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  Polypeptide formulations and methods for making, using and characterizing themUSPTO Application #: 20080113443Title: Polypeptide formulations and methods for making, using and characterizing them 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. (end of abstract) Agent: Attn: William J. Wood Gates & Cooper LLP - Los Angeles, CA, US Inventors: Poonam S. Gulati, Sarnath Chattaraj, Elango S. Minnoor, Eugene Levin, Xiao Zhu, William P. Van Antwerp USPTO Applicaton #: 20080113443 - Class: 436 85 (USPTO) The Patent Description & Claims data below is from USPTO Patent Application 20080113443. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001]This application is a Divisional Application claiming priority under Section 120 to U.S. patent application Ser. No. 11/060,255, filed Feb. 17, 2005, the contents of which are incorporated herein by reference. This application is related to U.S. patent application Ser. No. 10/989,038, U.S. patent application Ser. No. 10/861,837, and U.S. patent application Ser. No. 10/273,767, the contents of each of which are incorporated herein by reference. BACKGROUND OF THE INVENTION [0002]1. Field of the Invention [0003]The present invention relates generally to polypeptide formulations such as those used in the treatment and management of diabetes. [0004]2. Description of Related Art [0005]Advancing technologies have made a wide variety of biologically active polypeptides available in sufficiently large quantities for use in both diagnostic as well as therapeutic methodologies. Many polypeptides, however, can lose biological activity by a variety of chemical and physical means including deamidation, aggregation and denaturation. Consequently, the identification and characterization of compositions and methods that can be used to stabilize and/or assess the stability of these agents is essential for the optimization of their benefits. [0006]Stable polypeptide formulations are particularly important for use in devices that expose these agents to elevated temperatures and/or mechanical stress. Stable glucose oxidase formulations, for example, are used with glucose analyte sensors and related devices in the management of diabetes. Similarly, in continuous infusion systems, a fluid containing a therapeutic agent is pumped from a reservoir, usually to a subcutaneous, intravenous, or intraperitoneal depot. Stable insulin formulations, for example are used with continuous infusion systems and related devices in the treatment of diabetes. Formulations of such polypeptides must remain active even though subjected to extended periods of storage prior to use as well as a patient's body heat and motion during use. SUMMARY OF THE INVENTION [0007]Embodiments of the invention provide polypeptide formulations and methods for making, using and characterizing them. [0008]One embodiment of the invention is a method of determining the concentration of a non-ionic surfactant in an aqueous solution by subjecting the aqueous solution to a chromatographic separation step and then analyzing this solution via evaporative light scattering, such that the concentration of the non-ionic surfactant in the aqueous solution is determined. In certain embodiments of the invention, the non-ionic surfactant is extracted from the aqueous solution and then concentrated prior to the chromatographic separation step. In these methods, the chromatographic separation step can include reverse-phase chromatography. Optionally, this chromatographic separation step includes high pressure liquid chromatography. [0009]A related embodiment of the invention is a method of determining the concentration of a non-ionic surfactant in an aqueous solution by first extracting the non-ionic surfactant from the aqueous solution, concentrating it and then analyzing this concentrated extract via a high performance liquid chromatograph that is coupled to an evaporative light scattering detector so that the concentration of the non-ionic surfactant in the aqueous solution is determined. In certain embodiments of the invention the high performance liquid chromatograph uses a column containing a matrix that separates the components of the aqueous solution based on their polar and/or nonpolar characteristics. [0010]In certain embodiments of these methods for determining the concentration of a non-ionic surfactant in an aqueous solution, the non-ionic surfactant is a poloxamer. Optionally the non-ionic surfactant in the aqueous solution is poloxamer 171, Triton X-100, Triton X-405, Triton BRIJ-35, Tween-20 or Tween-80. The aqueous solution examined by these methods can include a wide variety of other components in addition to the nonionic surfactant. In one embodiment of the invention, the aqueous solution includes a pharmaceutically acceptable composition. Optionally the aqueous solution includes a therapeutic polypeptide such as an insulin. Typically, the concentration of these non-ionic surfactant in the aqueous solution is less than the critical micelle concentration. In certain embodiments of the invention, the concentration of the non-ionic surfactant in the aqueous solution is between about 0.1 and about 100 parts per million (ppm), and optionally is between about 1 and about 20 parts per million (ppm). [0011]Another embodiment of the invention is a highly stable glucose oxidase composition which includes about 90 KU/mL to about 110 KU/mL glucose oxidase, about 0.12% w/v to about 0.150% w/v potassium sorbate and about 0.01 M potassium phosphate buffer. In these embodiments of the invention, the glucose oxidase is stable for at least 6 months in a plastic container. In certain embodiments, the glucose oxidase is present in a concentration of about 100 KU/mL. Typically, the potassium sorbate is present in a concentration of about 0.150% w/v. [0012]A related embodiment of the invention is a method of making a glucose oxidase composition that is stable for at least 6 months in a plastic container by first preparing a dilute glucose oxidase solution and then concentrating this glucose oxidase solution so that the resulting concentrated solution includes glucose oxidase at a concentration of about 90 KU/mL to about 110 KU/mL, potassium sorbate at a concentration of 0.120% w/v to about 0.18% w/v; and potassium phosphate buffer at a concentration of about 0.01 M. In embodiments of the invention, the glucose oxidase solution is typically concentrated by a process including solid phase extraction or by a process including chromatography. [0013]Another related embodiment of the invention is a method of making a glucose sensor apparatus for implantation within a mammal by: providing a base layer; forming a conductive layer on the base layer, where the conductive layer includes a working electrode; forming an analyte sensing layer on the conductive layer using a composition including 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, where the analyte modulating layer includes a composition that modulates the diffusion of the analyte therethrough; and then forming a cover layer disposed on at least a portion of the analyte modulating layer, the cover layer including an aperture over at least a portion of the analyte modulating layer. Yet another embodiment of the invention is sensor made by this method. [0014]Other objects, features and advantages of embodiments of the present invention will become apparent to those skilled in the art from the following detailed description. It is to be understood, however, that the detailed description and specific examples, while indicating embodiments of the present invention are given by way of illustration and not limitation. Many changes and modifications within the scope of the present invention may be made without departing from the spirit thereof, and the invention includes all such modifications. BRIEF DESCRIPTION OF THE DRAWINGS [0015]FIG. 1 provides a schematic of the well known reaction between glucose and glucose oxidase. As shown in a stepwise manner, this reaction involves glucose oxidase (GOx), glucose and oxygen in water. In the reductive half of the reaction, two protons and electrons are transferred from .beta.-D-glucose to the enzyme yielding d-gluconolactone. In the oxidative half of the reaction, the enzyme is oxidized by molecular oxygen yielding hydrogen peroxide. The d-gluconolactone then reacts with water to hydrolyze the lactone ring and produce gluconic acid. In certain electrochemical sensors of the invention, the hydrogen peroxide produced by this reaction is oxidized at the working electrode (H.sub.2O.sub.2.fwdarw.2H++O.sub.2+2e.sup.-). [0016]FIG. 2 provides a diagrammatic view of a typical analyte sensor configuration. [0017]FIG. 3 shows data that is typical of a system suitability chromatogram. [0018]FIG. 4 shows a representative chromatogram of a reference standard. [0019]FIG. 5 shows a representative chromatogram of a U400 HRI sample. [0020]FIG. 6 shows a representative chromatogram of a rinse buffer solution sample. Continue reading... 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