Claims for Patent: 9,974,770

Summary for Patent: 9,974,770

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, Dr Reddys Laboratories Ltd
Application Number:	US15/434,814
Patent Claims:	1. A method of treating a human suffering from or susceptible to cephalic pain comprising intranasal administration of a composition comprising citric acid salt of sumatriptan, or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide ester and optionally a pharmaceutically acceptable excipient, wherein, said composition provides a Tmax substantially equivalent to subcutaneous administration of said sumatriptan. 2. The method as claimed in claim 1, wherein said composition provides Tmax value of less than 30 minutes. 3. The method as claimed in claim 1, wherein said composition provides Tmax value ranging from about 4 minutes to about 15 minutes. 4. The method as claimed in claim 1, wherein said alkyl glycoside or saccharide alkyl ester is selected from dodecyl maltoside (1-O-n Dodecyl-β-D-Maltopyranoside), tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate and sucrose monotetradecanoate. 5. The method as claimed in claim 4, wherein said alkyl glycoside or saccharide alkyl ester is dodecyl maltoside (1-O-n-Dodecyl-β-D-Maltopyranoside). 6. The method as claimed in claim 1, wherein said composition upon nasal administration provides a ratio of Cmax to AUC0-inf of at least about 0.3. 7. The method 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%. 8. The method as claimed in claim 7, wherein said alkyl glycoside or saccharide alkyl ester is present in a concentration of at least about 0.1%. 9. The method as claimed in claim 1, wherein said composition upon nasal administration provides AUC0-2 ranging from about 22 to about 160 ngh/mL. 10. The method as claimed in claim 1, wherein said composition upon nasal administration provides AUC0-6 ranging from about 25 to about 160 ngh/mL. 11. The method as claimed in claim 1, wherein said human is suffering from or susceptible to migraine or cluster headache. 12. A method of treating a human suffering from or susceptible to cephalic pain comprising intranasal administration of composition comprising citric acid salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally a pharmaceutically acceptable excipient, wherein said composition a Tmax value of less than or equal 15 minutes. 13. The method as claimed in claim 12, wherein said composition provides a Tmax substantially equivalent to subcutaneous administration of said sumatriptan. 14. The method as claimed in claim 12, wherein said composition upon nasal administration provides AUC0-2 ranging from about 22 to about 160 ngh/mL. 15. The method as claimed in claim 12, wherein said composition upon nasal administration provides AUC0-6 ranging from about 25 to about 160 ngh/mL. 16. The method as claimed in claim 12, wherein said composition upon nasal administration provides a ratio of Cmax to AUC0-inf of at least about 0.3. 17. The method as claimed in claim 12, wherein said alkyl glycoside or saccharide alkyl ester is selected from dodecyl maltoside (1-O-n-Dodecyl-β-D-Maltopyranoside), tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate and sucrose monotetradecanoate. 18. The method as claimed in claim 12, wherein said alkyl glycoside or saccharide alkyl ester is present in a concentration of from about 0.05 to about 3.0%. 19. The method as claimed in claim 17, wherein said alkyl glycoside or saccharide alkyl ester is present in a concentration of at least about 0.1%. 20. The method as claimed in claim 12, wherein said human is suffering from or susceptible to migraine or cluster headache.