Spray-dried collectin compositions and process for preparing the same

Abstract

The present invention relates to a spray-dried composition comprising as an active ingredient at least one member protein of the collectin family or its functional equivalent for treating and preventing microbial infectious diseases. The present invention also relates to a method for producing the same composition. The composition produced by the method of the present invention is effective in suppressing infections caused by viruses, bacteria, fungi, and parasites. Since the composition is developed in a form suitable for inhalation, it can directly provide the active ingredient to the sites of infection from these microbes, and thus treat and prevent respiratory infections and external wounds.

Description

TECHNICAL FIELD[0001]The present invention relates to a dry powder collectin composition which comprises one or more collectins. The present invention also relates to a method for preparing the dry powder collectin composition, especially a spray-dried powder composition suitable for pulmonary administration.BACKGROUND OF THE INVENTION[0002]Mannose-binding lectin (“MBL”) is a mammalian serum protein which is involved in innate immunity against microbial infections. MBL recognizes the specific glycosylation patterns of the proteins on the cell surface of the infecting microorganism and binds to them to suppress the microbial infection according to three pathways described below. In the first pathway, MBL binds the microbial glycosylated protein to form a complex, and then activates MBL associated serine proteases (“MASPs”). The MASPs, in turn, cleave the second and fourth complement components (“C4” and “C2”), leading to an activation of the complement system. In the second pathway, ...

AI Technical Summary

Benefits of technology

[0011]The present invention provides a dry powder collectin composition which comprises one or more collectins, and one or more excipients selected from the group consisting of tonicity enhancing agents, divalent ion salts, protein excipients, carbohydrates, and polymer excipient, for enhancing the particle physical characteristics, and pharmacological and biological properties of the composition. In particular, the dry powder collectin composition is a spray-dried collectin composition with a particle size ranging from 1 to 5 μm, which is aerosolizable for inhalation to treat or prevent respiratory infections. The spray-dried collectin composition can also be administered directly to other cavities and sites of microbial infection on the surface for treatment and / or prevention of such infections. Suitable divalent ion salt may contain calcium cation, which may be important for the biological activities of the collectins selected.

Problems solved by technology

Since treating MBL in a solution phase is not suitable for curing these respiratory diseases and external wounds, special formulations are required.

Although there have been many studies on MBL, the extent to which MBL is involved in the defense against the infections in epithelia and external wounds mentioned above is poorly understood.

Freeze-drying is suitable for heat-sensitive proteins, but it is not suitable for producing a uniform powder with a diameter of a few micrometers, a form that can be readily inhaled.

Since proteins in general are not stable against heat, there are not many cases of protein drug formulations spray-dried with hot air.

However, there have been no studies reported on spray-drying methods for producing powder collectin composition in general, human recombinant MBL compositions in particular, for treating illnesses such as respiratory inflammation.

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