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

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“…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 ].…”

Enhanced Solubility and Stability of Aripiprazole in Binary and Ternary Inclusion Complexes Using Hydroxy Propyl Beta Cyclodextrin (HPβCD) and L-Arginine

“…The efficacy of most of the oral dosage forms depends upon their dissolution in gastrointestinal fluids before they can be absorbed systemically. It gives the rate of release of drug from the product [30]. All the samples were enclosed in the capsule shells, and the dissolution test was performed using the pedal method (USP 41 Dissolution Apparatus (II), 2018).…”

“…Fresh 10 mL SGF must be added after each sample was taken. Samples were analyzed at 219 nm using UV1700 (Shimadzu Kyoto, Japan) [30,31]. Percentage dissolution efficiency (DE) was determined using the trapezoidal method:…”