Abstract

A composition comprising a protein and a polyalkoxy fatty acyl surfactant of general formula I (I) wherein R1-C(=O) is a fatty acyl group, R2 is H or a substituted or unsubstituted hydrocarbyl group, X1 is O or NH, X2 is O or NH, n is 0 or an integer of 1-5, R3 is a polymeric group comprising polymerized units of general formula II and III (II) (III) wherein the weight ratio of said protein to said polyalkoxy fatty acyl surfactant is in the range of 200:1 to 1000:1.

Description

technical field [0001] The present invention relates to compositions comprising a protein and a polyoxyalkyl fatty acyl surfactant. Background technique [0002] Biologics (drugs derived from proteins or other biologically derived macromolecules) have rapidly become an important class of drugs. Due to the relatively fragile nature of proteinaceous materials, the development of bioactive substances that are therapeutically beneficial and stable enough to withstand processing, distribution, and drug administration remains a major challenge. Protein biopharmaceutical producers and formulators employ various processing techniques and formulation strategies to improve the storage stability of formulations, but the current excipient toolbox is rather small. Dry protein powders are generally more storage-stable, so many first-generation products are dried by freeze-drying or more recently spray-drying. However, dry products may have challenges associated with reconstitution, resu...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K39/395A61K47/14
CPCA61K39/395A61K9/08A61K47/14A61K47/26A61K39/39591A61K2039/505
Inventor J·S·卡茨S·L·乔丹
Owner DOW GLOBAL TECH LLC
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