Formulation and Evaluation of Herbal Medicated Jelly for Mouth Ulcer

A mouth ulcer, also known as an oral or mucosal ulcer, is a break in the mucous membrane of the oral cavity. It appears as a painful open sore caused by the loss of inflamed tissue and can occur at various sites in the body, though it is common in the mouth. These ulcers are usually round or oval and commonly develop on the inner cheeks or lips. Mouth ulcers are common and may result from local factors such as trauma from dentures, sharp or broken teeth, or irritation due to mechanical, chemical, or thermal causes. They can also be associated with certain systemic conditions, although most cases are not serious. Oral trauma is one of the leading causes of recurrent ulcers, often resulting in short-lived but painful lesions that typically heal within a few weeks without scarring. However, ulcers may recur if the source of irritation persists, and they can cause discomfort during eating, drinking, and brushing teeth [1].

Common Causes of Mouth Ulcers

1. Nutritional Deficiencies: Lack of essential nutrients like iron, vitamin B12, and vitamin C can lead to ulcer formation.
2. Poor Oral Hygiene: Inadequate oral care promotes bacterial growth and inflammation.
3. Infections: Viral infections such as herpes simplex and fungal infections like Candida may trigger ulcers.
4. Stress: Psychological stress can increase ulcer frequency by affecting the immune system.
5. Indigestion: Digestive problems, including acid reflux, may contribute to ulcers.
6. Mechanical Injury: Cheek biting, aggressive brushing, or ill-fitting dental appliances can cause ulcers.
7. Hormonal Imbalance: Hormonal changes during menstruation or pregnancy may increase risk.

Types of Mouth Ulcers

1. Minor Ulcers:

Small (2–8 mm), shallow sores with a white or yellow center and red border. They heal within 1–2 weeks without scarring and are the most common type.

2. Major Ulcers:

Larger (1–3 cm), deeper, and more painful with irregular borders. Healing may take several weeks and can leave scars, often causing difficulty in eating or speaking.

3. Herpetiform Ulcers:

Multiple tiny (1–2 mm) painful ulcers that appear in clusters and may merge into larger lesions. They usually heal in 1–2 weeks but tend to recur frequently [2].

The oral route is the most preferred method of drug administration due to its convenience, non-invasiveness, and patient compliance. However, conventional dosage forms like tablets and capsules pose swallowing difficulties, especially in pediatric, geriatric, and dysphagic patients, affecting compliance [3]. Oral medicated jellies have gained popularity as an alternative dosage form due to their palatability, ease of administration, and rapid disintegration in the oral cavity without the need for water [4]. Jellies are semisolid, transparent, non-greasy preparations that can be used for both internal and external applications and allow drug delivery through buccal, sublingual, and gingival routes [5]. Jelly dosage forms offer advantages such as improved patient compliance, accurate dosing, taste masking, and rapid or controlled drug release. They are particularly suitable for pediatric and geriatric patients and are gaining attention as innovative drug delivery systems in modern pharmaceutics [6]. Furthermore, the addition of flavors, colors, and suitable texture enhances patient acceptability, especially in children. Jellies are commonly prepared using natural or synthetic gelling agents like pectin, tragacanth, and methyl cellulose, along with preservatives and flavoring agents [7,8]

Types of Jellies

a) Medicated Jelly:

Used on mucous membranes and skin for local effects like antiseptic, anesthetic, or spermicidal action. They contain high water content, producing a cooling effect after evaporation.

b) Lubricating Jelly:

Primarily used to lubricate medical instruments such as gloves, catheters, and cystoscopes. They reduce friction and facilitate smooth insertion during procedures. Commonly used in diagnostic and surgical applications.

c) Miscellaneous Jelly:

Used for specialized purposes like patch testing and electrocardiography. They serve as conductive or supportive media in medical procedures. Applications vary depending on the requirement.

Fig. no. 1: - Medicated Jelly

Ideal Characteristics of Oral Medicated Jelly

• Should provide a pleasant mouthfeel with little to no residue after administration.
• Must include effective taste masking for bitter drugs.
• Should be stable and show minimal variation under different environmental conditions.
• Easy to handle, transport, and not fragile. [9]

Advantages of Medicated Jellies

1. Easy to administer anytime without the need for water.
2. Drug action can be stopped by removing or spitting out the jelly.
3. Suitable for patients with swallowing difficulties (dysphagia).
4. Improves patient compliance due to pleasant taste and texture.
5. Provides rapid onset of action.
6. Allows flexible and controllable treatment.

Disadvantages of Medicated Jellies

1. Require special packaging due to high water content and stability concerns.
2. Poor formulation can lead to unpleasant taste and reduced acceptability.

