INTRODUCTION:

The skin is the body’s first line of defence for external exposure. The signs of ageing are most viable in the skin. Although the skin is a large and logical target for drug delivery, its basic functions limit its utility for this purpose. The skin functions mainly to protect the body from external penetration (e.g. harmful substances and microorganisms) and to contain all body fluids. There are two important layers to the human skin: (1) the Epidermis and (2) the Dermis. For transdermal delivery, drugs must pass through the two sub layers of the epidermis to reach the microcirculation of the dermis.

The Stratum Corneum is the top layer of the skin and varies in thickness from approximately ten to several hundred micrometres, depending on the region of the body. It is composed of layers of dead, flattened keratinocytes surrounded by a lipid matrix, which together act as a brick-and-mortar system that is difficult to penetrate³.

“Dermatitis” is a word used to describe a number of skin irritations and rashes caused by genetics, an overactive immune system, infections, allergies, irritating substances and more. Common symptoms include dry skin, redness and itchiness. In the word “dermatitis,” “derma” means “skin” and “itis” means “inflammation.” The word as a whole means “inflammation of the skin.” The rashes range from mild to severe and can cause a variety of problems, depending on their cause. Dermatitis causes no serious harm to your body. It is not contagious, and it does not mean that your skin is unclean or infected. There are treatment methods and medications that can manage your symptoms^2,11,12. Dry skin makes the skin look and feel rough, itchy, flaky or scaly. The locations where these dry patches form vary from person to person^5,12.

Cream is defined as semisolid emulsion which is oil in water (o/w) or water in oil (w/o) type and these semisolid emulsions are intended for external application. Cream is classified as oil in water and water in oil emulsion. It is applied on outer part of superficial part of the skin and its main ability is to remain for a longer period of time at the site of application. The function of skin cream is to protect the skin against different environmental condition, weather and gives soothing effect to the skin. There are different types of creams like cleansing, cold, foundation, vanishing, night, massage, hand and body creams. The main aim of our work is to develop an herbal cream which can give multipurpose effect, like moisturizer, reduce acne and skin irritation, reduce skin diseases like eczema, psoriasis, dry skin, wrinkles, rashes etc. and also adding glow to the face. We have used two herbal ingredients in our preparation which are Dill seeds & Aloe Vera. Dill seeds are used as antibacterial and antimicrobial purposes. Aloe Vera gel is used as a moisturizer, to reduce pimples and acne and also used for treatment of burn wounds²².

Anethum sowa (Dill seeds) is an important member of the Apiaceae (Umbelliferae) family, which is native to southwest Asia, southeast Europe and also the Mediterranean region. It grows in many countries such as Iran, India, Russia and Egypt. It is known in Egypt as Shapt and has been used as an aromatic, medicinal and culinary herb since early decades. Compounds from aromatic plants have been recognized as a natural source for antibacterial and antifungal properties since early time in several countries. They are rich source of essential oils (EO) as it contains several biologically active ingredients used as antimicrobial agents as well as antibacterial agents^1,8. Bioactive components of dill are: essential oil, fatty oil, proteins, carbohydrates, fiber, mineral elements (potassium, calcium, magnesium, phosphorous, sodium), vitamin A and niacin. Essential oil is present in all parts of plant, but its content is the highest in the seeds (2-5%). The major component in dill seeds essential oil is carvone (20-60%). Besides carvone, there are also present: limonene, a- phelandrene, a-pinene, a-terpinene, apiole, dill apiole, 1,8-cineole, dihydro carvone and p-cymene and co-workers have found a high content of carvone (about 90%) in dill seeds essential oil from the territory of Southeast Serbia^9,24.

Aloe Vera is locally known as “Gwar Patha or Ghrit Kumari” is cactus like plant that grows in a hot, dry climate. As a result of its use as a folk medicine, it is claimed that Aloe Vera has wound healing properties, anti-inflammatory and immune-modulatory effects. The Aloe vera plant has been known and used for centuries for its health, beauty, medicinal and skin care properties. It is a natural product that is nowadays frequently used in the field of cosmetology. It can be applied topically as an emollient for burns, sunburns and mild abrasion and for inflammatory skin disorder. It has antifungal, antiviral, antioxidant and anti-inflammatory effects^4,13,14.

