Microneedle patches and methods

A microneedle patch comprising:

• a base substrate having a microneedle side and an opposing back side;
• an array of solid microneedles extending from the microneedle side of the base substrate, the solid microneedles being formed of a composition which comprises an active pharmaceutical ingredient, and a water-soluble matrix material in which the active pharmaceutical ingredient is dispersed;
• an indicator connected to the opposing back side of the base substrate, wherein the indicator is configured to provide an audible, tactile, and visual signal when a force applied to the patch by a user, in the course of applying the patch to a biological tissue to insert the solid microneedles into the biological tissue, meets or exceeds a predetermined threshold;
• a handle layer affixed to the base substrate and including an elongated tab portion extending laterally away from one side of the solid microneedles, the tab portion being configured for manual manipulation of the patch;
• and
• an adhesive layer disposed between and securing together the base substrate and the handle layer.

A microneedle patch for administration of a substance of interest into a biological tissue, the microneedle patch comprising:

• a base substrate having a microneedle side and an opposing back side;
• solid microneedles extending from the microneedle side of the base substrate, the solid microneedles being formed of or coated with a composition which comprises a substance of interest selected from active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, and markers;
• and
• an indicator which comprises:
• an indicator housing affixed to the opposing backside, and
• a mechanical force indicator disposed inside the housing and configured to provide an audible, tactile, and visual signal when a force applied to the patch by a user, in the course of applying the patch to a biological tissue to insert the solid microneedles into the biological tissue, meets or exceeds a predetermined threshold,
• wherein the mechanical force indicator is in line with and generally centered about the solid microneedles on the opposing back side of the base substrate,
• wherein the mechanical force indicator has:
• an initial configuration before providing the audible, tactile, and/or visual signal, and
• a signaling configuration which differs from the initial configuration and which provides, or which the transition thereto provides, the audible, tactile, and/or visual signal, and
• wherein the mechanical force indicator changes from the initial configuration to the signaling configuration upon receiving a force which meets or exceeds the predetermined threshold, and wherein the change from the initial configuration to the signaling configuration is irreversible upon removal of the force which meets or exceeds the predetermined threshold.

A microneedle patch for administration of a therapeutic or prophylactic agent into a patient's skin, the microneedle patch comprising:

• a base substrate having a microneedle side and an opposing back side;
• dissolvable microneedles extending from the microneedle side of the base substrate, the dissolvable microneedles being formed of a composition comprising a water-soluble matrix material in which the therapeutic or prophylactic agent is dispersed;
• a snap dome which is connected to the opposing back side of the base substrate and which is configured to deform when a force applied to the patch by a user, in the course of applying the patch to the skin to insert the dissolvable microneedles into the skin, meets or exceeds a predetermined threshold, to produce an audible, tactile, and visual signal indicative, to the user, of insertion of the dissolvable microneedles into the skin;
• a handle layer affixed to the base substrate and including an elongated tab portion extending laterally away from one side of the dissolvable microneedles, the tab portion being configured for manual manipulation of the patch;
• and
• an adhesive layer disposed between and securing together the base substrate and the handle layer,
• wherein the adhesive layer extends beyond the base substrate and is configured to adhere the patch to the skin and/or to a storage tray.

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 solid microneedles being formed of a composition which comprises (i) a therapeutic or prophylactic agent, and (ii) a matrix material in which the substance of interest is dispersed;
• a mechanical force indicator attached to the opposing back side of the base substrate, the mechanical force indicator being configured to provide audible, tactile, and visual indications when a force has been applied to the patch that meets or exceeds a predetermined threshold;
• and
• a handle layer affixed to the base substrate and including an elongated tab portion extending laterally away from the solid microneedles, the tab portion being configured for manual manipulation of the patch, wherein the mechanical force indicator comprises a button that is irreversibly displaced when the force applied to the patch meets or exceeds the predetermined threshold.