Lubricious germicidal ophthalmic solutions

Abstract

A novel class of lubricious ophthalmic solutions is formulated to permit the use of a recognized class of demulcents; namely, anionic polymeric demulcents in the presence of a cationic quaternary germicide wherein no precipitation of said germicide occurs.

1 . A lubricious aqueous ophthalmic solution having a pH between 7 and 8 consisting essentially of: 
 a.) from about 0.1-about 4.0% by weight of an anionic polymeric demulcent,    b.) from about 0.005-to about 0.1% by weight of a quaternary germicide,    c.) from about 0.1-to about 1.0% by weight of a polysorbate surfactant.    
   
   
       2 . The solution of  claim 1  wherein said anionic polymeric component is selected from the group consisting of anionic cellulose derivatives, anionic polymers derived from acrylic acid, anionic polymers derived from methacrylic acid, anionic polymers derived from alginic acid, anionic polymers derived from amino acids and mixtures thereof.  
   
   
       3 . The solution of  claim 1  wherein said anionic polymeric component comprises a carboxymethyl cellulose.  
   
   
       4 . The solution of  claim 1  wherein the anionic polymeric demulcent is sodium carboxymethylcellulose.  
   
   
       5 . The solution of  claim 1  wherein the quaternary germicide of is benzalkonium chloride at a concentration of 0.10-0.015%.  
   
   
       6 . The solution of  claim 1  wherein the polysorbate surfactant is selected from the group consisting of the monolaurate, monopalmitate, monostearate and monooleate of polyethylene sorbitan.  
   
   
       7 . The solution of  claim 1  wherein the polyethylene sorbitan is polyethylene sorbitan 20 or polyethylene sorbitan 80.  
   
   
       8 . The solution of  claim 1  further comprising monographed pharmacologically active substances.  
   
   
       9 . The solution of  claim 2  further comprising monographed pharmacologically active substances.  
   
   
       10 . The solution of  claim 3  further comprising monographed pharmacologically active substances.  
   
   
       11 . The solution of  claim 4  further comprising monographed pharmacologically active substances.  
   
   
       12 . The solution of  claim 5  further comprising monographed pharmacologically active substances.  
   
   
       13 . The solution of  claim 6  further comprising monographed pharmacologically active substances.  
   
   
       14 . The solution of  claim 7  further comprising monographed pharmacologically active substances.  
   
   
       15 . A process of preparing a solution of  claim 1  comprising the steps of 
 a) dissolving the anionic polymeric demulcent in water,    b) adding the polysorbate,    c) adding quaternary germicide,    d) adjusting the pH to the desired range with buffers,    e) adding water to adjust the concentration to the desired range.    
   
   
       16 . The process of  claim 15 , wherein the steps are carried out in the sequence of (b), (a), (c), (d), (e).  
   
   
       17 . The process of  claim 15 , wherein the order of the steps is (a), (b), (c), (d), (e).