Development, physical-chemical characterization and in vitro antibacterial activity evaluation of a fixed-dose combination isohydrafural-methyluracil hydrophilic ointment
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RUS, Lucia Maria; DONICI, Elena; VALICA, Vladimir; PRISACARI, Viorel; TOMUTA, Ioan; SHEPEL, Diana; HEGHES, Simona Codruta; IUGA, Cristina Adela; UNCU, Livia. Development, physical-chemical characterization and in vitro antibacterial activity evaluation of a fixed-dose combination isohydrafural-methyluracil hydrophilic ointment. In: Farmacia. 2019, nr. 5(67), pp. 857-865. ISSN 0014-8237.
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Farmacia
Numărul 5(67) / 2019 / ISSN 0014-8237

Development, physical-chemical characterization and in vitro antibacterial activity evaluation of a fixed-dose combination isohydrafural-methyluracil hydrophilic ointment


DOI: 10.31925/farmacia.2019.5.15
Pag. 857-865

Rus Lucia Maria1, Donici Elena2, Valica Vladimir2, Prisacari Viorel2, Tomuta Ioan1, Shepel Diana3, Heghes Simona Codruta1, Iuga Cristina Adela1, Uncu Livia2
 
1 Iuliu Haţieganu University of Medicine and Pharmacy Cluj-Napoca,
2 ”Nicolae Testemițanu” State University of Medicine and Pharmacy,
3 Institute of Chemistry
 
Disponibil în IBN: 26 octombrie 2019


Rezumat

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.

Cuvinte-cheie
In vitro antibacterial activity, Pharmaceutical preformulation, Stability evaluation