Parenteral preparations, challenges in formulations

摘要

Parenteral preparations are defined as solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection and implants (1). They are sterile preparations intended to be administered directly into the systemic circulation in human or animal body. They are required, like any pharmaceutical dosage forms, to meet the pharmaceutical quality standards as described in pharmacopeias and to be safe for the intended purpose of use (1-3). In addition to be sterile parenteral preparations must be pyrogen-free. Sterility can be achieved by different processes of sterilization that should be appropriate to the formulations (4), while the pyrogen-free aspect will require, if no depyrogenation process is used during the preparation of the sterile drug products, the use of pyrogen-free pharmaceutical ingredients; drug substances or API (Active Pharmaceutical Ingredient) and excipients.