Development of New Excipients

Over the last two decades, drug delivery systems (DDS) have gained importance and high growth rates are expected in the future. In principle, there are three types of excipients and the development processes for these vary significantly: modified excipients, coprocessed excipients and novel excipien...

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Bibliographic Details
Published inPharmaceutical Excipients pp. 269 - 301
Main Authors Kolter, Karl, Guth, Felicitas
Format Book Chapter
LanguageEnglish
Published United States John Wiley & Sons, Incorporated 2016
John Wiley & Sons, Inc
Subjects
Chemical engineering
CHEMISTRY
drug delivery systems
drug product development
new chemical entities
pharmaceutical excipients
pharmaceutical industry
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Summary:Over the last two decades, drug delivery systems (DDS) have gained importance and high growth rates are expected in the future. In principle, there are three types of excipients and the development processes for these vary significantly: modified excipients, coprocessed excipients and novel excipients. The most challenging task facing these three categories is the development of novel excipients that can be considered to be new chemical entities (NCE) as these could take at least 6‐7 years and incur very high costs. This chapter illustrates with three case studies that the development of new excipients poses a real challenge. It explains the difficulties that may arise from regulatory and safety requirements, development costs, manufacturing restrictions, and long time to market. The pharmaceutical industry prefers excipients that have a preapproved functional role in drug products in order to avoid an additional perceived risk in drug product development.
ISBN:111814564X
9781118145647
DOI:10.1002/9781118992432.ch7