[HTML][HTML] Linear solvation energy relationships (LSERs) for robust prediction of partition coefficients between low density polyethylene and water. Part I: Experimental …

T Egert, HC Langowski - European Journal of Pharmaceutical Sciences, 2022 - Elsevier
When equilibrium of leaching is reached within a product's duty cycle, partition coefficients
polymer/solution dictate the maximum accumulation of a leachable and thus, patient …

Evaluation of two cosolvency models to predict solute partitioning between polymers (LDPE) and water-ethanol simulating solvent mixtures

T Egert, HC Langowski - Pharmaceutical Research, 2022 - Springer
Purpose Binary water - ethanol mixtures, by mimicking a clinically relevant medium’s polarity-driven
extraction strength, facilitate experimental modeling of patient exposure to …

Simulated leaching (migration) study for a model container-closure system applicable to parenteral and ophthalmic drug products

D Jenke, T Egert, A Hendricker, J Castner… - PDA Journal of …, 2017 - journal.pda.org
A simulating leaching (migration) study was performed on a model container-closure
system relevant to parenteral and ophthalmic drug products. This container-closure system …

Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products

D Jenke, J Castner, T Egert, T Feinberg… - PDA Journal of …, 2013 - journal.pda.org
Polymeric and elastomeric materials are commonly encountered in medical devices and
packaging systems used to manufacture, store, deliver, and/or administer drug products. …

Predicting partitioning from low density polyethylene to blood and adipose tissue by linear solvation energy relationship models

…, A Böhme, AB Strobel, T Egert - Journal of Biomedical …, 2023 - Wiley Online Library
The variety of polymers utilized in medical devices demands for testing of extractables and
leachables according to ISO 10993‐18:2020 in combination with ISO 10993‐1:2018. The …

Predicting Leachables Solubilization in Polysorbate 80 solutions by a linear solvation energy relationship (LSER)

AB Strobel, T Egert, P Langguth - Pharmaceutical Research, 2021 - Springer
Purpose A linear solvation energy relationship (LSER) was developed to predict the partitioning
of neutral chemicals from polysorbate 80 (PS 80) micelles to water. Predicted partition …

Automated solid phase extraction (SPE) LC/NMR applied to the structural analysis of extractable compounds from a pharmaceutical packaging material of construction

…, JO Mullis, M Davis, S Pennino, T Egert… - PDA Journal of …, 2013 - journal.pda.org
The structural analysis (ie, identification) of organic chemical entities leached into drug
product formulations has traditionally been accomplished with techniques involving the …

[PDF][PDF] Extractables Characterization for Five Materials of

D Jenke, J Castner, T Egert - academia.edu
Polymeric and elastomeric materials are commonly encountered in medical devices and
packaging systems used to manufacture, store, deliver, and/or administer drug products. …

[PDF][PDF] Simulated Leaching (Migration) Study for a Model

D Jenke, T Egert, A Hendricker - academia.edu
A simulating leaching (migration) study was performed on a model container-closure
system relevant to parenteral and ophthalmic drug products. This container-closure system …

Evaluation of drug sorption on laboratory materials with abraham solvation parameters of drugs and its prevention

E Yamamoto, N Tominaga, H Kan-No, D Ando… - Pharmaceutical …, 2021 - Springer
Purpose Undesired drug sorption on laboratory material surfaces reduces the performance
of analytical methods and results in the generation of unreliable data. Hence, we …