Claims for Patent: 8,859,623

Summary for Patent: 8,859,623

Title:	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.
Inventor(s):	Witham; Patrick H. (Eugene, OR), Machiraju; Sailaja (Beaverton, OR), Bluett; Lauren Mackensie-Clark (Milwaukie, OR)
Assignee:	Paragon Bioteck, Inc. (Portland, OR)
Application Number:	14/080,771
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,859,623
Patent Claims:	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.