Solvent

Active pharmaceutical ingredients (APIs) can exist in multiple crystal forms, known as polymorphs, that are chemically identical. Polymorphs of an API can appear over the course of development and lead to deviations across batches affecting stability, tableting properties, flowability,…
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Co-amorphous systems have been shown to be a promising strategy to address the poor water solubility of many drug candidates. However, little is known about the effect of downstream processing-induced stress on these systems. The aim of this study is to investigate the compaction properties of…
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Emerging drug-delivery systems demand a controlled or programmable or sustained release of drug molecules to improve therapeutic efficacy and patient compliance. Such systems have been heavily investigated as they offer safe, accurate, and quality treatment for numerous diseases. Amongst newly…
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Purpose: To characterize the physicochemical and dissolution properties of Soluplus®/ibupofen solid dispersions prepared by solvent casting technique. Methods: Soluplus® was used as a film-forming agent whereas ibuprofen served as a poorly soluble biopharmaceutics classification system (BCS)…
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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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See the brochure by IOI Oleo Pharma about their Quality & Regulatory: EXCIPIENTS & ACTIVE PHARMACEUTICAL INGREDIENTS - MADE IN GERMANY Founded in 1905, IOI Oleo’s manufacturing site in Witten has been engaged since the beginning of the 1950s in the manufacturing of…
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Flavonoids are natural compounds that are attracting great interest in the biomedical field thanks to the wide spectrum of their biological properties. Their employment as anticancer, anti-inflammatory, and antidiabetic drugs, as well as for many other pharmacological applications, is extensively…
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Since 3D printing allows for patient-specific dosage forms, it has become a major focus in pharmaceutical research. However, it is difficult to scale up drug product manufacturing. Injection molding has been used in conjunction with hot-melt extrusion to mass produce drug products, but making…
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Maltodextrin (MD) is a natural polymer ideal for electrospinning due to its non-toxicity, water solubility, and low viscosity. In this investigation, MD solutions, each containing a different dextrose equivalent (DE) value of 18, 10, and 4, were studied in an ethanol/water solvent system for the…
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The European Medicines Agency, the U.S. Food and Drug Administration, and other regulatory agencies expect that all pharmaceutical products be assessed for the potential presence of N-nitrosoamine (nitrosamine) impurities. This white paper addresses general considerations for nitrosamine risk…
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