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EP-4098313-B1 - MICRONEEDLE PATCH

EP4098313B1EP 4098313 B1EP4098313 B1EP 4098313B1EP-4098313-B1

Inventors

  • MCALLISTER, DEVIN
  • PRAUSNITZ, MARK
  • HENRY, SEBASTIAN
  • NORMAN, JAMES J.

Dates

Publication Date
20260506
Application Date
20140930

Claims (12)

  1. A microneedle patch (200) for administration of a substance of interest into a biological tissue, the microneedle patch comprising: a base substrate (216) having a microneedle side and an opposing back side; solid microneedles (214) extending from the microneedle side of the base substrate (216), the solid microneedles (214) being formed of a composition which comprises (i) a substance of interest selected from active pharmaceutical ingredients, allergens, vitamins, cosmetic agents, cosmeceuticals, and markers, and (ii) a water soluble matrix material in which the substance of interest is dispersed; characterized in that the microneedle patch further comprises: an indicator (222, 300) connected to the opposing back side of the base substrate (216) , wherein the indicator (222, 300) is configured to provide an audible, tactile, and visual signal when a manual force applied to the patch by a user, in the course of applying the patch (200) to a biological tissue to insert the solid microneedles (214) into the biological tissue, meets or exceeds a predetermined threshold.
  2. The microneedle patch of claim 1, further comprising: a handle layer (210) affixed to the base substrate (216) and including an elongated tab portion (212) extending laterally away from one side of the solid microneedles (214), the tab portion (212) being configured for manual manipulation of the patch; and an adhesive layer (218) disposed between and securing together the base substrate (216) and the handle layer (210), wherein the adhesive layer (218) optionally extends beyond the base substrate (216) and is configured to adhere the patch (200) to the biological tissue and/or to a storage tray.
  3. The microneedle patch of claim 2, further comprising a tray having a recessed region dimensioned to receive in a non-contacting manner the microneedles (214), with the adhesive layer (218) releasably secured to an upper surface region of the tray, wherein, optionally, the tray has a partial ellipsoidal shape and part of the tab portion (212) extends beyond a perimeter of the tray.
  4. The microneedle patch of claim 1, further comprising: a handle layer (210) affixed to the base substrate (216) and including an elongated tab portion (212) extending laterally away from the solid microneedles (214), the tab portion (212) being configured for manual manipulation of the patch (200); and an adhesive layer (218) which comprises (i) a first adhesive composition disposed between and securing together the base substrate (216) and the handle layer (210), and (ii) a second adhesive composition disposed on the handle layer (210) beyond the base substrate (216) and configured to releasably secure the patch (200) to the biological tissue, wherein, optionally, the first adhesive composition has a coefficient of adhesion between the base substrate (216) and the handle layer (210) that is greater than the coefficient of adhesion of the second adhesive composition between the handle layer (210) and a patient's skin.
  5. The microneedle patch of claim 1, wherein the indicator (222, 300) is a mechanical force indicator which comprises a button that displaced when the force applied to the patch meets or exceeds the predetermined threshold.
  6. The microneedle patch of claim 5, wherein the mechanical force indicator (222, 300) is integrated with another component, which optionally comprises a latch, such that the displacement is irreversible when the force applied to the patch meets or exceeds the predetermined threshold, wherein the mechanical force indicator (222, 300) is in line with and generally centered about the solid microneedles (214) on the opposing back side of the base substrate (216), wherein the mechanical force indicator (222, 300) has: an initial configuration before providing the audible, tactile, and 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 visual signal, and wherein the mechanical force indicator (222, 300) changes from the initial configuration to the signaling configuration upon receiving a force which meets or exceeds the predetermined threshold and is irreversible upon removal of the force which meets or exceeds the predetermined threshold.
  7. The microneedle patch of any one of claims 1 to 6, wherein the substance of interest comprises an active pharmaceutical ingredient.
  8. The microneedle patch of any one of claims 1 to 6, wherein the substance of interest comprises a vaccine.
  9. The microneedle patch of any one of claims 1 to 8, wherein the matrix material is dissolvable in vivo, such that the entire portion of the microneedle (214) inserted into the biological tissue dissolves in vivo.
  10. The microneedle patch of any one of claims 1 to 9, wherein the solid microneedles (214) have a height from about 100 µm to about 2000 µm.
  11. The microneedle patch of any one of claims 1 to 10, which is configured to administer the substance of interest to a patient's skin by: grasping a tab portion of the microneedle patch (200) between a thumb and finger; applying the microneedle patch (200) to the patient's skin; pressing the microneedle patch (200) with a finger, thumb, or heel of hand, to apply a pressure sufficient to insert the microneedles (214) into the patient' s skin; and removing the microneedle patch (200) from the patient's skin by grasping the tab portion (212) of the microneedle patch (200) between the thumb and finger.
  12. The microneedle patch of claim 1, wherein the indicator (222, 300) is a mechanical force indicator in which the microneedles (214) will penetrate a patient's skin before the mechanical force indicator (222, 300) changes to its signaling configuration.

