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Solid Dispersion
Development of Robust Tablet Formulations with Enhanced Drug Dissolution Profiles from…
Fibre-based oral drug delivery systems are an attractive approach to addressing low drug solubility, although clear strategies for incorporating such systems into viable dosage forms have not yet been demonstrated. The present study extends our previous work on drug-loaded sucrose microfibres…
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Development of Mefenamic Acid-Soluplus® amorphous dispersions via hot melt extrusion and in silico…
The objective of this study was to increase the solubility of Mefenamic Acid (MA), a BCS class II drug by formulating amorphous solid dispersions via Hot-Melt Extrusion. The extrudates were prepared at different drug to polymer ratios and characterised by standard analytical techniques. Dissolution…
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Selective laser sintering additive manufacturing of dosage forms: Effect of powder formulation and…
Large batches of placebo and drug-loaded solid dosage forms were successfully fabricated using selective laser sintering (SLS) 3D printing in this study. The tablet batches were prepared using either copovidone (N-vinyl-2-pyrrolidone and vinyl acetate, PVP/VA) or polyvinyl alcohol (PVA) and…
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Evaluating Spray Drying and Co-precipitation as Manufacturing Processes for Amorphous Solid…
Amorphous solid dispersions feature prominently in the approach to mitigate low bioavailability of poorly water-soluble small molecules, particularly in the early development space focusing on toxicity evaluations and clinical studies in normal healthy volunteers, where high exposures are needed to…
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Amorphous Solid Dispersions Layered onto Pellets – An Alternative to Spray Drying?
Spray drying is one of the most frequently used solvent-based processes for manufacturing amorphous solid dispersions (ASDs). However, the resulting fine powders usually require further downstream processing when intended for solid oral dosage forms. In this study, we compare properties and…
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Application of biorelevant in vitro assays for the assessment and optimization of ASD-based…
Amorphous solid dispersions (ASD) have been a successful formulation strategy to overcome the poor aqueous solubility of many novel drugs, but the development of pediatric formulations presents a special challenge due to variable gastrointestinal conditions in children. It was the aim of this work…
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Enhancement of itraconazole solubility and release by hot-melt extrusion with Soluplus®
Formulation of poorly water-soluble drugs is a significant challenge in the development of oral solid dosage forms. The objective was to investigate the effect of hot-melt extrusion process and formulation variables on the solid state, solubility and release of an ionizable poorly soluble drug,…
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From Screening to Downstreaming – 4th Seminar on Amorphous Solid Dispersion
See the 4th Seminar on Amorphous Solid Dispersion.
As technology provider in the field of ASD, Shin-Etsu together with the partners Alexanderwerk, Frewitt, PROCEPT and Thermo Fisher Scientific, will share latest insights of ASD development steps ranging from initial screening phase up to downstream…
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Downstream processing of amorphous solid dispersions into tablets
Amorphous solid dispersions have gained tremendous attention as a commercially viable solubility enhancement technique for poorly water-soluble drugs. However, poor drug loading associated with poor drug-polymer miscibility is a major challenge in the downstream processing of ASDs. While many…
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Enhancing the oral drug delivery through hot melt extrusion techniques
Hot melt extrusion has been developed as a fresh technique for taste masking, in recent years. This method provides many aids as compared to traditional methods like avoiding the use of solvents, continuous manufacturing, ease to scale up, and adaptability to meet the goals of FDA for quality…
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