Preparation and Evaluation of Herbal Gel for Oral Ulcer Management
Shreya Vinayak Chaudhari*, Sejal Rajendra Chaudhari, Vrushali Yashwant Chaudhari,
Sunila Atul Patil, Sunil Pandit Pawar
P.S.G.V.P. Mandal’s College of Pharmacy, Shahada.
*Corresponding Author E-mail: shreyachaudhari2021@gmail.com
ABSTRACT:
The present study focuses on the formulation and evaluation of an herbal gel composed of Guava leaves, Betel leaves, and Tulsi extracts, aimed at relieving pain and discomfort associated with oral ulcers. Oral ulcers, commonly caused by local trauma and aphthous stomatitis, are a widespread condition that often necessitates effective and safe treatment options. With increasing preference for herbal remedies in primary healthcare-especially in developing countries due to their biocompatibility, cultural acceptance, and minimal side effects-this formulation offers a promising alternative to conventional therapies. This study supports the potential of herbal gels as effective and well-tolerated treatments for mouth ulcers, reinforcing the value of natural medicine in modern therapeutic applications.
KEYWORDS: Herbal gel, Mouth ulcer gel, Guava leaves, Betel leaves, Ocimum sanctum.
a) Define gel: Materials that are partially liquid and partially solid are called gels. They develop when a liquid becomes trapped in a web of interconnected particles or big molecules. The word "gel" is derived from "gelatin," a substance that forms gels. Both words tracing back to the Latin word "gelu," meaning "frost" or "freeze," are related.
b) Properties of gel:
1. An appropriate antimicrobial agent should be present.
2. They display the solid state's mechanical properties.
c) Uses of gel:
1. As methods of drug delivery that are taken orally.
2. Cosmetics such as skin and hair care products, shampoos, fragrances, and dentifrices.
3. As thickeners in oral liquid, suppository bases, protective colloids in suspensions.1
d) Scope of herbal: Worldwide, both in developed and developing nations, the use of medicinal plants is growing. Numerous herbs are being investigated for their potential to prevent and treat oral health issues as part of the expanding field of herbal medicine research. Herbs have long been used by people to treat various oral health conditions and to clean their teeth and gums.2
e) Mouth ulcer: Oral ulcers are common sores in the mouth caused by the shedding of dead tissue due to inflammation. They appear as open wounds on the skin or the inner lining of the mouth.3
f) Factors responsible for the mouth ulcers:
1.Toothpastes and Mouthwashes with sodium lauryl sulfate
2.Stress (emotional or mental)
3.Hormonal changes (e.g., during pregnancy)4
Common Names: Nagaballi, Nagurvel, Saptaseera, Sompatra, Tamalapaku, Tambul,
Family: Piperaceae5
Biological source: Betel consist of fresh and dried leaves of Piper betel L.
Geographical Source: leaf that grows in tropical and subtropical regions like East Africa, India, Sri Lanka, Malaysia, Indonesia, and the Philippines.6
Chemical Constituents: Volatile betel oil, which contains the two essential phenols chavibetol and chavicol, is the main component of betel leaves.7
Uses/Property: Refreshing the mouth because of their antibacterial qualities, which help freshen breath. Betel leaves also act as natural stimulant medications to relieve bloating, reduce excess secretions, and stop bleeding.
b) Tulsi:
Common names: Green Tulsi (Ram Tulsi) and Black Tulsi (Krishna Tulsi)
Family: Lamiaceae9
Biological source: Tulsi consist of fresh and dried leaves of Ocimum sanctum L.
Geographical source: It is native to the Indian subcontinent.10
Chemical Constituents: Eugenol (71%) and methyl eugenol (20%) make up the majority of the volatile oil found in Ocimum sanctum (Holy Basil) leaves. [11]
Uses/Property: When it comes to treating common oral infections, tulsi leaves are highly effective. Tulsi leaves, when chewed, support dental hygiene.12
c) Guava leaves:
Common names: “Guava” in English, guayabo in Spanish.13
Family: Myrtaceae.
Biological source: Guava consist of fresh and dried leaves Psidium guajava L.14
Geographical source: India, Mexico, Hawaii, and Egypt are among the many nations that grow guavas. Grown best are guava trees.
