Claims for Patent: 9,610,280

Summary for Patent: 9,610,280

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:	DR. REDDY'S LABORATORIES LIMITED (Hyderabad, IN)
Application Number:	14/925,564
Patent Claims:	1. A method of treating a human suffering from or susceptible to cephalic pain comprising intranasal administration of a composition comprising of an aqueous solution of a citric acid 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. 2. The method as claimed in claim 1, wherein the composition is adjusted to a pH value in the range of about 4 to about 8. 3. The method as claimed in claim 2, wherein the composition is adjusted to a pH value in the range of about 4.2 to about 7.5. 4. The method as claimed in claim 1, wherein the human is suffering from or susceptible to migrane or cluster headache. 5. The method as claimed in claim 1, wherein an alkyl glycoside or saccharide alkyl ester is selected from dodecyl maltoside (1-O-n-Dodecyl-.beta.-D-Maltopyranoside), tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate and sucrose monotetradecanoate. 6. The method as claimed in claim 5, wherein an alkyl glycoside or saccharide alkyl ester is 1-O-n-Dodecyl-.beta.-D-Maltopyranoside. 7. The method as claimed in claim 1, wherein the composition upon nasal administration provides a ratio of C.sub.max to AUC.sub.0-inf of at least about 0.3. 8. The method as claimed in claim 1, wherein the quantity of alkyl glycoside or saccharide alkyl ester is at least about 0.1%. 9. A method of treating a human suffering from or susceptible to cephalic pain comprising intranasal administration of an aqueous solution of a citric acid 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 15 minutes upon said administration. 10. The method as claimed in claim 9, wherein the composition is adjusted to a pH value in the range of about 4 to about 8. 11. The method as claimed in claim 10, wherein the composition is adjusted to a pH value in the range of about 4.2 to about 7.5. 12. The method as claimed in claim 9, wherein an alkyl glycoside or saccharide alkyl ester is selected from dodecyl maltoside (1-O-n-Dodecyl-.beta.-D-Maltopyranoside), tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate and sucrose monotetradecanoate. 13. The method as claimed in claim 12, wherein an alkyl glycoside or saccharide alkyl ester is 1-O-n-Dodecyl-.beta.-D-Maltopyranoside. 14. The method as claimed in claim 9, wherein the composition upon nasal administration provides a ratio of C.sub.max to AUC.sub.0-inf of at least about 0.3. 15. The method as claimed in claim 9, wherein the quantity of alkyl glycoside or saccharide alkyl ester is at least about 0.1%. 16. The method as claimed in claim 9, wherein the human is suffering from or susceptible to migraine or cluster headache.