Antiviral nasal drops comprising recombinant interferon a biocompatible polymer and an antioxidant

Abstract

The present invention can be used in pharmacology specifically in the preparation of interferon-containing compositions, which are capable of conserving their biological activity and can be administered intranasally, e.g. in the preparation of nasal drops. This invention essentially refers to an antiviral agent in the form of nasal drops that contains a genetically engineered alpha, beta or gamma interferon with a viscosity of (1.1−30.0)* 10 10 −3 Pascal .second, a biocompatible polymer and a buffer mixture. The agent may further include an antioxidant, and the ingredients are contained in the following amounts per ml buffer mixture: 1,000 to 5,000 500,000 IU of genetically engineered interferon; 0.005 to 0.714 g of biocompatible polymer; and 0.0001 to 0.0008 g of an antioxidant. TRILON B® (disodium salt of EDTA) is used as the antioxidant, whereas polyvinylpyrrolidone and/or polyethylene oxide is (are) used as the biocompatible polymer(s) at polyvinylpyrrolidone/polyethylene oxide ratio of 1:1-50.

1. An antiviral drug presented as nasal drops comprising genetically engineered alpha, beta or gamma interferon, at least one biocompatible polymer selected from the group consisting of polyvinyl pyrrolidone and polyethylene oxide, and a biocompatible antioxidantthe drug viscosity being 11-300 Pascal second , said antioxidant being TRILON B® ( disodium salt of ethylenediaminetetraacetic acid ) , wherein the antiviral drug comprises per ml of a buffered saline solution:  
   the genetically engineered alpha, beta, or gamma interferon in an amount of  1 , 000 - 500 , 000  IU;    
   the at least one biocompatible polymer in an amount of  0 . 005 - 0 . 714  g; and    
   the antioxidant in an amount of  0 . 0001 - 0 . 0008  g .  
 
     
     
       2. The antiviral drug of  claim 1  wherein the antioxidant is TRILON B® (disodium salt of ethylenediaminetetraacetic acid). 
     
     
       3. The antiviral drug of  claim 1  or  claim 2   comprising polyvinyl pyrrolidone and polyethylene oxide in a ratio of 1:1 to 1:50. 
     
     
       4. An antiviral drug presented as nasal drops comprising genetically engineered alpha, beta or gamma interferon, at least one biocompatible polymer selected from the group consisting of polyvinyl pyrrolidone and polyethylene oxide, and a biocompatible antioxidant, said antioxidant being TRILON B® ( disodium salt of ethylenediaminetetraacetic acid ) , wherein the antiviral drug comprises  per ml of a buffered saline solution:
 a.the genetically engineered alpha, beta or gamma interferon in an amount of 1,000-300,000 IU;  
 b.the at least one biocompatible polymer selected from the group consisting of polyvinyl pyrrolidone and polyethylene oxidein an amount of 0.005-0.714 g; and  
 c.the antioxidant in an amount of 0.0001-0.0008 gthe drug viscosity being 11-300 Pascal second .  
 
     
     
       5. The antiviral drug of  claim 4  wherein the antioxidant is TRILON B® (disodium salt of ethylenediaminetetraacetic acid). 
     
     
       6. The antiviral drug of  claim 4  or  claim 5  comprising polyvinyl pyrrolidone and polyethylene oxide. 
     
     
       7. The antiviral drug of  claim 4  or  claim 5  comprising polyvinyl pyrrolidone and polyethylene oxide in a ratio of 1:1 to 1:50. 
     
     
       8. The antiviral drug of  claim 1 , wherein said drug comprises per ml of buffered saline solution:
   genetically engineered interferon beta in the amount of  500 , 000  IU,        polyvinylpyrrolidone in the amount of  0 . 014  g,        polyethylene oxide in the amount of  0 . 7  g, and        Trilon B® in the amount of  0 . 0008  g.     
     
     
       9. The antiviral drug of  claim 1 , wherein said drug comprises per ml of buffered saline solution:
   genetically engineered interferon alpha in the amount of  10 , 000  IU,        polyvinylpyrrolidone in the amount of  0 . 01  g,        polyethylene oxide in the amount of  0 . 1  g, and        Trilon B® in the amount of  0 . 0004  g.     
     
     
       10. The antiviral drug of  claim 1 , wherein said drug comprises per ml of buffered saline solution:
   genetically engineered interferon gamma in the amount of  1 , 000  IU,        polyvinylpyrrolidone in the amount of  0 . 05  g, and        Trilon B® in the amount of  0 . 0001  g.