Clinical and Preclinical Studies, Bioavailability and Pharmacokinetics of Hot‐Melt Extruded Products

Guns, Sandra; Mooter, Guy Van den

doi:10.1002/9780470711415.ch10

Cited by 1 publication

(1 citation statement)

References 27 publications

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“…Provided that there is sufficient in vitro data on dissolution and precipitation, the in vivo drug release profile of ASD can be described, combining drug dissolution, and nucleation with crystal growth models, which are yet to be incorporated into commercial PBPK models (73). Clinical data of HME-based drug products, including ASDs, are still rarely reported in literature (74). Currently process and product modeling are linked via in vitro data, i.e., the process modeling aims to cover the process behavior and aspires to predict the in vitro performance of the drug, whereas product modeling aims to link the in vitro data and predict the expected in vivo behavior.…”

Section: Biopharmaceutics Assessmentmentioning

confidence: 99%

Developing HME-Based Drug Products Using Emerging Science: a Fast-Track Roadmap from Concept to Clinical Batch

et al. 2020

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This paper presents a rational workflow for developing enabling formulations, such as amorphous solid dispersions, via hot-melt extrusion in less than a year. First, our approach to an integrated product and process development framework is described, including state-ofthe-art theoretical concepts, modeling, and experimental characterization described in the literature and developed by us. Next, lab-scale extruder setups are designed (processing conditions and screw design) based on a rational, model-based framework that takes into account the thermal load required, the mixing capabilities, and the thermo-mechanical degradation. The predicted optimal process setup can be validated quickly in the pilot plant. Lastly, a transfer of the process to any GMP-certified manufacturing site can be performed in silico for any extruder based on our validated computational framework. In summary, the proposed workflow massively reduces the risk in product and process development and shortens the drug-to-market time for enabling formulations.

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Section: Biopharmaceutics Assessmentmentioning

confidence: 99%