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 . 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.