Triptan microporation delivery system

Inventors

Adachi, Hirotoshi • Horie, Shohei • Hanatani, Akinori • Nishimura, Masato • Yamada, Yuki • Hua, Joe

Assignees

Passport Technologies Inc

Abstract

A transdermal delivery system for delivery of a triptan into a tissue membrane of a subject. The system includes a transdermal microporation apparatus for heating a skin surface and a triptan drug delivery patch. The drug delivery patch comprises a top layer comprising an adhesive, a middle layer comprising the triptan, and a bottom layer. A method for treating a subject comprises identifying a subject having a migraine, using the transdermal microporation apparatus to open a plurality of micropores in the skin of the subject, and applying the triptan drug delivery patch to the subject's skin over the micropores for a period of time effective to deliver the triptan through the micropores in an amount effective to treat the subject's migraine.

Core Innovation

The invention relates to treating a subject with a migraine by opening a plurality of micropores in the subject’s skin and delivering a therapeutically effective amount of a triptan through the plurality of micropores. The delivery is performed by applying a patch to the subject’s skin over the plurality of micropores for a period of time, such that the triptan is delivered through the micropores during that period of time. The patch includes a top layer comprising an adhesive, a middle layer comprising a triptan and a skin irritation reducer, and a bottom layer comprising a release liner.

The disclosed patch system includes a middle layer formulated to include both the triptan and a skin irritation reducer. The skin irritation reducer is specified as an organic acid or a salt of an organic acid, and dependent claim language further defines a molar ratio between the triptan and the skin irritation reducer. The disclosure also constrains a stabilizer in the patch middle layer, including an amount range for the stabilizer.

The disclosed approach also encompasses a transdermal drug delivery patch system that combines a microporation apparatus with the triptan drug delivery patch. The microporation apparatus is described as enabling opening micropores in skin, and dependent claim language further narrows the microporation mechanism through a thermal tissue ablation structure with a filament array and through constraints on poration energy, filament density, and micropore area. Additional constraints describe selecting triptan actives among sumatriptan, rizatriptan, and zolmitriptan, and configuring a microporation apparatus with a conductive member and a power supply that provides current pulses.

Claims Coverage

The partial content includes three independent claims: one method claim for treating migraine, one system claim for a transdermal patch system, and one method claim for delivering a triptan drug. Across these claims, the coverage centers on opening micropores in skin and delivering a therapeutically effective amount of a triptan through those micropores using a multilayer triptan patch, with additional inventive features directed to patch layer composition and microporation apparatus configuration.

Across the independent claims, the core claim coverage requires opening a plurality of micropores in the subject’s skin and applying a multilayer triptan patch over the micropores for a period of time, where the patch has an adhesive top layer, a middle layer with a triptan and a skin irritation reducer, and a release liner bottom layer. The system claim further ties this patch to a microporation apparatus, while dependent claim language adds constraints on microporation hardware and operation and on formulations, ratios, and component identities for the triptan and the skin irritation reducer.

Stated Advantages

Documented Applications