A new drug assessment method developed in Russia

Print 07 September 2017
GMP News

Russian scientists proposed a new method for assessing the medicines that will allow to avoid testing drugs in humans.

In health care system, the clinical trials are conducted in order to collect data on safety and efficacy of new medicinal products or medical devices. All drugs, even the so-called “generics,” the copies of original drugs, must pass the testing. There is a two-stage system to study the generics. First, they are tested in vitro; and next, if the results of the first tests are good, the studies are conducted in healthy volunteers (in vivo). The results of such tests allow to assess how the drug dissolves and is absorbed by the human body.

The trials conducted on a group of volunteers require considerable resources from the pharmaceutical company, which increases the costs of the drugs that it manufactures.

Igor Shokhin, Doctor of Pharmaceutical Sciences, a graduate of I.M. Sechenov Moscow Medical Academy (now Sechenov University), and the head of Center of Pharmaceutical Analytics, developed a methodology that allows to transfer the Phase II clinical trials of a new drug to the lab. The researchers of the Center use a special device to simulate the environment of a drug once it gets into the stomach. This allows to change the acidity and temperature in order to imitate the intake of the drug on empty stomach when the acidity is higher than usual, or on a full stomach when the acidity goes down while the temperature may rise. In both cases, an important part of the process is to mix the solution at a certain frequency.

Some time after the tablet dissolves, it is necessary to take samples of liquid and analyze them using a spectrophotometer. The device allows to assess at what point the tablet coat begins to dissolve and release the active substances. Following the analysis, the researchers build a kinetic dissolution curve, which is evaluated by using the mathematical analysis to establish how the dissolution curve of the new drug differs from similar data for the original medication.

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