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Quality by Design: Next Steps to Realize Opportunities? - page 5 / 37

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MODERN TABLET FORMULATION DESIGN AND MANUFACTURE Larry L. Augsburger and Mark J. Zellhofer

“Tablet dosage forms have to satisfy a unique design compromise. The desired properties of rapid or controlled disintegration and dissolution of the primary constituent particles must be balanced with the manufacturability and esthetics of a solid compact resistant to mechanical attrition.”

“The objective of preformulation studies is to develop a portfolio of information about the drug substance to serve as a set of parameters against which detailed formulation design can be carried out. Preformulation investigations are designed to identify those physicochemical properties of drug substances and excipients that may influence the formulation design, method of manufacture, and pharmacokinetic-biopharmaceutical properties of the resulting product.”

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