Microarray with polymer-free microstructures, methods of making, and methods of use
AssigneeCorium International, Inc.
InventorsZhongli Ding, Guohua Chen, Parminder Singh
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Abstract
A microprojection array comprising an approximately planar base and a plurality of microprojections, wherein the array comprises a therapeutic macromolecule and a stabilizing excipient. Described herein are microstructures having a proximal and distal layer, wherein the distal layer which contains the therapeutic molecule does not rely on the presence of a structure-forming polymer to impart the mechanical strength necessary to penetrate the skin. Methods of forming the array, and methods of using the array are contemplated.
Claims25
A microstructure apparatus comprising:
- a backing having a first surface and a second surface opposed thereto;
- a microstructure array comprising a plurality of microstructures extending outwardly from the first surface of the backing;
- each of the plurality of microstructures comprising a biodegradable distal layer and at least one proximal layer positioned between the distal layer and the first surface of the backing;
- wherein the distal layer comprises at least one therapeutic macromolecule and a stabilizing excipient, wherein the at least one therapeutic macromolecule is present in the distal layer at a concentration of about 30% to 90%.
A microstructure apparatus comprising:
- a backing having a first surface and a second surface opposed thereto;
- a microstructure array comprising a plurality of microstructures extending outwardly from the first surface of the backing;
- each of the plurality of microstructures comprising a biodegradable distal layer and at least one proximal layer positioned between the distal layer and the first surface of the backing;
- wherein the distal layer comprises at least one therapeutic macromolecule and a stabilizing excipient, wherein the distal layer does not comprise a structure-forming polymer.
A method for making a microstructure array comprising:
- (a) mixing a polypeptide solution with a stabilizing excipient to form a polypeptide molding solution, wherein the molding solution does not comprise a structure-forming polymer;
- (b) dispensing the polypeptide molding solution on a mold having an array of microstructure cavities;
- (c) filling the microstructure cavities in the mold;
- (f) removing excess solution or suspension polymer matrix on the mold surface;
- (g) drying the solution in a chamber having at least one of:
- (i) a partial pressure of about 30 psi to 60 psi at a temperature of about 5° C. to 50° C.;
- or
- (ii) a relative humidity of about 10% to 95% at a temperature of about 5° C. to 50° C.;
- and
- (h) drying the solution or suspension at about 5° C. to 50° C. to form an array of microstructures.
Dependencies are inferred from the claim text.