Substance for anticancer drugs PROSPIDIA CHLORIDE

Purpose

Pharmaceutical substance for production of anti-tumor drugs for injection, parenteral, local and intraperitoneal application.
The technology enables to organize the production of an original drug of sustained local anticancer effect and increased efficiency of treatment of gastric cancer patients with disseminated lesions of the abdominal cavity - PROSPIDELONG.

An original anticancer drug, which has no analogues.

The novelty of the product is:

• a synthesized gel-forming dextran mixed ester containing phosphoric acid and carbamate groups is used as a carrier polymer;
• the active material is PROSPIDIA CHLORIDE domestic substance, which is immobilized on a polymeric carrier by electrostatic interaction between the quaternary ammonium and phosphoric acid groups, donor-acceptor interaction between the tertiary amine and carbamate groups, and is distributed in a hydrogel spatial grid. Each type of interaction has its own interaction kinetics of the active component release into the abdominal cavity, causing local anticancer effects on the tumor cells which have not been removed during the surgery over the entire drug absorption period (5-15 days);
• the dextran mixed ester which contains phosphoric acid and carbamate groups has potentiating effect on anticancer drug activity: the efficiency of PROSPIDELONG while in vitro and in vivo experiments significantly excels the effect of PROSPIDIN.

The methods of obtaining of the gel-forming dextran mixed ester with phosphoric acid and carbamate groups as well as finished dosage drug form PROSPIDELONG were developed. The researchers created prototypes and investigated the parameters of acute and subacute toxicity of intraoperative introduction into the abdominal cavity of experimental animals. Using transplantable tumors models of sarcoma M-1, Jensen sarcoma and Seidel hepatoma they demonstrated that a single intraperitoneal introduction of PROSPIDELONG increases the average lifetime and the number of fully cured animals. The researchers also received the package of standard technical documentation and initiated clinical trials of PROSPIDELONG as a local anti-tumor therapy drug in gastric cancer patients with disseminated peritoneum lesion.

Characteristics of the substance

• White crystalline powder;
• The powder is hygroscopic, water-soluble and practically insoluble in ethanol, chloroform and other organic solvents;
• pH of 6.0-7.0;
• Basic substance content ranges from 99.0 % to 102.0 % in dry substance equivalent;
• Shelf life - 2 years.

Product description
Powder packed in 0.1 kg jars of dark glass

Peculiarities

• Provision of pharmaceutical industry of the Republic of Belarus with high-quality substance for production of finished dosage forms;
• The social effect consists in ensuring of independence from imports of the substance for production of effective anticancer drugs.

Ready state

• The scheme for synthesis of pharmaceutical substance PROSPIDIA CHLORIDE has been reproduced;
• Manufacturer's monograph ФСП РБ 1501-10;
• Experimental-industrial regulations ОПР BY 190007888.155/1-2010;
• Registration certificate № 10/11/1815 from 08.11.2010;
• The work on substance registration in CIS countries (Russia, Armenia, Ukraine, Kazakhstan) are being conducted

The developer: Research Institute for Physical Chemical Problems of BSU
Production: UE Unitechprom BSU

Offer: finished substance sale