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Labeled Pharmaceutical Substances

#G-1144


Development of Technology for Preparation of Pharmaceutical Substances Morphine, Codeine, Methadone, and Dimedrol Labeled by Stable Isotopes N-15 and C-13

Tech Area / Field

  • CHE-SYN/Basic and Synthetic Chemistry/Chemistry
  • MED-OTH/Other/Medicine
  • CHE-OTH/Other/Chemistry

Status
3 Approved without Funding

Registration date
30.03.2004

Leading Institute
Tbilisi State University, Georgia, Tbilisi

Collaborators

  • Universitaet des Saarlandes, Germany, Saarbrücken\nPacific Northwest National Laboratory, USA, WA, Richland

Project summary

The purpose of the project is the development of methodology for application of an isotope 13C as an infrastructural marker of Dimedrol and Methadone - model pharmaceuticals of drug action; this development includes elaboration of technology of obtaining substances, labeled by stable isotope 13C, and techniques of their identification and quantitative determination.

The other purpose of the project is the development of intensive technology of obtaining drug compounds of vegetative origin labeled by stable isotope 15N and being valid in legal circulation; this development also comprises the working out of methods of quantitative determination of labeled substances.

In the base of our strategy lays the tendency to promote the solution of a severe problem connected with the fact, that outflow of pharmaceuticals, which are subject to a special control, presently occurs from chemical - pharmaceutical plants and medical institutions. This problem is aggravated by the distribution of these pharmaceuticals of drug action in the black market in the form of powders and solutions without any packing and external marks. It hinders the determination of sources of plunders and ways of distribution by the law-enforcement agencies.

Prof. Samsonia and his colleagues have more than twenty years' experience in the field of:

- fine organic synthesis, including the synthesis of pharmaceutical substances labeled by stable isotopes (Prof. Samsonia, Prof. Chikvaidze, Candidate of Chemical Sciences Japaridze, etc.);

- study of herbs (about 200);

- extraction and research of inpidual alkaloids and phenolic compounds (the methods of extraction and separation of natural inpidual psychotropic compounds and cooperative phenolic substances have been developed by Prof. Samsonia, Prof. Chikvaidze, Candidate of Biologic Sciences Kacharava, etc.);

and also in the field of:

- physicochemical researches of structures of synthetic and natural biologically active compounds by means of methods of a nuclear magnetic resonance and mass spectrometry (Prof. Tsitsishvili, Assistant Prof. Salia);

- application of artificial soils in plant growing;

- standardization of labeled compounds;

- drawing up of the technical specifications and officinal articles;

- researches for a toxicity and definition of pharmacokinetic constants (Prof. Baramidze, Prof. Lejava).

Nowadays, there are no technologies of internal structural labeling of drug pharmaceuticals, while the offered possibility of usage of stable isotopes will essentially facilitate the activity of law-enforcement agencies, and will also allow to improve qualitatively the monitoring systems at the chemical-pharmaceutical plants and medical establishments.

The practical value of the project is encompassed by the issue that the structural marking of pharmaceuticals and “isotope coding” of consignments of production will extremely hamper their falsifying, will allow to boost the control at the enterprises and treatment-and-prophylactic institutions, and will also give practical possibility to defend prestige of the manufacturers. Alongside with it, the law-enforcement agencies will get an opportunity to determine the primary source of plunder of drug substances and to define the ways of their clandestine (illegal) distribution. The proposed solutions do not mean the change of the existing technological schemes of production of synthetic pharmaceuticals as well as of drugs on the basis of natural vegetative raw material; thus, with application “of isotope dilution”, the rising of product cost will be minor. The received results will promote the realization of the indicated possibilities both in Georgia, and in other countries - manufacturers of pharmaceuticals, subject to the special control.

In order to accomplish the project we propose the development of “isotope dilution” method, which will allow to produce consignments of pharmaceuticals with given and strictly definite concentration of a marking isotope within the compound’s structure, that will serve “as an isotope code” to the given consignment of medications.

The following problems will be solved within the framework of performance of the proposed project:

1. Obtaining drug compounds of vegetative origin, labeled by isotope 15N, and analysis of a biotransformation of nitrogen in the chain: fertilizer - plant - alkaloids.

2. Development of methods of obtaining, techniques of identification and control of coded medications, labeled by stable isotopes 13C and 15N.

3. Standardization of labeled compounds, drawing up of the temporary technical specifications and officinal articles, research for a toxicity and determination of pharmacokinetic constants.

The Georgian group of the scientists will fulfill the clauses 1-3. The tests of a designed method of verification of coded medications will be conducted in Pacific Northwest National Laboratory, U.S. Department of Energy, 902 Battelle Boulevard, P.O. Box 999, Richland, WA 99352, USA and Saarbruecken University, Department of Organic Chemistry, 66041 Saarbruecken, Germany. Dr. Dennis W. Wester (USA) and Prof. Uli Kazmaier (Germany) will be our contact for this work.


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The International Science and Technology Center (ISTC) is an intergovernmental organization connecting scientists from Kazakhstan, Armenia, Tajikistan, Kyrgyzstan, and Georgia with their peers and research organizations in the EU, Japan, Republic of Korea, Norway and the United States.

 

ISTC facilitates international science projects and assists the global scientific and business community to source and engage with CIS and Georgian institutes that develop or possess an excellence of scientific know-how.

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