Many sterile injectable drug products today are of higher viscosity than has been commonplace in the past.[26] In some cases, the increased viscosity results from the properties of the drug substance, most notably with larger biomolecules. In other cases, the trend toward greater patient centricity is leading to the development of higher-concentration products and products designed to be long acting, both with the intent of reducing dosing frequency. Sterile injectable drug products initially administered via IV that have been reformulated for self-administration at home via injection also often have high viscosities and/or require the delivery of large quantities.
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Complex injectable products include APIs formulated as liposomes, microspheres, micelles, and submicron crystals in suspensions or emulsions, often as long-acting injectables with reduced dosing frequencies. They provide opportunities for life cycle extensions of biologics with improved therapeutic indices and reduced toxicities, as well as the potential for targeted delivery. Specialized particle technology continues to enable the particle-based drug delivery platforms that are often required to produce high-quality sterile complex injectable products.
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As the challenge of poor solubility increases with both small molecule APIs and biologic drug substances, the range of technologies used to overcome this issue is expanding as well. For sterile injectable products, the formation of nano-emulsions continues to attract interest as an alternative to the use of surfactants, nanoparticles, liposomes, and conventional emulsions, all of which have limitations.[63]
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Lipid nanoparticles are the next generation of liposomes, which have been used as delivery vehicles for several approved drug products. LNPs have a more complex architecture that provides enhanced physical stability and confers the ability to provide targeted delivery.[66] They have come to prominence as key components of the COVID-19 mRNA vaccines developed by Pfizer/BioNTech and Moderna.
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In addition to LNPs, the use of polymeric nanoparticles and microparticles has drawn increased attention as a means to achieve the targeted delivery of potent drug substances. Polymeric particles can be carefully designed to encapsulate specific APIs and include specific functionalities that ensure binding to and release of the payload at the desired target cells. Bioavailability can be enhanced as well, as is the case for other nano/microscale delivery systems. Several polymers with GRAS status that are known to be biocompatible, biodegradable, and non-immunogenic can be used in the formation of nanoparticle/microparticle delivery vehicles.[67]
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The key role that LNPs play in the delivery of mRNA vaccine actives highlights the increasing importance of excipients in many sterile injectable drug products. A wide range of excipients are used in injectable drug formulations, including solvents and cosolvents (typically water or vegetable oils); solubilizing, wetting, suspending, emulsifying, and thickening agents; chelating agents; antioxidants and reducing agents; antimicrobial compounds; buffering and pH-adjusting agents; bulking agents, protectants, and tonicity adjustors; and other special additives.[70]
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