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.

its physical description, particle size, crystalline required. Infant-size rectal suppositories may also be employed, although drug absorption from the rectum is often erratic. During childhood and even adulthood, a per-son may have diffi culty swallowing solid dosage forms, especially uncoated tablets. For this rea-

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