Means and methods for the determination of substances in biological assays

The invention claims a new method for the determination of substances in biological assays like serum or plasma that carry SH-groups sensitive towards oxidation. By this method the degradation of the corresponding substance can be prevented and eliminated as a source of errors.

Full description:

In antiplatelet therapy the efficacy of Clopidrogel is well established. Clopidigrel is an inhibitor of thrombocyte-aggregation and is used in the prevention of myocardial infarction and apoplexy where it is more efficient than other therapeutics like aspirin. More than 30 million patients have been treated worldwide with Clopidogrel. The efficiacy of Clopidogrel correlates with the plasma concentration of its active thiol metabolite. However, unpredictable interindividual heterogeneity in platelet inhibition, suggested to be due to differences in metabolism of Clopidrogel to its active form, limits its therapeutic value. Therefore the determination of this metabolite in the patient´s plasma is of decisive importance for the control of a successful therapy. So far this determination was not possible because of the extreme instability of the active metabolite.

A research team at the institute of pharmacology in the medical university of Cologne has developed a new method to stabilize the active metabolite of Clopidogrel. The invention opens the possibility to evaluate pharmakokinetic determinants of Clopidrogel action and to test current hypothesis of response variability. The stabilization enables an exact determination of the plasma-concentration and in sequence an individual and patient-related Clopidiogrel-therapy.

Due to the instability of the active metabolite the addition of stabilizing reagents to blood sample tubes is best performed by coating the inner walls of the tubes. Thereby the active metabolite is stabilized in the patient´s plasma immediately after the blood collection.

The coating-technology seems to be of special interest for companies producing blood collection tubes.

Potential application:

• Coating of blood collection tubes with stabilizing substances
• determination of the concentration of medicaments carrying instable SH-groups,

chance for an individual and patient-related therapy

Competition advantages:

• Individual and patient-related therapy and exclusion of therapy-resistant persons (therapeutic drug monitoring)
• increase of the benefit of substances used for medical treatment
• reduction of costs

Required know-how:

Partner should be active in producing blood collection tubes and should have experience in the coating of tube walls with stabilizing substances.

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