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Hot-melt extrusion
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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SEDEX—Self-Emulsifying Delivery Via Hot Melt Extrusion: A Continuous Pilot-Scale Feasibility Study
The aim of this study was to develop a continuous pilot-scale solidification and characterization of self-emulsifying drug delivery systems (SEDDSs) via hot melt extrusion (HME) using Soluplus® and Kollidon® VA-64. First, an oil-binding capacity study was performed to estimate the maximal amount of…
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The impact of applying an additional polymer coating on high drug-loaded amorphous solid dispersions…
Inhibiting surface crystallization is an interesting strategy to enhance the physical stability of amorphous solid dispersions (ASDs), still preserving high drug loads. The aim of this study was to investigate the potential surface crystallization inhibitory effect of an additional polymer coating…
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Extrusion 3D printing of minicaplets for evaluating in vitro & in vivo praziquantel delivery…
This study aimed to explore extrusion three dimensional (3D) printing technology to develop praziquantel (PZQ)-loaded minicaplets and evaluate their in vitro and in vivo delivery capabilities. PZQ-loaded minicaplets were 3D printed using a fused deposition modelling (FDM) principle-based extrusion…
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