A Systematic Review of Clinical Trials on the Efficacy and Safety of CRLX101 Cyclodextrin-Based Nanomedicine for Cancer Treatment.

CRLX101 is a cyclodextrin-based nanopharmaceutical designed to improve the delivery and efficacy of the anti-cancer drug camptothecin. Cyclodextrins have unique properties that can enhance drug solubility, stability, and bioavailability, making them an attractive option for drug delivery. The use of cyclodextrin-based nanoparticles can potentially reduce toxicity and increase the therapeutic index compared to conventional chemotherapy. CRLX101 has shown promise in preclinical studies, demonstrating enhanced tumor targeting and prolonged drug release. This systematic review followed PRISMA guidelines, assessing the efficacy and toxicity of CRLX101 in cancer treatment using clinical trials. Studies from January 2010 to April 2023 were searched in PubMed, Scopus, Web of Science, and Cochrane Database of Systematic Reviews, using specific search terms. The risk of bias was assessed using ROBINS-I and Cochrane risk-of-bias tools. After screening 6018 articles, 9 were included in the final review. These studies, conducted between 2013 and 2022, focused on patients with advanced or metastatic cancer resistant to standard therapies. CRLX101 was often combined with other therapeutic agents, resulting in improvements such as increased progression-free survival and clinical benefit rates. Toxicity was generally manageable, with common adverse events including fatigue, nausea, and anemia.

Encapsulation of finasteride with native and modified γ-cyclodextrins. Extensive characterization of the complexes.

The aim of this work was to study the complexation process of FIN with native and modified CDs, to develop an aqueous solution for the topical treatment of male androgenic alopecia. The effect of pH and temperature in the complexation process were studied by solubility studies. The complexes FIN-CDs were characterized by 1HNMR and 2-D NMR (ROESY) spectroscopy. Molecular modeling studies and NMR data were used to build three-dimensional models of the complexes. FTIR, DSC and SEM techniques were also applied to strengthen physicochemical characterization, geometry as well as structural aspects evidencing the effective inclusion of FIN into the CDs' hydrophobic cavity. The most effective CDs in the FIN complexation were γ-CDs, and their modified HP-γ- and methyl-γ-CDs by forming 1:1 complexes. The Kc value obtained for γ-CDs was 9687 ± 51 M-1, whereas the Kc values obtained for HP-γ- and methyl-γ-CDs were lower, indicating that the presence of HP or methyl groups hinder the entry of FIN in the hydrophobic cavity of γ-CDs. In conclusion, FIN aqueous solubility could be increased by complexation with CDs and the aqueous solutions obtained can be used to improve FIN therapeutic possibilities in a pleasant preparation for the patient that guarantees the adherence to the treatment.