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DEVELOPMENT, PHYSICAL-CHEMICAL CHARACTERIZATION AND IN VITRO ANTIBACTERIAL ACTIVITY EVALUATION OF A FIXED-DOSE COMBINATION ISOHYDRAFURAL-METHYLURACIL HYDROPHILIC OINTMENT

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This research was focused on the pharmaceutical development of a novel, fixed-dose combination isohydrafural-methyluracil ointment on a water soluble base polyethylene glycol (PEG). Differential scanning calorimetry (DSC) and Fourier transform… Click to show full abstract

This research was focused on the pharmaceutical development of a novel, fixed-dose combination isohydrafural-methyluracil ointment on a water soluble base polyethylene glycol (PEG). Differential scanning calorimetry (DSC) and Fourier transform infra-red spectroscopy (FTIR) were applied in order to determine the compatibility between active pharmaceutical ingredients (APIs) and between APIs excipients. Nine formulations (F1 F9) were tested for: physical appearance and homogeneity, pH, viscosity and osmotic activity. The optimal formulation presented the concentrations of PEG 400 76.72%, PEG 1500 19.18% and a fixed-dose combination of 0.1% isohydrafural and 4% methyluracil. It showed higher antibacterial properties both to Gram-positive and Gram-negative bacteria than nitrofural 2% ointment (Furacilin, Belarus). The long-term stability testing of the optimized formulation of isohydrafural and methyluracil revealed the shelf-life of two years.

Keywords: dose combination; combination isohydrafural; methyluracil; isohydrafural methyluracil; fixed dose

Journal Title: FARMACIA
Year Published: 2019

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