Application of mechanism-based modeling to predict drug quality during the pharmaceutical unit operations of granulation
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Journal of Pharmaceutical Investigation https://doi.org/10.1007/s40005-020-00489-6
REVIEW
Application of mechanism‑based modeling to predict drug quality during the pharmaceutical unit operations of granulation and compression: a review Mi Seo Park1 · Du Hyung Choi1 Received: 17 March 2020 / Accepted: 25 April 2020 © The Korean Society of Pharmaceutical Sciences and Technology 2020
Abstract Background Interest in simulation and modeling techniques in the pharmaceutical industry has grown drastically in recent years. These techniques have improved our understanding of the fundamental pharmaceutical processes by providing valuable insights into the manufacturing processes. Area covered This review focused on mechanism-based modeling and its application in simulating intermediate quality attributes and drug product quality for pharmaceutical unit operations related to granulation and compression process. On the basis of the mechanism, granulation is categorized as wet and dry. Various mathematical modeling principles and case studies were introduced with predictive values and intermediate quality attributes of drug product. Expert opinion Modeling techniques used to predict drug quality in a pharmaceutical unit operation can be classified into two categories: empirical models and mechanism-based models. According to the Food and Drug Administration-mandated Quality by Design (QbD) concept, the use of proper modeling can help determine the effect of process parameters on product quality and establish scale-up strategies for commercial processes. Consequently, Mechanism-based modeling provides valuable insights into the manufacturing process, which can result in improvements in the pharmaceutical continuous manufacturing process. Keywords Mechanism-based modeling · Simulation · Granulation · Compression · Quality by design
Introduction According to the principles of Quality by Design (QbD), the design space for a formulation and process should be established during pharmaceutical development to discover optimal settings. It is also important to determine the correlation between potential critical material attributes, such as active pharmaceutical ingredients and excipients and potential drug product critical quality attributes (CQAs) to obtain adequate design space for a particular formulation. Similarly, the effect of prospective critical process parameters on the potential CQAs should be ascertained during the manufacturing development stage (Pandey et al. 2013; Lee et al. 2017; Han et al. 2019). In the design of experiment * Du Hyung Choi [email protected] 1
Department of Pharmaceutical Engineering, Inje University, Gimhae, Gyeongnam 621‑749, Republic of Korea
(DoE) approach, generally, 3–5 components and 5–6 different unit operations are studied, and the effects of variations in each parameter and their interactions on the potential drug product quality are examined (Aksu et al. 2013; Kan et al. 2014; Visser et al. 2015; Lee et al. 2017; Badawy et al. 2019; Han et al. 2019). This usually results in an
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