Studies on Stability of Alprostadil (Lipo-PGE1 and DN-PGE1) Targeting Preparation
Studies on Stability of Alprostadil (Lipo-PGE1 and DN-PGE1) Targeting Preparation
Fan Xu1,2*, Cheng Wu3 and Su Zeng1
ABSTRACT
Objective of this study was to investigate the compatibility and stability of alprostadil (lipo-PGE1 and DN-PGE1) after compatibility with different volume of 0.9% sodium chloride or 5% glucose, and to provide a basis for drug safe use in the clinic. PGE1 lipid microspheres (lipo-PGE1) and alprostadil dried emulsion (DN-PGE1) were compatibility with different volumes of 0.9% sodium chloride and 5% glucose, respectively. After the compatibility of different concentrations, the changes of pH, particle size distributions, the particles greater than 5μm and encapsulation rate of the compatibility solutions were observed within 8 h by using electronic acidimeter, Malvern zeta sizer nanoparticle size analyzer, accusizer APS 780 particle size analyzer and Agilent 6460 LC-MS/MS mass spectrometer. From the experimental results, 5 μg:50ml group kept good targeting within 6 h. The encapsulation rate of 5 μg:100ml group decreased significantly after 6 h, and the percentage of fat globules > 5 μ m (PFAT5) in 10 μg:10ml group was relatively high. The risk of embolism was easily caused by injection or small pot dripping, which may be related to the insufficient amount of solvent and the incomplete dispersion of lipid microspheres. As for the two dosage forms of lipo-PGE1 and DN-PGE1, the average particle size and PFAT5 after the preparation of DN-PGE1met the USP standard, and the stability indexes were more advantageous. The clinical treatment of alprostadil targeted injection can be prepared by pharmacy intravenous admixture service. The drug concentration should be more than 0.05 μg/ml, and the drug concentration 0.1 μg/ml is the most appropriate. Lipo-PGE1 and DN-PGE1 injection can be administered by intravenous drip. The finished infusion should be used up within 6 h after the dispensing.
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