Combining crystalline and polymeric excipients in API solid dispersions–Opportunity or risk?

H Veith, F Wiechert, C Luebbert, G Sadowski - European Journal of …, 2021 - Elsevier
Amorphous solid dispersions (ASDs) are often metastable against crystallization of the
active pharmaceutical ingredient (API) and thus might undergo unwanted changes during …

Crystallization risk assessment of amorphous solid dispersions by physical shelf-life modeling: a practical approach

B Liu, F Theil, K Lehmkemper, D Gessner… - Molecular …, 2021 - ACS Publications
Amorphous solid dispersions (ASDs) of a poorly water-soluble active pharmaceutical
ingredient (API) in a polymer matrix can enhance the water solubility and therefore generally …

Mutual impact of phase separation/crystallization and water sorption in amorphous solid dispersions

C Luebbert, M Wessner, G Sadowski - Molecular Pharmaceutics, 2018 - ACS Publications
The molecular integration of poorly water soluble active pharmaceutical ingredients (APIs) in
a suitable polymeric matrix is a possible approach to enhance the dissolution behavior and …

[HTML][HTML] Factors influencing the crystallization-onset time of metastable ASDs

F Wolbert, IK Fahrig, T Gottschalk, C Luebbert… - Pharmaceutics, 2022 - mdpi.com
In formulation development, amorphous solid dispersions (ASD) are considered to improve
the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs) …

A prediction system: Regulating effect of small-molecule additives on properties of amorphous solid dispersions prepared by hot-melt extrusion technology

P Shen, C Zhang, E Hu, Y Gao, S Qian, J Zhang… - European Journal of …, 2023 - Elsevier
Amorphous solid dispersions (ASDs) with solubility advantage are suffering from the
recrystallization risk and subsequent reduced dissolution triggered by high hygroscopicity of …

[HTML][HTML] Solvent influence on the phase behavior and glass transition of Amorphous Solid Dispersions

S Dohrn, C Luebbert, K Lehmkemper… - European Journal of …, 2021 - Elsevier
Understanding the long-term stability of amorphous solid dispersions (ASDs) is important for
their successful approval for market. ASD stability does not only depend on the interplay …

Physical stability of API/polymer-blend amorphous solid dispersions

K Lehmkemper, SO Kyeremateng, M Bartels… - European Journal of …, 2018 - Elsevier
The preparation of amorphous solid dispersions (ASDs) is a well-established strategy for
formulating active pharmaceutical ingredients by embedding them in excipients, usually …

Thermodynamic modeling of solvent-impact on phase separation in amorphous solid dispersions during drying

S Dohrn, P Reimer, C Luebbert… - Molecular …, 2020 - ACS Publications
Understanding and prevention of unwanted changes of a pharmaceutical formulation during
the production process is part of the critical requirements for the successful approval of a …

Stability challenges of amorphous solid dispersions of drugs: A critical review on mechanistic aspects

M Pisay, S Padya, S Mutalik… - Critical Reviews™ in …, 2024 - dl.begellhouse.com
The most common drawback of the existing and novel drug molecules is their low
bioavailability because of their low solubility. One of the most important approaches to …

Choosing appropriate solvents for ASD preparation

C Luebbert, D Real, G Sadowski - Molecular pharmaceutics, 2018 - ACS Publications
Amorphous solid dispersions (ASDs) are often used for formulating poorly water-soluble
active pharmaceutical ingredients (APIs). In an ASD, the amorphous API is embedded in a …