EXPERIMENTAL DESIGN IN RESEARCH AT THE CREATION OF TABLET MEDICINES. Message 4. Using the method “Quality by Design” (QbD) in optimizing the composition and technology of tablet drugs
DOI:
https://doi.org/10.11603/2312-0967.2021.2.12153Keywords:
experimental design, quality by design, mathematical experiment planning, tabletsAbstract
The aim of the work. Analysis and systematization of literature data on the use of the approach Quality by Design in order to develop the optimal composition and technology of tablet drugs.
Materials and Methods. The methods of information search, analysis of scientific literature data on the possible application of the approach Quality by Design and its practical use in the development of the composition and technology of tablet drugs are used.
Results and Discussion. The work describes the general concept of the approach Quality by Design in pharmaceutical technology of medicines. Data on the practical application of this approach in the development of the composition and technology of tableted drugs, their optimization.
Conclusions. Quality by Design is an important and widely used technique in the development of medicines. During using the Quality by Design approach, the main attention is paid to the safety and efficacy of the drug, the technological understanding of the pharmaceutical process and applied methods are generalized, the scientific substantiation of risk assessment, determination of critical quality indicators, and analysis of their impact on the final quality of the developed product.
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