INTRODUCTION:

Due to the absence of any oil glands, the skin of the feet has a tendency to grow drier. The skin cracks as a result of this dryness.^1,2,3,4 Dry and cracked feet are a result of inadequate moisturising, excessive exposure to pollutants, and a few medical disorders include eczema, diabetes, thyroid, and psoriasis. The plant Aegel Marmelos, often known as Bael Patra, belongs to the Rutaceae family and has a long history of use in India. It is a perennial rhizomatous plant that is frequently located in the Himalayas at elevations of 3500–7500 feet.

It has been regarded as valuable in the past. Diabetes, cardiovascular disease, and other diseases have been treated with biochemical compounds found in bael leaves, fruits, and seeds. The most important substances present in plants include tannins, phenols, terpenoids, steriods, and alkaloids.^5,6,7,8

Kokum butter is an oil made from the seeds of the kokum tree, a fruit-bearing tree. The majority of the kokum trees, also known as Garcinia indica, are grown in India's tropical areas. The kokum tree's fruit and seeds have a number of culinary, cosmetic, and therapeutic uses. The most well-known use of kokum butter is likely as a powerful emollient, or moisturising ingredient.^9,10,11,12 It may be used to practically every area of the body to increase moisture levels, including your skin, lips, feet, scalp, and hair. Cream, which is classed as water-in-oil/oil-in-water and is meant for application on the skin or exposed mucosa, includes medication that has been dispersed or suspended in water removable or emollient bases to provide localised and occasionally systemic effects at the application site. The purpose of skin cream is to protect the skin from environmental abrasion and any dry skin problems. A skin cream should help the skin do its usual tasks, such as hydrating dry skin and enabling waste to be expelled via the pores. The cooling of the body through water evaporation (perspiration) and radiation helps to maintain the body's natural blood heat.^13,14,15

MATERIALS AND METHODS:

Materials:

Aegle marmelos powder was purchased from Manikarnika herbal shop. Distilled water was used throughout the research work.

Method of Bael leaf powder extract preparation:

· The Aegle marmelos leaf extract was prepared by usging maceration process.

· 250gm of bael leaf powder was added in 60% water and 40% ethanol solution in a large container.

· Solution was kept for 3 days with occasional stirring.

· The solution was then filtered with muselin cloth and then it was air dried for 7 days.

a) Maceration

b) Filteration

c) Extract:

Method of formulation of herbal foot crack cream:

The cream was prepared by making two phases i.e (phase A and phase B). Phase A was prepared by weighing and mixing cetyl alocohol, lavender oil, glycerol mono sterate, propylene glycol, kokum butter, liquid paraffin, salicylic acid, bees wax, coco butter.^16,17,18This ingredients were heated up to 80°C.Phase B was prepared by mixing distilled water and adding sodium lauryl Sulphate.The mixture was heated up to 80°C. Then phase B was added in phase A. Add aegle marmelos leaf extract. Mortal and pestle was used to the tricurate cream. The cream was allowed to cool and then transeferd to air tight container.^19,20,21,22

Oil phase ingredients (Part A):

· Cetyl Alocohol

· Lavender Oil

· Glycerol Mono Sterate

· Propylene Glycol

· Kokum Butter

· Liquid Paraffin

· Salicylic Acid

· Bees Wax

· Coco Butter

Aqueous phase ingredients (Part B):

· Distilled Water

· Sodium Lauryl Sulphate

Evaluation of herbal cream:

1) Organoleptic Characteristics:

Physical appearance, colour, texture, phase separation and homogeneity were examined for all formulations. Visual observation was used to assess these features.^23,24 By pressing a little amount of the prepared cream and gels between the thumb and index finger, homogeneity and texture were determined. The texture and homogeneity of the formulations were assessed using the consistency of the formulations and the presence of coarse particles. The immediate skin feel was also assessed (including stiffness, grittiness and greasiness)^25,26,27,28

2) Drug diffusion:

The drug diffusion of all 9 batches of herbal foot cream are carried out by Franz diffusion cell using cellophane membrane. Franz diffusion cell consist of 2 compartments one is donor and other is receiver. And in between th 2 compartment cellophane mebrane is placed.^29,30,31,32

3) Drug content:

For determination of drug content 1gm of cream was dissolved in 30ml of distilled water and kept for 1hour by continuous stirring. After 1hour the absorbance of that sample was taken at 281nm and drug content was calculated.

