Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Patent
1999-01-29
2000-06-27
Winakur, Eric F.
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
600317, A61B 500
Patent
active
060817348
DESCRIPTION:
BRIEF SUMMARY
The invention concerns a system for monitoring the regular intake of a medicament by a patient as well as a medicine dosage form for such a monitoring system.
The regular intake of a medicament is often of great importance for its effectiveness. For example with antibiotics, a premature termination leads to reoccurrence of the disease or to the generation of resistance. Nevertheless, medicine is often not taken regularly according to prescription or intake is interrupted at a premature stage. For certain therapies with which the regular intake of the medication is of great importance (e.g. TBC, HIV and other serious infectious diseases) in-patient treatment in the hospital is therefore required in order to guarantee the individual monitoring of the regular administering of the medicine. Such an in-patient treatment for the sole reason of monitoring the intake of the medication can be disadvantageous to the recuperation processes and is very expensive.
There is therefore an urgent need for a reliable monitoring of the regular intake of medication at reasonable expense. There is no current solution to this problem. For some therapies involving medication, analytical investigations of the concentration of the medication in the blood (so-called "drug tests") are carried out to adjust the optimum effective concentration of the drug. Such analytical procedures are, however, only available for a small number of medicaments and require the removal of blood for each investigation as well as performing a relatively difficult analysis procedure. Drug tests do not allow self-monitoring of the intake of a medication by the patient and also do not allow the physician to monitor the regular intake of the medication without the cooperation of the patient.
In order to solve this problem, the invention proposes a monitoring system which includes, as mutually adapted system components, a dosage form of the medicament and a detection apparatus for non-invasive detection of a substance contained in the dosage form (subsequently referred to as "detection substance") in the body of the patient. The detection apparatus is adapted for reagent-free direct measurement of a measuring quantity correlating with the presence of the detection substance in the body of the patient.
In the most general form of the invention, the detection substance can be formed by the medication itself i.e. the therapeutically active agent. This is, however, limited to active agents which can be detected in a non-invasive manner. Nearly all chemotherapy medicaments have characteristic IR bands which can be utilized for such detection. Examples of medication which facilitate non-invasive detection are: antibiotics such as tetracycline, nitrofurone and nalidixic acid, the tuberculosis medicaments rifampicin and isonicotinic acid hydrazide, the malaria medicament Chloroquine sulphate and also anticoagulant agents such as maramar and heart/circulation medication such as nitroglycerin and digoxin.
In other cases the typical IR-bands are overlapped by the bands of substances naturally present in the body. In such cases or in the event that the concentration of the effective agent is too small, the non-invasive detectable substance contained in the dosage form is, according to a preferred embodiment of the invention, a non-toxic marking substance differing from the medication (active agent). The marking substance is selected such that it does not encroach upon the pharmaceutical effectiveness of the medicament's active agent and has no additional negative side effects in the body of the patient (preferentially it is completely inert within the body) while nevertheless allowing easy detection of its presence in the body of the patient. This embodiment allows to optimize the marking substance with respect to ease of detection thereof. In accordance with a preferred embodiment of the invention, damaging toxic effects on the body can, if necessary, be avoided by capsulation or bonding within a macromolecular protective molecular structure, in particular a protective
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Roche Diagnostics GmbH
Winakur Eric F.
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