Freeze Dried Injectable Drug Product Development: Selection of Non Functional Additives

Abstract

Excipients used in injectable formulation during pharmaceutical product development are the integral part to achieve desired product critical quality attributes. This review deals with understanding of the physicochemical properties of excipients used in injectable formulation development drug products. However, in spite of proper excipients selection, judicious use during formulation manufacturing process based on their critical properties is also important to avoid negative effects such as loss of drug solubility, activity and stability. This review article deals with proper selection of excipients in injectable drug products which gives stability (physical and chemical), high critical temperature, good bulking properties avoiding melt back and collapse with improved dried product appearance. Article also emphasized on appropriate selection of excipients for injectable dosage forms and linking their physiochemical properties with optimum manufacturing method with suitable case studies. This review will highlight various excipient related issues optimizing product performance with documented references and practical approaches based on scientific justification. The reader will gain better understanding of excipients complexity during stability studies and resolving problems with practical approach.