Department of Research and Development

 

Laboratory of technology of finished dosage forms carries out the development of formulations and production technology of oral drug products. For these reasons the laboratory is equipped with the necessary technological and analytical equipment.

Technological equipment is designed to develop various technological processes that simulate the conditions of industrial production:

In the Laboratorytest methods of drug substances and finished dosage forms are developed, as well as stabilitystudies of finished dosage forms during storage under natural and accelerated conditions are carried out.

To confirm the equivalence of the developed drug product to the original drug an in vitro dissolution test is used. During the test three basic dissolution media with different pH values are used: 1.2-corresponds to an empty human stomach, 4.5-corresponds to a full stomach, 6.8-corresponds to an intestinal medium. Thus, only after confirmation of the equivalence in vitro, it is possible to obtain permission to conduct bioequivalent or clinical trials on humans.

The enterprise is recognized to be competent in performance of research and development, experimental and technological works, and is accredited as the scientific organization (the Certificate of accreditation of the Scientific organization No. 205 of March 16, 2018).