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Granulation development in batch-to-batch and continuous processes from a quality by design perspective
09 Jun 2023 | Contributor(s):: Ko, Seung Jin, Lee, Ju-Hyun, Kang, Chin-Yang, Park, Jun-Bom
The process of quality by design (QbD) is of great importance in drug development. This review describes the design of experiments (DoE) method, which is an important component of QbD. DoE is predominantly divided into a screening phase and an optimization phase. The screening phase uses...
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Converting a batch based high -shear granulation process to a continuous dry granulation process; a demonstration with ketoprofen tablets
09 Jun 2023 | Contributor(s):: Taipale-Kovalainen, Krista, Ketolainen, Jarkko, Korhonen, Ossi, Ervasti, Tuomas
When one wishes to convert a batch based manufacturing process of an existing tablet product to a continuous process, there are several available strategies which can be adopted. Theoretically, the most straightforward way would be to proceed with the corresponding processing principles, for...
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Application of continuous twin screw granulation for the metformin hydrochloride extended release formulation
09 Jun 2023 | Contributor(s):: Kim, Su-Hyeon, Hwang, Kyu-Min, Cho, Cheol-Hee, Nguyen, Thi-Tram, Seok, Su Hyun, Hwang, Kyu-Mok, Kim, Ju-Young, Park, Chun-Woong, Rhee, Yun-Seok, Park, Eun-Seok
This study focuses on evaluating the potential of transferring from a batch process to continuous process for manufacturing of the extended release formulation. Metformin hydrochloride (HCl) was used in the model formulation which was intended to contain the high amount of hydrophilic drug. The...