Formulation and Evaluation of Topical Preparation (Proposal)

Formulation and Evaluation of Topical Preparation for Antifungal Activity (Proposal)

1. Summary of research
2. Background and Review of literature
3. Aims and Objectives
4. Research Design and Methods
5. References Abstract

Background

Date palm is the most grown fruit in hot countries especially Saudi Arabia. It contains an impactful list of an essential nutrient, vitamin, minerals, and phenol that benefit a human being.

Aim

formulating a topical date palm extract cream and evaluation of its antifungal activity. Method: preparation of vanishing and cold cream and characterizing them by a number of tests such as ensuring cream homogeneity, PH level. Physical and chemical stability. Introduction Phoenix dactylifera L (date palm) is a monocot plant from the Arecaceae family (Khan et al., 2018).

Dates are a high source of energy they contain carbohydrate, fat, protein, fiber, minerals and small amount of vitamins such as C, B1, B2, A ,riboflavin ,niacin and thiamine (Assirey, 2015,Essa et al., 2015,Farouk et al., 2018). Carbohydrate and fiber content vary depending on ripening stage, date cultivar and environmental condition (Alfaro-Viquez et al., 2018). Dates contains anthocyanins, phenolics, sterols, carotenoids, procyanidins and flavonoids (Temitope Olabisi and Ojotule, 2017).

They have been used as traditional medicine for treating diverse disorder such as fever, inflammation, memory disorder and paralysis (Stephen et al., 2018). Now days studies discovered that date have a countless health benefits for human being which are antioxidant , anticancer, hepatoprotective, nephroprotective, neuroprotective, gastrointestinal protective, anti-diabetic, antimicrobial, antiviral ,antihyperlipidemic , antidiarrheal ,laxative and sexual improvement activity (Assirey, 2015, Hamad et al., 2015,El-Far et al., 2016,M et al., 2016,Temitope Olabisi and Ojotule, 2017).

Method To prepare Vanishing cream Vanishing cream is emulsion base which is oil in water, the oil phase gives the cream shine and pearl look because of stearic acid in oil. To form emulsion, the alkali will react with stearic acid to form stearate soap. Then mix Sodium Hydroxide (NaOH) with Potassium Hydroxide (KOH) to give cream hard and soft properties. The different between Vanishing cream and cold cream is vanishing cream have larger quantity of water phase.

The benefits of vanishing cream are

1.  easy to rub on skin
2.  not greasy
3.  skin cooling.

Experiment Objective

To prepare 30 g of Vanishing Cream (o/w) Sr. No Ingredients Formula

1.  Stearic Acid 18 gm
2.  Potassium Hydroxide 0.8 gm
3.  Glycerine 5 gm
4.  Propyl Paraben 0.01 gm
5.  Methyl Paraben 0.1 gm
6.  Purified Water 76.2 gm

Apparatus

• Porcelain dish (china dish),
• Water bath,
• Ointment Spatula,
• Thermometer,
• Beaker

Chemicals

1. Stearic acid,
2. Potassium hydroxide,
3. Glycerine,
4. Propyl paraben,
5. Methyl paraben

Procedure

1. Heat the oil phase (i.e. stearic acid) and water phase (i.e. potassium hydroxide, glycerine, propyl paraben, methyl paraben, water) to approximately 65°C.
2. Add the aqueous phase slowly to the oil phase with stirring to form a crude emulsion.
3. Cool to nearly 50°C and homogenize.
4. Cool with agitation until congealed.

To prepare 30 g of Cold Cream (w/o)

Method for Preparation of Creams

• Heat oil soluble materials over steam bath until melted in evaporating dish.
• Heat all water soluble materials to approximately the same temperature
• Add water to Oil with constant stirring.
• Remove evaporating dish from heat; continue stirring until at room temperature.

NOTE: Always add water phase to oil phase because oil phase tends to remain in dish.

Apparatus

• Porcelain dish (china dish),
• Water bath,
• Ointment Spatula,
• Thermometer,
• Beaker

Chemicals

1. Spermaceti,
2. White Wax,
3. Mineral Oil,
4. Sodium tetraborate

Procedure (Fusion Method)

1. Reduce the cetyl esters wax and the white wax to small pieces.
2. Melt the cetyl esters wax and white wax together in the Ointment Melting Apparatus. NOTE: boiling wax is extremely flammable. Do not bring the wax to a boil.
3. Once the waxes are melted, add the mineral oil.
4. Continue heating until the temperature of the mixture reaches 70°C; maintain at 70°C for 5 minutes. (Oil phase)
5. In a separate beaker, dissolve the sodium tetraborate in the purified water, warmed to 70°C. (Aqueous phase)
6. Gradually add this warm solution (aqueous phase) to the melted oil mixture (oily phase)
7. Remove from heat. While the mixture is cooling, stir rapidly and continuously until it has congealed. Otherwise, the phases will separate.

