Skip to main content

Novel Formulation and Clinical Evaluation of Levofloxacin Hemihydrate gel for the Treatment of Impetigo

مؤلف البحث
Aly A. Abdel Rahman1, Sayed M. Mohamed1, Eman M. Samy1, Marwa A. Sayed1, Eman. M. K. Youssef 2 and
Helal F. Hetta3
مجلة البحث
Journal of American Science
الناشر
Marwa Ahmed Sayed
تصنيف البحث
1
عدد البحث
14(10)
موقع البحث
http://www.jofamericanscience.org
سنة البحث
2018
المشارك في البحث
ملخص البحث

Levofloxacin hemihydrate (LVFX) is a fluoroquinolone antibiotic used for the treatment of complicated
and uncomplicated skin infections. Impetigo is a highly infectious superficial bacterial disease, most common among pre-school children. The present study was designed to formulate and evaluate topical gel containing levofloxacin hemihydrate for treatment of impetigo. The gel was formulated using different types and concentrations of gelling polymers. The used polymers, viz; hydroxypropylmethyl cellulose (HPMC), sodium carboxymethyl cellulose (NaCMC), carbopol 934, sodium alginate (Na-alginate), pluronic ® F-127 and poly vinyl alchohol (PVA 14000). Drug-polymers compatibility studies were carried out sing DSC and FT-IR techniques, then the prepared formulae were characterized physically in terms of pH,drug content, spread ability and rheological properties. Drug-polymers compatibility studies were carried out using DSC and FT-IR techniques. In-vitro drug release in phosphate buffer pH 7.4 and kinetics of the drug release were studied. In vitro microbiological studies of (LVFX) gel were performed using agar cup diffusion method. Patients with clinically diagnosed impetigo were topically treated with the best formula of LVFX gel. Results have revealed that the used polymers are compatible with the drug. The prepared LVFX gels with different gelling agents showed acceptable physical properties and good drug
release. Among all the prepared gels, formula (G1) using HPMC as a gelling agent attained superior physical
properties, drug release (80.30±0.11%) after 2 hrs. No significant changes in the physical properties and in the
percent of drug release were observed for formula (G1) at (5 ±2°C/60 ±5 % RH, 25±2°C / 65 ±5% RH and 40±2°C /
75 ± 5 RH) after 3 months of storage. These results we reconfirmed by thin layer chromatography. Also, formula
(G1) was found to have the highest antimicrobial activity against methicillin resistant staphylococcus aureus
(MRSA), streptococcus pyogenes, Escherichia coli, and Klebsiellapneumoniae. LVFX topical gel (G1) was well
tolerated with high rates of clinical response (significant reduction in the time of healing after 4 days) for treating
impetigo.