METHODS AND COMPOSITIONS OF STABLE PHENYLEPHRINE FORMULATIONS
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.