An expanding horizon of complex injectable products: development and regulatory considerations

Abstract

There has been a constant evolution in the pharmaceutical market concerning the new technologies imbibed in delivering drug substances for various indications. This is either market-driven or technology-driven to improve the overall therapeutic efficacy and patients’ quality of life. The pharmaceutical industry has experienced rapid growth in the area of complex injectable products because of their effectiveness in the unmet market. These novel parenteral products, viz, the nanoparticles, liposomes, microspheres, suspensions, and emulsions, have proven their worth as “Safe and Effective” products. However, the underlying challenges involved in the development, scalability, and characterization of these injectable products are critical. Moreover, the guidelines available do not provide a clear understanding of these complex products, making it difficult to anticipate the regulatory requirements. Thus, it becomes imperative to comprehend the criticalities and develop an understanding of these products. This review discusses various complexities involved in the parenteral products such as complex drug substances, excipients, dosage forms, drug administration devices like pre-filled syringes and injector pens, and its different characterization tools and techniques. The review also provides a brief discussion on the regulatory aspects and associated hurdles with other parenteral products. Graphical abstract

Application of biodegradable microsphere injections: an anticancer perspective

“…Traditional terminal sterilization methods (such as autoclaving, filtration, gamma radiation and ionizing radiation) are not applicable because the microspheres contain biodegradable materials or proteins or peptides. 131 Manufacturers can only set up many sterile clean rooms to ensure that the entire preparation process is free from contamination, which adds to the production burden. 132 Morgan B. Giles et al 133 designed a simple, low-cost encapsulation process that does not require organic solvents and allows simple and cost-effective sterilization of blank microspheres prior to drug loading.…”

“…47,48 The advantages of chitosan are its biological adhesion and strong permeability, 49 which can be used for embolization therapy. The injection of 131 I-labeled chitosan-collagen composite microspheres through hepatic arteries into hepatocellular carcinoma rats which effectively increased the overall survival of the intervening sites from 19 days to 44 days. 50 It has been reported that chitosan microspheres can deliver traditional Chinese medicine.…”

Long-Acting Injectable Antipsychotics—A Review on Formulation and In Vitro Dissolution

“…The usage of these strategies is beneficial during the registration process since a simplified standard document of common elements (CTD) can be submitted to the FDA, EMA or a national Regulatory Agency. More detailed review of the regulatory aspects can be found elsewhere [ 145 , 146 ]. Reformulation of the “old drug” strategy has also been observed for the LAI antipsychotics [ 144 ].…”