IJRPC 2011, 1(4) Praveen et al.

ISSN: 22312781

INTERNATIONAL JOURNAL OF RESEARCH IN PHARMACY AND CHEMISTRY

Available online at www.ijrpc.com Research Article

DEVELOPMENT AND EVALUATION OF

ANTI-DANDRUFF HAIR GEL
Praveen S. Patil*1, Vinod M. Reddy2, Karnakumar V. Biradar1, Chandrashekhar B. Patil1
and K. Sreenivasa rao1.
1R.R.K.S College of Pharmacy Naubad Bidar, Karnataka, India.
2S.V.E.T College of Pharmacy Humnabad, Bidar, Karnataka, India

*Corresponding Author: [email protected]

ABSTRACT
In the present study, an attempt was made to develop Clotrimazole Anti-Dandruff hair gel.
The different formulation were developed using polymers such as Corbopol 940, Corbopol
934, PEG 200 etc. These polymers were selected based on their use in gel formulation. All
the formulations were evaluated Active Content, Physical appearance, PH, Viscosity,
Extrudability, Antifungal activity, Drug release Profile, Compatibility and Stability study.
In Stability study, formulation F7 was shows no appreciable changes as compared to other
formulation during the study period of three months. Formulation F7 was shows
maximum zone of inhibition to an Anti-fungal activity during in vitro study. Therefore F7
could be used as an effective formulation for Anti-Dandruff hair gel of clotrimazole as
compared to other formulation.

Keywords: Anti-Dandruff hair gel, Clotrimazole, Stability study and in vitro study.

INTRODUCTION imidazole and Empirical formula C22 H17 CIN2,

Dandruff is a common embarrassing disorder used in the treatment of variety of fungal
which effects 5% of the global population1. infections. Various Antifungal agents are
Pityrodporium Ovale is strongly suspected to widely used in hair shampoos for the
play a role in the manifestation of the treatment of dandruff. These products show
seborrheic dermatitis2, 3. Currently available temporary effect for span of hours in a day on
treatment options for the management of the scalp. Therefore, an attempt has been
dandruff include therapeutic use of zinc made for formulation of Clotrimazole Anti-
pyrithione, salicylic acid, imidazole dandruff hair gels which may give
derivatives, glycolic acid, steroids, and antidandruff action for number of hours.
sulphur and coal tar derivatives. However,
these agents show certain limitations, either MATERIALS AND METHODS
due to poor clinical efficacy or due to the Clotrimazole was procured from halcyon labs,
compliance issues. Further more, these drugs pvt, ltd, Mumbai, India. Carbopol 940,
are unable to prevent recurrence4. Corbopol 934, PEG 200, propyl paraben ,
Clotrimazole is a broad spectrum synthetic methyl paraben were procured from SD fine
antifungal agent having the chemical name 1- chemicals, Mumbai., India and all others
(o -Chloro-(alpha), (alpha)-diphenylbenzyl)

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chemicals and reagents were of either Extrudability determination of formulations

