Abstract: Drug delivery devices and methods are provided for delivering one or more drugs into a biological tissue. The devices include microneedles that may be separable from the drug delivery devices, control drug release rate and/or direction, or a combination thereof. When the microneedles are separable, a force applied to the drug delivery devices may be effective to penetrate a biological tissue with the microneedles and then to separate the microneedles from the drug delivery devices. The drug delivery devices may be capable of achieving discrete periods of drug release. Methods for delivery drug with microneedles also are provided.

Abstract: A method for targeting epidermal delivery of an agent of interest is provided, where the method includes inserting at least one microneedle into the skin of a patient at a non-perpendicular angle, the at least one microneedle having the agent of interest. The at least one microneedle may be inserted into the skin of a patient using a system including the at least one microneedle and an angled insertion apparatus.

Abstract: Drug delivery devices and methods are provided for delivering one or more drugs into a biological tissue. The devices include microneedles that may be separable from the drug delivery devices, control drug release rate and/or direction, or a combination thereof. When the microneedles are separable, a force applied to the drug delivery devices may be effective to penetrate a biological tissue with the microneedles and then to separate the microneedles from the drug delivery devices. The drug delivery devices may be capable of achieving discrete periods of drug release. Methods for delivery drug with microneedles also are provided.

Abstract: The present disclosure provides methods for administering formulations to the suprachoroidal space of the eye to achieve targeted drug delivery to a desired site of action within the eye. The methods include using a pushing formulation that includes a material such as a gel that expands due to physiochemical cues; or using an electric field to affect the movement of a formulation within the suprachoroidal space; or a combination of a pushing formulation with an electric field.

Abstract: Provided herein are microneedle particles, compositions that include microneedle particles, methods of treating skin, and methods of delivering a substance of interest. The microneedle particles may include one or more microneedles, and the microneedle particles may be configured to prevent the entire microneedle particle from penetrating the biological tissue. The microneedle particles may be dispersed in a liquid medium to form a composition. A biological tissue may be contacted with the microneedle particles to pre-treat the biological tissue, and a substance of interest may be applied to the pre-treated biological tissue.

Abstract: Methods and devices are provided for sweat inducement, which is useful in diagnostics, such as diagnosis of cystic fibrosis in a patient. The method includes applying a microneedle patch, which comprises microneedles which comprise pilocarpine or another sweat-inducing agent, to the skin of the patient effective to cause the microneedles to penetrate across the epidermis and into the dermis releasing the pilocarpine or another sweat-inducing agent into the skin in an amount effective to induce secretion of sweat from the skin. The secreted sweat can be collected and analyzed, for example by measuring chloride concentration in the sweat, which may be indicative of cystic fibrosis.

Abstract: A microneedle array is provided for administrating a drug or other substance into a biological tissue. The array includes a base substrate; a primary funnel portion extending from one side of the base substrate; and two or more solid microneedles extending from the primary funnel portion, wherein the two or more microneedles comprise the substance of interest. Methods for making an array of microneedles are also provided. The method may include providing a non-porous and gas-permeable mold having a two or more cavities each of which defines a microneedle; filling the cavities with a fluid material which includes a substance of interest and a liquid vehicle; drying the fluid material to remove at least a portion of the liquid vehicle and form a plurality of microneedles that include the substance of interest, wherein the filling is conducted with a pressure differential applied between opposed surfaces of the mold.

Abstract: Separable microneedle arrays and microneedle patches are provided that may achieve sustained release of drug. The microneedle arrays may include one or more features that facilitate separation of the microneedles, such as a bubble structure. The microneedle arrays may include an effervescent material.

Abstract: Separable microneedle arrays and microneedle patches are provided that may achieve sustained release of drug. The microneedle arrays may include one or more features that facilitate separation of the microneedles, such as a bubble structure. The microneedle arrays may include an effervescent material.

Abstract: A microneedle array is provided for administrating a drug or other substance into a biological tissue. The array includes a base substrate; a primary funnel portion extending from one side of the base substrate; and two or more solid microneedles extending from the primary funnel portion, wherein the two or more microneedles comprise the substance of interest. Methods for making an array of microneedles are also provided. The method may include providing a non-porous and gas-permeable mold having a two or more cavities each of which defines a microneedle; filling the cavities with a fluid material which includes a substance of interest and a liquid vehicle; drying the fluid material to remove at least a portion of the liquid vehicle and form a plurality of microneedles that include the substance of interest, wherein the filling is conducted with a pressure differential applied between opposed surfaces of the mold.

