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Hot-melt extrusion
Development of 3D-printed dual-release fixed-dose combination through double-melt extrusion
This study aimed to develop a 3D-printed fixed-dose combination tablet featuring differential release of two drugs using double-melt extrusion (DME). The hot-melt extrusion (HME) process was divided into two steps to manufacture a single filament containing the two drugs. In Step I, a…
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Stability of Dexamethasone during Hot-Melt Extrusion of Filaments based on Eudragit® RS, Ethyl…
Hot-melt extrusion (HME) potentially coupled with 3D printing is a promising technique for the manufacturing of dosage forms such as drug-eluting implants which might even be individually adapted to patient-specific anatomy. However, these manufacturing methods involve the risk of thermal…
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Formulation Development and Evaluation of Cannabidiol Hot-Melt Extruded Solid Self-Emulsifying Drug…
Cannabidiol (CBD) is a highly lipophilic compound with poor oral bioavailability, due to poor aqueous solubility and extensive pre-systemic metabolism. The aim of this study was to explore the potential of employing Hot Melt Extrusion (HME) technology for the continuous production of Self…
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A review of hot melt extrusion technology: Advantages, applications, key factors and future…
Abstract
After decades of development, hot melt extrusion (HME) technology has matured as a well-established pharmaceutical methodology. Through the process of extruding both drug and carrier materials in a molten state under specific conditions of pressure, velocity, and screw design, this…
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Quality by design approach for fabrication of extended-release buccal films for xerostomia employing…
The study endeavors the fabrication of extended-release adipic acid (APA) buccal films employing a quality by design (QbD) approach. The films intended for the treatment of xerostomia were developed utilizing hot-melt extrusion technology. The patient-centered quality target product profile was…
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Systematic Development of Hot Melt Extrusion-Based Amorphous Solid Dispersion: Integrating Quality…
Abstract
Purpose
The study aimed to develop and optimize apremilast (APST) solid dispersion formulations using copovidone (Kollidon VA64) as the carrier and vitamin E TPGS as the surfactant to enhance solubility and dissolution, and to utilize in silico Physiologically Based Biopharmaceutics…
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Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration…
Abstract
Forty-eight (48) drug products (DPs) containing amorphous solid dispersions (ASDs) have been approved by the U.S. Food and Drug Administration in the 12-year period between 2012 and 2023. These DPs comprise 36 unique amorphous drugs. Ten (10) therapeutic categories are represented, with…
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Advantages of combining polymers and lipids in extrusion processes
This poster was presented at the 14th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical (PBP) Technology, 18 - 21 March 2024, Vienna, Austria:
INTRODUCTION
Hot melt extrusion (HME) has become increasingly popular in pharmaceutical manufacturing over the last
decade1. This…
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Amorphous solid dispersion of a binary formulation with felodipine and HPMC for 3D printed floating…
Abstract
This study focuses on the combination of three-dimensional printing (3DP) and amorphous solid dispersion (ASD) technologies for the manufacturing of gastroretentive floating tablets. Employing hot melt extrusion (HME) and fused deposition modeling (FDM), the study investigates the…
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Development of immediate-release formulation with reliable absorption of rivaroxaban in various meal…
The bioavailability of rivaroxaban at the higher doses (15 and 20 mg) is considerably reduced when the drug is administered on an empty stomach. This can lead to inadequate anticoagulant effect, and therefore, it is recommended to use the higher doses at fed state. However, proper posology may…
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