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 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 T max substantially equivalent to subcutaneous administration of said sumatriptan.
2. The method as claimed in claim 1 , wherein said composition provides T max value of less than 30 minutes.
3. The method as claimed in claim 1 , wherein said composition provides T max 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 C max to AUC 0-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 AUC 0-2 ranging from about 22 to about 160 ngh/mL.
10. The method as claimed in claim 1 , wherein said composition upon nasal administration provides AUC 0-6 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 T max value of less than or equal 15 minutes.
13. The method as claimed in claim 12 , wherein said composition provides a T max substantially equivalent to subcutaneous administration of said sumatriptan.
14. The method as claimed in claim 12 , wherein said composition upon nasal administration provides AUC 0-2 ranging from about 22 to about 160 ngh/mL.
15. The method as claimed in claim 12 , wherein said composition upon nasal administration provides AUC 0-6 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 C max to AUC 0-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.