Microneedle patch storage systems
Microneedle patches and systems, and methods for use of such patches and systems are disclosed. In one aspect, a microneedle patch is provided including a tab portion for handling the microneedle patch. In another aspect, a system is provided including a microneedle patch and a tray for housing the microneedle patch. In still another aspect, various indicators providing for providing feedback prior to, during, and after administration of the microneedle patch are provided. Advantageously, the described microneedle patches and systems provide improved handling and ease of application of the microneedle patches to skin for the delivery of therapeutic agents.
1 . A system for storing and transporting a microneedle patch, the system comprising:
(i) a microneedle patch comprising:
a base substrate;
an array of microneedles extending from the base substrate, the microneedles which comprises a substance of interest in a dry solid form; and
a handle layer affixed to the base substrate and comprising a tab portion which extends laterally away from the microneedles and permits a person to manually hold the tab portion to manipulate the patch without contacting the microneedles; and
(ii) a tray comprising an upper surface region surrounding one or more recessed regions, wherein each of the one or more recessed regions is dimensioned to receive in a non-contacting manner the array of microneedles of the microneedle patch,
wherein at least a portion of an adhesive layer releasably secures the microneedle patch to the upper surface region of the tray.
2 . The system of claim 1 , wherein at least part of the tab portion extends beyond a perimeter of the tray.
3 . The system of claim 1 , wherein the tray includes a line of weakness in the form of perforations or a score line.
4 . The system of claim 1 , wherein the tray comprises a rigid or semi-rigid thermoplastic material.
5 . The system of claim 1 , wherein the handle layer is constructed of a material that is different from a material of construction of the tab portion.
6 . The system of claim 5 , wherein the handle layer comprises a flexible polymer.
7 . The system of claim 1 , wherein the substance of interest comprises a vaccine or other active pharmaceutical ingredient.
8 . The system of claim 1 , wherein the microneedles are dissolvable microneedles and the composition further comprises a water-soluble matrix material in which the substance of interest is dispersed.
9 . The system of claim 8 , wherein the water-soluble matrix material comprises carboxymethylcellulose sodium, polyvinyl alcohol, and/or a sugar.
10 . The system of claim 1 , wherein the adhesive layer has a coefficient of adhesion between the base substrate and the handle layer that is greater than the coefficient of adhesion between the handle layer a patient's skin.
11 . The system of claim 1 , further comprising an indicator connected to the base substrate, wherein the indicator is configured to provide audible, tactile, and/or visual signals when a force applied to the patch by a user, in the course of manually applying the patch to a person's skin to insert the microneedles into the skin, meets or exceeds a predetermined threshold.
12 . The system of claim 1 , wherein the adhesive layer is disposed between and secures together the base substrate and the handle layer.
13 . A system for storing and transporting a microneedle patch, the system comprising:
(i) a microneedle patch comprising:
a base substrate having a microneedle side and an opposing back side;
an array of microneedles extending from the microneedle side of the base substrate, the microneedles being formed by molding a composition which comprises a substance of interest selected from active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, and markers, wherein the substance of interest is in a dry solid form; and
a handle layer affixed to the base substrate and comprising a tab portion which extends laterally away from the microneedles and permits a person to manually hold the tab portion to manipulate the patch without contacting the microneedles; and
(ii) a tray comprising at least one recessed region dimensioned to receive in a non-contacting manner the array of microneedles of the microneedle patch,
wherein the microneedle patch is releasably secured to the tray.
14 . The system of claim 13 , wherein the tray comprises a rigid or semi-rigid thermoplastic material.
15 . The system of claim 13 , wherein the material of construction of the handle layer is different from the material of construction of the tab portion.
16 . The system of claim 13 , wherein the handle layer comprises a flexible polymer.
17 . The system of claim 13 , wherein at least part of the tab portion extends beyond a perimeter of the tray.
18 . The system of claim 13 , wherein the tray includes a line of weakness in the form of perforations or a score line.
19 . The system of claim 13 , comprising an adhesive layer disposed between and securing together the base substrate and the handle layer.
20 . The system of claim 19 , wherein a portion of the adhesive layer of the microneedle patch is releasably secured to the tray.