Chemical Constituents: Total Lipids of Proteins, The carbohydrate Total Dietary Fiber Moisture essential oils, polysaccharides, minerals, vitamins, enzymes, triterpenoids, alkaloids, steroids, glycosides, tannins, flavonoids, and saponins.15
Uses/Property: The guava plant has numerous therapeutic uses. It possesses antifungal and antibacterial qualities. The leaves have antiseptic, anti-inflammatory, and astringent properties. Tea prepared from the leaves is used to treat diarrhea, dysentery, and other illnesses.16
d) Carbopol 934: Many industries use carbopol, a water-soluble polymer, as an emulsifying, stabilizing, suspending, thickening, and geling agent.
Synonyms: acrylic acid, polymers, acrylic acid homopolymer, acrylic acid resin.
Molecular formula: C5H10O2
Chemical properties: Carbomers are a white powder that is fluffy, acidic, hygroscopic, and has a faint smell.
Uses :carboxypolymethylene is a binder ,film -former and emulsion stabiliser. It can also help increase product viscocity.17
e) Propylene Glycol: Propylene glycol is a colorless, odorless, slightly sweet-tasting
Synonyms: Propylene glycol, α-Propylene glycol, 1,2-Propanediol.
Uses: Propylene glycol is use as an anti-caking, emulsifying, humectant.18
f) Methyl Paraben: One of the parabens, methylparaben, also goes by the chemical formula CH3(C6H4(OH)COO), and it is a preservative.
Synonyms: Methyl p- hydroxybenzoate.
Uses: A common ingredient in many cosmetics items is methyl paraben, antifungal agent.19
g) Propyl paraben: Propylparaben is the n-propyl ester of p-hydroxybenzoic acid, sometimes written as propyl paraben. It can be found naturally in a variety of plants and insects.
Synonyms: Propyl paraben, Propyl p-hydroxybenzoate, Propyl parahydroxybenzoate, Nipasol.
Uses: a common preservative in water-based cosmetics, including bath products, shampoos, lotions, and creams. utilized similarly as an anti-fungal preservation agent and food additive.20
h) Triethanolamine: This organic compound is viscous and a combination of a triol and a tertiary amine. Three alcohol groups make up a triol molecule. A potent base is triethanolamine.
Synonyms: Trolamine, Triethlolamine, 2’2’2’’-Trihydroxyethylamine.
Pharmaceutical Uses: Triethanolamine is mostly utilized in the production of surfactants, like emulsifiers. It is frequently used as an ingredient in both consumer and industrial product formulations.21
3. MATERIALS AND METHOD USED:
Materials: Betel, Tulsi, Guava leaves, Carbapol 934, Propylene glycol, Methyl paraben, Propyl paraben, Triethanolamine are the various material used in present work.
A. Extraction Procedure: -Weight accurately 50 gm Quantity of Tulsi, Betel and Guava leaves powders. Added to 250 ml of ethanol and subjected to cold maceration process. The flask was stored for 48 hrs. With occasional shaking. The mixtured was filtered by using whatman no.1 filter paper. After collected the dilute Extract.
B. Formulation of Gel : Gel was prepared by using 1.5 gm of carbapol and dispersed uniformly in 30 ml of distilled water with continuous stirring by using mechanical stirrer. Avoiding air entrapment and allowed to soak overnight. Next day triethanolamine was added drop by drop with constant stirring till pH was neutralized and gel was formed. Triethanolamine was added slowly to the dispersion with continuous stirring until a gel was formed. Then the measured quantity of aqueous extract of Betel , tulsi , guava leaves added to gelling agent and mixed with continuous stirring in 15-20 min. Propylene glycol (co-solvent), propyl paraben and methyl paraben (presarvatives) were added in required quantities dissolved in water and added slowly with continuous stirring until a homogeneous gel was formed. The consistency was checked every time to improve the viscosity of the preparation. Volume made with water and stirred continuously till a uniform gel was obtained.
Fig: Gel Formulation.
