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:
a citric acid salt of sumatriptan or a pharmaceutically acceptable solvate thereof,
a pharmaceutically acceptable vehicle, and
a mucosal permeation enhancer selected from the group consisting of 1-O-n-Dodecyl-β-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate,
wherein upon said intranasal administration said pharmaceutical composition provides a T max substantially equivalent to subcutaneous administration of said sumatriptan.
2. The pharmaceutical composition of claim 1 , wherein said mucosal permeation enhancer is present in a concentration of from about 0.05% to about 3.0%.
3. The pharmaceutical composition of claim 1 , wherein said T max ranges from about 4 to about 15 minutes.
4. A method of treating cephalic pain or migraine in a subject in need thereof, said method comprising intranasally administering to said subject the pharmaceutical composition of claim 1 .
5. The method of claim 4 , wherein said T max ranges from about 4 to about 15 minutes.
6. A pharmaceutical composition comprising:
an aqueous buffered solution comprising a citric acid salt of sumatriptan or a physiologically acceptable solvate thereof; and
means for enhancing penetration of a drug via mucosal membrane and effecting a T max upon intranasal administration that is substantially equivalent to subcutaneous administration of the sumatriptan, wherein said means for enhancing penetration of a drug via mucosal membrane comprises alkyl glycoside or saccharide alkyl ester.
7. The pharmaceutical composition of claim 6 , wherein said alkyl glycoside or saccharide alkyl ester is selected from 1-O-n-Dodecyl-β-D-Maltopyranoside, tridecyl maltoside, sucrose monododecanoate, sucrose monotridecanoate, and sucrose monotetradecanoate.
8. The pharmaceutical composition of claim 6 , wherein said alkyl glycoside or saccharide alkyl ester is present in a concentration of from about 0.05% to about 3.0%.
9. The pharmaceutical composition of claim 6 , wherein said pharmaceutical composition provides T max value of less than 30 minutes upon intranasal administration.
10. The pharmaceutical composition of claim 6 , wherein said pharmaceutical composition provides a T max value of less than about 30 minutes.
11. The pharmaceutical composition of claim 6 , wherein said means for enhancing penetration of a drug via mucosal membrane is not a cyclodextrin.