Biosensor coating composition and methods thereof

• US 8,262,874 B2
• Filed: 04/14/2008
• Issued: 09/11/2012
• Est. Priority Date: 04/14/2008
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Forrow, Nigel John, Karinka, Shridhara Alva
• Primary Examiner(s): Barton, Jeffrey T
• Assistant Examiner(s): DIETERLE, JENNIFER M
• Application Number:
  US12/102,374
• Publication Number:
  US 20090255811A1
• Time in Patent Office: 1,611 Days
• Field of Search: 204400-40315, 205/777.5, 205/778, 205/792, 436501-518, 600309-367, 4352871-2879
• US Class Current: 204/403.11
• CPC Class Codes: C12Q 1/001 Enzyme electrodes
• CPC Class Codes: C12Q 1/004 mediator-assisted
• CPC Class Codes: C12Q 1/006 for glucose

Abstract

The disclosure provides for reagent compositions for biosensors comprising release polymers, methods of making such biosensors and films of reagent compositions comprising release polymers. The reagent compositions comprise a release polymer and an effective analyte detecting amount of an enzyme an enzyme cofactor and a redox compound capable of acting in a biosensor as (i) a redox mediator associated with a working electrode (ii) a redox couple associated with a reference electrode or (iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode.

Claims

1. A biosensor comprising:

at least one electrode; and

a reagent composition associated with the at least one electrode, the reagent composition comprising;

a polymer mixture comprising polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol or a polymer mixture comprising polyvinyl acetate and polyvinylpyrrolidone and an effective analyte detecting amount of;

an enzyme;

an enzyme cofactor; and

a redox compound capable of acting in a biosensor as

(i) a redox mediator for a working electrode;

(ii) a redox couple for a reference electrode;

or

(iii) a redox mediator for a working electrode and the redox couple for a reference electrode.

2. The biosensor of claim 1 wherein the polymer mixture has dispersed within it an effective amount of

an enzyme;

an enzyme cofactor; and

a redox compound capable of acting in a biosensor as

(i) a redox mediator for a working electrode;

(ii) a redox couple for a reference electrode;

or

(iii) a redox mediator for a working electrode and the redox couple for a reference electrode.

3. The biosensor of claim 1 wherein the polymer mixture comprises polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol.

4. The biosensor of claim 1 wherein the polymer mixture comprises polyvinyl acetate and polyvinylpyrrolidone.

5. The biosensor of claim 1 wherein the redox compound comprises:

[M(PQ)₃]X₂

wherein;

M is Ni, Mn, Fe, Co, Os, or Ru;

PQ is

6. The biosensor of claim 1 wherein the reagent composition further comprises:

the enzyme is a NAD(P)-dependent dehydrogenase;

the enzyme cofactor is NAD sodium salt; and

the redox compound is [Ni(PQ)3]C12, [Ni(PQ)3]Br2 or mixtures thereof;

wherein PQ is

7. The biosensor of claim 1 wherein:

the redox compound is [M(PQ)₃]X₂

wherein;

M is Fe or Ru;

PQ is

8. The biosensor of claim 1 wherein:

the redox compound is [OS(PQ)₃]X₂

wherein;

9. The biosensor of claim 1 wherein:

the enzyme is dehydrogenase; and

the enzyme cofactor comprises NAD sodium salt, FAD or PQQ.

10. The biosensor of claim 1 wherein:

the enzyme is NAD(P)-dependent dehydrogenase;

the enzyme cofactor is NAD sodium salt; and

the redox mediator is [Ni(PQ)3]C12, [Ni(PQ)3]Br2 or mixtures thereof

wherein PQ is

25. The composition of claim 1 wherein the reagent composition covers at least a portion of the working electrode, at least a portion of the reference electrode or both at least a portion of the working electrode and at least a portion of the reference electrode.

26. The composition of claim 1 wherein the rheology of the reagent composition is substantially Newtonian and is in the range from about 0.5 mPa s to about 25 mPa s.

27. The composition of claim 1 wherein the polymer mixture has dispersed within it an effective amount of:

an enzyme;

an enzyme cofactor; and

a redox compound capable of acting in a biosensor as

(i) a redox mediator for a working electrode;

(ii) a redox couple for a reference electrode;

or

(iii) a redox mediator for a working electrode and the redox couple for a reference electrode.

28. The composition of claim 1 wherein the polymer mixture comprises polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol.

29. The composition of claim 1 wherein the polymer mixture comprises polyvinyl acetate and polyvinylpyrrolidone.

30. The composition of claim 1 wherein the number average molecular weight (M_n) of the polyvinyl alcohol-polyethylene glycol graft copolymer is from about 30,000 to about 60,000.

31. The composition of claim 1 wherein the number average molecular weight (M_n)of the polyvinyl acetate is from about 10,000 to about 2,000,000.

