indicates better spreadability9. Sp

indicates better spreadability9. Spreadability is
measured as S = m × l /t
6. Consistency or hardness of ointment : It
was measured by Penetrometer. Three
containers were filled carefully and completely,
without forming air bubbles and stored at 25+
0.50C for 24 hrs. Three samples were stored at
25+ 0.50C and with shear for 5min. Three
samples were melted and carefully and
completely filled three containers, without
forming air bubbles stored at 25+ 0.50C for 24
hrs. Test samples were placed on Penetrometer.
Temperature of penetrating object was adjusted
at 25+ 0.50C and position was also adjusted
such that its tip just touches the surface of
sample.
7. Viscosity of ointment : The viscosity was
determined by CAP- 2000 Brookfield viscometer.
Test sample was taken in a clean and dry 250 ml
beaker and the viscosity of the test sample was
determined by standard operating procedure of
Viscometer by using spindle nos. 1 to 4. Each
spindle was used for finding the viscosity of the
sample at speeds of 0.3, 0.6, 1.5,3,6,12,30 and
60r.p.m. respectively. Their rheological
characteristics were also tested at 250 C using
Brookfield viscometer11.
8. Microbiological studies :The antibacterial
activity of various ointment formulations of
clotrimazole and ichthammol against various
strain of anaerobic and aerobic microorganism
were evaluated by standard cup plate method
and the inhibition zone diameters were
measured with the help of zone reader. Bacillus
substilis, staphylococcus aureus, Escherichia coli
(aerobic organism) and bacterioids fragilis
(anaerobic organism) were used for testing of
antibacterial activity.
9. Diffusion study :In modified kiescary chein
diffusion cell, 2 gm of ointment was kept in donor
compartment. The entire surface of cellophane
membrane was in contact with the receptor
compartment containing 22 ml of phosphate
buffer pH 7.4. The receptor compartment was
continuously stirred (100rpm) using the magnetic
stirrer. The temperature was maintained 37±
1°C.The surface area available for diffusion was
calculated and found to be 3.14 cm2. The study
was carried out for 5 hrs and the sample was
withdrawn at 30 minute time interval and same
volume was replaced with free phosphate buffer.
The content of clotrimazole and ichthammol from
withdrawn sample was measured after suitable
dilution. The experiment was carried out in
triplicate and average values are reported.
10. Stability studies :The international
conference on harmonization (ICH) harmonized
tripartite guidelines on stability testing of new
drug substance and product was issued on 27,
1993. The formulated clotrimazole and
ichthammol ointment were filled in the
collapsible tubes and stored at different
temperature condition viz. 250C+ 20C/60℅ RH+5℅RH, 300C+ 20C/65℅ RH+ 5℅RH, 400C+
20C/75℅ RH+ 5℅RH for a period of three
months and studied for appearance, pH,
extrudability, viscosity, spreadability and assay
of the drug13.
CONCLUSION:
A combinational therapy is
the need of hour to treat eczema and pruritis.
This can be achieved by clotrimazole and
ichthammol (an antifungal and antiseptic).In this
study, ointment was formulated with different
bases like white soft paraffin, cetostearyl alcohol
hard paraffin, light liquid paraffin and
microcrystalline wax. From the study, it can be
concluded that formulation containing hard
paraffin, cetostearyl alcohol, Light liquid paraffin
and microcrystalline wax was better than
formulation with white soft paraffin and
cetostearyl alcohol alone. By combining these
drugs with appropriate ointment bases (as
formulation B) a better therapyand patient
compliance can be attained.