Polypeptide formulations and methods for making, using and characterizing them
First Claim
Patent Images
1. A method of determining the concentration of a non-ionic surfactant in an aqueous solution comprising the steps of:
- (a) subjecting the aqueous solution to a chromatographic separation step; and
(b) analyzing the aqueous solution to from (b) via evaporative light scattering, such that the concentration of the non-ionic surfactant in the aqueous solution is determined.
1 Assignment
0 Petitions
Accused Products
Abstract
Embodiments of the invention include polypeptide formulations and methods for making, using and characterizing them. Embodiment of the invention include stabilized polypeptide formulations, for example stable glucose oxidase formulations that can be used with glucose sensors used in the management of diabetes. Another embodiment of the invention includes methods to characterize the concentration of nonionic surfactants in stabilized polypeptide formulation for example stable insulin formulations that can be used in the treatment of diabetes.
-
Citations
22 Claims
-
1. A method of determining the concentration of a non-ionic surfactant in an aqueous solution comprising the steps of:
-
(a) subjecting the aqueous solution to a chromatographic separation step; and
(b) analyzing the aqueous solution to from (b) via evaporative light scattering, such that the concentration of the non-ionic surfactant in the aqueous solution is determined. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
-
-
14. A method of determining the concentration of a non-ionic surfactant in an aqueous solution comprising:
-
(a) extracting the non-ionic surfactant from the aqueous solution;
(b) concentrating the non-ionic surfactant from (a); and
(c) analyzing the concentrated non-ionic surfactant from (b), wherein the concentrated non-ionic surfactant is analyzed via high performance liquid chromatography coupled to an evaporative light scattering detector, such that the concentration of the non-ionic surfactant in the aqueous solution is determined.
-
-
15. A composition comprising:
-
(a) glucose oxidase, wherein the glucose oxidase is present in a concentration of about 90 KU/mL to about 110 KU/mL;
(b) potassium sorbate, wherein the potassium sorbate is present in a concentration of about 0.12% w/v to about 0.15% w/v; and
(c) a potassium phosphate buffer;
wherein the potassium phosphate buffer is present in a concentration of about 0.01 M. - View Dependent Claims (16, 17, 18)
-
-
19. A method of making a glucose oxidase composition that is stable for at least 6 months in a plastic container, the method comprising:
-
(a) preparing a glucose oxidase solution; and
(b) concentrating the glucose oxidase solution (a);
wherein the resulting concentrated glucose oxidase solution comprises glucose oxidase having a concentration of about 90 KU/mL to about 110 KU/mL, potassium sorbate having a concentration of 0.12% w/v to about 0.18% w/v; and
a potassium phosphate buffer having a concentration of about 0.01 M, so that the glucose oxidase composition that is stable for at least 6 months in a plastic container is made. - View Dependent Claims (20)
-
-
21. A method of making a sensor apparatus for implantation within a mammal comprising the steps of:
-
providing a base layer;
forming a conductive layer on the base layer, wherein the conductive layer includes a working electrode;
forming an analyte sensing layer on the conductive layer using a composition comprising glucose oxidase having a concentration of about 90 KU/mL to about 110 KU/mL, potassium sorbate having a concentration of about 0.12% w/v to about 0.18% w/v; and
a potassium phosphate buffer having a concentration of about 0.01 M;
optionally forming a protein layer on the analyte sensing layer;
forming an adhesion promoting layer on the analyte sensing layer or the optional protein layer;
forming an analyte modulating layer disposed on the adhesion promoting layer, wherein the analyte modulating layer includes a composition that modulates the diffusion of the analyte therethrough; and
forming a cover layer disposed on at least a portion of the analyte modulating layer, wherein the cover layer further includes an aperture over at least a portion of the analyte modulating layer. - View Dependent Claims (22)
-
Specification