Transcription of Dosage Form Design: Pharmaceutical and Formulation ...
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Dosage Form Design: Pharmaceutical and Formulation ...
CHAPTER prescribe. The general area of study concerned with the Formulation , manufacture, stability, and effectiveness of Pharmaceutical Dosage forms is termed proper design and Formulation of a Dosage form requires consideration of the physi-cal, chemical, and biologic characteristics of all of the drug substances and Pharmaceutical ingredients to be used in fabricating the prod-uct. The drug and Pharmaceutical materials must be compatible with one another to produce a drug product that is stable, effi cacious, attrac-tive, easy to administer, and safe. The product should be manufactured with appropriate mea-sures of quality control and packaged in contain-ers that keep the product stable. The product should be labeled to promote correct use and be Drug substances are seldom administered alone; rather they are given as part of a Formulation in combination with one or more nonmedicinal agents that serve varied and specialized pharma-ceutical functions.
physical, chemical, biologic, and pharmaceutical sciences. The early stages of any new formula-tion include studies to collect basic information on the physical and chemical characteristics of the drug substance. These basic studies are the preformulation work needed before actual prod-uct formulation begins. PREFORMULATION STUDIES
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