Dissolvable microneedle patch for large molecule therapeutic delivery

A method of manufacturing a dissolvable microneedle patch for intradermal administration of a hormone to a subject, the method comprising:

• a) preparing a matrix material by mixing non-crosslinked high molecular weight hyaluronic acid, methylcellulose, and at least one large molecule therapeutic with heated water to form a hydrated matrix material;
• b) cooling the hydrated matrix material to room temperature;
• and
• c) casting the cooled matrix material into a microneedle mold and drying the matrix material within the microneedle mold to form a plurality of microneedles extending from a base layer of the microneedle patch.

A method of delivering a hormone to a subject in need thereof, the method comprising:

• applying a dissolvable microneedle patch to a skin of the subject, wherein the dissolvable microneedle patch comprises:
• a substantially planar base layer;
• and
• a plurality of microneedles extending from a surface of the base layer, wherein each of the plurality of microneedles has a height of 1000-3000 μm, wherein each of the plurality of microneedles comprises a solidified matrix, wherein the solidified matrix comprises:
• (a) 0.5-20% w/w non-crosslinked high molecular weight hyaluronic acid having a molecular weight of 1000-1400 kDa;
• (b) 0.5-20% w/w methylcellulose having a viscosity of 100-8000 cP;
• and
• (c) 0-20% w/w non-crosslinked low molecular weight hyaluronic acid having a molecular weight of 20-1000 kDa, wherein the solidified matrix comprises the hormone and no added chemical crosslinking agents,
• exerting sufficient force on the microneedle patch to cause the plurality of microneedles to penetrate the skin and enter intradermal tissue of the subject;
• maintaining the microneedle patch in contact with the skin until at least a portion of the solidified matrix dissolves;
• and
• removing the microneedle patch from the skin,
• wherein less than 100% of the hormone is encapsulated in a biodegradable polymer, wherein the plurality of microneedles dissolve within 1-14 days following insertion and the biodegradable polymer degrades within 1-14 days following insertion.