Method of rapidly achieving therapeutic concentrations of triptans for treatment of migraines
AssigneeZosano Pharma Corporation
InventorsMahmoud Ameri, Donald Kellerman, Peter E. Daddona, Yi Ao
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Abstract
Compositions, devices and methods employing therapeutic concentrations of a triptan for treatment of migraine are described. Also described are methods and apparatuses for delivery of zolmitriptan for achieving a Tmax as quick as 2 minutes and not later than 30 minutes in the majority of subjects.
Claims4
1-30. (canceled)
An intracutaneous delivery system that is bioequivalent to an intracutaneous delivery system comprising a plurality of microprojections that are adapted to penetrate or pierce the stratum corneum of a human patient, the microprojections having a solid formulation coating disposed thereon, wherein the coating comprises zolmitriptan or a pharmaceutically acceptable salt thereof in an amount of about 1 mg to about 5 mg per system, and wherein at least 95% of the zolmitriptan is released from the system within about 5 minutes when measured by USP Paddle Over Disk Method (Apparatus 5), wherein:
- bioequivalence is established by (a) a 90% Confidence Interval (CI) for AUC which is between 0.80 and 1.25;
- and (b) a 90% CI for Cmax which is between 0.80 and 1.25.
An intracutaneous delivery system that is bioequivalent to an intracutaneous delivery system comprising:
- a. A disposable patch assembly having a plurality of microprojections disposed in an array of about 3 cm2 to about 6 cm2, the array having a density of about 200 to about 2000 microprojections/cm2, the microprojections adapted to penetrate or pierce the stratum corneum of a human patient;
- b. the microprojections having a solid formulation coating disposed thereon, wherein the coating comprises amorphous zolmitriptan or a pharmaceutically acceptable salt thereof in an amount greater than about 0.6 mg/cm2 to less than about 1 mg/cm2;
- c. the microprojections having a width of about 10 μm to about 500 μm and a tip angle of about 30 to about 70 degrees;
- and
- d. wherein at least 95% of the zolmitriptan is released from the system within about 5 minutes when measured by USP Paddle Over Disk Method (Apparatus 5), wherein:
- bioequivalence is established by (a) a 90% Confidence Interval (CI) for AUC which is between 0.80 and 1.25;
- and (b) a 90% CI for Cmax which is between 0.80 and 1.25.
An intracutaneous delivery system that is bioequivalent to an intracutaneous delivery system for the treatment or alleviation of migraine or cluster headache, comprising a plurality of microprojections that are adapted to penetrate or pierce the stratum corneum of a human patient, the microprojections having a solid formulation coating disposed thereon, wherein the coating comprises amorphous zolmitriptan or a pharmaceutically acceptable salt thereof in an amount of about 1 mg to about 5 mg per system, wherein at least 95% of the zolmitriptan is released from the system within about 5 minutes when measured by USP Paddle Over Disk Method (Apparatus 5), and wherein upon application of the system to a selected area of skin of the patient, the Tmax of a therapeutically effective blood plasma concentration occurs within about 45 minutes of the application, the Cmax is about 5 to about 25 ng/ml, and the AUCO-2 hr is about 5 to about 20 ng/ml*hour, wherein:
- bioequivalence is established by (a) a 90% Confidence Interval (CI) for AUC which is between 0.80 and 1.25;
- and (b) a 90% CI for Cmax which is between 0.80 and 1.25.
Dependencies are inferred from the claim text.