4) Centrifugation testing:

For cetrifugation testing all 9 batches of herbal foot cream are placed in cetrifugation testing apparatus and the separation of two phases was observed.³³

5) Freeze thaw test:

In freeze thaw testing herbal foot creams were placed in freezer at low temperature (-8°C ± 2°C) for 24 hours and then creams were placed at room temperature (25°C ± 2°C) for 24 hours. This cycle was repeated for 5 times and changes were observed by visual observations.

6) Spreadability:

Two horizontal glass plates were used to measure the spreadability of cream formulations. 1gm of sample was applied to the glass plate and standard weight of 25gm was placed to the upper plate. After one minute, the spreading diameter of 1 gm of sample between two horizontal glass plates was measured to determine the spreadability of the formulations.^35,36

Spreadability = m × l/t

Where,

m= Standard weight which is tied to or placed over the upper slide (25g)

l = length of a glass slide (5cm)

t = time taken in seconds.

7)Irritancy test:

The formulated cream was applied to the required area of the skin. After 1 hr the skin was checked for any irritancy, redness or inflammation on the skin.

8) Washability test:

A small amount of cream was applied and washed under running water.

9) Stability study:

The stability study was performed as per ICH guidelines. The formulated harbal creams are filled in well closed containers and stored at different temperatures aand humidity conditions, viz. 250 C and 60% RH for period of 3 months and studied for appearance, pH, viscosity.

RESULT AND DISCUSSIONS:

Organoleptic Characteristics:

Organoleptic properties for all 9 formulation batches was observed and f3 batch was find to be have good homogeneity and immediate skin feel among all the 9 formulation batches. The observed results for f3 batch is mentioned in the table 2.

Various formulations of the compositions reported in Table 1 were generated using Design of Expert software (DOE).

Table 1. Batches obtained from Design of Expert Software (DOE)

Sr No	Ingredients	F1	F2	F3	F4	F5	F6	F7	F8	F9	F10
1	Baelleaf extract	1	1	1	1	1	1	1	1	1	1
2	Gylcerol mono sterate	0.4	0.4	0.4	0.4	0.4	0.4	0.4	0.4	0.4	0.4
3	Propylene glycol	1	1	1	1	1	1	1	1	1	1
4	Sodium laury Sulphate	0.12	0.12	0.12	0.12	0.12	0.12	0.12	0.12	0.12	0.12
5	Cetyl alcohol	0.44	1.44	1.44	2.44	1.80	2.44	1.44	0.02	0.44	1.44
6	Kokum butter	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5
7	Coca butter	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5
8	Liquid paraffin	0.66	0.24	1.55	0.66	1.66	2.66	3.07	1.66	2.66	1.66
9	Salicylic acid	0.2	0.2	0.2	0.2	0.2	0.2	0.2	0.2	0.2	0.2
10	Bees wax	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5	1.5
11	Lavender oil	0.6	0.6	0.6	0.6	0.6	0.6	0.6	0.6	0.6	0.6
12	Distilled water	8	8	8	8	8	8	8	8	8	8

Table 3. Evaluation results for all batches

Form-ulation	Drug diffusion	Drug content	Centri- fugation	Sprea- dability	Irritancy test	Washability test	Freeze thaw test
F1	77.20	89.21	No	2.5 ± 0.10	Passed	Passed	Passed
F2	80.08	84.76	No	2.4 ± 0.9	Passed	Passed	Passed
F3	89.76	97.33	No	2.4 ± 0.10	Passed	Passed	Passed
F4	84.47	91.02	No	3.1 ± 0.12	Passed	Passed	Passed
F5	72.09	88.67	No	3.0 ± 0.11	Passed	Passed	Passed
F6	85.36	90.35	No	3.1 ± 0.9	Passed	Passed	Passed
F7	78.67	91.03	No	2.3 ± 0.13	Passed	Passed	Passed
F8	77.90	86.56	No	2.4 ± 0.11	Passed	Passed	Passed
F9	79.98	88.49	No	2.5 ± 0.10	Passed	Passed	Passed

Stability study of herbal cream:

All the study shows that all 9 creams are stable for 3 months but all the formulations are showing some deviations in parameters but it was not too much so it was acceptable. The result for all formulations for 1st, 2nd and 3rd month in below tables.

