Development of test systems for personalized treatment of oncological diseases
Development of test systems for personalized treatment of oncological diseases

Issues of modern Pharmacotherapy:

  1. The effectiveness of modern Pharmacotherapy does not exceed 60% despite evidence-based medicine;
  2. Increase in the number of adverse drug reactions including fatal ones;
  3. When taking a standard dose, the concentration of some drugs varies over a wide range depending on patients.

It is necessary to assess properly the condition of xenobiotic metabolism (including medicines) individually for each patient since drugs are removed through the biotransformation system.

In order to adequately select drugs and their dosage regimen (improving pharmacotherapy), the diagnostics of the cytochrome Р450 (CYP450) isoenzymes activity is of great importance. These isoenzymes are responsible for over 50% of metabolism of widely used drugs dependent on Phase I. The activity of various CYP can be assessed simultaneously by injecting a cocktail made of the selected drugs, which are substrates of the relevant enzymes, with further collection of plasma samples aimed at quantifying the ratio of plasma concentration between the parent drugs and their metabolites.

The cytochrome Р450 (CYP450) isoenzymes can be diagnosed using Combi Cap, a capsule containing microcapsules of a few medications, in order to phenotype patients, which will allow to select drugs and their dosage regimen when treating diseases.

Project goals
  • Development of CombiCap test system.
  • A capsule containing microcapsules of a few medications to assess properly the condition of xenobiotic metabolism (including medicines) individually for each patient in order to adequately select drugs and their dosage regimen (improving pharmacotherapy).
Project leader All participants
Rimma Abramovich

Rimma Abramovich

Project results
The formula and the production technology of the Combi Cap diagnostic system in capsules were developed and improved.
A unified approach was developed to control the quality of capsules of the diagnostic system using NMR spectroscopy according to their integral intensity of proton signals using 1Н NMR spectroscopy in deuterated DMSO.
The possibility of carrying out a Dissolution test for CombiCap capsules was studied.
A draft product specification for the developed diagnostic system was developed.
Equipment All list
Agilent Technologies 6340 Triple Quad LC/MS (HPLC-/MS/МS)
Highly sensitive determination of medicinal substances and their metabolites in biological media of humans and animals.
Bruker micrOTOF-Q II (HPLC-/MS/МS)
Highly sensitive determination of medicinal substances and their metabolites in biological media of humans and animals.
Shimadzu LC/MS – 8040 (HPLC-/MS/МS)
Quantitative and qualitative analysis of complex multicomponent systems.
Jeol JMS GCmate II (GC/МS)
Quantitative and qualitative analysis of complex multicomponent systems.
Jeol JNM-ECA 600 NMR-spectrometer
Quantitative and qualitative analysis of complex multicomponent water organic systems, conducting metabolomic studies.
Harro Höfliger Modu C LS
Filling and closing gelatin capsules for research and clinical aims.
BOSCH XSpress laboratory tablet rotary press
Tablet pressing.
BOSCH Mycromix laboratory mixer granulator
Granules production.
BOSCH Mycrolab mixer granulator
Coating tablets.
Application area
  • Diagnostic test system.
  • Pharmaceutical Science.
  • Medicine.
Partners

City

Moscow, Russia

Subject of cooperation:
Clinical studies

City

Moscow, Russia

Subject of cooperation:
Collecting oncology patients’ biomaterial for research