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BACKGROUND: Hierarchical structure (e.g., micelle, vesicle, nanoparticle and nanoemulsion) formulations can improve the pharmaceutical properties of a biotherapeutic (e.g., a drug) by, for example, enhancing circulation half-life and facilitating the accumulation in a target tissue. Compared to conventional approaches, formulations of hierarchical structures can protect antigen/adjuvant payloads from the surrounding biological environment, thus increasing their half-life and minimizing their systemic toxicity. A critical advantage of the said formulations is the release of the payload at the desired site. Previously, approaches such as changes in pH or redox potential, the presence of an enzyme, or externally applied stimuli (light, heat, ultrasounds, magnetic field) are have been employed. However, to date, there are no formulations that respond to changes in macromolecule concentration, such as those that occur upon entry into a cell or other physical region where macromolecules are present at a higher concentration than in physiological fluids. Thus, there is an unmet need and accordingly, new formulations that respond to changes in macromolecule concentration are required.
Full text of patent: https://patents.google.com/patent/US12187848B2/en?oq=12%2c187%2c848