PREFORMULATION: STRENGTHEN THE FOUNDATION FOR FORMULATION AND DEVELOPMENT
Keywords:
Process, Preformulation, Development, Properties, AnalyticalAbstract
The preformulation is the first step in the rational development of a dosage form of a drug substance alone and when combined with excipients. The main objective of this study to generate useful information to the formulator to design an optimum drug delivery system. Preformulation studies strengthen the scientific foundation of the guidance, provide regulatory relief and conserve resources in the drug development and evaluation process, improve public safety standards, enhance product quality, facilitate the implementation of new technologies, and facilitate policy development and regulatory decision making. Preformulation studies give directions for development of formulation in choice of drug form, excipients, composition, physical structure, helps in adjustment of pharmacokinetic and biopharmaceutical properties, support for process development of drug substance support and useful data for development of analytical methods.
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