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Research Article
same method was followed for preparation of control sample L = Length moved by the glass slide
without adding any Lantana camara leaves extract.
T = Time (in sec.) taken to separate the slide completely each other.
Formulation
D. Stability Study
As per method described above the formulae were tabulated in
Table 1. Along with control sample gel were prepared with addition The stability study was performed as per ICH guidelines 6. The
of 2.5g and 5g of Lantana camara leaves extract to prepared 2.5% formulated gel were filled in the collapsible tubes and stored at
and 5% Lantana camara gel respectively. different temperatures and humidity conditions, viz. 250 C ± 20C/
60% ± 5% RH, 300 C ± 20C/ 65% ± 5% RH, 400 C ± 20C/ 75% ± 5%
EVALUATION OF TOPICAL GEL FORMULATION RH for a period of three months and studied for appearance, pH, and
spreadibility30.
A. Physical Evaluation
APPLICATION OF HERBAL GEL AND SKIN IRRITATION STUDY
Physical parameters such as color and appearance were checked.
0.5 gm of the herbal gel was used as the test substance was applied
B. Measurement of pH to an area of approximately 6 cm2 of skin and covered with a gauze
pH of the gel was measured by using pH meter. patch. The patch was loosely held in contact with the skin by means
of a semi-occlusive dressing for the duration of 1 hour and gauze
C. Spreadibility was removed. At the end of the exposure period, i.e., 1 hour, residual
test substance was removed, without altering the existing response
Spreadibility was determined by the apparatus which consists of a
or integrity of the epidermis. Observations have recorded after
wooden block, which was provided by a pulley at one end 31. By this
removal of the patch. Control animals were prepared in the same
method spreadibility was measured on the basis of slip and drag
manner and 0.5 gm of the gel base i.e., gel formulated using all
characteristics of gels. An excess of gel (about 2g) under study was
ingredients except the herbal mixture was applied to the control
placed on this ground slide. The gel was then sandwiched between
animals and observations were made as similar to the test animals 32.
this slide and another glass slide having the dimension of fixed
ground slide and provided with the hook. A. one kg weighted was The gel was applied to the skin once a day for 7 days and observed
placed on the top of the two slides for 5 minutes to expel air and to for any sensivity and the reaction if any was graded as33
provide a uniform film of the gel between the slides. Excess of the gel
was scrapped off from the edges. The top plate was then subjected to RESULTS AND DISCUSSIONS
pull of 80 gm. With the help of string attached to the hook and the The herbal gel was prepared and subjected to evaluation of the
time (in seconds) required by the top slide to cover a distance of 7.5 various parameters. The herbal Gel was dark greenish in color and
cm be noted. A shorter interval translucent in appearance and had a cool and smooth feeling on
Indicate better spreadibility. Spreadibility was calculated using the application. pH also maintained constant throughout the study
following formula: which was found to be 6.90 to 7.0 and the gel was non-irritant upon
application on the skin. Spreadibility were also measured and found
S=M×L/T to be less variant than the initially prepared gel after performing
stability study. Further stability test for three months has been
Where,
carried out and results revealed gel containing 2.5% Lantana
S = Spreadibility, Camara showed better stability than 5%. The gel was non-irritant
upon application on to the skin. The control and experimental rats
M = Weight in the pan (tied to the upper slide) showed no signs of tremor, convulsion and reflex abnormalities
Table 1: Different formulations prepared with this ingredients along with quantity.
FORMULATIONS INGREDIENTS QUANTITY
Carbopol 934 1 gm
Methyl Paraben (0.5%) 0.2 ml
Propyl Paraben (0.2%) 0.1 ml
Control
Propylene glycol 400 (5%) 5 ml
Triethanolamine (q.s) 1.2ml
Distilled water Upto 100 ml
Table 2: Physical evaluation of all formulations at the time of gel formulation (initial month).
SPREADIBILITY
FORMULATION COLOR APPEARANCE pH
(GM.CM/SEC)
Control White Clear and Transparent 14.20 6.99
F- I (2.5%) Greenish Clear and Transparent 19.32 7.0
F – II (5%) Greenish Clear and Transparent 16.12 6.92
Table 3: 250 C ± 20C/ 60% ± 5% RH AT 2ND months.
SPREADIBILITY
FORMULATION COLOR APPEARANCE pH
(GM.CM/SEC)
Control White Clear and Transparent 14.12 6.99
F- I (2.5%) Greenish Clear and Transparent 19.90 7.0
F – II (5%) Greenish Clear and Transparent 17.01 6.92
Table 4: 300 C ± 20C/ 65% ± 5% RH AT 3RD months.
SPREADIBILITY
FORMULATION COLOR APPEARANCE pH
(GM.CM/SEC)
Control White Clear and Transparent 14.07 6.99
F- I (2.5%) Greenish Clear and Transparent 18.92 7.0
F – II (5%) Greenish Clear and Transparent 16.82 6.92
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Pawar et al.
Asian J Pharm Clin Res, Vol 6, Issue 3, 2013, 122-124
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