Nadifloxacin-Loaded Thermosensitive In Situ Gel Formulations with a Quality by Design Approach
6 affiliations
- 1University of Health Sciences Faculty of Pharmacy, Department of Radiopharmacy, İstanbul, Türkiye
- 2İstinye University Faculty of Pharmacy, Department of Pharmaceutical Technology, İstanbul, Türkiye
- 3İstinye University, Institute of Graduate Education, Department of Stem Cell and Tissue Engineering, İstanbul, Türkiye
- 4İstinye University, Stem Cell and Tissue Engineering Application and Research Center (ISUKOK), İstanbul, Türkiye
- 5İstinye University Faculty of Pharmacy, Department of Analytical Chemistry, İstanbul, Türkiye
- 6University of Health Sciences Faculty of Pharmacy, Department of Pharmaceutical Technology, İstanbul, Türkiye
Abstract
Objectives: In our study, we aimed to prepare topical in situ gels containing nadifloxacin (NDF), used in the treatment of acne and superficial skin infections, and to evaluate them using characterization studies.
Materials and Methods: Thermosensitive (temperature-sensitive) in situ gels were produced by the cold methodusing poloxamer 188 (P188) and poloxamer 407 (P407) after methylcellulose (MC) and gellan gum (GG) were dissolved. Finally, the NDF concentration in the gels was 1% (w/w). The prepared gels exhibited desirable properties, as shown by Fourier-transform infrared spectroscopy, and in clarity, pH, gelation temperature, gelling capacity, viscosity, mechanical properties (springiness, resilience, and cohesiveness), spreadability (work of adhesion, work of shear, stickiness, and firmness), drug content uniformity, in vitro release, and cytocompatibility (MTT cytotoxicity assay). The impact of critical materials in the formulation on the results was evaluated using quality by design.
Results: The gelation temperatures of all NDF-included in situ gels were found to be in the range of 30–35.2 °C. Furthermore, the cytotoxicity of these gels was evaluated using MTT analysis. Based on the observed results, the most suitable gel was identified as N3, which contains 17.5% P407, 7% P188, 0.7% MC, 0.1% GG, and 1% NDF.
Conclusion: After further studies to determine its effectiveness against acne, it could become an alternative to existing creams for acne and superficial skin infections on the market.
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BibTeX
@article{bulbul2026nadifloxacinloaded,
title = {{Nadifloxacin-Loaded Thermosensitive In Situ Gel Formulations with a Quality by Design Approach}},
author = {Ece ÖZCAN BÜLBÜL and Burçin İZBUDAK and Ayça BAL ÖZTÜRK and Neslihan ÜSTÜNDAĞ OKUR},
journal = {Turkish Journal of Pharmaceutical Sciences},
year = {2026},
month = oct,
doi = {10.4274/tjps.galenos.2026.39953},
url = {https://doi.org/10.4274/tjps.galenos.2026.39953},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Nadifloxacin-Loaded Thermosensitive In Situ Gel Formulations with a Quality by Design Approach
AU - Ece ÖZCAN BÜLBÜL
AU - Burçin İZBUDAK
AU - Ayça BAL ÖZTÜRK
AU - Neslihan ÜSTÜNDAĞ OKUR
PY - 2026
DA - 2026/10/27
JO - Turkish Journal of Pharmaceutical Sciences
DO - 10.4274/tjps.galenos.2026.39953
UR - https://doi.org/10.4274/tjps.galenos.2026.39953
AB - Objectives: In our study, we aimed to prepare topical in situ gels containing nadifloxacin (NDF), used in the treatment of acne and superficial skin infections, and to evaluate them using characterization studies. Materials and Methods: Thermosensitive (temperature-sensitive) in situ gels were produced by the cold methodusing poloxamer 188 (P188) and poloxamer 407 (P407) after methylcellulose (MC) and gellan gum (GG) were dissolved. Finally, the NDF concentration in the gels was 1% (w/w). The prepared gels exhibited desirable properties, as shown by Fourier-transform infrared spectroscopy, and in clarity, pH, gelation temperature, gelling capacity, viscosity, mechanical properties (springiness, resilience, and cohesiveness), spreadability (work of adhesion, work of shear, stickiness, and firmness), drug content uniformity, in vitro release, and cytocompatibility (MTT cytotoxicity assay). The impact of critical materials in the formulation on the results was evaluated using quality by design. Results: The gelation temperatures of all NDF-included in situ gels were found to be in the range of 30–35.2 °C. Furthermore, the cytotoxicity of these gels was evaluated using MTT analysis. Based on the observed results, the most suitable gel was identified as N3, which contains 17.5% P407, 7% P188, 0.7% MC, 0.1% GG, and 1% NDF. Conclusion: After further studies to determine its effectiveness against acne, it could become an alternative to existing creams for acne and superficial skin infections on the market.
SN - 1304-530X
SN - 2148-6247
ER -