Stabilized standards and calibrators containing rapamycin and tacrolimus bound to anti-rapamycin and anti-tacrolimus antibodies
AssigneeAbbott Laboratories
InventorsFrank Grenier, Thomas F. Holzman, Allan H. Smith, Alan C. Tsurutani
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Abstract
The present invention is directed to an in vitro aqueous composition comprising a drug, preferably tacrolimus or rapamycin, having enhanced stability. The invention utilizes a binding protein, preferably antibodies to tacrolimus or rapamycin, to stabilize the drug in an aqueous matrix.
Claims42
A method for calibrating a sample to be analyzed in an immunoassay to detect the presence or amount of rapamycin in said sample, which comprises:
- a) adding to said sample a calibrator composition of rapamycin bound to anti-rapamycin antibodies in amounts sufficient to stabilize rapamycin;
- and
- b) extracting said rapamycin from said anti-rapamycin antibodies using an extraction reagent prior to said immunoassay;
- c) performing said immunoassay on said calibrator composition;
- and
- d) creating a callbration curve based on the results of said immunoassay for use as a standard in an immunoassay for rapamycin in a patient sample.
A method for stabilizing an aqueous composition containing a drug normally unstable under aqueous conditions, which comprises adding an effective amount of a binding protein thereto, wherein said drug is rapamycin and said binding protein is anti-rapamycin antibodies.
A method for calibrating a sample to be analyzed in an immunoassay to detect the presence or amount of tacrolimus in said sample, which comprises:
- a) adding to said sample a calibrator composition of tacrolimus bound to anti-tacrolimus antibodies in amounts sufficient to stabilize tacrolimus;
- and
- b) extracting said tacrolimus from said anti-tacrolimus antibodies using an extraction reagent prior to said immunoassay;
- c) performing said immunoassay on said calibrator composition;
- and
- d) creating a calibration curve based on the results of said immunoassay for use as a standard in an immunoassay for tacrolimus in a patient sample.
A method for stabilizing an aqueous composition containing a drug normally unstable under aqueous conditions, which comprises adding an effective amount of a binding protein thereto, wherein said drug is tacrolimus and said binding protein is anti-tacrolimus antibodies.
Dependencies are inferred from the claim text.