C. Kim, D.A. Weitz, and W. Jhe
Seoul National University,
Korea
Keywords: High-Concentration Formulation, Visco-Elasticity, Subcutaneous Injection pharmaceuticals
Summary:
High-concentration formulation enable patients to self-administer subcutaneous injections, offering significant convenience over traditional intravenous injections. As a result, competitive development of high-concentration drugs has been underway after the COVID-19 pandemic. However, simply increasing the concentration of drugs can lead to drastic changes in rheological properties such as sudden increases in viscosity, precipitation, aggregation, and phase separation, which significantly impact the efficacy of the drug. In the development phase, due to the limited volume of samples at the hundreds of microliter level and the high cost, as well as the capacity limitations of commercial rheometers requiring a minimum volume of several milliliters, evaluations of feasibility have mainly relied on indirect methods such as light scattering. We plan to develop a novel bio-medical instrumentation that allows visco-elasticity characterization of very small-volume complex fluids, as small as tens of nanoliter and even down to the molecular interfacial scale. We aim at demonstrating the working principle of the small-volume technique based on the highly sensitive force sensor by using the standard sample, silicone oil, and are seeking to expand to pharmaceutical especially high-concentration formulation samples. Our novel instrumentation may establish solid development and widen its applicability and usefulness creating a new field of science and technology besides the diverse fields of R&D and fluid-based platforms such as pharmaceutics, bio, oil, cosmetics, medicine, food, and chemical industries. We will further improve our current bench-top setup into a prototype instrumentation, which can be further refined suitable for commercialization into the market.