Description

Background The present application is in the field of microneedle patches for the transport of therapeutic or biological molecules into the skin or across tissue barriers. Transdermal drug delivery provides several advantages over other routes for administering a drug formulation to a patient. One method for transdermal drug delivery involves using microneedle arrays to bypass the barrier properties of the stratum corneum. Although microneedle arrays were first reported over 15 years ago, numerous obstacles have prolonged the development of microneedle arrays and delayed its commercialization. For example, the small size of the microneedles makes verifying effective administration of the therapeutic agents difficult. Many groups have looked to use of applicators and other types of special insertion devices that are used to apply a pre-set force that will ensure that the microneedles penetrate the stratum corneum. These applicators and other insertion devices, however, can be cumbersome to use and unnecessarily increase the cost of using the microneedle arrays. For example, most microneedle systems under development either have separate, complex applicators or integrated applicators. The separate, complex applicators are used to handle and apply microneedle patches to the patients and can be burdensome to the user, bulky, costly for single use applications, and/or non-ideal for multi-person administration (e.g., mass vaccinations) due to cross-contamination issues. The integrated applicators are integrated into the microneedle devices themselves and become wearable systems that must be worn for the duration of the required wear time, which adds an undesirable level of 3-dimensionality to a wearable patch/device. Other problems that have been difficult to overcome have included the scale-up of consistent and reliable methods of manufacture of microneedle arrays, development of highly concentrated and stable therapeutic agents that can be effectively administered using microneedle arrays, and cost effective systems for protecting the microneedles after manufacture until their use. Devices comprising microneedles for administering substances into biological tissues are known, for example, from US2011/121486 A1, US2007/088248 A1, and US 2008/183144 A1. Thus, there remains a need for simple, effective, and economically desirable devices for transdermal administration of a variety of drug types to a patient. Summary Improved microneedle patches have been developed which address one or more of the above-described needs. A microneedle patch according to claim 1, for administration of an active pharmaceutical ingredient (API) or other substance of interest into a biological tissue is provided by the present invention. Preferred embodiments are set forth in the dependent claims. Associated methods of use, storing, transporting and administering a substance of interest into a biological tissue are also described herein to aid understanding the invention. These methods do not form part of the claimed invention. Also, a system for storing and transporting one or more microneedle patches is described. The system includes one or more microneedle patches and a tray with an upper surface region surrounding one or more recessed regions. Each of the one or more recessed regions is dimensioned to receive in a non-contacting manner the one or more solid microneedles of a corresponding microneedle patch, with a portion of the adhesive layer of the microneedle patch being releasably secured to the upper surface region of the tray. Methods for administering an API or other substance of interest to a patient with a microneedle patch are also described (not part of the present invention). The methods include removing the microneedle patch from a tray in which the microneedle patch is releasably secured by manually grasping a tab portion of the microneedle patch, e.g., between the thumb and finger; applying the microneedle patch to a patient's skin; manually pressing the microneedle patch, e.g., with a finger, thumb, or heel of hand, to apply a pressure sufficient to insert the one or more microneedles into the patient's skin, and removing the microneedle patch from the patient's skin by grasping the tab portion of the microneedle patch between the thumb and finger. Similar steps could also be used to apply the patch to a biological tissue other than the skin. Additional aspects will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the aspects described below. The advantages described below will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive. Brief Description of the Drawings FIGS. 1A, 1B, and 1C are cross-sectional v