Microneedle array having an active ingredient in the form of salts

Inventors

Henning, AndreasHille, ThomasWauer, GabrielSPILGIES, HeikoPracht, Rolf

Assignees

LTS Lohmann Therapie Systeme AG

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Publication Number

US-12397142-B2

Patent

Publication Date

2025-08-26

Expiration Date


Abstract

The invention relates to a microneedle array, in particular to an applicator system, and to the use thereof for the intradermal delivery of active ingredients in the form of salts, in particular medicinal drugs in the form of salts, wherein this microneedle array is suitable for penetrating the skin of humans or animals, and the microneedles are made of a formulation, containing at least one active ingredient in the form of a salt and at least one biodegradable polymer.

Core Innovation

The invention relates to a microneedle array for use in the intradermal delivery of an analgesic in the form of a salt, wherein a plurality of dissolvable microneedles are arranged on a carrier. The microneedle array is applied by way of an applicator system that comprises a trigger device, so that the carrier can be used to place the dissolvable microneedles into the skin.

In the microneedles, the analgesic salt is incorporated into a formulation composed of buprenorphine hydrochloride and at least one water-soluble polymer. The water-soluble polymer is selected from polyvinylpyrrolidone and polyvinyl alcohols, and the microneedles are configured to be dissolvable so that, after penetration into the skin, the penetrated microneedles dissolve in-situ and directly resorb in the skin.

In some configurations the microneedles are not hollow and are configured in a helical shape that can be rotatably disposed, where rotating motion facilitates penetration into the skin and effectuate anchoring in the skin, and the applicator system includes trigger-device concepts including a trigger device that is electrically controlled or otherwise provides triggering for applying the microneedle array.

Claims Coverage

The independent claims are clm-00001, clm-00008, and clm-00009. Across these claims, the main inventive features are the dissolvable intradermal microneedle array carrying an analgesic salt in a water-soluble polymer formulation, and applicator/trigger-device and microneedle-configuration limitations including an electrically controlled trigger device and a helical rotatable microneedle configuration.

Intradermal dissolvable microneedle array with analgesic salt on a carrier

A microneedle array for use in the intradermal delivery of an analgesic in the form of a salt, wherein a plurality of dissolvable microneedles are arranged on a carrier.

Applicator system with trigger device

The microneedle array is applied by way of an applicator system comprising a trigger device.

Formulation with buprenorphine hydrochloride and water-soluble polymer

The microneedles are composed of a formulation consisting of buprenorphine hydrochloride and at least one water-soluble polymer.

Water-soluble polymer selected from polyvinylpyrrolidone and polyvinyl alcohols

The water-soluble polymer is selected from polyvinylpyrrolidone and polyvinyl alcohols.

Electrically controlled trigger device applicator system

The applicator system comprises a trigger device which is electrically controlled.

Helical microneedle shape configured for rotatable disposition with penetration and anchoring

The microneedles are configured in a helical shape and can be rotatably disposed, and rotating motion facilitates penetration into the skin and effectuate anchoring in the skin.

Overall, the independent-claim coverage centers on dissolvable intradermal microneedles arranged on a carrier and applied using an applicator system with a trigger device, where the microneedles use a formulation consisting of buprenorphine hydrochloride mixed with a water-soluble polymer selected from polyvinylpyrrolidone and polyvinyl alcohols. Additional independent coverage includes an electrically controlled trigger-device applicator system and a helical rotatable microneedle configuration that facilitates penetration and anchoring in the skin.

Stated Advantages

Microneedle dissolution in-situ with direct resorption in the skin after penetration.

Avoids the need for hollow/canalled microneedles by using dissolvable microneedles that resorb.

Documented Applications

Intradermal delivery of an analgesic in the form of a salt using a microneedle array.

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