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home > pmps > autumn 2003 > oral delivery of poorly soluble drugs, part 2: formulation strategies for solid dosage forms and novel delivery systems for controlled release
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Oral Delivery of Poorly Soluble Drugs, Part 2: Formulation Strategies for Solid Dosage Forms and Novel Delivery Systems for Controlled Release

The preferred route of oral administration is limited to those drug molecules that are permeable across the gastric mucosa and are at least sparingly soluble. A large majority of the new chemical entities and many existing drug molecules are poorly soluble, thereby limiting their potential uses and increasing the difficulty of formulating bioavailable drug products. There are numerous methods that may facilitate solubility to further enhance performance of poorly soluble drugs for oral administration - several of the techniques available to formulators aimed at facilitating solubility were generally discussed in Part 1 of this article (1). This review focuses on formulation components and novel controlled release technologies, employed to produce a solid oral dosage form which can increase or enhance in vivo solubility of poorly soluble molecules.

While this review focuses on solid oral systems, a number of other systems are available for the oral delivery of low solubility drugs, including lipid-based soft-gel systems and self-emulsifying formulations comprising a lipid component and one or more surfactants. Such lipid-based systems are effective in their pursuit of solubilising low solubility drugs, but often require unique production processes and may be difficult to incorporate into controlled release formulations. Osmotic pumps also offer a highly effective method of delivery and are capable of linear release for even nearly insoluble drugs, but are limited in formation flexibility and are complex to manufacture. Solid dosage forms remain the most economic method of delivering any compound precisely due to the large range of technologies available and their familiarity to both the formulator and the manufacturer.


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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 Federici
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