Journal Club

1. Formulation and Evaluation of Proniosomal
Topical Antifungal Gel of Miconazole Nitrate
Journal Club
Name : Faisal Mainuddin Bagwan
College Name : MGV’s Pharmacy College,
Panchavati, Nashik.
Department : Quality Assurance
(M.Pharm Second Year)
Roll No:33
Date:06/05/2024
Guided By : Dr.Suvarna.A.Katti

2. “ To be a centre of professional excellence by contributing honestly
to the pharmacist moulding process”
Mission:
• Impart high quality education to graduates
• Contribute to all spheres of professional activities
• Upload human values and ethics
• Nurture them into globally competent professionals
Vision:

3. Research Paper
Sr
no
Title Parameters
1 Title of Article Formulation and Evaluation of
Proniosomal Topical Antifungal
Gel of Miconazole Nitrate
2 Author Suvarnalata S. Mahajan, Rajesh
Y. Chaudhari, Vijay R. Patil
3 Title of journal International Journal of
Pharmaceutical
Sciences and Drug Research
4 Impact Factor 7.01
5 Year of
Publication
2021

4. Content
 Abstract
 Introduction
 Materials
 Procedure
 Result
 Conclusion

5. Abstract
The research aimed to develop an antifungal gel formulation using
Miconazole Nitrate for the treatment of fungal infections.
Developed proniosomal topical gel had the potential to act as a
controlled release drug carrier, which sustains the drug release for
many hours and exhibit good antifungal activity
1

6. Introduction
2
 Fungal infections also called mycoses.
 The topical drug administration is a drug delivery
system anywhere in the body through ophthalmic,
rectal, vaginal and skin as topical routes.
 Skin is the most accessible organs on human body for
the topical administration.

7. Anhydrous free-flowing formulations or liquid crystals with a
jelly-like consistency of water-soluble carrier coated with
suitable noisome forming surfactants.
Proniosomal gel formulations were prepared using different
combinations of non-ionic surfactants (span), cholesterol, and
lecithin through the coacervation phase separation method.
Proniosomes
3

8. 4
 The formulations were characterized for various parameters
such as particle size, shape, entrapment efficiency, in vitro
drug permeation, and stability .
Cont…

9. Drug Profile
 Miconazole nitrate
Antifungal agent of imidazole class.
 Nature:-Lipophilic (weak base with pKa 6.7)
5

10. Material
Miconazole nitrate, Soya lecithin (Phospholipid), Cholesterol,
Non-ionic surfactants span 20,40,60,80 were purchased from
Himedia Laboratories Pvt. Ltd, Mumbai.
Ethanol and other reagents and solvents were purchased from
Research Lab. Fine Chem Industries.
Dialysis membrane Himedia Laboratories Pvt. Ltd,
6

11. Formulation Code MF1 MF2 MF3 MF4 MF5 MF6 MF7 MF8 MF9 MF10
Miconazole (mg) 80 80 80 80 80 80 80 80 80 80
Span20 (mg) 1800 900 900 900
Span40 (mg) 1800 900 900 900
Span60 (mg) 1800 900 900 900
Span80 (mg) 1800 900 900 900
Cholestrol (mg) 200 200 200 200 200 200 200 200 200 200
Lecithin (mg) 1800 1800 1800 1800 1800 1800 1800 1800 1800 1800
Ethanol (ml) 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0
Phosphate Buffer
(pH6.8) (mL)
1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0
Composition of proniosomal gel formulations of miconazole nitrate
7

12. Method of preparation of Proniosomal Gel
In clean, dry wide mouth vial
A measured amount of Ethanol (0.1ml) added
Mix all the ingredients well and cover the vial with lid
All the vials are warmed on water bath at 60-70℃ for 5min
Aqueous phase was added and warmed on water bath
The glass vials were kept in a dark place to cool at room
temperature
• Drug
• Surfactant
• Lecithin
• Cholestrol
Until the surfactant
dissolved completely
Until a clear Solution was formed
Until the dispersion was
converted into proniosomal gel
8

13. Evaluation parameters of gel
1. Physical Appearance of Proniosomal Gel
2. PH determination
3. Vesicle Size Determination
4. Entrapment Efficiency Determination
5. In vitro drug release
9

14. Physical Appearance of Proniosomal Gel
The prepared gel was watched through the naked eye to
characterize the color and physical state of gel.
The appearance of each formulation was checked for its
color, consistency, and fluidity.
10

15. PH determination
Weigh about one gram of the gel was dissolved in 25 mL
of distilled water.
The pH was determined at 27 °C using the pH meter
11

16. Vesicle Size Determination
For Size and size distribution studies,
The proniosomal gel (100 mg) was hydrated first in a small glass test
tube 10 ml of phosphate buffer (pH 6.8) with manual shaking for 10
minutes.
After hydration, the aqueous dispersion of niosomes was observed
under an optical microscope at 10X and 40 X magnification.
12

