[HTML][HTML] Hot-melt extrusion in the pharmaceutical industry: toward filing a new drug application

MF Simões, RMA Pinto, S Simões - Drug Discovery Today, 2019 - Elsevier
The pharmaceutical development of amorphous solid dispersions (ASDs) by hot-melt
extrusion (HME) is briefly reviewed. A systematic step-by-step approach is presented, where …

Physical stability of amorphous solid dispersions: a physicochemical perspective with thermodynamic, kinetic and environmental aspects

X Lin, Y Hu, L Liu, L Su, N Li, J Yu, B Tang… - Pharmaceutical …, 2018 - Springer
Abstract Purpose Amorphous solid dispersions (ASDs) have been widely used in the
pharmaceutical industry for solubility enhancementof poorly water-soluble drugs. The …

Quality-by-design in hot melt extrusion based amorphous solid dispersions: An industrial perspective on product development

A Butreddy, S Bandari, MA Repka - European Journal of Pharmaceutical …, 2021 - Elsevier
An industrially feasible approach to overcome the solubility and bioavailability limitations of
poorly soluble active pharmaceutical ingredients is the development of amorphous solid …

[HTML][HTML] Advances in the development of amorphous solid dispersions: The role of polymeric carriers

J Zhang, M Guo, M Luo, T Cai - Asian Journal of Pharmaceutical Sciences, 2023 - Elsevier
Amorphous solid dispersion (ASD) is one of the most effective approaches for delivering
poorly soluble drugs. In ASDs, polymeric materials serve as the carriers in which the drugs …

Moisture sorption by polymeric excipients commonly used in amorphous solid dispersion and its effect on glass transition temperature: I. Polyvinylpyrrolidone and …

NG Patel, ATM Serajuddin - International Journal of Pharmaceutics, 2022 - Elsevier
Moisture plays a critical role in the stability of amorphous solid dispersions (ASD) as it can
lower the glass transition temperature (T g) and thereby increase molecular mobility …

Solid-state analysis of amorphous solid dispersions: Why DSC and XRPD may not be regarded as stand-alone techniques

S Dedroog, T Pas, B Vergauwen, C Huygens… - … of Pharmaceutical and …, 2020 - Elsevier
Amorphous solid dispersions (ASDs) are single-phase amorphous systems, where drug
molecules are molecularly dispersed (dissolved) in a polymer matrix. The molecular …

The application of temperature-composition phase diagrams for hot melt extrusion processing of amorphous solid dispersions to prevent residual crystallinity

DE Moseson, LS Taylor - International journal of pharmaceutics, 2018 - Elsevier
Hot melt extrusion (HME) can be used to produce amorphous solid dispersions (ASDs) at
temperatures below the drug's melting point if the drug and polymer exhibit melting point …

Impact of polymer type and relative humidity on the long-term physical stability of amorphous solid dispersions

K Lehmkemper, SO Kyeremateng… - Molecular …, 2017 - ACS Publications
The purpose of this work is to compare the long-term physical stability of amorphous solid
dispersion (ASD) formulations based on three different commercially used excipients …

What are the important factors that influence API crystallization in miscible amorphous API–excipient mixtures during long-term storage in the glassy state?

A Newman, G Zografi - Molecular Pharmaceutics, 2021 - ACS Publications
In this Perspective, the authors examine the various factors that should be considered when
attempting to use miscible amorphous API–excipient mixtures (amorphous solid dispersions …

Predicting solubility/miscibility in amorphous dispersions: it is time to move beyond regular solution theories

BD Anderson - Journal of pharmaceutical sciences, 2018 - Elsevier
The evolving challenges associated with the development of poorly soluble drug molecules
have been met with major advances in drug solubilization. In particular, amorphous solid …