Parenteral Preparations

Parenteral (Gk, para enteron, beside the intestine) dosage forms differ from all other drug dosage forms, because they are injected directly into body tissue through the primary protective systems of the human body, the skin, and mucous membranes. They must be exceptionally pure and free from physical, chemical, and biological contaminants. These requirements place a heavy responsibility on the pharmaceutical industry to practice current good manufacturing practices (cGMPs) in the manufacture of parenteral dosage forms and on pharmacists and other health care professionals to practice good aseptic practices (GAPs) in dispensing parenteral dosage forms for administration to patients. Certain pharmaceutical agents, particularly peptides, proteins, and many chemotherapeutic agents, can only be given parenterally, because they are inactivated in the gastrointestinal tract when given by mouth. Parenterally-administered drugs are relatively unstable and generally highly potent drugs that require strict control of administration to the patient. Due to the advent of biotechnology, parenteral products have grown in number and usage around the world. This chapter focuses on the unique characteristics of parenteral dosage forms and the basic principles for formulating, packaging, manufacturing, and controlling the quality of these unique products. The references and bibliography at the end of this chapter contain the most up-to-date texts, book chapters, and review papers on parenteral product formulation, manufacture, and quality control. Overview Of UniqUe CharaCteristiCs Of Parenteral DOsage fOrms