Formulations comprising triptan compounds
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 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 max substantially equivalent to subcutaneous administration of said triptan. Other aspects and embodiments are contemplated and described.
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 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-β-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-β-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 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 max to AUC 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 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-β-D-Maltopyranoside), tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate and sucrose monotetradecanoate.
13. The pharmaceutical composition of claim 1 , which provides AUC 0-2 ranging from about 22 to about 160 ng·h/mL.
14. The pharmaceutical composition of claim 1 , which provides AUC 0-6 ranging from about 25 to about 160 ng·h/mL.
15. The pharmaceutical composition as claimed in claim 1 , wherein C 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.