Compositions and methods of using lamellar bodies for modifying linear biological macromolecules

Abstract

Compositions comprising therapeutically effective amounts of lamellar bodies for the modification of linear macromolecules are disclosed. These lamellar compositions are useful in the treatment of conditions or diseases characterized by a preponderance of heavy mucous secretions, such as otitis media, cystic fibrosis, bronchitis, sinusitis and nasal congestion. Methods of treating these diseases and conditions by administering a therapeutically effective amount of a composition to a patient requiring such treatment are also disclosed.

1 . A composition comprising a therapeutically effective amount of lamellar bodies for the modification of linear macromolecules.  
     
     
         2 . The composition of  claim 1 , wherein said lamellar bodies comprise about 44-70% phosphatidylcholine, about 15-23% sphingomyelin, about 6-10% phosphatidyl ethanolamine, about 2-6% phosphatidyl serine, about 2-4% phosphatidyl inositol and about 4-12% cholesterol by weight.  
     
     
         3 . The composition of  claim 2 , wherein said composition further comprises about 0-3% by weight of lysophosphatidyl choline.  
     
     
         4 . The composition of  claim 1 , wherein said lamellar bodies comprise about 54% phosphatidyicholine, about 19% sphingomyelin, about 8% phosphatidyl ethanolamine, about 4% phosphatidyl serine, about 3% phosphatidyl inositol and about 10% cholesterol by weight.  
     
     
         5 . The composition of  claim 4 , wherein said composition further comprises about 2% by weight of lysophosphatidyl choline.  
     
     
         6 . The composition of  claim 1 , wherein said linear macromolecules are selected from the group consisting of DNA, mucin, actin, and bacterial-derived alginate.  
     
     
         7 . A pharmaceutical composition comprising a therapeutically effective amount of lamellar bodies for the modification of linear macromolecules and a pharmaceutically acceptable carrier.  
     
     
         8 . The pharmaceutical composition of  claim 7 , wherein said lamellar bodies comprise about 44-70% phosphatidylcholine, about 15-23% sphingomyelin, about 6-10% phosphatidyl ethanolamine, about 2-6% phosphatidyl serine, about 2-4% phosphatidyl inositol and about 4-12% cholesterol by weight and a pharmaceutically acceptable carrier.  
     
     
         9 . The pharmaceutical composition of  claim 8 , wherein said composition further comprises about 0-3% by weight of lysophosphatidyl choline.  
     
     
         10 . The pharmaceutical composition of  claim 7 , wherein said lamellar bodies comprise about 54% phosphatidylcholine, about 19% sphingomyelin, about 8% phosphatidyl ethanolamine, about 4% phosphatidyl serine, about 3% phosphatidyl inositol and about 10% cholesterol by weight and a pharmaceutically acceptable carrier.  
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein said composition further comprises about 2% by weight of lysophosphatidyl choline.  
     
     
         12 . The pharmaceutical composition of  claim 7  wherein the linear macromolecules are selected from the group consisting of DNA, mucin, actin, and bacterial-derived alginate.  
     
     
         13 . The pharmaceutical composition as in any of claims  7 - 12 , further comprising inclusion of therapeutic moieties in the pharmaceutical composition along with the lamellar bodies.  
     
     
         14 . The pharmaceutical composition of any one of claims  7 - 11  for the treatment of a disease or condition characterized by a preponderance of heavy mucous secretions.  
     
     
         15 . The pharmaceutical composition of  claim 14 , wherein said disease or condition characterized by a preponderance of heavy mucous secretions is selected from the group consisting of Otitis Media, cystic fibrosis, bronchitis, sinusitis and nasal congestion.  
     
     
         16 . A method of treating Otitis Media comprising the steps of: 
 a) inserting a needle through the tympanic membrane;    b) introducing a composition including lamellar bodies through the needle into the ear; and    c) allowing the lamellar bodies to modify the viscosity of the mucin in the ear such that it is capable of draining from the ear.    
     
     
         17 . The method of  claim 16 , wherein the composition is introduced into the middle ear.  
     
     
         18 . The method of treating Otitis Media as set forth in  claim 16  or  17 , comprising the steps of: 
 a) inserting a needle through the tympanic membrane;    b) introducing a composition including lamellar bodies through the needle into the ear, and    c) allowing the lamellar bodies to modify the composition and the biological properties of the contents present in the pathological secretion, including linear macromolecules of the type mucus, DNA, actin and alginate, to the effect that the physical properties of the secretions such as viscosity and adhesiveness are altered, permitting therapeutic drainage of the middle ear.    
     
     
         19 . The method of treating Otitis Media as set forth in  claim 16  or  17 , comprising the steps of: 
 a) inserting a catheter into the pharyngeal opening of the Eustachian tube;    b) introducing a composition, including lamellar bodies through the catheter into the ear.    
     
     
         20 . A method of performing a functional endoscopic sinus surgery (FESS) procedure on the sinus of a patient comprising the steps of: 
 a) applying a composition including lamellar bodies to the sinus;    b) allowing lamellar bodies in the composition to modify the viscosity of the linear macromolecules in the area of the sinus such that it is capable of being removed; and    c) introducing a surgical instrument into the nasal passage such as to remove tissue from the sinus.    
     
     
         21 . The method of  claim 20 , wherein said linear macromolecules are selected from the group consisting of mucus, DNA, actin and alginate.