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R. Vallejo,J. Gonzalez-Valdivieso,M. Santos,S. Rodriguez-Rojoa,F.J. Ariasb 한국공업화학회 2021 Journal of Industrial and Engineering Chemistry Vol.93 No.-
This study presents a new groundbreaking methodology for integrating innovative concepts todevelop novel drug-delivery strategies. This methodology combines genetically engineered elastin-likerecombinamers (ELRs) with supercriticalfluid (SCF) techniques to encapsulate a poorly water-solubledrug in a one-step process. The chemotherapeutic agent docetaxel (DTX) is encapsulated with a blockcopolymer ELR containing the RGD peptide, a specific target sequence for cancer cells, using thesupercritical anti-solvent (SAS) technique in a high process yield of up to 70%. SEM studies showspherical microparticles of 10 mm after encapsulation. After dispersion under physiological conditions,microparticles disaggregate into stable monodisperse nanoparticles of 40 nm size and30 mVz-potential. This protects the drug, as confirmed by NMR analysis, thereby increasing the watersolubility of DTX up tofifty orders of magnitude. The delivery process is governed by the Fick diffusionmechanism and indicates that the presence of DTX on the particles surface is practically negligible. Cellular assays showed that, due to the presence of the cancer target sequence RGD, breast cancer cellswere more affected than human endothelial cells, thus meaning that the strategy developed in thiswork opens the way to new controlled release systems more precise than non-selectivechemotherapeutic drugs.
Brock, G.,Heiselman, D.,Maggi, M.,Kim, S.W.,Rodriguez Vallejo, J.M.,Behre, H.M.,McGettigan, J.,Dowsett, S.A.,Hayes, R.P.,Knorr, J.,Ni, X.,Kinchen, K. Williams and Wilkins Co 2016 The Journal of urology Vol.195 No.3
<P>Purpose: We determined the effect of testosterone solution 2% on total testosterone level and the 2 symptoms of hypogonadism, sex drive and energy level. Materials and Methods: This was a randomized, multicenter, double-blind, placebo controlled, 16-week study to compare the effect of testosterone and placebo on the proportion of men with a testosterone level within the normal range (300 to 1,050 ng/dl) upon treatment completion. We also assessed the impact of testosterone on sex drive and energy level measured using SAID (Sexual Arousal, Interest and Drive scale) and HED (Hypogonadism Energy Diary), respectively. A total of 715 males 18 years old or older with total testosterone less than 300 ng/dl and at least 1 symptom of testosterone deficiency (decreased energy and/or decreased sexual drive) were randomized to 60 mg topical testosterone solution 2% or placebo once daily. Results: Of study completers 73% in the testosterone vs 15% in the placebo group had a testosterone level within the normal range at study end point (p < 0.001). Participants assigned to testosterone showed greater baseline to end point improvement in SAID scores (low sex drive subset p < 0.001 vs placebo) and HED scores (low energy subset p = 0.02 vs placebo, not significant at prespecified p < 0.01). No major adverse cardiovascular or venous thrombotic events were reported in the testosterone group. The incidence of increased hematocrit was higher with testosterone vs placebo (p = 0.04). Conclusions: Once daily testosterone solution 2% for 12 weeks was efficacious in restoring normal testosterone levels and improving sexual drive in hypogonadal men. Improvement was also seen in energy levels on HED though not at the prespecified p < 0.01. No new safety signals were identified.</P>