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.

1 - 46 . (canceled) 
     
     
         47 . A method for preparing a dry powder collectin composition comprising one or more collectins, a tonicity enhancing agent, a divalent cation salt and a carbohydrate, the method comprising:
 (i) preparing an aqueous solution comprising one or more collectins, a tonicity enhancing agent, a divalent cation salt and a carbohydrate; and   (ii) spray-drying the collection solution under conditions comprising an inlet air temperature is from about 50° C. to about 220° C. and an outlet air temperature is from about 42° C. to 120° C.   
     
     
         48 . The method of  claim 47 , further comprising sterilizing the collectin composition produced in step (i). 
     
     
         49 . The method of  claim 47 , wherein the collecting solution comprises a carbohydrate at a concentration of from about 0.1 to about 4% (w/v). 
     
     
         50 . The method of  claim 49 , wherein the carbohydrate is sucrose or lactose. 
     
     
         51 . The method of  claim 47 , the collectin solution further comprises a protein excipient. 
     
     
         52 . The method of  claim 51 , wherein the protein excipient is casein. 
     
     
         53 . The method of  claim 47 , wherein the collectin is selected from the group consisting of mannose-binding lectin, surfactant protein A, surfactant protein D, conglutinin, collectin liver 1, collectin placenta 1, CL-43, and CL-46. 
     
     
         54 . The method of  claim 53 , wherein the collectin is mannose-binding lectin (MBL). 
     
     
         55 . The method of  claim 54 , wherein the collectin is a recombinant mannose-binding lectin. 
     
     
         56 . The method of  claim 47 , wherein the dry powder collectin composition has a particle size ranging from about 0.1 to about 10 micrometers. 
     
     
         57 . A method for treating an infectious disease in a subject in need thereof comprising administrating a therapeutically effective amount of a dry powder collectin composition comprising one or more collectins, a tonicity enhancing agent, a divalent cation salt and a carbohydrate and being prepared according to the method of  claim 47 . 
     
     
         58 . The method of  claim 57 , wherein the infection is caused by infectious microbes. 
     
     
         59 . The method of  claim 58 , wherein the infectious microbes are bacteria, viruses, fungi, or parasites. 
     
     
         60 . The method of  claim 59 , wherein the virus has a viral envelope. 
     
     
         61 . The method of  claim 59 , wherein the virus is human immunodeficiency viruses, influenza, adenovirus, herpes viruses, SARS (severe acute respiratory syndrome) corona virus, or rhinovirus. 
     
     
         62 . The method of  claim 59 , wherein the bacteria have a glycosylation pattern recognizable by a collectin. 
     
     
         63 . The method  claim 59 , wherein the bacterium is  Staphylcoccus aureus, Hemophilus influenzae , or  Staphylococcus pyogens.    
     
     
         64 . The method of  claim 59  wherein the fungus has a glycosylation pattern recognizable by a collectin. 
     
     
         65 . The method of  claim 59 , wherein the fungus is  Candida albicans.