analytical or laboratory graded were used. The hair gel formulations were filled into
collapsible metal tubes. The tubes were
Instruments used for the study pressed to extrude the material and the
Digital weighing balance (Shimazdu extrudability of the formulation was checked.
Electronics), pH Meter (Elico pH Meter, The comparative extrudability of the hair gel
Hyderabad), Brook field viscometer (Startech formulations is shown in Table-3.
Lab,Hyderabad), I.R.spectrophotometer
(Startech Lab, Hyderabad) and Mechanical Viscosity Determination of formulations
stirrer (Remi Motors Ltd, Mumbai). Brook field viscometer was used to determine
viscosity. The sufficient quantity of gel was
METHODS filled in wide mouth jar separately the height
Formulation of Anti-dandruff hair gel of the gel was filled in the wide mouth jar
Measured quantity of methyl paraben, should sufficiently allow to dip the spindle.
glycerin and weighed quantity of polyethylene The RPM of the spindle was adjusted to 2.5
glycol were dissolved in about 35 ml of water RPM. The viscosities of the formulations were
in beaker. Then it was stirred at high speed recorded. The results of viscosity of gel
using mechanical stirrer.Then carbopol 940 formulations are shown in the Table-3.
and PVP were added slowly to the beaker
containing above liquid while stirring. Determination of drug content of
Crushed menthol was incorporated slowly in formulations
above dispersion after smooth dispersion is For estimating the drug content of the hair gel
obtained. Then Triethanolamine (gelling formulations for F1 to F8, the common
agents) was added slowly while stirring till to procedure was followed. About 500
attain gel structure. The clotrimazole was milligrams of the above hair gel formulations
levigated using stainless steel spatula and were separately weighed and then each hair
porcelain slab.The gel was finally transferred gel formulation is separately dissolved in 50
in aluminum collapsible tube and labeled ml of methanol. Then the above volumetric
accordingly. The details of formulations were flask containing formulation should shake for
shown in table no 1 and 2. 15 minutes for the extraction of drug from the
gel. Then dissolved drug was titrated with
Characterization of Hair gels (IR Studies) perchloric acid as the method described in
The prepared hair gel formulations were B.P.1 ml of 0.1M perchloric acid is equivalent to
tested for compatibility of the drug with 34.48 mg of C22H17ClN2. The amount of
gelling agents using IR studies. IR studies clotrimazole present was calculated and
confirmed absence of drug, gelling agents depicted in Table-3.
interactions with hair gel formulations F5 to
F8. Drug & Gelling agents interactions were In-vitro study
observed with hair gel formulations F1 to F4. Diffusion Studies
Hence, F5 to F8 hair gel formulations were The in-vitro diffusion of drug from the
selected for further studies in this present different gel preparations were studied using
investigation. the classical standard cylindrical tube
fabricated in the laboratory; a simple
Evaluation of Anti-dandruff hair gel modification of the cell is a glass tube of 15mm
Physical appearance internal diameter and 100mm height. The
The physical appearance was visually checked diffusion cell membrane was applied with one
for the texture of hair gel formulations and gram of the formulation and was tied securely
observations were shown in Table – 3. to one end of the tube, the other end kept open
to ambient conditions which acted as donor
pH determination of formulations compartment. The cell was inverted and
The pH of all hair gel formulations were immersed slightly in 250 ml of beaker
determined by using the digital pH meter. containing 100 ml of phosphate buffer pH 7.4
Electrodes were completely dipped into the as a receptor base and the system was
hair gel formulations and pH was noted. The maintained for 2 hrs at 37 0.5 o C. The sample
results are presented in Table-3. was withdrawn at the 10 minutes interval of

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the time for 2 hrs. The media was stirred using indicating the hair compatibility and shown in
magnetic bead hot plate magnetic stirrer. table no 3.

Titrimetric measurement Viscosity Determination

10 ml of samples were withdrawn and The viscosity of formulation F (6) was found to
transferred to conical flasks at 20 minutes be highest and viscosity of formulation F (1)
interval for 2 hours and replenished with fresh found to be least at 2.5 RPM.and they were
media 10 ml. The clotrimazole content was showed in table 3.
estimated titrimetrically as described in B.P.1
ml of 0.1M perchloric acid is equivalent to 34.48 Extrudability determination
mg of C22H17ClN2. In-vitro diffusion profile, The results of the Extrudability indicate that
namely cumulative drug release was the F5 to F8 had better Extrudability than F1 to
calculated and shown in Tables – 4 to 7 & F4. All formulation showed good
Figures - 1to 8. The diffusion of the drug form Extrudability when extruded from metallic
the selected hair gel formulations were collapsible tube (Table –3).
compared with marketed formulations. The
results were shown in Table -8 & Figure – 9. In-Vitro study
Diffusion Study
Antifungal activity In vitro diffusion study was carried out using
The hair gel formulation (F5 to F8) which the procedure as described earlier. The release
showed optimal release was subjected to profiles of the formulations are shown in the
antifungal activity by adopting disc diffusion Table-4 to 7 and in the Figures- 1 to 8.
method at Startech Labs, Hyderabad. The test
organizing was Pityrodporium Ovale (strain 27) Comparative Drug Release Profile
in sabouraud’s dextrose agar media. Comparative in vitro drug release profile is
Commercial Clotrimazole ointment was taken shown in the Table – 8 and Figure-9.
as standard. Clotrimazole is a well known
effective antifungal drug and it is available as Compatibility study
a topical formulation. The results are recorded The prepared hair gel formulations were
in Table -9. tested for compatibility of the drug with
gelling agents using IR studies (as shown in
Stability Studies charts.) IR studies confirmed absence of drug,
The hair gel formulation F7 was subjected to gelling agents interactions with hair gel
stability performance as it was exhibited good formulations F5 to F8. Drug & Gelling agents’
drug release and exhibited maximum zone of interactions were observed with hair gel
inhibition when compared to other formulations F1 to F4. Hence, F5 to F8 hair gel
formulations. The gel formulation F7 which formulations were selected for further studies
was filled earlier in collapsible tube was stored in this present investigation.
at room temperature and 40C at 75% RH. The
stability study was conducted for the period of Antifungal activities
3 months. The parameters like Appearance, Among the formulations, F7 showed better
pH, Extrudability, Colour, % drug content release and maximum zone of inhibition than
were tested at the every month. The results other formulation. Hence, Hair gel
were shown in Table – 10. formulation F7 was considered as best
formulation as shown in the Table – 9.
RESULT AND DISCUSSION
Active content and physical appearance Stability Study of the Formulation F7
The formulations evaluated for the active The hair gel formulation F7 was subjected to
content. The results were found in acceptable stability performance as it was exhibited good
range and % of drug content shown in table no drug release and exhibited maximum zone of
3. inhibition when compared to other
formulations. The stability study was
pH determinations conducted for the period of 3 months. The
It was found that all the formulations have pH parameters like Appearance, pH,
in range 6.80 to 7.11 that suited the hair, Extrudability, Colour, % drug content were
tested at the every month. No appreciable

