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 - 14 . (canceled) 
     
     
         15 . A method of administering a composition for pupil dilation, comprising: storing the composition for at least 6 months between −10 and 10 degrees Celsius; administering the composition into an eye of an individual in need thereof after the storage; wherein the composition comprises R-phenylephrine hydrochloride and an aqueous buffer; and wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 95% of the chiral purity before the storage. 
     
     
         16 . The method of  claim 15 , wherein the composition is stored between 2 and 8 degrees Celsius. 
     
     
         17 . The method of  claim 15 , wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 97% of the chiral purity before the storage. 
     
     
         18 . The method of  claim 15 , wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 99% of the chiral purity before the storage. 
     
     
         19 . The method of  claim 15 , wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 99.5% of the chiral purity before the storage. 
     
     
         20 . The method of  claim 15 , wherein the composition is stored for at least 12 months. 
     
     
         21 . The method of  claim 15 , wherein the composition comprises 2.5% w/v or 10% w/v R-phenylephrine hydrochloride. 
     
     
         22 . The method of  claim 15 , wherein the composition is packaged in a 1-15 mL plastic or glass bottle. 
     
     
         23 . The method of  claim 22 , wherein the plastic or glass bottle is about 2 mL, about 3 mL, about 5 mL about 10 mL or about 15 mL. 
     
     
         24 . The method of  claim 22 , wherein the plastic or glass bottle is opaque. 
     
     
         25 . A method of administering a composition for pupil dilation, comprising: administering the composition into an eye of an individual in need thereof; wherein the composition comprises R-phenylephrine hydrochloride and an aqueous buffer; and wherein the chiral purity of R-phenylephrine hydrochloride after 6 months of storage between −10 and 10 degrees Celsius is at least 95% of the chiral purity before the storage. 
     
     
         26 . The method of  claim 25 , wherein the composition is stored between 2 and 8 degrees Celsius. 
     
     
         27 . The method of  claim 25 , wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 97% of the chiral purity before the storage. 
     
     
         28 . The method of  claim 25 , wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 99% of the chiral purity before the storage. 
     
     
         29 . The method of  claim 25 , wherein the chiral purity of R-phenylephrine hydrochloride after the storage is at least 99.5% of the chiral purity before the storage. 
     
     
         30 . The method of  claim 25 , wherein the composition is stored for at least 12 months. 
     
     
         31 . The method of  claim 25 , wherein the composition comprises 2.5% w/v or 10% w/v R-phenylephrine hydrochloride. 
     
     
         32 . The method of  claim 25 , wherein the composition is packaged in a 1-15 mL plastic or glass bottle. 
     
     
         33 . The method of  claim 32  wherein the plastic or glass bottle is about 2 mL, about 3 mL, about 5 mL about 10 mL or about 15 mL. 
     
     
         34 . The method of  claim 32 , wherein the plastic or glass bottle is opaque.