TECHNOLOGICAL DEVELOPMENT AND EVALUATION OF MICROBIOLOGICAL
EMULSIFIED SYSTEM FOR THE TREATMENT OF DIAPER DERMATITIS
Santiago RR1,2, Silva KS1,2, Silva KC1, Silva KG1,3, Gullo FP4, Almeida AMF4, Gianinni MJM4, Egito
EST1,2,3 #
1.
Laboratório de Sistemas Dispersos (LASID), Departamento de Farmácia, Universidade Federal do Rio
Grande do Norte, Natal-RN, Brasil.
2.
Programa de Pós-graduação em Ciências Farmacêuticas, Universidade Federal do Rio Grande do Norte,
Natal-RN, Brasil
3.
Programa de Pós-graduação em Ciências da Saúde, Universidade Federal do Rio Grande do Norte, NatalRN, Brasil
4.
Programa de Pós-graduação em Biociências e Biotecnologia Aplicadas a Farmácia, Universidade Estadual
Paulista Júlio de Mesquita Filho, Araraquara-SP, Brasil
INTRODUCTION
Diaper dermatitis, also known as diaper rash, refers to inflammation of the skin covered by nappy, affecting
50% of infants (1-4). Treatment usually involves increasing the frequency of diaper changes, using
superabsorbent disposable diapers, and applying topical agents such as ointments or creams using zinc oxide
(ZnO). When secondary Candida albicans infection is present, a topical antifungal agent is beneficial (1, 5-8).
The aim of this work was to develop and characterize emulsion with sesame oil, a scientifically proven
medicinal oil (9, 10), as lipophilic phase, added of zinc oxide.
MATERIALS AND METHODS
Phase diagrams were built by visual inspection of the surfactant (S) and co-surfactant (CS) admixtures
[Tween® 20 - Vetec Química fina Ltda, Brazil (S) and Span® 80 Vetec Química fina Ltda, Brazil (CS)] at the
percentage rate of 10:0 to 0:10. To this S/CS admixture, sesame oil (Vital Âtman Ltda, Brazil) was added in
the proportions from 1:9 to 9:1, respectively and the final mixture was titrated with distilled water. The
dispersed systems obtained during the performance of the phase diagrams were classified according to their
physicochemical aspects. After the construction of the phase diagram, seven cream emulsion formulations
were obtained from a certain region of these pseudo-ternary diagrams. The ZnO (Mapric) was incorporated
into the CEMs at the concentration of 10% (w/w), obtaining thus, a total of fourteen formulations. The stability
of all formulations was analyzed by the evaluation of their particle size, stability under storage, stability under
centrifugation, pH value and conductivity measurements. To evaluate the antifungal activity a strain of C.
albicans ATCC 64548 was used. The microdilution method was used to assess the antifungal activity
according to the document M27-A2 Clinical and Laboratory Standards Institute (CLSI), with modifications.
RESULTS
As a result of the centrifugation process, only three formulations remained stable (F1, F8 and F10). Among
these, two contain ZnO, indicating that the presence of this powder increases the stability of the formulation.
The first signs of instability, evaluate by visual analysis, were observed after 4 weeks at both 4 and 45ºC. The
formulations showed small droplet size. However, those with ZnO had lower droplet size, which may be due
to the powder measurement detected by the equipment. The presence of ZnO also increased the pH, changing
the formulations from acidic to neutral. Concerning the conductivity assay, except for F10 formulation, the
presence of ZnO increased its value. The microdilution method reveals a minimum inhibitory concentration of
0.6% of the formulation.
CONCLUSIONS
After performing the stability studies, F10 formulation present the better result in all tests. Therefore, this
formulation was further subjected to the test of antifungal activity and has presented good results. As a
#
Corresponding author. Tel +55 3342 9808, fax +55 3342 9808; e-mail: [email protected]
conclusion, this formulation could be used not only as a prevention product, but also as an aid treatment of
diaper dermatitis associated with secondary infection by C. albicans.
ACKNOWLEDGMENTS
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – CAPES
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