Document Detail


Formulation, characterization, and clinical evaluation of microemulsion containing clotrimazole for topical delivery.
MedLine Citation:
PMID:  21725708     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The objective of the present study was to formulate and evaluate microemulsion systems for topical delivery of clotrimazole (CTM). The solubility of CTM in various oils was determined to select the oil phase of the microemulsion systems. Pseudoternary phase diagrams were constructed to identify the area of microemulsion existence. Five CTM microemulsion formulations (M1-M5) were prepared and evaluated for their thermodynamic stability, pH, refractive index, droplet size, viscosity, and in vitro release across cellulose membrane. Among the prepared microemulsion formulations, M3 (lemon oil/Tween 80/n-butanol/water) and M4 (isopropyl myristate/Tween 80/n-butanol/water) microemulsion systems were found to be promising according to their physical properties and CTM cumulative percentage release. Gel form of M3 and M4 were prepared using 1% Carbopol 940 as the hydrogel matrix. Both formulations were evaluated in the liquid and gel forms for drug retention in the skin in comparison to the marketed CTM topical cream and their stability examined after storage at 40°C for 6 months. Microemulsion formulations achieved significantly higher skin retention for CTM over the CTM cream. Stability studies showed that M4 preparations were more stable than M3. The in vitro anti-fungal activity of M4 against Candida albicans was higher than that of the conventional cream. Moreover, clinical evaluation proved the efficacy and tolerability of this preparation in the treatment of various topical fungal infections.
Authors:
Fahima M Hashem; Dalia S Shaker; Mohamed Khalid Ghorab; Mohamed Nasr; Aliaa Ismail
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Publication Detail:
Type:  Journal Article     Date:  2011-07-02
Journal Detail:
Title:  AAPS PharmSciTech     Volume:  12     ISSN:  1530-9932     ISO Abbreviation:  AAPS PharmSciTech     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-08-31     Completed Date:  2012-03-25     Revised Date:  2013-06-28    
Medline Journal Info:
Nlm Unique ID:  100960111     Medline TA:  AAPS PharmSciTech     Country:  United States    
Other Details:
Languages:  eng     Pagination:  879-86     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Helwan University, Cairo, Egypt.
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical*
Adolescent
Adult
Animals
Antifungal Agents* / administration & dosage,  chemistry
Benzyl Alcohol / chemistry
Clotrimazole* / administration & dosage,  chemistry,  therapeutic use
Dermatomycoses / drug therapy*
Drug Compounding
Drug Evaluation, Preclinical
Drug Stability
Emulsions / administration & dosage,  chemistry*
Female
Glycerol / analogs & derivatives,  chemistry
Humans
Male
Mice
Middle Aged
Myristates / chemistry
Oils / chemistry
Oleic Acid / chemistry
Particle Size
Plant Oils / chemistry
Polysorbates / chemistry
Skin Absorption
Solubility
Surface-Active Agents / chemistry
Chemical
Reg. No./Substance:
0/Antifungal Agents; 0/Emulsions; 0/Myristates; 0/Oils; 0/Plant Oils; 0/Polysorbates; 0/Surface-Active Agents; 0/lemon oil; 0RE8K4LNJS/isopropyl myristate; 100-51-6/Benzyl Alcohol; 112-80-1/Oleic Acid; 23593-75-1/Clotrimazole; 56-81-5/Glycerol; 63393-92-0/cremophor EL
Comments/Corrections

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