Polypeptide formulations and methods for making, using and characterizing them

• US 7,241,586 B2
• Filed: 02/17/2005
• Issued: 07/10/2007
• Est. Priority Date: 02/17/2005
• Status: Active Grant

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Inventors: Chattaraj, Sarnath, Gulati, Poonam S., Levin, Eugene, Van Antwerp, William P., Minnoor, Elango S., Zhu, Xiao
• Primary Examiner(s): Weber; Jon
• Assistant Examiner(s): MARTIN, PAUL C
• Application Number:
  US11/060,255
• Publication Number:
  US 20060183178A1
• Time in Patent Office: 873 Days
• Field of Search: None
• US Class Current: 435/25
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61K 38/443 acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2333/904 acting on CHOH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
• CPC Class Codes: G01N 30/02 Column chromatography
• CPC Class Codes: G01N 30/06 Preparation
• CPC Class Codes: G01N 30/74 Optical detectors measurement of intensity, velocity, spectral content, polarisation, or phase of infrared, visible or ultraviolet light G01J

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.

Claims

1. 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.

2. The composition of claim 1, wherein the glucose oxidase is stable for at least 6 months in a plastic container.

3. The composition of claim 1, wherein the glucose oxidase is present in a concentration of about 100 KU/mL.

4. The composition of claim 1, wherein the potassium sorbate is present in a concentration of about 0.15% w/v.