To use, a MAT is applied to the skin pushing the
micro-needles through the stratum corneum, the
outermost dead layer of skin, into the viable epidermis.
The MAT is held in place by a traditional adhesive patch.
The micro-needle array dissolves into the interstitial
fluids that bathe the viable epidermis, thereby delivering
the drug or vaccine.
TheraJect micro-needles do not penetrate deeply enough to impinge on
the capillaries or nerves in the dermis layer like syringes; therefore, the
procedure is both blood-free and pain-free.
DrugMAT uses a transdermal patch with an array of micro-needles
formulated to contain drug or vaccine. DrugMAT components are selected
from a broad range of dissolving materials, many of which are FDA GRAS
(Generally Regarded As Safe). Drugs or vaccines to be delivered are
mixed with the materials before the needles are formed or are coated
onto the MATs after needle formation.
MATs are fabricated in an ambient temperature process that results in
hard, sharp drug micro-needles about 0.5 mm in length (a length which
has not yet been optimized but which is easy to modify). The materials
used to create DrugMATs and VaxMATs are inexpensive, readily available,
safe and stable. The manufacturing processes and equipment are
simple and amenable to scale-up, improvement, and broad
commercialization.
Because some patients may not be dexterous enough to fully insert the
DrugMAT micro-needles into the skin, an applicator device has been
prototyped and is under development.
The passage of the micro-needle array into the epidermis, followed by the
dissolving of the array, creates micro-channels through the stratum
corneum. These micro-channels allow further drug delivery from a
reservoir in the DrugMAT patch. The rate of delivery, fast versus slow
dissolving, can be controlled by the formulation of the needle materials,
and the design of the patch.
TheraJectMAT and VaxMAT are novel, unique
technologies, protected by issued and pending
patents.