17. Entrapment Efficiency Determination
In a glass tube, 0.2 gm of proniosomal gel was taken and 10 mL
of phosphate buffer (pH 6.8) was added.
This aqueous suspension was sonicated in a sonicator bath for
10 minutes
The percentage of drug encapsulation (EE%) calculated
13

18. In vitro drug release
 Prepare Franz Diffusion Cell
Soak membrane in phosphate buffer (pH 6.8)
Spread proniosomal gel (20 mg of drug) uniformly on membrane
Collect samples at specified time intervals (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours)
Dilute samples with phosphate buffer (pH 6.8) Analyze samples spectrophotometrically
for Miconazole Nitrate concentration
Plot Cumulative % drug release (Miconazole Nitrate) versus time
14

19. Result
15

20. Physical examination
16
Proniosomal gel of Miconazole Nitrate
prepared by using
span (20, 40, 60) have pale yellow semi solid
gel like appearance, and
span 80 have light brownish gel like
appearance

21. Physico-chemical evaluation of formulation
Formulation
code
Physical appearance
MF1 Pale yellow semi solid gel
MF2 Pale yellow semi solid gel
MF3 yellow semi solid gel
MF4 Light brownish gel
MF5 Pale yellow semi solid gel
MF6 Pale yellow semi solid gel
MF7 Light brownish semi solid gel
MF8 Pale yellow semi solid gel
MF9 Light brownish semi solid gel
MF10 Light brownish semi solid gel
17

22. pH
18
It was found that the pH of all the
formulations was in the range of 5.60 to
7.20, which suits the skin pH, so
compatible with skin
Formulation code pH
MF1 6.31 ± 0.26
MF2 6. 52 ± 0.24
MF3 6.83 ± 0.14
MF4 6.90 ± 0.34
MF5 7.24 ± 0.05
MF6 5.81 ± 0.20
MF7 6.74 ± 0.12
MF8 6.82 ± 0.18
MF9 7.21 ± 0.03
MF10 7.52 ± 0.07

23. Vesicle Size Determination
o Miconazole Nitrate proniosomes were investigated, revealing a
mean vesicle size ranging from 2.70 ± 0.42 to 6.34 ± 0.30 µm.
o Optical microscopic images of hydrated proniosomal gel
formulations (MF5, MF6, MF3, and MF8) were captured,
depicting multilamellar niosomes with spherical morphology
and no signs of aggregation or agglomeration.
Optical microscopic examination
of formulations MF5 (A),
MF6 (B), MF3(C) and MF8 (D)
20

24. 21
Formulation
code
Mean Vesicle size
(µm)
MF1 6.11 ± 0.30
MF2 5.80 ± 0.35
MF3 3.40 ± 0.15
MF4 4.75± 0.66
MF5 3.10 ± 0.56
MF6 3.90± 0.45
MF7 2.70 ± 0.42
MF8 3.10 ± 0.12
MF9 4.10 ± 0.69
MF10 6.34 ± 0.30
Vesicle Size Determination

25. Entrapment Efficiency Determination
Encapsulation efficiency of proniosomal
gel formulations ranged from 83 to 91.25%.
The encapsulation efficiency of
formulations batches MF1 to MF10
22
Formulation code EE %
MF1 84
MF2 86.13
MF3 86.56
MF4 83
MF5 87.28
MF6 89.35
MF7 84.23
MF8 91.25
MF9 85.12
MF10 85.47

26. In vitro drug release
23
The result indicated that formulation MF8 containing span 40
and span 60 combination was shown higher drug release
72.03% up to 12 hours.
Among the ten formulations, the first four formulations from
MF1 to MF4 prepared using single nonionic surfactant (Span),
and the remaining six formulations was prepared using a
combination of different grades of span.

27. Cumulative percent drug permeation of
proniosomal gel formulation (MF6 to MF10)
Cumulative percent drug permeation of
proniosomal gel formulation (MF1 to MF5)
24

28. 25
Conclusion
The formulation of the antifungal cream containing
Miconazole was found to be safe and effective for the
treatment of fungal infections, as indicated by in vitro diffusion
studies.

29. Reference
1. Kar K, and Sudheer P. Formulation and Evaluation of Niosomal Drug Delivery System of
Ketoprofen. RGUHS J Pharm Sci. 2015; 5(4):173-180.
2. Nagalakshmi S, Ramaswamy R, Renuga, Sowjanya, Premalatha, Vijayanjani and
Shanmuganathan S. Design, Development and Evaluation of Miconazole Nitrate Topical
Gel for Fungal Infections. Int J Pharm Sci Res. 2015;6(3):1266-1272.
3. Basha BN, Prakasam K, Goli D. Formulation and evaluation of Gel containing
Fluconazole-Antifungal Agent . Int. J. Drug Dev. & Res.2011; 3(4):109-128.
4. Sawant KK, Patel RP, Shah SK. Preparation and evaluation of niosomes of Miconazole
nitrate. Drug Del Tech. 2005:56-58
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30. THANK YOU
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