Table:1. Composition of Developed formulation.
|
Sr. No. |
Ingredients Name |
F1 |
F2 |
F3 |
F4 |
Role of ingredients |
|
1. |
Carbapol 934 |
4.5 gm |
3.5 gm |
2.5gm |
1.5 gm |
Gelling agent |
|
2. |
Propylene glycol |
1ml |
1ml |
1ml |
1 ml |
Co-solvent |
|
3. |
Methyl paraben |
0.00015mg |
0.00015mg |
0.00015mg |
0.00015mg |
Preservative |
|
4. |
Propyl paraben |
0.01mg |
0.01mg |
0.01mg |
0.01mg |
Preservative |
|
5. |
Triethanolamine |
q.s. |
q.s. |
q.s. |
q.s. |
For adjust pH, antioxidant |
|
6. |
Guava leaves extract |
2.5ml |
2ml |
1.5ml |
1 ml |
Anti- inflammatory |
|
7. |
Tulsi extract |
2ml |
1.5ml |
1 ml |
0.5 ml |
Antiseptic, flavouring agent |
|
8. |
Betel extract |
2ml |
1.5ml |
1 ml |
0.5 ml |
Anti-microbial |
|
9. |
Distilled water |
60ml |
50ml |
40ml |
30ml |
Volume adjusts |
1. Clarity of Gel: Visual inspection is used to determine the gel's clarity.
2. Physical Appearance:
Color: Through visual inspection, the formulation's color was verified.
Consistency: Applying the formulation to the skin allowed for the consistency to be verified.
Odor: By combining the gel with water and smelling it, the formulation's odor was assessed.22
3. Homogenisity: After the gels were placed into the container, the homogeneity of each created gel formulation was examined visually. It was reported that the gel formulation was homogeneous.
4. Measurement of pH: The gel formulation's pH was measured with a digital pH meter. After dissolving 1g of gel in 10ml of distilled water, let it sit for two hours. Following three full dips of the glass electrode into the gel system, the pH of the formulation was measured, and the average readings were then reported. [23]
5. Spreadability: Spreadability is defined as the amount of time, measured in seconds, it takes for two slides to separate the gel that is positioned between them when a specific stress is applied.24
6. Drug Content: 10 ml of an appropriate solvent was combined with 1 g of the produced gel. After filtering the stock solution and measuring absorbance, aliquots with varying concentrations were made using appropriate dilutions.2
5. RESULT:
Table:2.
|
Formulation |
Clarity |
Physical Apperance |
Homogenisity |
pH |
Spreadability |
Drug Content |
|
F1 |
+ |
Yellowish green |
Good |
5.2 |
4.3 |
65% |
|
Pleasant |
||||||
|
Consistent |
||||||
|
F2 |
++ |
Yellowish green |
Good |
4.2 |
5.6 |
71% |
|
Pleasant |
||||||
|
Consistent |
||||||
|
F3 |
+++ |
Yellowish green |
Good |
4.5 |
6.6 |
77.75% |
|
Pleasant |
||||||
|
Consistent |
||||||
|
F4 |
+++ |
Yellowish green |
Good |
7 |
6.9 |
83.81% |
|
Pleasant |
||||||
|
Consistent |
Table 3: Spectrometric Test
|
Conc. |
Absorbance |
|
20 |
0.653 |
|
30 |
0.774 |
|
40 |
0.886 |
|
50 |
0.998 |
Fig: Linearity curve for gel formulation
6. CONCLUSION:
From the mentioned results, it was concluded that the prepared gel formulations are in good appearance with suitable pH range. Formulated gel have good homogeneity, proper gel strength and spread ability. The gel is neither too thick nor too thin. The all-formulated gels are found to be stable in closed container as compared to open container. Therefore, the study concluded that the natural remedies are more acceptable and they are safer with minimum side effects than synthetic preparations. Thus, the data presented in this study, it was concluded that the formulated gel of extract of Guava Leaves, Betel Leaves and Tulsi Leaves possesses a significant therapeutically efficacious and have suitable vehicle for drug delivery. Thus, the formulated gel is suitable for treatment of mouth ulcer.
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Received on 30.04.2025 Revised on 02.06.2025 Accepted on 01.07.2025 Published on 08.07.2025 Available online from July 12, 2025 Asian J. Pharm. Tech. 2025; 15(3):242-246. DOI: 10.52711/2231-5713.2025.00037 ©Asian Pharma Press All Right Reserved
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