Claims for Patent: 12,409,184

Summary for Patent: 12,409,184

Title:	Iloprost compositions and formulations thereof
Abstract:	The present disclosure generally relates to treatment of systemic sclerosis with symptomatic Raynaud's Phenomenon by intravenous or subcutaneous administration of iloprost or a pharmaceutically acceptable salt thereof.
Inventor(s):	Wade W. BENTON, Kevin A. CHRISTAL
Assignee:	BTG International Inc
Application Number:	US19/018,702
Patent Claims:	1. A pharmaceutical composition formulated for injection, comprising a pre-dilution formulation comprising: i. about 0.1 mg/mL of iloprost, or a pharmaceutically acceptable salt thereof or a stereoisomer thereof, relative to a total volume of the pre-dilution formulation; ii. about 0.24 mg/mL of tromethamine, relative to a total volume of the pre-dilution formulation; iii. sodium chloride; and iv. ethanol; wherein the pre-dilution formulation has a pH of about 8 to about 9; and wherein the pre-dilution formulation is diluted by about 100-fold prior to injection to form the composition for injection, said composition for injection being stable for up to 4 hours at 20° C. to 25° C. 2. The pharmaceutical composition of claim 1, wherein the composition for injection comprises about 1 μg/mL of iloprost, or a pharmaceutically acceptable salt or a stereoisomer thereof, relative to a total volume of the composition for injection. 3. The pharmaceutical composition of claim 2, wherein the composition for injection comprises about 1 mL of the pre-dilution formulation in about 100 mL of 0.9% sodium chloride. 4. The pharmaceutical composition of claim 3, wherein the composition for injection is for intravenous infusion. 5. A kit, comprising: the pre-dilution formulation of claim 1; and an IV bag comprising 0.9% sodium chloride for diluting the pre-dilution formulation. 6. The kit of claim 5, wherein the IV bag comprises about 100 ml of the 0.9% sodium chloride. 7. The kit of claim 5, wherein the IV bag is made of polyvinyl chloride (PVC). 8. The pharmaceutical composition of claim 1, wherein the pre-dilution formulation is provided as a single-use vial, and wherein each single use vial contains about 1 mL of the pre-dilution formulation. 9. The pharmaceutical composition of claim 1, wherein the pre-dilution formulation comprises about 0.242 mg/mL of tromethamine, relative to a total volume of the pre-dilution formulation. 10. The pharmaceutical composition of claim 1, wherein the pre-dilution formulation is formulated as a sterile solution. 11. The pharmaceutical composition of claim 1, wherein the pre-dilution formulation comprises no preservatives. 12. The pharmaceutical composition of claim 1, wherein the pre-dilution formulation comprises about 9.0 mg/mL of sodium chloride, relative to a total volume of the pre-dilution formulation.