The shelf life of ASDs: 1. Measuring the crystallization kinetics at humid conditions

F Wolbert, K Nikoleit, M Steinbrink… - Molecular …, 2022 - ACS Publications
Amorphous solid dispersions (ASDs), where an active pharmaceutical ingredient (API) is
dissolved in a polymer, are a favored formulation technique to achieve sufficient …

[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) …

[HTML][HTML] The shelf life of ASDs: 2. Predicting the shelf life at storage conditions

F Wolbert, C Luebbert, G Sadowski - International journal of pharmaceutics …, 2023 - Elsevier
Amorphous solid dispersions (ASDs) are a widely used formulation technology for poorly
water-soluble active pharmaceutical ingredients (API). Depending on the API-polymer …

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 …

Simultaneous Water Sorption and Crystallization in ASDs 1: Stability Studies Lasting for Two Years

B Grönniger, K Kimpe, A Singh… - Molecular …, 2024 - ACS Publications
One way to increase the slow dissolution rate and the associated low bioavailability of newly
developed active pharmaceutical ingredients (APIs) is to dissolve the API in a polymer …

In-situ determination of crystallization kinetics in ASDs via water sorption experiments

C Luebbert, G Sadowski - European Journal of Pharmaceutics and …, 2018 - Elsevier
Amorphous solid dispersions (ASD) are intended to improve the bioavailability of poorly
water-soluble active pharmaceutical ingredients. However, the development of long-term …

[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 …

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 …

A mechanistic model for predicting the physical stability of amorphous solid dispersions

AT Ojo, PI Lee - Journal of Pharmaceutical Sciences, 2021 - Elsevier
In this paper, we establish a mechanistic model for the prediction of amorphous solid
dispersion (ASD) stability. The novel approach incorporates fundamental physical …

Simultaneous Water Sorption and Crystallization in ASDs 2: Modeling Long-Term Stabilities

B Grönniger, E Fritschka, K Kimpe… - Molecular …, 2024 - ACS Publications
The physical stability of amorphous solid dispersions (ASDs) is a major topic in the
formulation research of oral dosage forms. To minimize the effort of investigating the long …