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Anti-Tumor Preparations Based on Cisplatin

#3377


Production Technology for Microcapsulated Platinum-Containing Anti-Tumor Drug Formulations

Tech Area / Field

  • MED-DRG/Drug Discovery/Medicine
  • BIO-CGM/Cytology, Genetics and Molecular Biology/Biotechnology
  • BIO-CHM/Biochemistry/Biotechnology
  • MED-OTH/Other/Medicine

Status
3 Approved without Funding

Registration date
11.10.2005

Leading Institute
Research Center of Toxicology and Hygienic Regulation of Biopreparations, Russia, Moscow reg., Serpukhov

Supporting institutes

  • Medical Radiological Scientific Center, Russia, Kaluga reg., Obninsk

Collaborators

  • Unitech Pharmaceuticals, Inc., USA, MI, Ann Arbor

Project summary

The project objective is to develop anti-tumor platinum-containing drug dosage form using the technology of protein microcapsulation. For the studies, it is proposed to use the substance of cisplatin, a patented anti-tumor drug with broad spectrum of action (US patent 4, 419, 351, December 6, 1983). As a cisplatin dosage form, denatured albumin microspheres of human blood (MSA) possessing high biocompatibility and controlled biodegradability in human organism will be used. The rate of albumin microspheres proteolytic degradation in organism can be adjusted by varying the sizes and degrees of protein matrix particles lacing. It is supposed that programming of MSA proteolysis speed could help change the period of semiejection of cisplatin incorporated in protein particles’ matrix. Cisplatin will be used as the reference preparation in the study of different aspects of toxicity, pharmacokinetic characteristics and anti-tumor activities of new dosage form.

The proposed studies are of great importance and urgency because cisplatin being an effective chemotherapeutical drug for treatment of tumors of different localization is highly toxic and this makes its application rather limited and complicated.

In the framework of the proposed project it is planned to carry out complex studies on development and biological testing of cisplatin incorporated in MSA of different sizes and different degrees of protein lacing for selection of optimal drug dosage form with high anti-tumor efficacy and low toxicity.

To achieve the goal, the following tasks will be fulfilled:

  1. Develop a method for encapsulation of cisplatin in MSA of different sizes by thermo-lacing of protein.
  2. Develop a method for encapsulation of cisplatin in MSA of different sizes by chemical lacing of protein.
  3. Develop methods for cisplatin-loaded MSA analysis.
  4. Study in vitro kinetics of cisplatin extraction from MSA obtained in different technological conditions.
  5. Produce test cisplatin-loaded MSA samples for using in biological studies.
  6. Perform physico-chemical characterization of cisplatin incorporated in MSA.
  7. Conduct comparative studies of antitumor efficiency of cisplatin incorporated in MSA produced at different technological conditions.
  8. Conduct comparative studies of cisplatin toxicity in standard dosage form and incorporated in MSA obtained at different technological conditions.
  9. Select optimal variant of the preparation with the highest anti-tumor efficacy and low toxicity.

Expected results

As a result of the project implementation, new dosage form of cisplatin will be developed by its encapsulation into protein MSA. The developers expect that the new dosage form will offer the following advantages compared to the patented cisplatin substance:

  • lower toxicity for humans at the same anti-tumor activity.
  • higher efficiency towards a number of tumors with definite localization achieved due to additional effects of dissemination of new transport form in organism depending on the median size of particles and the degree of protein MSA lacing.

Based on the project results, a draft Standing Order on production of microcapsulated form of cisplatin with optimal physico-chemical and biological characteristics will be developed.

Research teams of the institutions- developers include experienced scientists and technical experts and have in their disposal extensive equipment to carry out experimental and clinical studies on synthesis of new and refining the existing chemotherapeutic preparations, as well as to conduct pre-clinical studies of new anti-tumor drugs and evaluate their efficiency.


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