They are required, like any pharmaceutical dosage form, to meet the quality standards described in pharmacopeias and to be safe for their intended purpose. In addition to being sterile, parenteral preparations must be pyrogen-free.
Sterility can be achieved using a number of formulation-appropriate sterilisation techniques, whereas, if no depyrogenation process is used during the preparation of the sterile drug products, the use of pyrogen-free pharmaceutical ingredients, drug substances or active pharmaceutical ingredients (APIs) and excipients will be required.
They are usually supplied in single-dose glass or plastic containers or, more frequently, in prefilled syringes or pens to facilitate ease of use.
This article will describe the main challenges encountered during the formulation of parenteral preparations.
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