Characterization of the Vanishing cream containing drug

1. Drug content: The amount of drug in the cream will be determined by taking 100 mg of the cream formulation and dissolve it in 10 mL of methanol after that it will be filtrated. Also, it will be analyzed the content of the Drug spectrophotometrically using (UV-VIS) at specific ?max.
2. Irritation to skin: In this test, the cream formulation will be applied on four healthy volunteers who should not have any sensitivity to the drug. They will inform about the nature of the formulation and obtain written approval from them about the irritation effect of the formulated cream.
3. Homogeneity test: Cream homogeneity will have tested by the visual appearance of the cream. Moreover, will press a small quantity of cream between the fingers (thumb & index), and noticing the uniformity of formulation .
4. pH evaluation: The cream pH value will have measured by a digital pH meter. The range of skin pH is = (4.5 – 6) and the average pH is = 5.5, so the pH of the formulation will use should be close to this range.
5. In vitro release: cellophane membrane was stretched over the end of an open-ended glass tube and made watertight using a rubber band. The tube will be immersed vertically in a 100-mL beaker containing 50 mL of buffer (pH 5.5) maintained in a thermostatically controlled shaker, 50 stroke/min maintained at 37.0±1.0°C (WiseBath, WSB-45 DATHAN Scientific Co., Ltd, Korea). The formulation (1 g equivalent to 50 mg) will be placed into the glass tube. At predetermined time intervals for up to 24 h, 5 mL aliquots of the release medium will be withdrawn for analysis and replaced with an equal volume of release medium and buffer, at the same temperature to maintain a constant volume. The absorbance of the collected samples will be measured spectrophotometrically at specific ?max.
6. Anti-fungal studies: The antifungal action for formula will be studied using different strains of fungi by the agar well diffusion method. The inhibition zones for all formulae were compared with known standard antifungals.
7. Physical and Chemical Stability: Physical stability will be checked by storing the cream at room temperature = (25 °C) and at (4 °C), for one month. The physical stability will evaluate of any sedimentation and particle size determination by visual observation. Also will use spectrophotometry to determine The chemical stability of cream on different days.
8. Expected results: Formulated cream will be in shiny and pearly appearance and Easy rubbing on the skin. The drug content in the cream will be effectively Suitable for use. The cream will be not irritant to the skin. The cream will be homogeneous with pH of the cream will be close to skin pH. The cream will be physically and chemically stable and are suitable for anti-fungal effects.

REFERENCES

1. Alfaro-Viquez, E., Roling, B., Krueger, C., Rainey, C., Reed, J. and Ricketts, M. (2018). An extract from date palm fruit (Phoenix dactylifera) acts as a co-agonist ligand for the nuclear receptor FXR and differentially modulates FXR target-gene expression in vitro. PLOS ONE, 13(1)
2. Assirey, E. (2015). Nutritional composition of fruit of 10 date palm (Phoenix dactylifera L.) cultivars grown in Saudi Arabia. Journal of Taibah University for Science, 9(1), pp.75-79.
3. El-Far, A., Shaheen2,, H., Daim, M., Jaouni, S. and Mousa, S. (2016). Date Palm (Phoenix dactylifera): Protection and Remedy Food. Current Trends in Nutraceuticals, 1, pp.1-10.
4. Essa, M., Braidy, N., Awlad-Thani, K., Vaishnav, R., Al-Asmi, A., Guillemin, G., Al-Adawi, S. and Subash, S. (2015). Diet rich in date palm fruits improves memory, learning and reduces beta amyloid in transgenic mouse model of Alzheimer?s disease. Journal of Ayurveda and Integrative Medicine, 6(2), p.111.
5. Farouk, A., Ali, H., Rahman Al-, A. and Shaheen, M. (2018). Effect of Maturation Stages on Flavor Profile and Antioxidant Activity of Date Palm Fruits (Phoenix dactylifera) Grown in Saudi Arabia. International Journal of Pharmacology, 14(3), pp.407-414.
6. Hamad, I., AbdElgawad, H., Al Jaouni, S., Zinta, G., Asard, H., Hassan, S., Hegab, M., Hagagy, N. and Selim, S. (2015). Metabolic Analysis of Various Date Palm Fruit (Phoenix dactylifera L.) Cultivars from Saudi Arabia to Assess Their Nutritional Quality. Molecules, 20(8), pp.13620-13641.
7. Khan, T., Kuerban, A., Razvi, S., Mehanna, M., Khan, K., Almulaiky, Y. and Faidallah, H. (2018). In vivo evaluation of the hypolipidemic and antioxidative effect of ‘Ajwa’ (Phoenix dactylifera L.) date seed extract in the high-fat diet-induced hyperlipidemic rat model. Biomedicine & Pharmacotherapy, 107, pp.675-680.
8. M, M., M, S., A, S. and M, S. (2016). Effects of dietary supplementation of date palm (Phoenix dactylifera) seed extract on body composition, lipid peroxidation, and tissue quality of common carp (Cyprinus carpio) juveniles based on the total volatile nitrogen test. Iranian Journal of Fisheries Sciences, 17(2), pp.394-402.
9. Stephen, S., Samuel, S., Yusuf, T., Abel, N., and Michael, N. (2018). Histological and histochemical assessment on the effect of ethanol fruit extract of Phoenix dactylifera L. (Date Palm) on the cerebral cortex of lead acetate treated wistar rats. African Journal of Cellular Pathology, 10(1), pp.1-9.
10. Temitope Olabisi, O. and Ojotule, O. (2017). Phytochemical, Proximate and Antifungal Studies on Phoenix dactylifera L. IOSR Journal of Pharmacy and Biological Sciences, 12(03), pp.78-83. 

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