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US 12,214,150 B2Granted
Microneedle arrays with undercut features for cutaneous and non-cutaneous drug delivery
AssigneeUniversity of Pittsburgh—Of the Commonwealth System of Higher Education
InventorsLouis D. Falo, Jr., Emrullah Korkmaz
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Abstract
The disclosed methods relate to forming microneedle arrays from a production mold that comprises a flexible mold material. The disclosed methods can be used to reproducibly manufacture undercut dissolvable and coated microneedle arrays with various shapes and structures.
Claims20
A method of forming a microneedle array comprising:
- forming a production mold of a flexible material, the production mold comprising a plurality of cavities, with each of the plurality of cavities being shaped to define a plurality of respective microneedles that each have a stem, a microneedle tip, a filleted base, and at least one undercut feature;
- delivering a biodegradable matrix into each of the plurality of cavities of the production mold to form the stem, microneedle tip, and filleted base of each respective microneedle, wherein at least one bioactive material is incorporated into at least a portion of the biodegradable matrix, the biodegradable matrix comprising a first dissolvable material;
- forming a backing layer adjacent a lower portion of the stem;
- and
- removing the microneedles from the production mold by pulling the microneedles out of the mold,
- wherein the at least a portion of the biodegradable matrix that includes the at least one bioactive material is delivered into at least the microneedle tip defined by the respective cavities of the production mold,
- wherein the flexible material has sufficient elasticity to allow for the molded microneedle array to be removed from the production mold in a single pull without damaging the integrity of the shape of the microneedles as defined by the mold, and
- wherein the backing layer is formed from a conformable material.
5 more elements
A method of forming a flexible elastomer production mold comprising:
- generating a 3D model drawing of a microneedle array that includes a plurality of microneedles with at least one undercut feature, at least one fillet feature, and at least one backing layer;
- forming a master microneedle array from the 3D model drawing using 3D laser printing with a wear-resistant resin;
- forming a negative elastomer mold from the master microneedle array, wherein the negative elastomer mold comprises microneedle-shaped wells with the at least one undercut feature and the at least one fillet feature;
- forming at least one replica of the master microneedle array from the negative elastomer mold via UV-curable micromolding;
- and
- forming the production mold of the microneedle array using the at least one replica, wherein the production mold is formed of a flexible material.
3 more elements
Dependencies are inferred from the claim text.