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Hot-melt extrusion
Improving drug release rate, drug-polymer miscibility, printability and processability of FDM…
Slow drug release, low drug-polymer miscibility, poor printability of polymers used, and high processing temperature are major challenges in developing FDM 3D-printed tablets. These challenges were addressed in this investigation by having a model basic drug, haloperidol (mp: 151.5 °C), interact…
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Design and optimization of ciprofloxacin hydrochloride biodegradable 3D printed ocular inserts: Full…
Coupling hot-melt extrusion (HME) with fused deposition modeling three-dimensional printing (FDM-3DP) can facilitate the fabrication of tailored, patient-centered, and complex-shaped ocular dosage forms. We fabricated ciprofloxacin HCl ocular inserts by coupling high-throughput, solvent-free, and…
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Preparation and in vitro evaluation of hot-melt extruded pectin-based pellets containing ketoprofen…
This work developed high drug-load pellets for colon targeting in minimal steps by coupling hot-melt extrusion (HME) with a die-surface cutting pelletizer, offering a potential continuous pellet manufacturing process. Ketoprofen (KTP) was selected as a model drug for this study due to its thermal…
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New Development in Understanding Drug–Polymer Interactions in Pharmaceutical Amorphous Solid…
Pharmaceutical amorphous solid dispersions (ASDs) represent a widely used technology to increase the bioavailability of active pharmaceutical ingredients (APIs). ASDs are based on an amorphous API dispersed in a polymer, and their stability is driven by the presence of strong intermolecular…
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Investigation of hot melt extrusion process parameters on solubility and tabletability of…
Reports in the literature indicate that hot-melt extrusion (HME) processing techniques could alter the mechanical properties of the pharmaceutical physical blend, which may alter successful processing during tableting. The aim of this study was to evaluate whether HME processing conditions have an…
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Downstream Processing of Amorphous Solid Dispersions into Orodispersible Tablets
The formulation development of amorphous solid dispersions (ASDs) towards a patient-friendly oral solid dosage form is proving to be still challenging. To increase patient’s compliance orodispersible tablets (ODTs) can be seen as promising alternative. Two different ASDs were prepared via hot melt…
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Exposing Profound Screening Potential of Ethanol-Based Dissolution Media in the Development of…
Characterization of drug release from modified-release products in the presence of alcohol is required to evaluate the possibility of dose dumping due to safety assurance reasons. A generic product containing BCS IV drug and HPMCAS polymer was formulated as amorphous solid dispersion with hot-melt…
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Pharmaceutical Hot Melt Extrusion Process Development Using QbD and Digital Twins
Pharmaceutical product development guided by Quality by Design (QbD) is based on a complete understanding of the critical process parameters (CPPs) that are important for achieving the desired product critical quality attributes (CQAs). The effect of process settings, such as the screw speed, the…
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Parteck MXP Excipients for Hot Melt Extrusion
Two Polyvinyl Alcohol Grades Providing Excellent Performance for Solubility Enhancement and Stabilization
Poor solubility of APIs is a critical challenge in drug development. One formulation technique to address this challenge is hot melt extrusion (HME). Mercks Parteck® MXP range of polymers…
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BASF Pharma Solutions excipient accepted into FDA Pilot Program for novel excipients – Press…
Florham Park, New Jersey, December 5, 2022 –
BASF Pharma Solutions, a global business unit of BASF, announces today that the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), Office of New Drugs, has accepted their excipient, Soluplus®, into the FDA’s Pilot…
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