Table 4 : Stability study for first month.

Formulation no:	Appearance	Viscosity (cp)	PH
F1	Yellowish brown	3900	5.89
F2	Yellowish brown	3700	6.00
F3	Yellowish brown	3800	6.05
F4	Yellowish brown	3400	5.78
F5	Yellowish brown	3300	6.11
F6	Yellowish brown	3400	6.02
F7	Yellowish brown	3800	5.94
F8	Yellowish brown	3300	5.99
F9	Yellowish brown	3800	6.01

Table 5: Stability study of second month

Formulation no:	Appearance	Viscosity(cp)	PH
F1	Brown	3900	6.11
F2	Brown	3800	6.18
F3	Brown	3800	6.15
F4	Brown	3500	6.20
F5	Brown	3500	6.16
F6	Brown	3400	6.32
F7	Brown	3800	6.44
F8	Brown	3300	6.28
F9	Brown	3800	6.25

Table 6: Stability study of third month

Formulation no:	Appearance	Viscosity(cp)	PH
F1	Brown	3900	6.18
F2	Brown	3900	6.26
F3	Brown	3700	6.25
F4	Brown	4000	6.38
F5	Dark brown	3900	6.27
F6	Dark brown	3800	6.40
F7	Brown	3700	6.54
F8	Brown	3800	6.33
F9	Brown	3900	6.43

DISCUSSION:

Several parameters were applied to the produced cream. An optimised batch was discovered to be the F3 batch. The standard procedure for making herbal cream was used to make Aegel Marmelos foot cream. The cream was dark and smelled good. The herbal cream's viscosity was 3700cp and its pH was 6.25. The cream was free of any tough or pointed particles. Cream had a smooth texture as a result. Spreadability was good for the herbal cream. At temperatures of 25, 30, 40, and 50°C, the herbal cream remained stable.

CONCLUSION:

In daily life, human feet skin is exposed to variety of factors that have detrimental effects on dermal integrity resulting in dry skin and cracks. The most common protective and preventive step taken against dry skin and cracked feets is the use of emollients and moisturizing creams and lotions. Knowing the gravity of the problem the study was planned to exploit the properties of Aegle marmelos leaves extract. During the literature survey it was observed that Bael leaves extract can act as antioxidant, antiseptic, insecticidal, carminative, antimicrobial agent, and moisturizing agent. Considering this fact, it was thought to study the properties of the extract in cream-based formulation. Hence an attempt was made to prepare 9 different formulations on the basis of different percentage and converted it into cream. The formulations were then evaluated for its physico-chemical parameters and antimicrobial activity.

Herbal foot cream was formulated and evaluated using Aegle marmelos leaf extract. Herbal creak cream was prepared using general method for preparation of cream. Herbal crack cream had light brown color and pleasant odour. The cream batch containing 1.44gm of cetyl alcohol and 1.55ml of liquid paraffin shows higher values of drug diffusion. So that F3 batch was concluded as optimized batch within these 9 batches. From in vitro studies it is concluded that cetyl alcohol and liquid paraffin both are used to increase penetration of cream.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

ACKNOWLEDGMENTS:

The authors would like to thank Dhande Pathlab Diagnostic Pvt. Ltd. Pune for their kind support during hematological and all other lab studies.

REFERENCES:

1. Mandal PK, Mukherjee AK. Investigation on partial structure of a glycoprotein from bael seed. Carb Res 1981; 98:85-91.

2. Sharma PC, Bhatia V, Bansal N, Sharma A. A review on bael tree. Nat Prod Rad 2007; 6: 171-178.

3. Mishra BB, Singh DD, et al. “Antifungal constituents isolated from the seeds of Aegle marmelos,” Phytochem, 2010, 71(2): 230-234

4. Shree ABR, Jayanthi A, Sudhakar SR, Unnikrishnan KP, Balachandran I. Anatomical and chemical studies on roots of Aegle marmelos and Atalantia monophylla. J Trop Med Plants 2005; 6:123-131.

5. Parichha, S. Bael (Aegle marmelos) nature’s most natural medicinal fruit. Orissa Rev. 2004; Sept:16-17

6. Yadav N. Phytochemical and Pharmacological Profile of Leaves of Aegle Marmelos Linn. Pharm Review, 2009; 144-150.

7. Das U. Effect of Aqueous Extract of Leaf of Aegle marmelos on Testicular Activities in Rats. Ira J Pcology Therap, 2006.

8. Nugroho A, Riyanto S. Effects of skimmianine, a quinoline alkaloid of aegle marmelos correa roots, on the histamine release from rat mast cells. J Bas App Sci, 2010; 6: 141-148.

9. S. Shyamala Gouri and k. Vasantha 2010.Phytochemical screening and Antibacterial activity of Syzygium cumini(L)Myrtaceae Leaf Extract.International Journal of Pharmatech research. Vol 2 pp 1569-1573.

10. Patil R. H., Chaudhary B. & Settipalli S.(2009), “Antifungal and Antiaflatoxigenic activity of Aegle marmelos Linn.”, Pharmacognosy Journol.

11. Mohammed MMD, Ibrahim NA, El-Sakhawy FS, Mohamed KM, Deabes DA-H. Two new cytotoxic furoquinoline alkaloids isolated from Aegle marmelos (Linn.) Correa. Nat Prod Res. 2016;30(22): 2559-2566.

12. Manandhar MD, Shoeb A, Kapil RS, Popli SP. New alkaloids from Aegle marmelos. Phytochemistry. 1978;17(10): 1814-1815.

13. P. Santhana Krishnan V, Karthikeyan G, Janaki P, Poonkodi B, Sathya R. Isolation of Heraclenin from Aegle marmelos correa and screening for its antimicrobial activity through in vitro & in silico studies. Nat Prod J. 2016;6(2): 134-141.

14. Sivraj R, Balakrishnan A. Preliminary phytochemical analysis of Aegle marmelos. Int J Pharm Sci Res, 2011; 2(1): 146-150.

15. Das U. Effect of Aqueous Extract of Leaf of Aegle marmelos on Testicular Activities in Rats. Ira J Pcology Therap, 2006; 5: 21-25. K. Sudharameshwari1 and J. radhikaantibacterial screening of aegle marmelos, lawsonia inermis and albizzia libbeck issn 0189-6016©2007 afr. j. trad. cam (2007) 4 (2): 199 – 204

16. Nadkarni K. Indian materia medica. Bombay popular prakashan, 1993; 45-49.

17. Lambole V, Gajera V. Phytopharmacological properties of Aegle marmelos as a potential medicinal tree: an overview. Int J Pharm Sci Rev Res, 2010; 5: 67-72.

18. Jaswanth A. Wound healing activity of Aegle marmelos. Ind J Pharm Sci, 2000; 63: 41-44.

19. Nugroho A, Riyanto S. Effects of skimmianine, a quinoline alkaloid of aegle marmelos correa roots, on the histamine release from rat mast cells. J Bas App Sci, 2010; 6: 141-148.

20. Sharma P, Bhatiya V. A review on Bael tree, Nat Prdt Radi. 2007; 6(2): 171-178.

21. Nair R, Kalariya T and Chanda S. Antibacterial Activity of some Selected Indian Medicinal Flora.Turk J Biol. 2005.

22. Jamal MAHM, Rahman MS, Hossain MB, et al. Antibacterial properties and chemical composition of essential oil from Aegle marmelos (L.) Corr. leaves growing in Bangladesh. J Essent Oil-Bearing Plants.

23. Prabir K. Mandal, Amal K. Mukherjee, “Investigations on the partial structure of a glycoprotein from bael (Aegle marmelos) seed” Carbohydrate Research, Volume 98 Issue1.

