4.5. Skin retention study
The skin retention of STZL was 32.68, 62.42 and 103.26 g for plain drug solution, commercial cream and HSM-4 respectively.
HSM-4 had 3 and 1.5 times higher drug deposition capacity than commercial cream and
plain drug solutions respectively.
This might be due to faster release observed for the drug from HSM-4 compared to commercial cream and plain drug solution thereby more drugs penetrates into the skin by which more amount of drug retains in the skin.
If more amount of drug retains in the skin, fungus present in deep tissues were treated more effectively.
Hence it can be inferred from skin retention study that the optimized formulation, HSM-4S was more efficient for topical fungal diseases.
4.6. Skin sensitivity study
The intensity criterion of skin irritation followed the protocol,that scores of <0.5
meant no irritation, 0.5–3 for slight irritation,>6 showed severe irritation and others showed moderate irritation.
The irritation studies showed very little visible irritation after application of
optimized HSM-4 and aqueous saline solution containing 2% w/w STZL for 5 days on the rabbit skin.
The average response scores of skin irritation found for HSM-4 are 0.06 ± 0.000(48 h) and 0.11 ± 0.003 (72 h); and for saline solution with 2% (w/w)STZL are 0.74 ± 0.032 and 1.28 ± 0.027 the saline solution of STZL induced significant erythema, edema and irritation.
This is because of the irritation property of STZL.
In contrast HSM-4 showed veryminute irritation may be due to encapsulation of STZL by ME inHSM.
4.7. Stability study
Optimized HSM exhibited transparency, clarity and no drug precipitation or color change when it was subjected to stability study at 5 ± 3◦C, 25 ± 2◦C and 40 ± 2◦C for 6 months.
The organoleptic features like gel viscosity, gel strength, physical appearance were also observed and no significant change was found in these characters.
The centrifuge tests showed that all formulations had good physical stability.
The o/w structure of HSM and suitable pH ranging from 6.0 to 7.0 provided a suitable circumstance for avoiding the hydrolysis of drug.
4.8. Anti-fungal study
The anti-fungal efficacy of the developed HSM-4 was compared with commercial formulations (onabet).
Developed HSM-4 was found to be more effective anti-fungal activity in compare to commercial cream (Fig. 3a and b). The average zone of Fig. 3. (a) In vitro antifungal of study of optimized Hydrogel of sertaconazole microemulsion gel (HSM-4) in Candida albicans.
(b) In vitro antifungal of study of Commercial cream in Candida albicans
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