Claims for Patent: 11,433,044

Summary for Patent: 11,433,044

Title:	Pharmaceutical formulations for subcutaneous administration of furosemide
Abstract:	The present teachings relate to liquid pharmaceutical formulations of furosemide, where the pharmaceutical formulations include a molar excess of tris(hydroxymethyl)aminomethane to furosemide, have a pH in the range of 7 to 8.5, and a concentration of tris(hydroxymethyl)aminomethane greater than or equal to about 50 mM. The present teachings can improve the stability of liquid pharmaceutical formulations including furosemide and the suitability of such pharmaceutical formulations for subcutaneous administration or delivery.
Inventor(s):	Michaels Scott A., Muntendam Pieter, Larsen Glenn R.
Assignee:	scPharmaceuticals Inc.
Application Number:	US16295085
Patent Claims:	1. A method of treating a human with or exhibiting the symptoms of edema , hypertension or heart failure , the method comprising: furosemide as the sole therapeutically active agent in the liquid pharmaceutical formulation, wherein the amount of furosemide in the liquid pharmaceutical formulation is about 5 mg/mL or greater; and', 'tris(hydroxymethyl)aminomethane, wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 500 mM;, 'administering subcutaneously to a human a liquid pharmaceutical formulation, wherein the liquid pharmaceutical formulation compriseswherein the liquid pharmaceutical formulation is isosmotic and has a pH between about 7 to about 8.5, and the molar ratio of tris(hydroxymethyl)aminomethane to furosemide is greater than about 1.5.2. The method of claim 1 , wherein the molar ratio of tris(hydroxymethyl)aminomethane to furosemide is greater than or equal to two.3. The method of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 250 mM.4. The method of claim 1 , wherein the liquid pharmaceutical formulation has a pH between about 7.2 to about 8.5. The method of claim 1 , wherein the amount of furosemide in the liquid_pharmaceutical formulation is between about 6 mg/mL to about 15 mg/mL.6. The method of claim 1 , wherein administering subcutaneously comprises using a pump device.7. The method of claim 6 , wherein the pump device is a patch device.8. A method of treating a human with or exhibiting the symptoms of edema claim 6 , hypertension or heart failure claim 6 , the method comprising: furosemide as the sole therapeutically active agent in the liquid pharmaceutical formulation, wherein the amount of furosemide in the liquid pharmaceutical formulation is about 15 mg/mL or greater; and', 'tris(hydroxymethyl)aminomethane, wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 500 mM;, 'administering subcutaneously to a human using a patch device a liquid pharmaceutical formulation comprisingwherein the liquid pharmaceutical formulation is isosmotic and has a pH between about 7.2 to about 8, and the molar ratio of tris(hydroxymethyl)aminomethane to furosemide is greater than or equal to 1.5.9. The method of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 150 mM.10. The method of claim 1 , wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 100 mM.11. The method of claim 1 , wherein the amount of furosemide in the liquid pharmaceutical formulation is about 15 mg/mL or greater.12. The method of claim 1 , wherein the amount of furosemide in the liquid pharmaceutical formulation is about 20 mg/mL or greater.13. The method of claim 1 , wherein the amount of furosemide in the liquid pharmaceutical formulation is about 25 mg/mL or greater.14. The method of claim 8 , wherein the molar ratio of tris(hydroxymethyl)aminomethane to furosemide is greater than or equal to two.15. The method of claim 8 , wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 250 mM.16. The method of claim 8 , wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 150 mM.17. The method of claim 8 , wherein the concentration of tris(hydroxymethyl)aminomethane in the liquid pharmaceutical formulation is in a range of about 50 mM to about 100 mM.18. The method of claim 8 , wherein the amount of furosemide in the liquid pharmaceutical formulation is about 15 mg/mL or greater.19. The method of claim 8 , wherein the amount of furosemide in the liquid pharmaceutical formulation is about 20 mg/mL or greater.20. The method of claim 8 , wherein the amount of furosemide in the liquid pharmaceutical formulation is about 25 mg/mL or greater.