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 pharmaceutically acceptable salt or solvate thereof, wherein the solution comprises:
10 mg sumatriptan;
citric acid monohydrate;
1-O-n-Dodecyl-β-D-Maltopyranoside;
a pH of about 5.0 to 6.0; and
optionally at least one pharmaceutically acceptable excipient,
wherein upon intranasal administration, the pharmaceutical composition provides a C max ranging from about 14 ng/mL to about 214 ng/ml.
2. The pharmaceutical composition of claim 1 , wherein the 1-O-n-Dodecyl-β-D-Maltopyranoside is present in the solution in a concentration range of about 0.05% to about 3.0%.
3. The pharmaceutical composition of claim 1 , wherein the solution comprises 1 molar equivalent of the sumatriptan and about 0.3 to 0.6 molar equivalent of the citric acid monohydrate.
4. The pharmaceutical composition of claim 1 , wherein upon intranasal administration of the pharmaceutical composition, the pharmaceutical composition provides a T max substantially equivalent to subcutaneous administration of sumatriptan.
5. The pharmaceutical composition of claim 1 , wherein the T max ranges from about 4 to about 15 minutes.
6. A method of treating migraine in a subject in need thereof, the method comprising:
intranasally administering a pharmaceutical composition comprising:
an aqueous buffered solution comprising sumatriptan or a pharmaceutically acceptable salt or solvate thereof, wherein the solution comprises:
10 mg sumatriptan;
citric acid monohydrate;
1-O-n-Dodecyl-β-D-Maltopyranoside;
a pH about 5.0 to 6.0; and
optionally at least one pharmaceutically acceptable excipient,
wherein the intranasal administration results in a C max ranging from about 14 ng/mL to about 214 ng/mL.
7. The method of claim 6 , wherein the 1-O-n-Dodecyl-β-D-Maltopyranoside is present in the solution in a concentration range of about 0.05% to about 3.0%.
8. The method of claim 6 , wherein the solution comprises 1 molar equivalent of the sumatriptan and about 0.3 to 0.6 molar equivalent of the citric acid monohydrate.
9. The method of claim 6 , wherein the T max ranges from about 4 to about 15 minutes.
10. The method of claim 6 , wherein the intranasally administering results in a T max substantially equivalent to subcutaneous administration of sumatriptan.
11. The method of claim 6 , wherein the pharmaceutical composition is administered 1 to 3 times per day.
12. An intranasal delivery system comprising:
a delivery device; and
a pharmaceutical composition for intranasal administration comprising an aqueous buffered solution comprising sumatriptan or a physiologically acceptable salt or solvate thereof, wherein the solution comprises:
10 mg of sumatriptan;
citric acid monohydrate;
1-O-n-Dodecyl-β-D-Maltopyranoside;
a pH of about 5.0 to 6.0; and
optionally at least one pharmaceutically acceptable excipient,
wherein the pharmaceutical composition provides a C max ranging from about 14 ng/ml to about 214 ng/mL.
13. The intranasal delivery system of claim 12 , wherein the delivery device comprises a dropper, a pipette, a spray device, or a pressurized metered dose inhaler.