Claims for Patent: 12,090,139

Summary for Patent: 12,090,139

Title:	Formulations comprising triptan compounds
Abstract:	The invention provides a pharmaceutical composition for intranasal administration comprising a salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient, wherein the said composition provides Tmax value of less than 30 minutes upon said administration. Other aspects and embodiments are contemplated and described.The invention also provides a pharmaceutical composition for intranasal administration comprising a triptan, a pharmaceutically acceptable vehicle and a mucosal permeation enhancer, wherein upon said administration said composition provides a Tmax substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.
Inventor(s):	Rajesh Gandhi, Sreekanth Manikonda, Arun Jana, Sameer Shrinivas Kunte
Assignee:	Tonix Medicines Inc
Application Number:	US17/750,354
Patent Claims:	1. A pharmaceutical composition for intranasal administration comprising: an aqueous buffered solution comprising sumatriptan or a pharmaceutically acceptable salt or solvate thereof, wherein the solution comprises: 10 mg sumatriptan; citric acid monohydrate; 1-O-n-Dodecyl-β-D-Maltopyranoside; a pH of about 5.0 to 6.0; and optionally at least one pharmaceutically acceptable excipient, wherein upon intranasal administration, the pharmaceutical composition provides a Cmax ranging from about 14 ng/mL to about 214 ng/ml. 2. The pharmaceutical composition of claim 1, wherein the 1-O-n-Dodecyl-β-D-Maltopyranoside is present in the solution in a concentration range of about 0.05% to about 3.0%. 3. The pharmaceutical composition of claim 1, wherein the solution comprises 1 molar equivalent of the sumatriptan and about 0.3 to 0.6 molar equivalent of the citric acid monohydrate. 4. The pharmaceutical composition of claim 1, wherein upon intranasal administration of the pharmaceutical composition, the pharmaceutical composition provides a Tmax substantially equivalent to subcutaneous administration of sumatriptan. 5. The pharmaceutical composition of claim 1, wherein the Tmax ranges from about 4 to about 15 minutes. 6. A method of treating migraine in a subject in need thereof, the method comprising: intranasally administering a pharmaceutical composition comprising: an aqueous buffered solution comprising sumatriptan or a pharmaceutically acceptable salt or solvate thereof, wherein the solution comprises: 10 mg sumatriptan; citric acid monohydrate; 1-O-n-Dodecyl-β-D-Maltopyranoside; a pH about 5.0 to 6.0; and optionally at least one pharmaceutically acceptable excipient, wherein the intranasal administration results in a Cmax ranging from about 14 ng/mL to about 214 ng/mL. 7. The method of claim 6, wherein the 1-O-n-Dodecyl-β-D-Maltopyranoside is present in the solution in a concentration range of about 0.05% to about 3.0%. 8. The method of claim 6, wherein the solution comprises 1 molar equivalent of the sumatriptan and about 0.3 to 0.6 molar equivalent of the citric acid monohydrate. 9. The method of claim 6, wherein the Tmax ranges from about 4 to about 15 minutes. 10. The method of claim 6, wherein the intranasally administering results in a Tmax substantially equivalent to subcutaneous administration of sumatriptan. 11. The method of claim 6, wherein the pharmaceutical composition is administered 1 to 3 times per day. 12. An intranasal delivery system comprising: a delivery device; and a pharmaceutical composition for intranasal administration comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable salt or solvate thereof, wherein the solution comprises: 10 mg of sumatriptan; citric acid monohydrate; 1-O-n-Dodecyl-β-D-Maltopyranoside; a pH of about 5.0 to 6.0; and optionally at least one pharmaceutically acceptable excipient, wherein the pharmaceutical composition provides a Cmax ranging from about 14 ng/ml to about 214 ng/mL. 13. The intranasal delivery system of claim 12, wherein the delivery device comprises a dropper, a pipette, a spray device, or a pressurized metered dose inhaler.