Abstract: Microneedle patches and systems, and methods for use of such patches and systems. 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.

Abstract: Methods and compositions are provided for reducing intraocular pressure, for example in the treatment of glaucoma or ocular hypertension. The method includes introducing into a suprachoroidal space of an eye of the patient a composition effective to maintain a reduction in IOP for at least 30 days. The composition may include a cross-linked hydrogel or a material configured to crosslink or further crosslink in vivo.

Abstract: Devices and methods are provided for administering a drug to a biological tissue in a patient, such as by intracellular and/or dermal delivery. The device includes a piezoelectric pulse generator; and an array of microneedle electrodes electrically coupled to the piezoelectric pulse generator, wherein the device, following insertion of the microneedle electrodes into the biological tissue, is configured to generate and deliver one or more electrical pulses through the microneedle electrodes effective to electroporate cells in the biological tissue and enable delivery of a drug into the electroporated cells.

Abstract: Provided herein are fluid formulations for administration to a suprachoroidal space of an eye of a patient. The fluid formulations may include a pharmaceutical agent, a binding molecule, or a combination thereof. The pharmaceutical agent and the binding molecule may be bonded to each other covalently, non-covalently, or a combination thereof. The pharmaceutical agent may be configured to bond to an ocular tissue. The binding molecule may be configured to bond to an ocular tissue. Methods of administering the fluid formulations, methods of expanding a suprachoroidal space, and methods of reducing the minimum force to separate the sclera and choroid are provided.

Abstract: Microneedle patches and systems, and methods for use of such patches and systems. 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.

Abstract: Methods are provided that involve the intentional and controlled precipitation of a drug or active agent, or a reduction of solubility of a polymer or other film-forming component of a formulation, or a combination of both methods, to improve the processes for making microneedles or other objects by casting into molds and the resulting parts produced by casting. The selective reduction in solubility of formulation components solves many problems associated with the casting of polymer formulations into molds. The methods are preferably adapted for making microneedles of biodegradable polymer and drug composites, and may also be used to produce other solid objects formed by casting into molds of compositions containing polymers and active agents.

Abstract: Provided herein are fluid formulations for administration to a suprachoroidal space of an eye of a patient. The fluid formulations may include a pharmaceutical agent, a binding molecule, or a combination thereof. The pharmaceutical agent and the binding molecule may be bonded to each other covalently, non-covalently, or a combination thereof. The pharmaceutical agent may be configured to bond to an ocular tissue. The binding molecule may be configured to bond to an ocular tissue. Methods of administering the fluid formulations, methods of expanding a suprachoroidal space, and methods of reducing the minimum force to separate the sclera and choroid are provided.

Abstract: Provided herein are microneedle particles, compositions that include microneedle particles, methods of treating skin, and methods of delivering a substance of interest. The microneedle particles may include one or more microneedles, and the microneedle particles may be configured to prevent the entire microneedle particle from penetrating the biological tissue. The microneedle particles may be dispersed in a liquid medium to form a composition. A biological tissue may be contacted with the microneedle particles to pre-treat the biological tissue, and a substance of interest may be applied to the pre-treated biological tissue.

Abstract: Provided herein are microneedle particles, compositions that include microneedle particles, methods of treating skin, and methods of delivering a substance of interest. The microneedle particles may include one or more microneedles, and the microneedle particles may be configured to prevent the entire microneedle particle from penetrating the biological tissue. The microneedle particles may be dispersed in a liquid medium to form a composition. A biological tissue may be contacted with the microneedle particles to pre-treat the biological tissue, and a substance of interest may be applied to the pre-treated biological tissue.

Abstract: Methods and devices are provided for targeted administration of a drug to a patient's eye. In one embodiment, the method includes inserting a hollow microneedle into the sclera of the eye at an insertion site and infusing a fluid drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused fluid drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. The fluid drug formulation may flow circumferentially toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye.