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Last Updated: December 12, 2025

Claims for Patent: 11,998,605

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Summary for Patent: 11,998,605

Title:	Stabilized aqueous compositions of neuromuscular blocking agents
Abstract:	The present invention relates to an aqueous composition comprising: Furthermore the present invention relates to a liquid pharmaceutical composition comprising or consisting of said aqueous composition and a method for producing said aqueous composition.
Inventor(s):	Juan Gil Béjar, Cristina Timoneda Ramia
Assignee:	B Braun Melsungen AG
Application Number:	US16/515,653
Patent Claims:	1. An aqueous solution comprising: (i) a steroidal neuromuscular blocking agent, wherein the steroidal neuromuscular blocking agent is rocuronium bromide, further wherein the steroidal neuromuscular blocking agent is present in the aqueous solution at a concentration ranging from 9 mg/mL to 11 mg/mL based on the total volume of the aqueous solution; (ii) an excipient that is D-gluconic acid and D-glucono-delta-lactone, wherein the excipient is present in the aqueous solution at a concentration ranging from 24 mg/mL to 26 mg/mL based on the total volume of the aqueous solution; and (iii) a buffering agent, wherein the buffering agent comprises sodium acetate, sodium citrate, or a combination thereof, wherein the solution has a pH ranging from 3.8 to 4.2. 2. The aqueous solution of claim 1, wherein a ratio of the D-gluconic acid to the D-glucono-delta-lactone ranges from about 20:1 to about 1:20. 3. The aqueous solution of claim 1, wherein the buffering agent further comprises a phosphate. 4. The aqueous solution of claim 1, wherein the osmolality of the aqueous solution ranges from 270 mOsm/kg to 340 mOsm/kg. 5. A liquid pharmaceutical composition comprising the aqueous solution of claim 1, wherein the rocuronium bromide concentration of the liquid pharmaceutical composition is 9 mg/mL to 11 mg/mL, the excipient concentration is 24 mg/mL to 26 mg/mL and the pH ranges from 3.8 to 4.2. 6. A muscle relaxant or anesthetic comprising the liquid pharmaceutical composition of claim 5, wherein the rocuronium bromide concentration of the liquid pharmaceutical composition is 9 mg/mL to 11 mg/mL, the excipient concentration is 24 mg/mL to 26 mg/mL and the pH ranges from 3.8 to 4.2. 7. The aqueous solution of claim 1, wherein the buffering agent is present in the aqueous solution at a concentration in the range of from 0.5 mg/mL to 50 mg/mL based on the total volume of the aqueous solution. 8. The aqueous solution of claim 1, wherein the steroidal neuromuscular blocking agent is present in the aqueous solution at a concentration of 10 mg/mL based on the total volume of the aqueous solution. 9. The aqueous solution of claim 1, wherein the excipient is present in the aqueous solution at a concentration of 25 mg/mL based on the total volume of the aqueous solution. 10. The aqueous solution of claim 1, wherein the steroidal neuromuscular blocking agent is present at a concentration of 10 mg/mL and the excipient is present at a concentration of 25 mg/mL based on the total volume of the aqueous solution. 11. A method for delivering the aqueous solution of claim 1 to a patient, comprising delivering the solution of claim 1 to the patient via an injection, wherein the composition relaxes one or more skeletal muscles of the patient.

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