ABSTRACT
The successful formulation of an injectable small-volume preparation requires knowledge and expertise to effect rational decisions regarding the selection of a suitable vehicle, added substances and the appropriate container and closure components. One of the most important considerations in formulating a parenteral product is the appropriate volume into which the drug should be incorporated. Consequently, parenteral product formulators should be aware of not only the nature of the solvent and solute in parenterals but also the solvent–solute interactions and the route of administration. The unsubstituted cyclodextrins are too toxic for parental use, but the chemically modified cyclodextrins appear to be innocuous when administered parenterally and have been shown to effectively enhance the solubility of several drugs including steroids and proteins. To minimize tissue damage and irritation, reduce hemolysis of blood cells and prevent electrolyte imbalance upon administration of small-volume parenterals, the product should be isotonic or nearly so. The preferred method for sterilization of parenteral emulsion is terminal autoclaving.
