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Image Hot-Melt extrusion - from theory to application in pharmaceutical formulation - where are we now

Hot-melt extrusion: from theory to application in pharmaceutical formulation – where are we now?

Newsfeeds - 10/04/2024 -
Hot-melt extrusion (HME) stands as a widely acknowledged and robust technology, effectively enhancing the bioavailability of poorly soluble active pharmaceutical ingredients while offering an efficient continuous manufacturing process. The twin-screw …
Image Rapid And Material-Sparing Feasibility Screening For Hot Melt Extrusion

Rapid and material-sparing feasibility screening for hot melt extrusion

Newsfeeds - 05/04/2024 -
Amorphous solid dispersions (ASD) present a solution for enhancing the bioavailability of crystalline APIs that are otherwise poorly soluble. Two primary methods for manufacturing ASDs are spray drying and hot …
tablet white powder

Formulation development and compaction of itraconazole amorphous solid dispersions tablets using quality by design principles

Bulletins - 02/01/2023 - by Hetvi Triboandas, Mariana Bezerra, Walkiria Schlindwein
Itraconazole (ITZ), a BCS Class II drug exhibiting low solubility (1-4 ng/mL in water) requires formulation enhancement to achieve enhanced bioavailability. To tackle this problem amorphous solid dispersions (ASDS) of …
Poly(2-alkyl-2-oxazoline)s: A polymer platform to sustain the release from tablets with a high drug loading

Poly(2-alkyl-2-oxazoline)s: A polymer platform to sustain the release from tablets with a high drug loading

Papers - 01/12/2022 - by Aseel Samaro, Maarten Vergaelen, Martin Purino, Ali Tigrine, Victor R. de la Rosa, Niloofar Moazami Goudarzi, Matthieu N. Boone, Valérie Vanhoorne, Richard Hoogenboom, Chris Vervaet
Achieving sustained release of highly dosed active pharmaceutical ingredients (APIs) from a matrix tablet poses a significant challenge. To tackle this issue, this study assessed the efficacy of thermoplastic poly(2-alkyl-2-oxazoline)s …
Itraconazole Amorphous Solid Dispersion Tablets: Formulation and Compaction Process Optimization Using Quality by Design Principles and Tools

Itraconazole amorphous solid dispersion tablets: formulation and compaction process optimization using Quality by Design principles and tools

Papers - 07/11/2022 - by Hetvi Triboandas, Kendal Pitt, Mariana Bezerra, Delphine Ach-Hubert, Walkiria Schlindwein
BCS Class II drugs, exemplified by itraconazole (ITZ), are characterized by poor solubility (1–4 ng/mL), necessitating solubility enhancement. Consequently, amorphous solid dispersions (ASDs) of ITZ and Kollidon® VA64 (KOL) were …
Comparison of hydroxypropylcellulose and hot-melt extrudable hypromellose in twin-screw melt granulation of metformin hydrochloride: effect of rheological properties of polymer on melt granulation and granule properties

Comparison of hydroxypropylcellulose and hot-melt extrudable hypromellose in twin-screw melt granulation of metformin hydrochloride: effect of rheological properties of polymer on melt granulation and granule properties

Papers - 23/12/2021 - by Amol Batra, Fengyuan Yang, Michael Kogan, Anthony Sosnowik, Courtney Usher, Eugene W. Oldham, Ningyi Chen, Kamaru Lawal, Yunxia Bi, Thomas Dürig
High-molecular-weight hypromellose (HPMC) and hydroxypropyl cellulose (HPC) are widely recognized as extended-release polymers. While conventional high-molecular-weight HPMCs are preferred for extended-release applications, their use in twin-screw melt granulation is limited …
Impact of incorporated drugs on material properties of amorphous solid dispersions

Impact of incorporated drugs on material properties of amorphous solid dispersions

Papers - 28/12/2020 - by Karsten Flügel, Katharina Schmidt, Lena Mareczek, Michael Gäbe, Robert Hennig, Markus Thommes
Despite the widespread use of amorphous solid dispersions (ASD) for poorly water-soluble drugs in the market, the formulation development of ASDs remains challenging. In the process of developing novel drugs, …
Formulating amorphous solid dispersions: Impact of inorganic salts on drug release from tablets containing Itraconazole-HPMC extrudate

Formulating amorphous solid dispersions: Impact of inorganic salts on drug release from tablets containing Itraconazole-HPMC extrudate

Papers - 03/12/2019 - by Ryusuke Takano, Reto Maurer, Laurence Jacob, Frank Stowasser, Cordula Stillhart, Susanne Page
Amorphous solid dispersions (ASD) are increasingly utilized to enhance the oral bioavailability of poorly water-soluble compounds. However, the hydrophilic polymers present in ASD often exhibit high water binding properties, leading …
Assessment of volumetric scale-up law for processing of a sustained release formulation on co-rotating hot-melt extruders

Assessment of volumetric scale-up law for processing of a sustained release formulation on co-rotating hot-melt extruders

Papers - 01/10/2019 - by Jeroen Van Renterghem, Shana Van de Steene, Tryfon Digkas, Margarethe Richter, Chris Vervaet, Thomas De Beer
In this study, we evaluated the applicability of the volumetric scale-up law for transitioning from a laboratory-scale extruder (11 mm diameter) to a pilot-scale extruder (16 mm diameter) with geometric …
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Determination of surface energies of hot-melt extruded sugar–starch pellets

Papers - 07/02/2018 - by Chi-Wah Yeung, Hubert Rein
Hot-melt extruded sugar–starch pellets present an alternative to conventional sugar spheres, yet their coating properties require further investigation. The European Pharmacopoeia 8.6 and the United States Pharmacopeia 40 outline the …