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 buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-β-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate, and wherein said composition upon intranasal administration provides a T max substantially equivalent to subcutaneous administration of said sumatriptan.
2. The composition as claimed in claim 1 , wherein said composition provides T max value of less than about 30 minutes.
3. The composition 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%.
4. The composition as claimed in claim 1 , wherein said composition provides T max value of less than about 15 minutes.
5. The composition as claimed in claim 1 , wherein said composition upon nasal administration provides AUC 0-2 ranging from about 22 to about 160 ngh/m-L.
6. The composition as claimed in claim 1 , wherein said composition administered intranasally for treating human suffering from or susceptible to cephalic pain.
7. The composition as claimed in claim 6 , wherein said composition administered intranasally for treating human suffering from or susceptible to migraine.
8. The composition as claimed in claim 6 , wherein said composition administered intranasally for treating human suffering from or susceptible to cluster headache.
9. The composition as claimed in claim 1 , wherein said composition comprises 2.5 mg to 25 mg of sumatriptan.
10. The composition as claimed in claim 1 , wherein said composition is contained in a single dose nasal delivery device and administered into one nostril.
11. A method of treating a human suffering from or susceptible to migraine or cluster headache, comprising: intranasal administration of a composition comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-β-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate, and said composition upon intranasal administration provides a T max substantially equivalent to subcutaneous administration of said sumatriptan.
12. The method as claimed in claim 11 , wherein said composition provides T max value of less than about 30 minutes.
13. The method as claimed in claim 11 , wherein said T max value of less than about 15 minutes.
14. The method as claimed in claim 11 , wherein said alkyl glycoside or saccharide ester is present in a concentration of from about 0.05% to about 3.0%.
15. The method as claimed in claim 11 , wherein said composition upon nasal administration provides AUC 0-2 ranging from about 22 to about 160 ngh/mL.
16. A method of treating a human suffering from or susceptible to migraine or cluster headache, comprising: intranasal administration of a composition comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable solvate thereof, citric acid monohydrate; and a mucosal permeation enhancer consisting of an alkyl glycoside or saccharide ester selected from 1-O-n-Dodecyl-β-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate; wherein said composition comprises 1 molar equivalent of sumatriptan and about 0.3 to 0.6 molar equivalent of citric acid monohydrate.
17. The method as claimed in claim 16 , wherein said composition provides T max value of less than 30 minutes.
18. The method as claimed in claim 16 , wherein said composition provides T max value of less than 15 minutes.
19. The method as claimed in claim 16 , wherein said alkyl glycoside or saccharide ester is present in a concentration of from about 0.05% to about 3.0%.
20. The method as claimed in claim 16 , wherein said alkyl glycoside or saccharide alkyl ester comprises 1-O-n-Dodecyl-β-D-Maltopyranoside.
21. The method as claimed in claim 16 , wherein said composition upon nasal administration provides AUC 0-2 ranging from about 22 to about 160 ngh/mL.