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Last Updated: November 2, 2024

Claims for Patent: 10,376,584

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Summary for Patent: 10,376,584

Title:	Stable pharmaceutical formulations of methylnaltrexone
Abstract:	Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.
Inventor(s):	Sanghvi; Suketu P. (Kendall Park, NJ), Boyd; Thomas A. (Grandview, NY)
Assignee:	Progenics Pharmaceuticals, Inc. (Tarrytown, NY)
Application Number:	15/474,614
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,376,584
Patent Claims:	1. A stable pharmaceutical preparation comprising a solution of methylnaltrexone or salt thereof and a chelating agent; wherein the chelating agent is ethylenediaminetriacetic acid (EDTA) or a derivative thereof. 2. The stable pharmaceutical preparation of claim 1, wherein the preparation comprises methylnaltrexone bromide. 3. The stable pharmaceutical preparation of claim 1, wherein the EDTA derivative is edetate calcium disodium. 4. The stable pharmaceutical preparation of claim 1, wherein the preparation further comprises an isotonicity agent and a buffering agent. 5. The stable pharmaceutical preparation of claim 4, wherein the isotonicity agent is sodium chloride and the buffering agent is glycine. 6. The stable pharmaceutical preparation of claim 5, wherein the preparation is suitable for parenteral delivery. 7. The stable pharmaceutical preparation of claim 1, wherein the preparation is delivered at a dose from about 0.01 to 1.00 mg/kg body weight per day. 8. The stable pharmaceutical preparation of claim 1, wherein the preparation is delivered at a dose from about 0.1 to 0.3 mg/kg body weight per day. 9. A method for treating an opioid-induced peripheral side effect comprising administering to a patient the stable pharmaceutical preparation of claim 1 in an amount effective to treat the side effect. 10. The method of claim 9, wherein the opioid induced peripheral side effect is constipation. 11. The pharmaceutical preparation of claim 1, wherein the concentration of methylnaltrexone or salt thereof ranges from about 1.0 to about 50.0 mg/ml. 12. The pharmaceutical preparation of claim 1, wherein the concentration of methylnaltrexone or salt thereof is about 20 mg/ml. 13. The pharmaceutical preparation of claim 1, wherein the concentration of chelating agent ranges from about 0.1 to about 25.0 mg/ml. 14. The pharmaceutical preparation of claim 1, wherein the concentration of chelating agent ranges from about 0.1 to about 2.5 mg/ml. 15. The pharmaceutical preparation of claim 1, wherein the methylnaltrexone or salt thereof is methylnaltrexone bromide and is at a concentration of about 20 mg/mL, and wherein the EDTA or a derivative thereof is at a concentration of about 0.1 to about 2.5 mg/ml.

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