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changes were found for the tested parameters. dandruff or seborrheic dermatitis. Anti-
The results were shown in Table – 10. dandruff hair gel containing 1.5% (F7) of
Clotrimazole with Corbopol 940 base could be
CONCLUSION used as an effective in treatment of Dandruff
The formulation of Anti-dandruff hair gel on scalp.
provides a method for treating a scalp

Table 1: Formulae of Hair Gels

Ingredients F1 F2 F3 F4
Clotrimazole 0.5 1.0 1.5 2.0
Carbopol 940 0.20 gm 0.20 gm 0.20 gm 0.20 gm
Polyethylene glycol 15 gm 15 gm 15 gm 15 gm
Alcohol 15 ml 15 ml 15 ml 15 ml
Water 20 ml 20 ml 20 ml 20 ml

Table 2: Formulae of Hair Gels

Ingredients F5 F6 F7 F8
Clotrimazole 0.5 1.0 1.5 2.0
Carbopol 940 0.30 gm 0.30 gm 0.30 gm 0.30 gm
Polyethylene glycol 7.0 gm 7.0 gm 7.0 gm 7.0 gm
Methyl paraben 0.075 gm 0.075 gm 0.075 gm 0.075 gm
Poly vinyl
0.05 gm 0.05 gm 0.05 gm 0.05 gm
Pyrrolidone
Menthol 0.5 gm 0.5 gm 0.5 gm 0.5 gm
Triethanolamine 0.6 ml 0.6 ml 0.6 ml 0.6 ml
Glycerin 3.0 ml 3.0 ml 3.0 ml 3.0 ml
Water Q.S. 50 ml 50 ml 50 ml 50 ml

Table 3: Evaluation of Hair Gels (Physico-Chemical Characteristics)

Extrudability % drug Viscosity
S.No Product Appearance pH*
* content* (cps)
Translucent, off white,
1 F1 6.80 ++ 95.5 90,00,007
smooth on application
Translucent, off white,
2 F2 6.82 ++ 96.6 90,00,015
smooth on application
Translucent, off white,
3 F3 6.81 ++ 96.7 90,00,130
smooth on application
Translucent, off white,
4 F4 6.82 ++ 96.2 90,00,105
smooth on application
Translucent, off white,
5 F5 6.91 +++ 97.1 90,00,169
smooth on application
Translucent, off white,
6 F6 6.93 +++ 97.7 90,00,235
smooth on application
Translucent, off white,
7 F7 7.01 +++ 97.5 90,00,098
smooth on application
Translucent, off white,
8 F8 7.11 +++ 98.1 90,00,195
smooth on application
*Each reading is an Average of three determinations
Excellent = +++, Good = ++.

Table 4: In-vitro Drug Release Profile of Hair gel (F5)

Time % of drug % of drug Log % of drug
S. No.
( in min) released remaining remaining
1 20 5.26 95.74 1.981
2 40 10.57 89.43 1.951
3 60 23.84 76.16 1.881
4 80 39.86 60.14 1.779
5 100 42.89 57.11 1.756
6 120 45.94 54.06 1.732
* Each reading is an average of three determination

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Table 5: In-Vitro Drug Release Profile of Hair Gel (F6)