Aloe contains two classes of Aloins: (1) nataloins, which yield picric and oxalic acids with nitric acid, and do not give a red coloration with nitric acid; and (2) barbaloins, which yield aloetic acid (C₇H₂N₃O₅), chrysammic acid (C₇H₂N₂O₆), picric and oxalic acids with nitric acid, being reddened by the acid. This second group may be divided into a-barbaloins, obtained from Barbados aloes, and reddened in the cold, and barbaloins, obtained from Socotrine and Zanzibar aloes, reddened by ordinary nitric acid only when warmed or by fuming acid in the cold. The plant produces at least 6 antiseptic agents such as lupeol, salicylic acid, urea nitrogen, cinnamonic acid, phenols and sulphur. All of these substances are recognized as antiseptics because they kill or control mould, bacteria, fungus and viruses, explaining why plant has the ability to eliminate many internal and external infections^15,25.

MATERIALS AND METHODS:

Procedure: Oil in water (o/w) emulsion-based cream (semisolid) formulation was formulated. The emulsifier (stearic acid) and other oil soluble components (cetyl alcohol, olive oil) were dissolved in oil phase (Part A) and heated at 75°C. The preservatives and other water-soluble components (Triethanolamine, Glycerin, Tween 80, Polyethylene Glycol, Sodium Benzoate, EDTA, Rose Water) were dissolved in Aqueous phase (Part B) and heated to 75°C. After heating, the aqueous phase was added in portions to oil phase with continuous stirring. Distilled water was added to q.s. 100ml. The cooling of emulsion causes formation of cream.

Table 1.The Formula for the Composition of Cream is given below:

Sr No.	Ingredients	F1	F2	F3	F4	F5	F6
1	Dill seed oil	0.5ml	1ml	1.5ml	2ml	2.5ml	3ml
2	Aloe vera juice	0.5ml	1ml	1.5ml	2ml	2.5ml	3ml

Phase A: Oil Phase

1	Stearic Acid	20g	20g	20g	20g	20g	20g
2	Cetyl Alcohol	5g	5g	5g	5g	5g	5g
3	Olive Oil	12.5ml	12.5ml	12.5ml	12.5ml	12.5ml	12.5ml

EVALUATION OF CREAM:

PHYSIOCHEMICAL EVALUATION OF PARAMETERS:

1. Appearance: The appearance of cream was judged by its colour, pearlescence and roughness²².

2. Wash Ability: This test is carried out by simply washing applied cream with water.

3. Determination of type of smear: It was determined by applying the cream on the skin surface of human volunteers. After application of the cream, the type of film or smear formed on the skin were checked²².

4. Homogeneity: The formulations were tested for the homogeneity by visual appearance and touch²².

5. pH: The pH meter was calibrated using standard buffer solution. About 0.5g of cream was weighed and dissolved in 50ml of water and its pH as measured²².

6. Viscosity: Viscosity of the formulation was determined by Brookfield viscometer at 20rpm by using spindle no. 64 at 25°C.

The sample (50g) was placed in a beaker and was allowed to equibrase for 5 minutes. Before measuring the dial reading using T-D spindle (No.64) at 20rpm speed, corresponding dial reading on the viscometer was noted. The measurements were carried in triplicates at room temperature. Direct multiplication of the dial readings with factors is given in the Brookfield viscometer. Catalogue gave the viscosity in centipoise²².

7. Acid value: Take 10gm of substance dissolved in accurately weighed, in 50ml mixture of equal volume of alcohol and solvent ether, the flask was connected to reflux condenser and slowly heated, until sample was dissolved completely, to this 1ml of phenolphthalein added and titrated with 0.1N NaOH, until faintly pink color appears after shaking for 30seconds³⁰.

Acid value = n*5.61/w

n = the number of ml of NaOH required

w = the weight of substance

8. Saponification value: Introduce about 2gm of substance refluxed with 25ml of 0.5 N alcoholic KOH for 30minutes, to this 1ml of phenolphthalein added and titrated immediately, with 0.5N HCL³⁰.

Saponification value = (b-a)*28.05/w

The volume in ml of titrant = a

The volume in ml of titrate = b

The weight of substance in gm = w

9. Irritancy Test: mark an area (one sq. cm) on the left-hand dorsal surface. The cream was applied to the specified area and time was noted. Irritancy, erythema, oedema was checked if any for regular intervals up to 24 hours and reported²³.

10. Spreadability Test: Sample was applied between two glass slides and was compressed to uniform thickness by placing 100gm weight for 5minutes. Weight was added to the pan. The time required to separate the two slides, i.e. the time in which the upper glass slide moved over the lower slide was taken as measure of spreadability. It was calculated using the formula:

S= m* L / T

Where S – Spreadability

m- Weight tied to upper glass slide

L- Length moved on glass slide

T- Time taken

The determinations were carried out in triplicate and the averages of three readings were recorded³⁰.

11. Antimicrobial Activity (Cup Plate Method): Prepare nutrient agar plate inoculated with test organism, with a depth of 4-5mm and then allow it to solidify. Divide the NA plate into four equal portions. Then with the help of a sterile borer make four cavities one in each portion. Then fill three cavities with antibiotic solution and in one fill the standard solution. Slowly incubate the plates at 37°C for 24 hours. After incubation measure the zone of inhibition³¹.

DETERMINATION OF THE TYPE OF EMULSION:

1. Dye solubility test: In this test, an emulsion is mixed with water soluble dye (amaranth) and observed under the microscope. If the continuous phase appears red, it means that emulsion is oil in water (o/w) type as the water is in the external phase and the dye will dissolve in it to give colour.

2. Accelerated stability test: Accelerated stability testing of prepared formulation was conducted for 2 most stable formulations at room temperature, studied for 7 days. They were formulation 3 and 4 at 40°C for 20 days. The formulations were kept both at room temperature and elevated temperature and observed on 0^th, 5^th, 10^th, 15^th, and 20^th day for the following parameters³¹.

RESULT:

Table 2. Determination of Physical Parameters of Prepared Cream

Sr No.	Properties	Observations
1.	Color	Light Yellow
2.	Odor	Aromatic
3.	State	Semisolid
4.	Texture	Smooth
5.	Grittiness	No Grittiness
6.	Wash Ability	Washable
7.	Type of Smear	Non-Greasy
8.	Homogeneity	Homogenous
9.	Emulsion Type	o/w

Figure 1.Formulated Cream (F1 to F6)

Table 3.Determination of pH

Sr. No.	Days	Formulations
Sr. No.	Days	F1	F2	F3	F4	F5	F6
1.	Initial Day	6	6.1	5.9	5.9	5.7	5.7
2.	7 days	6.1	6.2	5.9	5.8	5.6	5.6
3.	15 days	6.1	6.1	5.8	5.9	5.6	5.6
4.	21 days	6.2	6.2	5.9	5.8	5.5	5.7
5.	30 days	6.3	6.1	5.8	5.9	5.5	5.7

Figure 2.pH meter

Table 4.Viscosity

Sr. No.	Days	Formulations
Sr. No.	Days	F1	F2	F3	F4	F5	F6
1.	Initial Day	21530	22500	23550	25590	21530	22500
2.	7 days	25580	25580	25580	27050	25580	25580
3.	15 days	23520	27540	27590	27062	23520	27540
4.	21 days	24550	28540	28550	27075	24550	28540
5.	30 days	25533	29550	29590	27080	25533	29550

Table 5.Acid value and Saponification value

	F1	F2	F3	F4	F5	F6
Acid value	6.1	5.7	5.3	5.5	5.4	5.4
Saponification value	27.1	27.3	26.1	25.9	26.8	26.8

Table 6.Irritancy test

Formulation	Irritant effect
F1	NIL
F2	NIL
F3	NIL
F4	NIL
F5	NIL
F6	NIL

Table 7. Spreadability Test

Parameters	Formulations
Parameters	F1	F2	F3	F4	F5	F6
Spreadability	26.33± 0.3	24.47± 0.4	22.35 ±0.5	21.83± 0.6	21.76± 0.2	24.47± 0.4

Table 8. Antimicrobial evaluation of Streptomycin and Multipurpose cream

Sr. No	Zone of Inhibition
Sr. No	Marketed formulation (Streptomycin)	Herbal Preparation (Multipurpose cream)
F1	17±0.02	11±0.02
F2	18±0.02	11±0.02
F3	23±0.02	20±0.02
F4	24±0.02	22±0.02

Figure 3. Zone of Inhibitions

Table 9. Accelerated Stability Testing

Sr. No.	Evaluation Parameters	F3	F4
Sr. No.	Evaluation Parameters	Room Temperature	Accelerated conditions (45℃)
1.	Appearance	Good	Good
2.	Color	Light Yellow	Light Yellow
3.	pH	5.9	5.9
4.	Consistency	Semisolid and soft	Semisolid and soft
5.	Viscosity	23550	23550
6.	Spreadability	Excellent	Excellent
7.	Wash ability	Excellent	Excellent
8.	Irritancy test	No Irritation	No Irritation

DISCUSSION:

In the present work, Anethum sowa and Aloe barbadensis were selected which accelerate antimicrobial and moisturising process. The formulation Ⅲ and Ⅳ showed best results, may be because of Anethum sowa containing major constituents such as limonene and carvone and Aloe Vera plant containing ingredients like lupeol, salicyclic acid, urea nitrogen, cinnamonic acid, phenols and sulfur which have inhibitory effects on bacteria.

To date, numerous products such as petrolatum, zinc oxide, corticosteroids, talcum powder, vitamins A and D, and lanolin have become available for the treatment of Dermatitis. Although many patients may benefit from these products, some may be allergic to them. In addition, some of these products may have side effects at high concentrations. Corticosteroids are generally contraindicated for use in intertriginous and occluded areas of the skin, as their use has the potential to cause a variety of adverse events such as systemic absorption, skin atrophy, and growth delay

Plant-derived products have been extensively used in the traditional medicine. Recently, researchers have studied the anti-inflammatory effects of herbal drugs for the treatment of a number of inflammatory diseases such as dermatitis. Another important issue that deserves attention is the safety of these herbal products as there was no reported adverse effect in any of the groups. Based on the findings of the present study, the relevance of topical Anethum sowa and Aloe barbadensis as natural, effective, and safe treatments for Dermatitis is clearly supported.

CONCLUSION:

From the study it can be conducted that prepared multipurpose cream using Anethum sowa and Aloe barbadensis is suitable for treat or prevent skin dermatitis and show better alternative other than Allopathic cream. Hence reduce the side effect and skin dryness of human skin.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

ACKNOWLEDGMENTS:

The authors would like to thank all the members of Pharmacognosy, Pharmaceutics and Microbiology Department specially Mr. Navin Tank, Mr. Kalpendra Ukey, Mr. Vinit Patel, Mr. Nagesh Deshmukh, Mr. Dharmendra Dwivedi, Mr. Kailash Meshram and Mr. Dipak Funde.

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Received on 06.05.2023 Accepted on 08.06.2023

Research J. Topical and Cosmetic Sci. 2023; 14(2):73-78.

DOI: 10.52711/2321-5844.2023.00011

1)	Triethanolamine	5ml	5ml	5ml	5ml	5ml	5ml
2)	Glycerin	10ml	10ml	10ml	10ml	10ml	10ml
3)	Tween 80	10ml	10ml	10ml	10ml	10ml	10ml
4)	Polyethylene Glycol	10ml	10ml	10ml	10ml	10ml	10ml
5)	Sodium Benzoate	1.25g	1.25g	1.25g	1.25g	1.25g	1.25g
6)	EDTA	0.1g	0.1g	0.1g	0.1g	0.1g	0.1g
7)	Rose Water	10ml	10ml	10ml	10ml	10ml	10ml
8)	Distilled Water	q.s. up to 100ml	q.s. up to 100ml	q.s. up to 100ml	q.s. up to 100ml	q.s. up to 100ml	q.s. up to 100ml