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This study introduces a finite element analysis (FEA)-guided framework for designing separable bubble microneedles (BMNs) that optimize geometry and cavity parameters for controlled tip separation and robust insertion. The study tested minoxidil sulfate-loaded BMNs (MXS-BMNs) and insulin-loaded BMNs (INS-BMNs) for transdermal and sublingual delivery, respectively. The BMNs demonstrated effective payload release, with over 80% liberated within 10 minutes. In ex vivo tests, MXS-BMNs showed significantly higher minoxidil permeation compared to topical gel, and in vivo tests on mice showed accelerated hair regrowth. INS-BMNs effectively lowered glucose levels in diabetic rats, comparable to subcutaneous injections. This approach reduces empirical iteration, facilitating the development of efficient microneedle systems for rapid drug delivery.

The study investigated ZSYY001, a polymeric micellar paclitaxel formulation, in preclinical and phase I trials for advanced solid tumors. Preclinical tests on xenograft models showed significant tumor growth inhibition without weight loss. In the phase I trial, involving 18 patients, ZSYY001 was administered at doses up to 390 mg/m² without premedication, and no dose-limiting toxicities were observed. Common side effects included anemia and hair loss, but no acute hypersensitivity reactions occurred. The study found two partial responses and seven cases of stable disease, indicating promising antitumor activity. ZSYY001 was deemed safe, well-tolerated, and exhibited non-linear pharmacokinetics, suggesting it as a potential treatment option.