Microneedle device having a peptide therapeutic agent and an amino acid and methods of making and using the same
Assignee3M Innovative Properties Company
InventorsYing Zhang, Percy T. Fenn, Peter R. Johnson
Life of this patent
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Abstract
A medical device including an array of microneedles and a coating disposed on or within the microneedles and a method of making such a device are disclosed. The coating includes a peptide therapeutic agent and an amino acid. A method of stabilizing a peptide therapeutic agent with an amino acid on an array of microneedles is also disclosed. In some cases, the peptide therapeutic agent and the amino acid either both have a net positive charge or both have a net negative charge. In some cases, the peptide therapeutic agent is histidine.
Claims19
A medical device comprising:
- an array of microneedles;
- and
- a coating on or within at least a portion of the microneedles, wherein the coating comprises:
- a peptide therapeutic agent;
- and
- histidine,
- wherein the molar ratio of the histidine to the peptide therapeutic agent is less than 2:1, wherein the histidine stabilizes the peptide therapeutic agent in the coating, and wherein the peptide therapeutic agent is a parathyroid hormone-related protein (PTHrP) analogue represented by formula [Glu22,25,Leu23,28,31,Aib29,Lys26,30]hPTHrP(1-34)NH2.
A method of making a medical device comprising an array of microneedles and a coating on or within at least a portion of the microneedles, wherein the coating comprises:
- a peptide therapeutic agent;
- and
- histidine,
- wherein the molar ratio of the histidine to the peptide therapeutic agent is less than 2:1, the method comprising:
- providing an aqueous composition comprising the peptide therapeutic agent and histidine, wherein the molar ratio of the histidine to the peptide therapeutic agent in the aqueous composition is less than 2:1;
- contacting the microneedles with the aqueous composition;
- and
- volatilizing a portion of the aqueous composition to provide a coating on at least a portion of the microneedles, wherein the coating comprises at least the peptide therapeutic agent and the histidine, and wherein the peptide therapeutic agent is a parathyroid hormone-related protein (PTHrP) analogue represented by formula [Glu22,25,Leu23,28,31,Aib29,Lys26,30]hPTHrP(1-34)NH2.
A medical device comprising:
- an array of microneedles;
- and
- a coating on or within at least a portion of the microneedles, wherein the coating comprises:
- a peptide therapeutic agent;
- and
- histidine,
- wherein the molar ratio of the histidine to the peptide therapeutic agent is in a range from 0.25:1 to 55:1, and wherein the peptide therapeutic agent is a parathyroid hormone-related protein (PTHrP) analogue represented by formula [Glu22,25,Leu23,28,31,Aib29,Lys26,30]hPTHrP(1-34)NH2.
Dependencies are inferred from the claim text.