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Formulation Selection - Amorphous Dispersions & Other Tools for Drug Discovery Formulation Support

April 12, 2013

Low-solubility compounds are commonly encountered in the drug discovery process. It is widely estimated that more than half of the promising small molecules identified in current drug discovery programs exhibit low solubility. Molecules with low permeability and rapid metabolism also plague discovery programs. Each of these shortcomings poses challenges for oral absorption, which must be addressed because of the prevalence of new compounds that fall into these categories. This paper describes broadly applicable formulation approaches and biomodeling tools that have been successfully used to improve the solubility and in vivo performance of low-solubility compounds.

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Outsourcing Formulation Development and Manufacturing: An Early Approach Saves Time and Money

April 12, 2013

The global pharma outsourcing market will likely climb from about $85 billion in 2011 to as much as $150 billion by 2015, states JZMed, Inc., a market research company. Key components of the outsourcing market are formulation development and manufacturing. Demand for outsourced manufacturing will increase from drug developers of all sizes. A new report, Pharmaceutical Contract Manufacturing: World Market Outlook 2012-2022, predicts that the world market for pharmaceutical contract manufacturing was worth $47.6 billion in 2012, and the overall market will grow with a compound annual growth rate (CAGR) of over 6% through 2016.

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Optimizing Amorphous Solid Dispersion Formulation

April 1, 2013

Almost a third of new drug candidates require solubilization technology to achieve the best plasma exposure. As such, developing amorphous solid dispersion using a spry-drying process is an important topic. On December 13, 2012, David Vodak, vice president of chemistry, Bend Research, presented a webinar to AAPS members entitled, "Development of Amorphous Solid Dispersions Using the Spray-Drying Process: Early Development through Clinical Manufacture." Please click on our Webinars page for more information.

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Collaboration Targets Advances in Spray-Dried Dispersion Solutions for Poorly Soluble Drugs

March 13, 2013

Dow Chemical and Bend Research are developing and commercializing new materials for spray-dried dispersions that address technology gaps in manufacturability and delivery. Increasing numbers of drug candidates suffer from poor solubility issues. Various amorphous dispersion techniques have been developed that increase solubility. Much work remains to be done, however, to improve the performance of such methods. Enhancement of amorphous dispersions prepared using spray-drying is the focus of an exclusive collaboration between excipient producer The Dow Chemical Company (Dow) and CDMO Bend Research. The two companies are developing fully characterized polymers supported by complete quality-by-design (QbD) principles that can be tailored to meet the performance needs of specific drugs.

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Advancing Polymers for Solubility Enhancement

March 1, 2013

Poor solubility remains a major challenge in formulation development. As the number of new chemical entities that are poorly soluble keeps increasing, formulation scientists are faced with the important task of addressing these solubility issues so that more compounds can be translated into clinically useful medicines. A popular approach to this problem is to use polymers as solubilizing excipients. Pharmaceutical Technology brought together a panel of industry experts for a special forum to discuss solubilizing polymers and the related formulation strategies for poorly soluble drugs. Participants include Michael Morgen, PhD, director of new technology at Bend Research; Brian Koblinski, strategic marketing manager at Dow Wolff Cellulosics; and Firouz Asgarzadeh, PhD, director of technical services, North America, pharma polymers & services at Evonik Corporation.

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