Polymers for delivery of therapeutic proteins
AssigneeBoard of Regents, The University of Texas System
InventorsMichael KOETTING, Nicholas PEPPAS
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Abstract
In some aspects, improved hydrogel copolymers (e.g., comprising itaconic acid and N-vinylpyrrolidone) are provided and may be used, e.g., for oral delivery of a therapeutic protein. In some embodiments, improved methods for loading a therapeutic protein (e.g., a high isoelectric point protein) into a hydrogel copolymer are provided, and may comprise incubating the therapeutic protein and the hydrogel in a reduced ionic strength loading solution. In some embodiments, use of the reduced ionic strength loading solution can result in hydrogel copolymer-therapeutic protein compositions that display improved pharmacokinetic attributes, e.g., improved loading and/or release of a therapeutic protein.
Claims28
A polymer comprising:
- a) a copolymer comprising itaconic acid, methacrylic acid, and/or N-vinylpyrrolidone;
- wherein the copolymer is at least partially crosslinked;
- and
- b) a therapeutic protein wherein the therapeutic protein has been loaded into the copolymer using a solution having an ionic strength of less than about (150 mM PBS at about pH 7.4).
A method of producing a copolymer comprising a therapeutic protein, comprising:
- (a) admixing the copolymer and the therapeutic protein in a solution with an ionic strength of (less than 150 mM PBS at about pH 7.4);
- and
- (b) allowing the copolymer and the therapeutic protein to remain in the solution for a period of time sufficient to allow for incorporation or diffusion of the therapeutic protein into the copolymer;
- wherein the copolymer comprises itaconic acid, methacrylic acid, and/or N-vinylpyrrolidone;
- and wherein the copolymer is at least partially crosslinked.
28-53. (canceled)
Dependencies are inferred from the claim text.