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Substance of temozolomide for the production of anticancerdrug TEMOBEL and TEMODEX

Purpose

The pharmaceutical substance used for production of drugs with the active substance temozolomide (injections, capsules, etc.), particularly for production of an anticancer drug TEMOBEL (capsules of 20 mg, 100 mg, 200 mg).

The development of technology and organization of the production of domestic high-quality temozolomide substance, as well as generic drug (TEMOBEL) and original drug (TEMODEX) based on temozolomide aims at improving the effectiveness of cancer treatment and expensive medicine import substitution.

TEMOBEL is a generic drug, an analogue of Temodal produced by Schering-Plough company. TEMOBEL is 4 times chipper than its analogue at the same efficiency and tolerance.

TEMODEX is the original drug, which has only appointment analogues (for local chemotherapy of brain tumors): import drug “Gliadel (USA) and domestic drug “Cisplacel (Belarus).

The drug TEMODEX has a gelatinous form and fills the tumor bed and providing maximum local effect on the remaining tumor cells.

The function of cytostatic is performed by the domestic substance temozolomide, which is currently one of the most effective anticancer agents. The function of the carrier polymer is performed by the specially synthesized gelling phosphate dextran which is biocompatible with body tissue.

Prolongation of the antitumor effect of temozolomide can be achieved by incorporating it into the polymer composition via “double immobilization method by distribution of the hydrogel in the spatial grid and implementation of donor-acceptor interactions with the functional groups of the dextran phosphate.


The single implantation of the drug into the brain provides the antitumor effect which lasts during the whole period of the resorption of the gel (from 20 to 30 days).

The developers designed the finished dosage form of the drug TEMODEX and conducted preclinical trials which demonstrated high efficacy of the drug and absence of any toxic effects when implanted in experimental animals’ brains. The clinical trials on the use of the drug as a means for local chemotherapy in patients with primary metastatic brain tumors (Grade 1-4) were initiated.

Characteristics
  • Powder of white to white with a light pink tint color.
  • Practically insoluble in ethanol, slightly soluble in water and in 0.1 M of hydrochloric acid solution, moderately soluble in dimethylsulfoxide.
  • pH ranges from 5.0 to 7.0.
  • Content of the basic substance ranges from 99.0% to 102.0% in terms of dry substance. The quantity of heavy metals is lower than 20 ppm.
  • Shelf life: 12 months.
Form
Powder packed in 0.1 kg cans of dark glass.

Application
Medicine, Oncology

State of readiness
  • Certificate of registration № 10/12/1829;
  • Laboratory regulations LR 100050710.054 -2008
  • Experimental-industrial regulations, Manufacturer's monograph ФСП РБ 1526-10.
  • Works on registration of the substance in the CIS countries (Russia, Armenia, Ukraine, Kazakhstan) are in process.
Developer: Research Institute for Physical and Chemical Problems of the BSU

Production: UE Unitechprom of the BSU

Form of cooperation: finished product sale