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 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 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-β-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-β-D-Maltopyranoside.
7. The method as claimed in claim 1 , wherein the composition upon nasal administration provides a ratio of C max to AUC 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 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-β-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-β-D-Maltopyranoside.
14. The method as claimed in claim 9 , wherein the composition upon nasal administration provides a ratio of C max to AUC 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.