| Hygiene of populated places | ISSN: 2707-0441 eISSN: 2707-045X |
Issue 69, 2019 - Pages: 261-269
USE OF THE BIOPHARMACEUTICAL CLASSIFICATION SYSTEM FOR THE OPTIMIZATION OF THE DRUG QUALITY CONTROL IN THE UKRAINIAN MARKET
Ya.Yu. Nikolaieva1, N.V. Ostanina1, M.G. Levin1
1 STATE INSTITUTION “O.M. MARZIEIEV INSTITUTE FOR PUBLIC HEALTH” NAMSU
ÓÄÊ: 615.074
SUMMÀRY:
Objective. On the basis of the Biopharmaceutical Classification System we identified the pos-sible ways for the optimization of drug quality control in the Ukrainian market.
Materials. We used the Biopharmaceutical Classification System to optimize the drug quality control.
Results. Today, when using drugs, there is a frequent problem of the lack of the prescribed therapeutic, prophylactic effect, or vice versa, the side-effects are observed.
For effective organization of the quality control of oral medical preparations with an active substance in the form of a solid phase, it is necessary to use the conception of the Biopharmaceutical Classification System (BCS), in particular, to take into account the data on permeability and solubility of the corresponding pharmaceutical substances (PS). Thus, provision of the safety and effectiveness of the drugs is a main aspect connected with their turnover.
The safety aspect is a risk of the contact of dissolved PS with a high permeability with those areas of the gastrointestinal tract that are not intended for absorption.
A sufficient completeness of absorption of the PS is an aspect of effectiveness.
According to the authors, the preparations of the BCS classes 2 and 4 are the most problem-atic and requiring approaches that exceed the limits of the pharmacopoeial methods and quality con-trol methods.
Conclusions. At this time, there is a need to use BCS to optimize the quality control of solid oral drugs in the Ukrainian market. The potential possibilities of the use of the BCS for this optimiza-tion were considered and described, which will make it possible to detect more efficiently the drugs that may have potential problems with bioavailability / bioequivalence. Possible ways for such an optimization were discussed. This conception will allow us to direct the resources of regulatory authori-ties to the identification of the “problem” groups of drugs.
Materials. We used the Biopharmaceutical Classification System to optimize the drug quality control.
Results. Today, when using drugs, there is a frequent problem of the lack of the prescribed therapeutic, prophylactic effect, or vice versa, the side-effects are observed.
For effective organization of the quality control of oral medical preparations with an active substance in the form of a solid phase, it is necessary to use the conception of the Biopharmaceutical Classification System (BCS), in particular, to take into account the data on permeability and solubility of the corresponding pharmaceutical substances (PS). Thus, provision of the safety and effectiveness of the drugs is a main aspect connected with their turnover.
The safety aspect is a risk of the contact of dissolved PS with a high permeability with those areas of the gastrointestinal tract that are not intended for absorption.
A sufficient completeness of absorption of the PS is an aspect of effectiveness.
According to the authors, the preparations of the BCS classes 2 and 4 are the most problem-atic and requiring approaches that exceed the limits of the pharmacopoeial methods and quality con-trol methods.
Conclusions. At this time, there is a need to use BCS to optimize the quality control of solid oral drugs in the Ukrainian market. The potential possibilities of the use of the BCS for this optimiza-tion were considered and described, which will make it possible to detect more efficiently the drugs that may have potential problems with bioavailability / bioequivalence. Possible ways for such an optimization were discussed. This conception will allow us to direct the resources of regulatory authori-ties to the identification of the “problem” groups of drugs.
KEYWORDS:
Biopharmaceutical Classification System, solubility, permeability, quality control, generics, dissolu-tion test, disintegration test.
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FOR CITATION:
Nikolaieva Ya.Yu., Ostanina N.V., Levin M.G. Ispolzovanie biofarmatsevticheskoi klassifikatsionnoi sistemy dlia optimizatsii kontrolia kachestva lekarstvennykh preparatov na rynke Ukrainy [Use of the biopharmaceutical classification system for the optimization of the drug quality control in the Ukrainian market]. In : Hihiiena naselenykh mists : zb. nauk. pr. [Hygiene of Populated Places]. Kyiv ; 2019 ; 69 : 261-269 (in Russian).