Claims for Patent: 11,571,398

Summary for Patent: 11,571,398

Title:	Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Abstract:	The present disclosure provides compositions comprising ephedrine sulfate ready for immediate use in a clinical setting, and methods of making and using same.
Inventor(s):	Shahid Ahmed
Assignee:	Nexus Pharmaceuticals LLC
Application Number:	US17/943,185
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,571,398
Patent Claims:	1. A method of administering ephedrine to a subject having hypotension or at risk of developing hypotension in need thereof, the method comprising: removing, from sealed packaging, a syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, no preservative, water, an initial pH level of about 4.5 to about 7, and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: a pH level within 0.5 pH units of the initial pH level, an ephedrine sulfate concentration at least 95% of the packaged concentration, and a bacterial endotoxin level not more than 7 EU/mg; and injecting the sterilized ephedrine composition from the syringe into the subject without diluting the sterilized ephedrine composition. 2. The method of claim 1, wherein the method consists essentially of the steps of: removing, from sealed packaging, a syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, no preservative, water, an initial pH level of about 4.5 to about 7, and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: a pH level within 0.5 pH units of the initial pH level, an ephedrine sulfate concentration at least 95% of the packaged concentration, and a bacterial endotoxin level not more than 7 EU/mg; and injecting the sterilized ephedrine composition from the syringe into the subject without diluting the sterilized ephedrine composition. 3. The method of claim 1, wherein the method further comprises, before the step of removing: combining ephedrine sulfate, sodium chloride or dextrose, and water to form a batch solution comprising an initial ephedrine sulfate level of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, and no preservative; optionally contacting the batch solution with an acid or a base to obtain an initial pH level of the solution of 4.5 to 7; filtering the batch solution through a membrane filter to obtain a filtered batch solution; placing not more than 20 mL of the filtered batch solution into the syringe to obtain one or more filled syringes; and sealing each of the one or more filled syringes in the packaging. 4. A method of administering ephedrine to a subject having hypotension or at risk of developing hypotension in need thereof, the method comprising: removing, from sealed packaging, a syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, no preservative, water, an initial pH level of about 4.5 to about 7, and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: an ephedrine sulfate concentration at least 95% of the packaged concentration, and a level of (+)-1 S,2R-ephedrine not more than 0.5%; and injecting the sterilized ephedrine composition from the syringe into the subject without diluting the sterilized ephedrine composition. 5. The method of claim 4, wherein the method consists essentially of the steps of: removing, from sealed packaging, a syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, no preservative, water, an initial pH level of about 4.5 to about 7, and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: an ephedrine sulfate concentration at least 95% of the packaged concentration, and a level of (+)-1 S,2R-ephedrine not more than 0.5%; and injecting the sterilized ephedrine composition from the syringe into the subject without diluting the sterilized ephedrine composition. 6. The method of claim 4, wherein the method further comprises, before the step of removing: combining ephedrine sulfate, sodium chloride or dextrose, and water to form a batch solution comprising an initial ephedrine sulfate level of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, and no preservative; optionally contacting the batch solution with an acid or a base to obtain an initial pH level of the solution of 4.5 to 7; filtering the batch solution through a membrane filter to obtain a filtered batch solution; placing not more than 20 mL of the filtered batch solution into the syringe to obtain one or more filled syringes; and sealing each of the one or more filled syringes in the packaging. 7. A method of administering ephedrine to a subject having hypotension or at risk of developing hypotension in need thereof, the method comprising: removing, from sealed packaging, a syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, no preservative, water, an initial pH level of about 4.5 to about 7, and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: an ephedrine sulfate concentration at least 95% of the packaged concentration, and a pH level within 0.5 pH units of the initial pH level; and injecting the sterilized ephedrine composition from the syringe into the subject without diluting the sterilized ephedrine composition. 8. The method of claim 7, wherein the method consists essentially of the steps of: removing, from sealed packaging, a syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, no preservative, water, an initial pH level of about 4.5 to about 7, and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: a pH level within 0.5 pH units of the initial pH level, an ephedrine sulfate concentration at least 95% of the packaged concentration; and injecting the sterilized ephedrine composition from the syringe into the subject without diluting the sterilized ephedrine composition. 9. The method of claim 7, wherein the method further comprises, before the step of removing: combining ephedrine sulfate, sodium chloride or dextrose, and water to form a batch solution comprising an initial ephedrine sulfate level of 5 mg/mL, 9 mg/mL sodium chloride or 5% dextrose, and no preservative; optionally contacting the batch solution with an acid or a base to obtain an initial pH level of the solution of 4.5 to 7; filtering the batch solution through a membrane filter to obtain a filtered batch solution; placing not more than 20 mL of the filtered batch solution into the syringe to obtain one or more filled syringes; and sealing each of the one or more filled syringes in the packaging.