The AAPS Journal Theme Issue: "Perspectives on Clinical Drug Development of Long-Acting Injectables".

Abstract

The development of long-acting injectable (LAI) drugs has gained increased interest during the last decades because of their favorable properties towards compliance, safety, and efficacy by maintaining stable drug concentrations throughout an extended period following a single intramuscular (IM) or subcutaneous (SC) injection. Historically, several LAIs have been successfully marketed, mainly as lifecycle product extensions of oral formulations (1). More recently, several therapeutics are also being developed for LAI use only with limited or no information available from oral administration to be leveraged (2). There is therefore a need for more quantitative understanding of (i) the physicochemical properties, (ii) the influence of the formulations