Claims for Patent: 9,211,282

Summary for Patent: 9,211,282

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 LTD. (Hyderabad, IN)
Application Number:	12/817,740
Patent Claims:	1. A pharmaceutical composition for intranasal administration comprising 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 composition 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 composition as claimed in claim 1, wherein the composition is adjusted to a pH value in the range of about 4.5 to about 7.5. 4. The composition 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. 5. The composition as claimed in claim 4, wherein an alkyl glycoside or saccharide alkyl ester is 1-O-n-Dodecyl-.beta.-D-Maltopyranoside. 6. The composition as claimed in claim 1, wherein the composition is adjusted to a pH value in the range of about 5 to about 6. 7. The composition as claimed in claim 6, wherein the composition upon nasal administration provides T.sub.max value of less than or equal to 15 minutes. 8. The composition as claimed in claim 6, wherein the composition upon nasal administration provides a ratio of C.sub.max to AUC.sub.0-inf of at least about 0.3. 9. The composition as claimed in claim 1, wherein the quantity of alkyl glycoside or sachharide alkyl ester is at least about 0.1%. 10. The composition as claimed in claim 6, wherein the quantity of alkyl glycoside or sachharide alkyl ester is at least about 0.1%. 11. A pharmaceutical composition comprising an aqueous solution of a citrate salt of sumatriptan or a physiologically acceptable solvate thereof, an alkylglycoside or saccharide alkyl ester, and optionally at least one pharmaceutically acceptable excipient wherein the composition upon intranasal administration provides a T.sub.max value of less than or equal 15 minutes. 12. The composition as claimed in claim 11, 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 pharmaceutical composition of claim 1, which provides AUC.sub.0-2 ranging from about 22 to about 160 ngh/mL. 14. The pharmaceutical composition of claim 1, which provides AUC.sub.0-6 ranging from about 25 to about 160 ngh/mL. 15. The pharmaceutical composition as claimed in claim 1, wherein C.sub.max ranges from about 14 to about 214 ng/mL. 16. A method of treating a human suffering from or susceptible to cephalic pain which comprises intranasal administration of citrate salt of sumatriptan or a physiologically acceptable solvate thereof, an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient. 17. The method as claimed in claim 16, wherein the composition is adjusted to a pH value in the range of about 4 to about 8. 18. The method as claimed in claim 16, wherein the composition is adjusted to a pH value in the range of about 4.5 to about 6.5. 19. The method as claimed in claim 16, wherein the composition is adjusted to a pH value in the range of about 5 to about 6. 20. The method as claimed in claim 16, where in the composition is administered in the form of aqueous solution. 21. The method as claimed in claim 16, wherein a human suffering from or susceptible to migraine.