Claims for Patent: 11,110,054

Summary for Patent: 11,110,054

Title:	Ready-to-use injectable pharmaceutical compositions comprising neostigmine and glycopyrrolate
Abstract:	The present invention provides stable, ready-to-use injectable pharmaceutical compositions, comprising the combination of neostigmine, glycopyrrolate, a stabilizing amount of one or more aminopolycarboxylic acids, and a pharmaceutically acceptable liquid vehicle. Other aspects of the invention relate to methods for making such compositions and methods of using such compositions for reversing the effects of non-depolarizing neuromuscular blocking agents. Preferably, the composition comprises neostigmine methylsulfate, glycopyrronium bromide, ethylenediaminetetraacetic acid (EDTA) and a pharmaceutically acceptable liquid vehicle, and is provided in a pre-filled, ready-to-use sealed container, such as a pre-filled syringe, suitable for intravenous administration.
Inventor(s):	Rahul Dhulaji Bhise, Ajay Kumar Singh, Mahadeo Vasant Mahadik, Ashish Anilrao DUBEWAR, Molugu Prashanth Reddy
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US16/170,948
Patent Claims:	1. A stable ready-to-use injectable pharmaceutical composition for reversing the effects of non-depolarizing neuromuscular blocking agents in a patient in need thereof, comprising (i) about 1 mg/mL of neostigmine or a pharmaceutically acceptable salt, solvate or hydrate thereof, (ii) about 0.2 mg/mL of glycopyrrolate or a pharmaceutically acceptable salt, solvate or hydrate thereof, (iii) a pharmaceutically acceptable liquid vehicle, (iv) a tonicity modifier; and (v) a pH adjusting agent; wherein the level of Glycopyrrolate Impurity C in the composition is less than 1% when stored at 40° C. and 75% relative humidity for 3 months; wherein the tonicity modifier is sodium chloride; and wherein the pH adjusting agent is sodium hydroxide, hydrochloric acid or a mixture thereof. 2. The pharmaceutical composition according to claim 1, wherein the composition is provided in a sealed container selected from the group consisting of ampoules, vials and pre-filled syringes. 3. The pharmaceutical composition according to claim 1, wherein the composition is in the form of a solution, suspension, or emulsion. 4. The pharmaceutical composition according to claim 1, wherein the composition is suitable for subcutaneous, intravenous or intramuscular administration. 5. The pharmaceutical composition according to claim 1, comprising neostigmine methylsulfate and glycopyrronium bromide. 6. The pharmaceutical composition according to claim 1, wherein the composition has a pH ranging from about 3.0 to about 4.0. 7. A stable ready-to-use injectable pharmaceutical composition comprising (i) about 1 mg/mL of neostigmine methylsulfate, (ii) about 0.2 mg/mL of glycopyrronium bromide, (iii) a pharmaceutically acceptable liquid vehicle; (iv) a tonicity modifier; and (v) q.s. of a pH adjusting agent, wherein the level of Glycopyrrolate Impurity C in the composition is less than 1%, when stored at 40° C. and 75% relative humidity for 3 months; wherein the tonicity modifier is sodium chloride; and wherein the pH adjusting agent is sodium hydroxide, hydrochloric acid or a mixture thereof. 8. The pharmaceutical composition according to claim 7, wherein the composition is provided in a sealed container selected from the group consisting of ampoules, vials and pre-filled syringes. 9. The pharmaceutical composition according to claim 7, wherein the composition has a pH ranging from about 3.0 to about 4.0. 10. A stable ready-to-use injectable pharmaceutical composition consisting of (i) about 1 mg/mL of neostigmine methylsulfate, (ii) about 0.2 mg/mL of glycopyrronium bromide, (iii) a pharmaceutically acceptable liquid vehicle; (iv) sodium chloride as tonicity modifier; and (v) sodium hydroxide, hydrochloric acid or mixture thereof as pH adjusting agent, wherein the level of Glycopyrrolate Impurity C in the composition is less than 1%, when stored at 40° C. and 75% relative humidity for 3 months.