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home > pmps > summer 2003 > part 1: oral delivery of poorly soluble drugs
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Pharmaceutical Manufacturing and Packing Sourcer

Part 1: Oral Delivery of Poorly Soluble Drugs

By many estimates up to 40 per cent of new chemical entities (NCEs) discovered by the pharmaceutical industry today are poorly soluble or lipophilic compounds. The solubility issues complicating the delivery of these new drugs also affect the delivery of many existing drugs.

The ability to deliver poorly soluble drugs will grow in significance in the coming years as NCEs are relied upon for a larger share of the revenue within the pharmaceutical market by innovator companies. Similarly, generic drug manufacturers will need to employ economically efficient methods of delivery as more low solubility drugs go off patent, in order to maintain a competitive edge and sufficiently compete as profit margins shrink in this price-sensitive industry.

Relative to highly soluble compounds, low drug solubility often manifests itself in a host of in vivo consequences, including decreased bioavailability, increased chance of food effect, more frequent incomplete release from the dosage form and higher inter-patient variability. Poorly soluble compounds also present many in vitro formulation obstacles, such as severely limited choices of delivery technologies and increasingly complex dissolution testing with limited or poor correlation to the in vivo absorption.


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By Michael Hite, Lead Research Associate, Stephen Turner, Director of Product Development, and Cathy Federici, Research Associate, members of the Research and Product Development Group at SCOLR® Inc

Michael Hite, Lead Research Associate, Stephen Turner, Director of Product Development and Cathy Federici, Research Associate are all members of the Research and Product Development group at SCOLR® Inc, a drug delivery company specialising in the development and application of novel oral drug delivery systems. Michael is a graduate of Amherst College, Stephen is a graduate of Western Washington University and Cathy a graduate of Swarthmore College. They joined SCOLR® in 2000, 1999 and 2001 respectively.
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Michael Hite
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Stephen Turner
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Cathy Federic
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