Applications of Oral Medicated Jellies

• Pediatrics: Useful for children who have difficulty swallowing tablets or capsules.
• Geriatrics: Suitable for elderly patients with dysphagia or reduced cognitive ability.
• Oral Health: Effective in treating mouth ulcers, gingivitis, and periodontal diseases, etc.
• Systemic Drug Delivery: Enables controlled release of drugs such as antihypertensive, antidiabetic, and anti-inflammatory agents.
• Targeted Drug Delivery: Can deliver drugs to specific regions of the gastrointestinal tract like the intestine or colon. [10

Medicinal plants have been widely used for centuries in disease management. Psidium guajava (guava) possesses antibacterial, anti-inflammatory, antioxidant, and antiulcer properties, mainly due to bioactive compounds such as quercetin, which helps protect mucosal tissue from oxidative damage. [11] Similarly, Curcuma longa (turmeric), rich in curcumin, exhibits strong antioxidant and anti-inflammatory effects. These botanicals show potential in jelly-based formulations for managing mouth ulcers; however, further scientific validation is required. [12]

MATERIAL AND METHOD

The materials used in the formulation were selected based on their therapeutic and functional roles. Psidium guajava (guava leaves) and Curcuma longa (turmeric) were included for their anti-ulcer, anti-inflammatory, antimicrobial, and antioxidant properties. Gelatin served as the jelly base, while agar and tragacanth acted as gelling and thickening agents. Citric acid-maintained pH, sucrose and sorbitol improved taste and texture, and methyl paraben ensured preservation. Orange and orange oil were added for flavor and aroma to enhance patient acceptability. All the ingredients were carefully selected to ensure compatibility, stability, and effectiveness of the final jelly formulation. [13]

1. Sample collection and processing

Fresh leaves of P. guajava L. (guava) were collected and were rinsed gently with double distilled water, shade dried and powdered using a blender. Then powder was then passed through aluminium sieve to get uniform particle size. Guava leaf powder was stored in an air tight container for further studies.

2. Preparation of guava leaf extract

Then guava leaf powder (20 g) was boiled at 90 °C in 100 mL of double distilled water in sterile flask (150 mL) for 30 min. Then mixture was centrifuged at 4000 rpm for 10 min. Then supernatant was separated and stored at 4 °C for further studies. [14]

3. Preparation of Turmeric extract (Cold maceration)

Cold maceration was carried out on a magnetic stirrer at 450-500 rpm and room temperature. Briefly, 25.00 g of material was extracted with 150 ml. of solvent (ethanol). After 3 h of stirring, the solution was filtered to separate the solid material from the extract solution. The extract solution was evaporated at 40 deg^o C [15]

4. Preparation of Medicated Jelly

1. Required quantity of sugar is dissolved in warm purified water separately to form a clear syrup
2. The sugar syrup the gelling agent is added with continuous stirring and heated.
3. As the gelling agent dissolves completely, stabilizers and solubilizes are added to it and boiled for few minutes, thoroughly mixed.
4. When the mixture was completely dissolved, preservatives are added to it with continuous stirring. Then the pH stabilizers are also added.
5. Then, drug was added to it with continuous stirring, colour and flavour was added, jellies could have settled down and thoroughly mixed.
6. Then, transferred into moulds and the mixture could cool to room temperature to form jelly.
7. Prepared jelly is stored in airtight container under refrigerated conditions for further study [16]

Formulation Table of Medicated Jelly

Evaluation Tests

Evaluation of jelly dosage forms is important to ensure their quality, safety, effectiveness, stability, and patient acceptability. Since jellies are semi-solid in nature, both general pharmaceutical tests and texture-related evaluations are required. The following parameters are commonly used for evaluating chewable jelly formulations:

1. Organoleptic Properties Organoleptic evaluation gives initial information about patient acceptability.

1.1 Appearance Jellies are visually examined for colour uniformity, clarity or opacity, presence of air bubbles, and smoothness of the surface.

1.2 Taste and Odor Taste and odour are evaluated using sensory methods to ensure the jelly is palatable and free from any unpleasant smell.

2. Weight Variation Weight variation ensures uniformity of dose in each jelly unit. Individual jellies are weighed, the average weight is calculated, and the percentage deviation from the mean is determined.

3. pH Determination pH affects drug stability, taste, and microbial growth. The jelly is dispersed in purified water, and the pH is measured using a calibrated digital pH meter.

4. Texture Analysis Texture analysis is performed to evaluate mechanical properties such as firmness and chewability, which influence mouthfeel and patient acceptance.

5. Moisture Content Moisture content plays an important role in texture, stability, and prevention of microbial growth. It is determined using loss-on-drying or a moisture analyzer and expressed as percentage moisture content.

6. Disintegration Test Although not always required, a modified disintegration test can be used to study how the jelly breaks down. The jelly is placed in simulated oral or gastric conditions, and the time taken for complete breakdown is recorded. [17,18]

RESULT AND DISCUSSION

RESULT