Bimodal silica: a game-changing ingredient

Published: 3-Dec-2012

One of the primary bioavailability challenges is low solubility of the drug molecule. Currently several technologies are available to address the issue of low solubility, including surfactants, nano-milling, solid dispersion, hot-melt extrusion, cyclodextrins and lipidic formulations. However, there is no ‘one size fits all’ solution. H. Leonhard Ohrem and roger Weibel, Merck Millipore, describe how the company\'s innovative material can improve bioavailability

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H. Leonhard Ohrem and Roger Weibel, Merck Millipore, describe how the company’s innovative material, Silver winner in the CPhI Pharma Awards, can improve the bioavailability of poorly-water soluble APIs

The pharmaceutical industry is facing a serious issue: a shortage of new drugs. Existing patents are expiring and therapeutic pipelines are shrinking as more and more drug candidates fail during development phases. Approximately 40% of the failure can be attributed to poor bioavailability.

One of the primary bioavailability challenges is low solubility of the drug molecule. To put this into perspective, take marble, which is commonly considered insoluble. Marble has a solubility of approximately 14µg/ml (CaCO3). A typical drug such as itraconazole is 14,000 times less soluble. Today, developers have to deal with such low solubilities in more than 90% of all projects.

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