Integration of advanced methods and models to study drug absorption and related processes: An UNGAP perspective

Wilson, Clive G.; Aarons, Leon; Augustijns, Patrick; Brouwers, Joachim; Darwich, Adam S.; Waal, Tom de; Garbacz, Grzegorz; Hansmann, Simone; Hoc, Dagmara; Ivanova, Anela; Koziolek, Mirko; Reppas, Christos; Schick, Philipp; Garcı́a-Horsman, J. Arturo

doi:10.1016/j.ejps.2021.106100

Cited by 17 publications

(5 citation statements)

References 232 publications

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“…In vitro evaluations under conditions simulating drug administration in the fasted state are possible, after considering the appropriate level of simulation of the system and after confirming the usefulness of in vitro data against luminal data in humans. Micellar drug concentrations in the duodenal compartment of the in vitro biorelevant gastrointestinal transfer (BioGIT) system are in line with micellar drug concentrations in the upper small intestine (10). The BioGIT system has been shown to be useful for evaluating the impact of formulation and/or dose on early exposure, after oral administration of conventional or enabling drug products with a glass of water to fasted adults (11).…”

Section: In Vitro Evaluation Of Drug Presence In the Micellar Phase O...mentioning

confidence: 91%

Drug Dissolution in Oral Drug Absorption: Workshop Report

Raines,

Agarwal,

Augustijns

et al. 2023

AAPS J

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The in-person workshop “Drug Dissolution in Oral Drug Absorption” was held on May 23–24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout sessions. Three common topics that were re-visited by various lecturers were amorphous solid dispersions (ASDs), dissolution/permeation interplay, and in vitro methods to predict in vivo biopharmaceutics performance and risk. Topics that repeatedly surfaced across breakout sessions were the following: (1) meaning and assessment of “dissolved drug,” particularly of poorly water soluble drug in colloidal environments (e.g., fed conditions, ASDs); (2) potential limitations of a test that employs sink conditions for a poorly water soluble drug; (3) non-compendial methods (e.g., two-stage or multi-stage method, dissolution/permeation methods); (4) non-compendial conditions (e.g., apex vessels, non-sink conditions); and (5) potential benefit of having both a quality control method for batch release and a biopredictive/biorelevant method for biowaiver or bridging scenarios. An identified obstacle to non-compendial methods is the uncertainty of global regulatory acceptance of such methods.

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Section: In Vitro Evaluation Of Drug Presence In the Micellar Phase O...mentioning

confidence: 91%

Drug Dissolution in Oral Drug Absorption: Workshop Report

Raines,

Agarwal,

Augustijns

et al. 2023

AAPS J

Self Cite

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“…Intact skin is known to prevent the absorption of topical treatments. Even in injured skin, investigations have shown that drug molecules have low permeability, highlighting the need for innovative delivery mechanisms to ensure that drugs reach their intended target [ 18 ]. Lipid-based nano-drug delivery systems offer promising solutions to these problems.…”

Section: Mechanism Of Lipid-based Drug Delivery Systemsmentioning

confidence: 99%

Combinational System of Lipid-Based Nanocarriers and Biodegradable Polymers for Wound Healing: An Updated Review

Far

Naimi-Jamal

Sedaghat

et al. 2023

JFB

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Skin wounds have imposed serious socioeconomic burdens on healthcare providers and patients. There are just more than 25,000 burn injury-related deaths reported each year. Conventional treatments do not often allow the re-establishment of the function of affected regions and structures, resulting in dehydration and wound infections. Many nanocarriers, such as lipid-based systems or biobased and biodegradable polymers and their associated platforms, are favorable in wound healing due to their ability to promote cell adhesion and migration, thus improving wound healing and reducing scarring. Hence, many researchers have focused on developing new wound dressings based on such compounds with desirable effects. However, when applied in wound healing, some problems occur, such as the high cost of public health, novel treatments emphasizing reduced healthcare costs, and increasing quality of treatment outcomes. The integrated hybrid systems of lipid-based nanocarriers (LNCs) and polymer-based systems can be promising as the solution for the above problems in the wound healing process. Furthermore, novel drug delivery systems showed more effective release of therapeutic agents, suitable mimicking of the physiological environment, and improvement in the function of the single system. This review highlights recent advances in lipid-based systems and the role of lipid-based carriers and biodegradable polymers in wound healing.

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“…In vivo data on fluid dynamics, proteomics, transcriptomics, and drug behaviour can improve our ability to characterise variability in drug exposure through the use of systems modelling [ 65 , 66 , 67 , 68 ]. New in vitro experimental techniques, coupled with modelling, improve the translation of formulation effects from in vitro to human subjects [ 69 ]. Middle-out modelling approaches allow the estimation of variability and reverse translation of physiological parameters, leading to opportunities in virtual bioequivalence and mechanistic in vitro–in vivo extrapolation of drug formulations [ 70 , 71 , 72 , 73 ].…”

Section: Summary Of Webinarsmentioning

confidence: 99%

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

McAllister

Flanagan

Cole³

et al. 2022

Pharmaceutics

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A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scientists, together with regulatory and academic scientists, came together through a series of six webinars, to discuss progress in the field, emerging trends, and areas for continued collaboration and harmonisation. Each webinar also hosted a Q&A session where participants could discuss the shared topic and information. Although it was clear from the presentations and Q&A sessions that we continue to make progress in the field of CRDSs and the utility/success of PBBM, there is also a need to continue the momentum and dialogue between the industry and regulators. Five key areas were identified which require further discussion and harmonisation.

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Integration of advanced methods and models to study drug absorption and related processes: An UNGAP perspective

Cited by 17 publications

References 232 publications

Drug Dissolution in Oral Drug Absorption: Workshop Report

Drug Dissolution in Oral Drug Absorption: Workshop Report

Combinational System of Lipid-Based Nanocarriers and Biodegradable Polymers for Wound Healing: An Updated Review

Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

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