The International Coordinating Committee for the Registration of Technical Standards for Human Drugs (ICH) put forward the QbD concept (quality comes from the design concept) in the ICH Q8(R2) issued in 2009, and its main goal is consistent drug product quality or performance and subsequent cost reduce. The application of QbD concept in formulation design and process optimization can provide a reference for industrial production.
Under the traditional product design and production concept, product quality is extremely dependent on product testing and control, and QbD emphasizes that product quality comes from its pre-production design, rather than the testing of existing products. The QbD concept has important application value in process optimization and process verification. Design of Experiments (DOE) and multivariate statistical data analysis are indispensable foundations. Using DOE, you can evaluate the influence of each formula factor on each response value (and possibly the interaction between the factors), and determine the key factors based on statistical analysis. Once the key factors are determined and the levels of all key factors are optimized using DOE, the optimal formula can be determined.
Daling tablets are traditional Chinese medicine preparations made of Corydalis yanhusuo and other main ingredients. In order to meet the extraction requirements of Daling tablets production, some researchers have used the QbD concept to improve the quality control level of the alcohol extraction process of yanhusuo. The researchers used solvent multiples, extraction time, and soaking time as the key process parameters; the dry paste rate, dehydrofumarine content in the corydalis extract, and dehydrofumarine transfer rate were key quality attributes; the response surface method was used to establish the key process parameters Mathematical model between and key quality attributes, establish a design space with multiple indicators overlapping, select a better operating space, and finally perform process verification [1]. The study found that the QbD concept is helpful to the improvement of the alcohol extraction process of Corydalis yanhusuo, and obtain a reliable and suitable extraction operation space for the production of Daling tablets.
QbD is a systematic development method that emphasizes the understanding of products and production processes as well as process control based on sound science and quality risk management. Medicilon provides formulation process outsourcing services. Its process research and development department is committed to developing stable and low-cost processes suitable for large-scale production. It has rich experience in process optimization and the development of new, safe and environmentally friendly process routes. Its unique The “customized” process development model allows customers to obtain APIs as soon as possible for clinical research.
In order to prolong the duration of effective blood drug concentration, reduce the adverse reactions caused by the sudden release of drugs, and improve the compliance of patients with medication, traditional drugs can be designed into traditional sustained and controlled release preparations. The study found that it is scientific and effective to use the QbD concept in the design and optimization of the formulation process of sustained and controlled release preparations. Some researchers designed and optimized the formulation process of theophylline hydrophilic gel matrix sustained-release tablets based on the concept of “Quality by Design” (QbD) [2]. It is found that the formulation process of theophylline sustained-release tablets based on the QbD concept can meet the requirements of formulation design, and the products prepared by adjusting the key process parameters (CPPs) within the range of PAR (acceptable range) can meet the requirements of critical quality attributes (CQAs) , Which shows that the QbD concept is scientific and effective for the design and optimization of the formulation process of sustained and controlled release preparations.
The QbD concept is a systematic, structured, scientific and risk-based drug research and development method. It is an important tool for scientific and effective management of products, processes and analysis methods. It can be used to guide the development and control of drugs and processes, Generic drug preparation technology, guide the establishment of analytical methods, etc.
[1] Research on the quality control of the alcohol extraction process of Corydalis yanhusuo based on the concept of quality by design (QbD) [J].
[2] The formulation and optimization of theophylline gel matrix sustained-release tablets based on the QbD concept [J].
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