Complex injectables: Development, delivery, and advancement. Development, delivery, and advancement

As per the US Food and Drug Administration (FDA), complex parenteral products are those formulations which contain either complex ingredients or API, complex formulation, i.e., delivery carrier, complex route of administration, complex dosage form, or complex drug device combination. Narrowing complex products to complex parenteral products includes delivery systems for administration of drug via the parenteral route, including injections, ophthalmic, stents, and implantable devices. Complex injectables have gained increasing attention due to their widespread use in life-threatening and chronic diseases treatments. The category includes diabetes, oncology, and hormonal therapy to name but a few. The manufacturing of the complex injectable products is extremely complex and a great level of observation of quality and care is required during their manufacturing, packaging, distribution, and storage. In the few cases where both combination products are used, i.e., a drug-device combination (prefilled syringes, pen device) along with complex API (protein and peptides) and complex dosage form, i.e., liposomes, microspheres, or microparticles requires in-depth characterization and evaluation to confirm the suitability and safety of such products. The FDA has laid various guidelines for such complex injectable products which need to be followed and reviewed on a timely basis for smooth execution of such products for on-time commercialization. This chapter deals in depth with the various approved complex injectable products and characterization techniques involved in protein/peptide formulations, as well as characterization of complex dosage forms. The chapter also discusses the various devices being used presently as combination products (drug-device combinations). The chapter further gives an overview of the stability of proteins and peptides, along with aggregation and its detection.