Methods and compositions of stable phenylephrine formulations

Abstract

The invention is directed to methods and compositions of stabilizing phenylephrine formations. The composition has good time-dependent stability at low temperature and has no change in its outward appearance even after having been stored at least 6 months.

1 . A packaged composition comprising R-phenylephrine hydrochloride having chiral purity of at least 95% and an aqueous buffer for substantially maintaining chiral purity of R-phenylephrine hydrochloride, wherein the package identifies storing the composition at a storage temperature, and wherein the storage temperature is below room temperature. 
     
     
         2 . The packaged composition of  claim 1 , wherein the package identifies storage of the composition in a refrigerator. 
     
     
         3 . The packaged composition of  claim 1 , wherein the composition comprises R-phenylephrine hydrochloride having chiral purity of at least 99%. 
     
     
         4 . The packaged composition of  claim 1 , wherein the composition comprises R-phenylephrine hydrochloride having chiral purity of at least 99.3%. 
     
     
         5 . (canceled) 
     
     
         6 . (canceled) 
     
     
         7 . (canceled) 
     
     
         8 . (canceled) 
     
     
         9 . The packaged composition of  claim 1 , wherein the composition comprises 2.5% w/v or 10% w/v R-phenylephrine hydrochloride by weight. 
     
     
         10 . The packaged composition of  claim 1 , wherein the composition is in a 1-15 ml plastic or glass bottle. 
     
     
         11 . The packaged composition of  claim 1 , wherein the package identifies storing the composition at a temperature between −10 to 10 C. 
     
     
         12 . The packaged composition of  claim 1 , wherein the package identifies storing the composition at a temperature between 2 to 8 C. 
     
     
         13 . The packaged composition of  claim 1 , wherein the composition is in a plastic or glass bottle of about 2 ml, about 3 ml, about 5 ml, about 10 ml or about 15 ml. 
     
     
         14 . The packaged composition of  claim 1 , wherein the composition is in an opaque plastic or glass bottle. 
     
     
         15 . A method of using an ophthalmic composition for pupil dilation, the composition comprising R-phenylephrine hydrochloride having an initial chiral purity of at least 95% and an aqueous buffer, the method comprising:
 administering the composition into an eye of an individual in need thereof, wherein the composition is stored between −10 to 10 degree Celsius prior to administration, and wherein the composition comprises R-phenylephrine hydrochloride having a chiral purity of at least 95% when administered after storage.   
     
     
         16 . The method of  claim 15 , wherein the composition is stored between 2 to 8 degree Celsius. 
     
     
         17 . The method of  claim 15 , wherein the composition comprises R-phenylephrine hydrochloride having an initial chiral purity of at least 99%. 
     
     
         18 . The method of  claim 15 , wherein the composition comprises R-phenylephrine hydrochloride having an initial chiral purity of at least 99.3%. 
     
     
         19 . The method of  claim 15 , wherein the composition comprises 2.5% w/v or 10% w/v R-phenylephrine hydrochloride by weight. 
     
     
         20 . The method of  claim 15 , wherein the composition is packaged in a 1-15 ml plastic or glass bottle. 
     
     
         21 . The method of  claim 20 , wherein the package identifies storing the composition at a temperature between −10 to 10 C. 
     
     
         22 . The method of  claim 20 , wherein the package identifies storing the composition at a temperature between 2 to 8 C. 
     
     
         23 . The method of  claim 20 , wherein the composition is in a plastic or glass bottle of about 2 ml, about 3 ml, about 5 ml, about 10 ml or about 15 ml. 
     
     
         24 . The method of  claim 20 , wherein the plastic or glass bottle is opaque.