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Fluconazole-loaded solid lipid nanoparticles topical gel for treatment of pityriasis versicolor: formulation and clinical study.
Drug Deliv 2018; 25(1):78-90DD

Abstract

Solid lipid nanoparticles (SLNs) are very potential formulations for topical delivery of antifungal drugs. Hence, the purpose of this research was to formulate the well-known antifungal agent Fluconazole (FLZ)-loaded SLNs topical gel to improve its efficiency for treatment of Pityriasis Versicolor (PV). FLZ-SLNs were prepared by modified high shear homogenization and ultrasonication method using different concentration of solid lipid (Compritol 888 ATO, Precirol ATO5) and surfactant (Cremophor RH40, Poloxamer 407). The physicochemical properties and the in vitro release study for all FLZ-SLNs were investigated. Furthermore, the optimized FLZ-SLN formula was incorporated into gel using Carpobol 934. A randomized controlled clinical trial (RCT) of potential batches was carried out on 30 well diagnosed PV patients comparing to market product Candistan® 1% cream. Follow up was done for 4 weeks by clinical and KOH examinations. The results showed that FlZ-SLNs were almost spherical shape having colloidal sizes with no aggregation. The drug entrapment efficiency ranged from 55.49% to 83.04%. The zeta potential values lie between -21 and -33 mV presenting good stability. FLZ showed prolonged in vitro release from SLNs dispersion and its Carbapol gel following Higuchi order equation. Clinical studies registered significant improvement (p < .05) in therapeutic response (1.4-fold; healing%, 4-fold; complete eradication) in terms of clinical cure and mycological cure rate from PV against marketed cream. Findings of the study suggest that the developed FLZ loaded SLNs topical gels have superior significant fast therapeutic index in treatment of PV over commercially available Candistan® cream.

Authors+Show Affiliations

a Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Modern University for Technology and Information , Cairo , Egypt.b Department of Microbiology, Faculty of Medicine , Tanta University , Tanta , Egypt.c Department of Dermatology and venereology, Faculty of Medicine , Tanat University , Tanta , Egypt.d Department of Clinical Pharmacy, Faculty of Pharmacy , Al-Azhar University , Cairo , Egypt.e Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , The British University in Egypt (BUE) , Cairo , Egypt.f Department of Pharmaceutics and Industrial Pharmacy , Faculty of Pharmaceutical Sciences and Pharmaceutical Industries, Future University in Egypt , Cairo , Egypt. g Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Cairo University , Cairo , Egypt.g Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy , Cairo University , Cairo , Egypt.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29239242

Citation

El-Housiny, Shaimaa, et al. "Fluconazole-loaded Solid Lipid Nanoparticles Topical Gel for Treatment of Pityriasis Versicolor: Formulation and Clinical Study." Drug Delivery, vol. 25, no. 1, 2018, pp. 78-90.
El-Housiny S, Shams Eldeen MA, El-Attar YA, et al. Fluconazole-loaded solid lipid nanoparticles topical gel for treatment of pityriasis versicolor: formulation and clinical study. Drug Deliv. 2018;25(1):78-90.
El-Housiny, S., Shams Eldeen, M. A., El-Attar, Y. A., Salem, H. A., Attia, D., Bendas, E. R., & El-Nabarawi, M. A. (2018). Fluconazole-loaded solid lipid nanoparticles topical gel for treatment of pityriasis versicolor: formulation and clinical study. Drug Delivery, 25(1), pp. 78-90. doi:10.1080/10717544.2017.1413444.
El-Housiny S, et al. Fluconazole-loaded Solid Lipid Nanoparticles Topical Gel for Treatment of Pityriasis Versicolor: Formulation and Clinical Study. Drug Deliv. 2018;25(1):78-90. PubMed PMID: 29239242.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fluconazole-loaded solid lipid nanoparticles topical gel for treatment of pityriasis versicolor: formulation and clinical study. AU - El-Housiny,Shaimaa, AU - Shams Eldeen,Maii Atef, AU - El-Attar,Yasmina Ahmed, AU - Salem,Hoda A, AU - Attia,Dalia, AU - Bendas,Ehab R, AU - El-Nabarawi,Mohamed A, PY - 2017/12/15/entrez PY - 2017/12/15/pubmed PY - 2018/7/25/medline KW - Carpabol 934 KW - Fluconazole KW - Pityriasis Versicolor KW - clinical study KW - entrapment efficiency KW - solid lipid nanoparticles KW - topical delivery SP - 78 EP - 90 JF - Drug delivery JO - Drug Deliv VL - 25 IS - 1 N2 - Solid lipid nanoparticles (SLNs) are very potential formulations for topical delivery of antifungal drugs. Hence, the purpose of this research was to formulate the well-known antifungal agent Fluconazole (FLZ)-loaded SLNs topical gel to improve its efficiency for treatment of Pityriasis Versicolor (PV). FLZ-SLNs were prepared by modified high shear homogenization and ultrasonication method using different concentration of solid lipid (Compritol 888 ATO, Precirol ATO5) and surfactant (Cremophor RH40, Poloxamer 407). The physicochemical properties and the in vitro release study for all FLZ-SLNs were investigated. Furthermore, the optimized FLZ-SLN formula was incorporated into gel using Carpobol 934. A randomized controlled clinical trial (RCT) of potential batches was carried out on 30 well diagnosed PV patients comparing to market product Candistan® 1% cream. Follow up was done for 4 weeks by clinical and KOH examinations. The results showed that FlZ-SLNs were almost spherical shape having colloidal sizes with no aggregation. The drug entrapment efficiency ranged from 55.49% to 83.04%. The zeta potential values lie between -21 and -33 mV presenting good stability. FLZ showed prolonged in vitro release from SLNs dispersion and its Carbapol gel following Higuchi order equation. Clinical studies registered significant improvement (p < .05) in therapeutic response (1.4-fold; healing%, 4-fold; complete eradication) in terms of clinical cure and mycological cure rate from PV against marketed cream. Findings of the study suggest that the developed FLZ loaded SLNs topical gels have superior significant fast therapeutic index in treatment of PV over commercially available Candistan® cream. SN - 1521-0464 UR - https://www.unboundmedicine.com/medline/citation/29239242/Fluconazole_loaded_solid_lipid_nanoparticles_topical_gel_for_treatment_of_pityriasis_versicolor:_formulation_and_clinical_study_ L2 - http://www.tandfonline.com/doi/full/10.1080/10717544.2017.1413444 DB - PRIME DP - Unbound Medicine ER -