The effect of the composition of polysorbate 80 grades on their physicochemical properties

Polysorbate 80 is one of the most commonly used surfactants in the formulation of biotherapeutics, particularly those administered intravenously. It comprises a mixture of fatty acids but is not a precisely defined chemical entity. Hence, there are a range of different grades available in the market, all meeting compendial specifications. Polysorbate 80 is known to undergo auto degradation producing protein-damaging by-products, and to contain residual impurities that can have an impact on the stability and integrity of the active ingredients in the formulation. Given the variety of chemical compositions that polysorbate 80 can comprise, the degradation pathway and extent could vary depending on the grade used in the formulation. This study compared the physical and chemical properties of four commercially available polysorbate 80 grades with different degrees of purity and oleic acid content and investigated their degradation profiles. This study did not find any significant differences between the properties or degradation profiles of the four grades investigated. Further studies are underway to understand the formation of other reactive impurities and their impact on the model protein formulations

An Overview of 3D Printing Technologies for Soft Materials and Potential Opportunities for Lipid-based Drug Delivery Systems

Purpose: Three-dimensional printing (3DP) is a rapidly growing additive manufacturing process and it is predicted that the technology will transform the production of goods across numerous fields. In the pharmaceutical sector, 3DP has been used to develop complex dosage forms of different sizes and structures, dose variations, dose combinations and release characteristics, not possible to produce using traditional manufacturing methods. However, the technology has mainly been focused on polymer-based systems and currently, limited information is available about the potential opportunities for the 3DP of soft materials such as lipids. / Methods: This review paper emphasises the most commonly used 3DP technologies for soft materials such as inkjet printing, binder jetting, selective laser sintering (SLS), stereolithography (SLA), fused deposition modeling (FDM) and semi-solid extrusion, with the current status of these technologies for soft materials in biological, food and pharmaceutical applications. / Result: The advantages of 3DP, particularly in the pharmaceutical field, are highlighted and an insight is provided about the current studies for lipid-based drug delivery systems evaluating the potential of 3DP to fabricate innovative products. Additionally, the challenges of the 3DP technologies associated with technical processing, regulatory and material issues of lipids are discussed in detail. / Conclusion: The future utility of 3DP for printing soft materials, particularly for lipid-based drug delivery systems, offers great advantages and the technology will potentially support patient compliance and drug effectiveness via a personalised medicine approach