Methods and compositions of stable phenylephrine formulations
View Patent ↗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 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, wherein the chiral purity of R-phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6 months, 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.
2. The method of claim 1 , wherein the composition is allowed to be stored between 2 to 8 degree Celsius.
3. The method of claim 1 , wherein the composition comprises R-phenylephrine hydrochloride having an initial chiral purity of at least 99%.
4. The method of claim 1 , wherein the composition comprises R-phenylephrine hydrochloride having an initial chiral purity of at least 99.3%.
5. The method of claim 1 , wherein the chiral purity of R-phenylephrine hydrochloride is at least 97% of the initial chiral purity after 6 months.
6. The method of claim 1 , wherein the chiral purity of R-phenylephrine hydrochloride is at least 99% of the initial chiral purity after 6 months.
7. The method of claim 1 , wherein the chiral purity of R-phenylephrine hydrochloride is at least 99.5% of the initial chiral purity after 6 months.
8. The method of claim 1 , wherein the composition comprises 2.5% w/v or 10% w/v R-phenylephrine hydrochloride by weight.
9. The method of claim 1 , wherein the composition is packaged in a 1-15 ml plastic or glass bottle.
10. The method of claim 9 , wherein the package identifies storing the composition at a temperature between −10 to 10 C.
11. The method of claim 10 , wherein the package identifies storing the composition at a temperature between 2 to 8 C.
12. The method of claim 9 , 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.
13. The method of claim 9 , wherein the plastic or glass bottle is opaque.