24. Kirtikar K, Basu B. Indian medical plant. International book publication, 1995; 1: 499- 502.

25. Jain Sachin, Jain Neetesh, Tiwari A, Balekar N, Jain D K. Simple Evaluation of Wound Healing Activity of Polyherbal Formulation of Roots of Ageratum conyzoides Linn. Asian J. Research Chem. 2(2): April. -June, 2009 page 135-138.

26. Mital N. Manvar. In-Vitro Anti-inflammatory Activity of Traditionally reported Poly Herbal Combination. Asian Journal of Pharmacy and Technology. 2023; 13(1):1-3.

27. Krishna Murti, Vijay Lambole, Mayank Panchal, Megha Shah, Vipul Gajera. Evaluation of Wound Healing Activity of Polyherbal Formulation in Rats. Research J. Pharmacognosy and Phytochemistry 2011; 3(3): 112-115.

28. Saira Sehar, Mohsin Sher Ali Khan, Amiza, Touqir Hussain, M. Zahid, Moazina Mobeen, Imran Raza, Minnatullah. Synthesis of Zinc Oxide Nano particles from Moringa Tree leaves by Green Method and also check its Antibacterial activity against Gram Positive and Gram-Negative Bacteria. Asian Journal of Pharmacy and Technology. 2022; 12(3):213-7.

29. Savita S. Mali, Rekha L. Dhumal, Vijay D. Havaldar, Snehal S. Shinde, Nilam Y. Jadhav, Bhagyashri S. Gaikwad. A Systematic Review on Aegle marmelos (Bael). Res. J. Pharmacognosy and Phytochem. 2020; 12(1): 31-36.

30. S. Sathish Kumar, G. Melchias, P. Ravikumar, R. Chandrasekar, P. Kumaravel. Bioinspired synthesis of silver nanoparticles using Euphorbia hirta leaf extracts and their antibacterial activity. Asian J. Pharm. Res. 4(1): Jan.-Mar. 2014; Page 39-43.

31. Mariyappan M., Bharathidasan R., Mahalingam R., Madhanraj P., Panneerselvam A., Ambikapathy V. Antibacterial Activity of Cardiospermum halicacabum and Melothria heterophylla. Asian J. Pharm. Res. 1(4): Oct. - Dec. 2011; Page 111-113.

32. Mariyappan M., Bharathidasan R., Mahalingam R., Madhanraj P., Panneerselvam A., Ambikapathy V. Antibacterial Activity of Cardiospermum halicacabum and Melothria heterophylla. Asian J. Pharm. Res. 1(4): Oct. - Dec. 2011; Page 111-113.

33. Muhammed Shakkeel K.V, Anjan Kumar, Veeresh Babu. D, Narayana Swamy V.B. Pharmacological Evaluation of Trichilia connaroides Bark for Analgesic and Anti-inflammatory activity in Experimental Animal Models. Asian J. Pharm. Res. 5(3): July- Sept., 2015; Page 138-144.

34. Sumesh S Shah, Amit Gupta, Shweta Karne, Bharat Shinde. Immunological evaluation of Artocarpus heterophyllus for determining its antimicrobial and anti-inflammatory activity. Asian J. Pharm. Res. 2017; 7(2):106-110.

35. Uma Sankar Gorla, M. Savithri, G.S.N. Koteswara Rao, Y. Niharika, P. Devi Sree Sathya, V. Harika. Evaluation of anti-inflammatory activity of Hydroalcoholic extract of Ananas cosmosus fruit peel by HRBC membrane stabilisation. Asian J. Pharm. Res. 2018; 8(1):33-35.

36. Hitesh V. Shahare, Rakesh D. Amrutkar. Synthesis, Characterization and Antimicrobial Activity of Diphenylamino Isoxazoline Derivatives. Asian J. Pharm. Res. 2018; 8(3): 148-150.

Received on 19.02.2023 Modified on 11.12.2023

Research J. Topical and Cosmetic Sci. 2024; 15(1):1-5.

DOI: 10.52711/2321-5844.2024.00001

Sr. No.	Organoleptic property	Result
1	Physical appearance	Opaque
2	Colour	Cream
3	Texture	Smooth
4	Homogeneity	Homogeneous
5	Immediate skin feel	Moisturizing, no grittiness, light, not greasy