S. Time % of drug % of drug Log % of drug
No. ( in min) released remaining remaining
1 20 6.71 93.29 1.969
2 40 12.32 87.68 1.942
3 60 24.40 75.60 1.878
4 80 36.83 63.17 1.801
5 100 48.52 54.48 1.736
6 120 54.58 45.42 1.657
* Each reading is an average of three determinations

Table 6: In-Vitro Drug Release Profile of Hair gel (F7)

S. Time % of drug % of drug Log % of drug
No. ( in min) released remaining remaining
1 20 10.21 89.79 1.953
2 40 25.32 74.68 1.873
3 60 35.37 64.63 1.810
4 80 40.72 59.28 1.772
5 100 45.58 54.42 1.735
6 120 56.78 43.22 1.635

* Each reading is an average of three determinations

Table 7: In-Vitro Drug Release Profile of Hair gel (F8)

S. Time % of drug % of drug Log % of drug
No. ( in min) released remaining remaining
1 20 8.51 91.49 1.961
2 40 22.15 77.85 1.891
3 60 34.82 65.18 1.814
4 80 39.52 60.48 1.781
5 100 41.45 58.55 1.767
6 120 46.58 53.42 1.727
* Each reading is an average of three determinations

Table 8: Comparative In-Vitro Drug Release profiles of Hair Gels (F5 to F8)
% of drug release
S. No. Time
F5 F6 F7 F8
1 20 5.26 6.71 10.21 8.51
2 40 10.57 12.32 25.32 22.15
3 60 23.84 24.40 35.37 34.82
4 80 39.86 36.83 40.72 39.52
5 100 42.89 48.52 45.58 41.45
6 120 45.95 54.58 56.78 46.58
* Each reading is an average of three determinations

Table 9: Anti Fungal Activity

Zone of inhibition
S.No. Formulation
average diameter
1 F5 10
2 F6 18
3 F7 28
4 F8 28
5 CF 25

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Table 10: Stability Studies of Formulation F7

Observation
Sl. No. Initial First month Second month Third month
Parameters
RT 40c RT 40c RT 40c
1 pH 7.01 6.97 6.99 7.14 7.14 7.15 7.15
2 Extrudability Excellent Excellent Excellent Excellent Excellent Excellent Excellent
3 % drug content 97.5 97.7 97.5 97.5 97.4 97.4 97.4
Translucent Translucent & Translucent & Translucent & Translucent & Translucent & Translucent
4 Appearance & smooth. smooth. smooth. smooth. smooth. smooth. & smooth.

* Each reading is an average of three determinations.

50
45
40
% of Drug Release

35
30
25
20
15
10
5
0
0 20 40 60 80 100 120 140
Tim e (in M in .)

Fig. 1: In-vitro Drug Release Profile of Hair gel (F5)

1.95
log % of drug remaining

1.9

1.85

1.8

1.75

1.7
0 20 40 60 80 100 120 140
Tim e (in M in.)

Fig. 2: 1st order drug Release profile of hair gel (F5)

1 .95
Log % Drug Remaining

1.9

1 .85
1.8

1 .75

1.7
1 .65

1.6
0 20 40 60 80 100 12 0 14 0
Time (in Min.)

Fig. 3: In-Vitro Drug Release Profile of Hair Gel (F6)

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60

% of Drug Released
50

40

30

20

10

0
0 20 40 60 80 100 120 140
Time (in Min.)

Fig. 4: 1st Order Drug Release Profile of Hair Gel (F6)

60
50
% of Drug Released

40

30
20

10
0
0 20 40 60 80 100 120 140
Time (in Min.)

Fig. 5: In-Vitro Drug Release Profile of Hair gel (F7)

2
Log % of Drug Remaining

1.95
1.9
1.85
1.8
1.75
1.7
1.65
1.6
0 20 40 60 80 100 120 140
Time (in Min.)

Fig. 6: 1st order Drug Release Profile of Hair gel (F7)

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50
45

% of Drug Released
40
35
30
25
20
15
10
5
0
0 20 40 60 80 100 120 140
Tim e (in M in . )

Fig. 7: In-Vitro Drug Release Profile of Hair gel (F8)

2
Log % of Drug Remaining

1.95
1.9
1.85
1.8
1.75
1.7
1.65
0 20 40 60 80 100 120 140
Tim e (in M in.)

Fig. 8: 1st order Drug Release Profile of Hair gel (F8)

60

50
% of Drug Released

40
F5
F6
30
F7
F8
20

10

0
0 20 40 60 80 100 120 140
Tim e (in Min.)

Fig. 9: Comparative In-Vitro Drug Release profiles

of Hair gels (F5 to F8)

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