32. The composition of claim 1 wherein the redox compound is of the formula:

[M(PQ)₃]X₂

wherein;

M is Ni, Mn, Fe, Co, Os, or Ru;

PQ is

33. The composition of claim 1 wherein:

the enzyme is cholesterol dehydrogenase; and

the enzyme cofactor comprises NAD sodium salt, FAD or PQQ.

34. The composition of claim 1 wherein:

the enzyme is 3-hydroxybutyrate dehydrogenase; and

the enzyme cofactor comprises NAD sodium salt, FAD or PQQ.

35. The composition of claim 1 further comprising a trigger electrode.

36. The composition of claim 35 wherein the reagent composition covers at least a portion of the trigger electrode.

37. The composition of claim 1 wherein:

the enzyme is dehydrogenase; and

the enzyme cofactor comprises NAD sodium salt, NAD(P), NAD, FAD or PQQ.

38. The composition of claim 37 wherein the enzyme is glucose GDH dependent, cholesterol dependent or ketone dependent.

39. The composition of claim 37 wherein:

the enzyme is a NAD(P)-dependent dehydrogenase;

the enzyme cofactor is NAD sodium salt; and

the redox compound is [Ni(PQ)₃]Cl₂, [Ni(PQ)₃]Br₂ or mixtures thereof

wherein PQ is

40. The composition of claim 37 wherein:

the redox compound is [M(PQ)₃]X₂

wherein;

M is Fe or Ru;

PQ is

41. The composition of claim 37 wherein:

the redox compound is [OS(PQ)₃]X₂

wherein;

PQ is

42. The composition of claim 37 wherein:

the redox compound is independently [Fe(CN)₆]³⁻

(ferricyanide), [Ru(NH)₃]³⁺(hexaammine ruthenium(III)), 2,6-dichlorophenol indophenol (DCIP), [Os(dmo)₂(1-vinyl imidazole)X]X, [Os(dmo)₂(1-vinyl imidazole)X]X₂, [Os(dmo)₂(imidazole)X]X, [Os(dmo)₂(imidazole)X]X₂, [Os(dmo)₂(1-methyl imidazole)X]X₂, [Os(dmo)₂(methylimidazole)X]X₂

11. A biosensor film comprising

a polymer mixture comprising polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol or a polymer mixture comprising polyvinyl acetate and polyvinylpyrrolidone and an effective analyte detecting amount of:

an enzyme;

an enzyme cofactor; and

a redox compound capable of acting in a biosensor as

(i) a redox mediator for a working electrode;

(ii) a redox couple for a reference electrode;

or

(iii) a redox mediator for a working electrode and the redox couple for a reference electrode.

12. The biosensor film of claim 11 wherein the polymer mixture has dispersed within it an effective amount of:

an enzyme;

an enzyme cofactor; and

a redox compound capable of acting in a biosensor as

(i) a redox mediator for a working electrode;

(ii) a redox couple for a reference electrode;

or

(iii) a redox mediator for a working electrode and the redox couple for a reference electrode.

13. The biosensor film of claim 11 wherein the redox compound is of the formula:

[M(PQ)₃]X₂

wherein;

M is Ni, Mn, Fe, Co, Os, or Ru;

PQ is

14. The biosensor film of claim 11 wherein:

the enzyme is dehydrogenase; and

the enzyme cofactor comprises NAD sodium salt, FAD or PQQ.

15. The biosensor film of claim 11 wherein:

the enzyme is a NAD(P)-dependent dehydrogenase;

the enzyme cofactor is NAD sodium salt; and

the redox compound is [Ni(PQ)₃]Cl₂, [Ni(PQ)₃]Br₂ or mixtures thereof

wherein PQ is

16. The biosensor film of claim 11 wherein:

the redox compound is [M(PQ)₃]X₂

wherein;

M is Fe or Ru;

PQ is

17. The biosensor film of claim 11 wherein:

the redox compound is [OS(PQ)₃]X₂

wherein;

PQ is

18. The biosensor film of claim 11 further comprising a colorant.

19. The biosensor film of claim 18 wherein the colorant is a flavin mononucleotide (FMN) of the structure:

20. The biosensor film of claim 11 wherein the polymer mixture comprises polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol.

21. The biosensor film of claim 20 wherein the number average molecular weight (M_n) of the polyvinyl alcohol-polyethylene glycol graft copolymer is from about 30,000 to about 60,000.

22. The biosensor film of claim 11 wherein the polymer mixture comprises polyvinyl acetate and polyvinylpyrrolidone.

23. The biosensor film of claim 22 wherein the number average molecular weight (M_n) of the polyvinyl acetate is from about 10,000 to about 2,000,000.

24. A reagent composition comprising:

a polymer mixture comprising polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol or a polymer mixture comprising polyvinyl acetate and polyvinylpyrrolidone and an effective analyte detecting amount of;

an enzyme;

an enzyme cofactor; and

a redox compound capable of acting in a biosensor as

(i) a redox mediator associated with a working electrode;

(ii) a redox couple associated with a reference electrode;

or

(iii) the redox mediator associated with the working electrode and the redox couple for the reference electrode.