Monitoring patient compliance and bioavailability of drugs by deproteinizing body fluids
First Claim
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1. Method of monitoring patient compliance and bioavailability of drugs contained in a body fluid consisting essentially of the following steps:
- (a) mixing and shaking mechanically the body fluid with a 0.1 M to 5.0 M aqueous zinc sulfate solution to precipitate proteins, and an appropriate solvent to extract the drug during deproteinizing, in a single step, and recovering at least 97% of the drug;
(b) centrifuging the mixture of (a), to obtain the separation of phases;
(c) recovering the supernatant of (b) and measuring the drug concentration in body fluid using a colorimetric assay or a High-Performance Liquid Chromatography method, and (d) obtaining drug levels down to at least 0.3 μ
g/ml.
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Abstract
The present invention is a method for drug level detection by using a simplified and effective deproteinizing step from body fluids, such as plasma, blood, urine, saliva, tear fluid, followed by drug extraction and measurement using an accurate technique, such as a colorimetric assay or a High-Performance Liquid Chromatography method. In a particular embodiment, the invention is directed to a method to quantify rifampicin in order to monitor its levels in body fluids and also to a Kit for rifampicin concentration measurement.
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Citations
18 Claims
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1. Method of monitoring patient compliance and bioavailability of drugs contained in a body fluid consisting essentially of the following steps:
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(a) mixing and shaking mechanically the body fluid with a 0.1 M to 5.0 M aqueous zinc sulfate solution to precipitate proteins, and an appropriate solvent to extract the drug during deproteinizing, in a single step, and recovering at least 97% of the drug;
(b) centrifuging the mixture of (a), to obtain the separation of phases;
(c) recovering the supernatant of (b) and measuring the drug concentration in body fluid using a colorimetric assay or a High-Performance Liquid Chromatography method, and (d) obtaining drug levels down to at least 0.3 μ
g/ml.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. Method of monitoring patient compliance and bioavailability of rifampicin contained in a small amount of a body fluid comprising the following steps:
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(a) mixing and shaking mechanically the body fluid with a 0.1 M to 5.0 M aqueous zinc sulfate solution, an organic solvent selected from the group consisting of acetonitrile/2-propanol, benzene, toluene, dichloromethane, chloroform and a mixture thereof, to extract rifampicin and, optionally, an antioxidizing agent to precipitate proteins and strip off bound drug at same time or in a single step;
(b) centrifuging the mixture of (a) to obtain the separation of phases;
(c) recovering the organic phase supernatant of (b) and measuring the drug concentration in said supernatant by using a colorimetric assay or a High-Performance Liquid Chromatography method down to at least 0.3 μ
g/ml.- View Dependent Claims (11, 12, 13, 14)
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15. Kit for measuring rifampicin concentration in a body fluid containing the following components:
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(a) a standard solution of 0.1 M to 5.0 M of aqueous zinc sulfate, optionally, including an antioxidizing agent;
(b) an organic solvent selected from the group consisting of acetonitrile/2-propanol, benzene, toluene, dichloromethane, chloroform and a mixture thereof;
(c) a serum standard containing a know amount of rifampicin to prepare a standard curve for user conditions. - View Dependent Claims (16, 17, 18)
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Specification