Drug prefilled non-reusable syringes as drug-device

Abstract

Due to a staggering increase in the number of patients who self-administer drugs to treat chronic diseases, and growing use of biologics drugs, manufacturers started showing shift from vial-and-syringe format, prone to dosing errors and low patient-compliance rates to single use, disposable syringes filled with a prescribed unit dose of medication called prefilled syringes to deliver protein-based drugs, sustained release formulations, and other parenteral medications. Being the fastest growing segment of the injectable drug delivery devices market, it has the potential to unlock significant value by providing the next level of safe and highly effective treatments for patients. However, getting these products to the market in a timely, compliant, and sustainable manner is not easy. New and challenging technical problems will persist. Interacting with key regulatory authorities, such as FDA, requires a dedicated and collaborative effort as their approaches continue to evolve. The intent of this review article is to provide concise information on the latest regulatory aspects of prefilled syringe, methods of their manufacture, methods of filling syringes as a drug product. This type of knowledge can familiarize the reader with the prefilled syringes as a combination product & its possible challenges.