Development and formulation of a new natural product for the treatment of pityriasis versicolor and skin dermatophyte infections
Development and formulation of a new natural product for the treatment of pityriasis versicolor and skin dermatophyte infections
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Date
2015-04-07
Authors
Kassem, Abdulkarim
Journal Title
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Publisher
University of Khartoum
Abstract
Tinea versicolor (TV) and skin dermatophytes (SD) infections are
common diseases widely spread in tropical areas and among poor
populations. There are some chemical drugs used in the treatment of TV
and S.D infections. These drugs have side effects; especially oral drugs
which have toxic effects on liver and kidneys. Some are very expensive and
recurrence rate of the disease is high.
The aim of this study was to prepare a new, non expensive, effective
and safe pharmaceutical formulation for treatment of TV and SD infections
using a naturally available volcanic stone extract.
This volcanic stone is native to Yemen where it is used traditionally
for treatment of TV and SDinfections by soaking in water and wiping the
affected areas of the skin.
In this study chemical analysis was done for the stone which
identified its constituents and the amount of each constituent.
In vitro microbiological studies were done to know the effect of the
stone extracts on cultures of differentfungi and bacteria. Comparative
studies were carried out to investigate the microbiologicalactivity of the
stone extracts with other drugs used for treatment of fungi infections. The
results achieved showed high microbiological activity of stone extracts
against TV and other dermatophytes infections.
The stone extract was then formulated in a suitable pharmaceutical
formulation (aqueous cream) and the physical and chemical properties of
this formulation were determined. The stability of the finished formulation
was carried out.
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Pharmacological studies of the stone extract were done for the
smooth muscle receptors in the small intestine and aortic muscle from the
rabbit and on the receptors ofthe skeletal muscle from the frog, and also on
the receptors of the uterus muscle from the rat. The results of these studies
showed that there are no pharmacological effects on these receptors.
Toxicological studies of the stone extract (100 mg/kg) were tried on
twelve rats; six were used as control and the others six as test. The drug
was given to the test group for twentyone days (sub chronic study) in high
doses (100 mg/kg) and after that blood was taken from both groups. Blood
was analyzed for all parameters and different enzymes and the results were
compared with the control groups. The results showed that there were no
significant difference between the two groups this indicate that the drug is
free of toxic effects.
The five important organs of the control rat (liver, Kidney, heart,
small intestine and spleen) were taken. Specimens were prepared for
histopathological studies. The results confirmed that there is no damage or
effect on these organs.
Clinical trials using the pharmaceutical formulation were carried out
in Sudan after the approval of the study by the Ethics Committee of the
Research Administration, Federal Ministry of Health, Sudan. Clinical
comparative studies were done on one hundred volunteers; fifty were
treated with clotrimazolecream and the other fifty with the new cream
formulation. The results were analyzed and statistically compared using
SPSS. This showed that the new creamformulation was effective for the
treatment of TV and other S.D infections with no recurrences
Description
265 Pages
Keywords
naturalproduct, treatment,pityriasis,versicolor