Claims for Patent: 10,603,305

Summary for Patent: 10,603,305

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 T.sub.max 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 T.sub.max substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.
Inventor(s):	Gandhi; Rajesh (Sagar, IN), Manikonda; Sreekanth (Visakhapatnam, IN), Jana; Arun (Panna, IN), Kunte; Sameer Shrinivas (Mumbai, IN)
Assignee:	Upsher-Smith Laboratories, LLC (Maple Grove, MN)
Application Number:	15/924,881
Patent Claims:	1. A pharmaceutical composition for intranasal administration, comprising: an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-.beta.-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate, and wherein said composition upon intranasal administration provides a T.sub.max substantially equivalent to subcutaneous administration of said sumatriptan. 2. The composition as claimed in claim 1, wherein said composition provides T.sub.max value of less than about 30 minutes. 3. The composition as claimed in claim 1, wherein said alkyl glycoside or saccharide alkyl ester is present in a concentration of from about 0.05% to about 3.0%. 4. The composition as claimed in claim 1, wherein said composition provides T.sub.max value of less than about 15 minutes. 5. The composition as claimed in claim 1, wherein said composition upon nasal administration provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/m-L. 6. The composition as claimed in claim 1, wherein said composition administered intranasally for treating human suffering from or susceptible to cephalic pain. 7. The composition as claimed in claim 6, wherein said composition administered intranasally for treating human suffering from or susceptible to migraine. 8. The composition as claimed in claim 6, wherein said composition administered intranasally for treating human suffering from or susceptible to cluster headache. 9. The composition as claimed in claim 1, wherein said composition comprises 2.5 mg to 25 mg of sumatriptan. 10. The composition as claimed in claim 1, wherein said composition is contained in a single dose nasal delivery device and administered into one nostril. 11. A method of treating a human suffering from or susceptible to migraine or cluster headache, comprising: intranasal administration of a composition comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-.beta.-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate, and said composition upon intranasal administration provides a T.sub.max substantially equivalent to subcutaneous administration of said sumatriptan. 12. The method as claimed in claim 11, wherein said composition provides T.sub.max value of less than about 30 minutes. 13. The method as claimed in claim 11, wherein said T.sub.max value of less than about 15 minutes. 14. The method as claimed in claim 11, wherein said alkyl glycoside or saccharide ester is present in a concentration of from about 0.05% to about 3.0%. 15. The method as claimed in claim 11, wherein said composition upon nasal administration provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/mL. 16. A method of treating a human suffering from or susceptible to migraine or cluster headache, comprising: intranasal administration of a composition comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-.beta.-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate. 17. The method as claimed in claim 16, wherein said composition provides T.sub.max value of less than 30 minutes. 18. The method as claimed in claim 16, wherein said composition provides T.sub.max value of less than 15 minutes. 19. The method as claimed in claim 16, wherein said alkyl glycoside or saccharide ester is present in a concentration of from about 0.05% to about 3.0%. 20. The method as claimed in claim 16, wherein said alkyl glycoside or saccharide alkyl ester comprises 1-O-n-Dodecyl-.beta.-D-Maltopyranoside. 21. The method as claimed in claim 16, wherein said composition upon nasal administration provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/mL.