Formulation and Evaluation of Agele Marmelos Lozenges

Lozenges are small, often medicated tablets designed to dissolve slowly in the mouth, providing a localized effect in the throat or oral cavity. Typically composed of sugar, flavouring agents, and active pharmaceutical ingredients, lozenges are commonly used to soothe sore throats, relieve coughs, or deliver medication for oral health. ^[1] The formulation allows for prolonged contact with mucous membranes, enhancing the therapeutic effect of the ingredients, which can include soothing agents like menthol or herbal extracts. Lozenges come in various shapes and flavours, catering to different preferences and needs, and are an effective delivery method for both over-the-counter and prescription medications. Their ease of use and palatable nature make them a popular choice for individuals seeking relief from oral discomfort without the need for liquid medication. Lozenges serve several purposes, primarily aimed at providing relief for various oral and throat They are commonly used to soothe sore throats, reduce coughing, and alleviate dry mouth. ^[2] By the 19th century, lozenges gained prominence as a convenient form of medication, particularly with the development of sugarbased formulations. Pharmaceutical companies began to mass-produce lozenges, incorporating active ingredients for various therapeutic purposes. The Victorian era saw a rise in the popularity of medicinal lozenges, often marketed for their soothing properties. ^[3]

Importance of lozenges in medicine:

 Lozenges hold significant importance in medicine due to their effective delivery system for localized treatment of oral and throat conditions. Their design allows for slow dissolution in the mouth, ensuring prolonged contact with mucous membranes, which enhances the therapeutic effects of the active ingredient. ^[4] This makes lozenges particularly useful for soothing sore throats, alleviating coughs, and providing relief from dry mouth. Additionally, they can incorporate a variety of medications, including local anaesthetics, antiseptics, and herbal remedies, making them versatile for treating infections or discomfort. ^[5] Their ease of use, palatable nature, and convenience-requiring no water or swallowing-make them an ideal choice for patients, especially children and the elderly, who may have difficulty with traditional medications. As a noninvasive option, lozenges contribute to patient compliance and comfort, highlighting their valuable role in modern therapeutic practices. ^[6]

Advantages of Lozenges:

• It is easy to administer to both pediatric and geriatric patients.
• It has a pleasant taste and will extend the time a quantity of drug remains in the oral cavity to elicit local activity.
• It very well may be given to those patients who experience issues in gulping.
• It can decrease dosing recurrence.
• No disintegration.
• Do not require water for intake.
• Less production times.
• Less production cost. ^[7]

Disadvantages of Lozenges

• Possible draining of drug from oral cavity to stomach along with saliva.
• The lozenges dosage form could be used as candy by children mistakenly.
• A hard candy lozenge is a high temperature required for their preparation.
• Heat stable drugs are suitable. ^[8]

Types of Lozenges

Therapeutic lozenges

Therapeutic lozenges are specialized formulations designed to provide targeted relief for various oral and throat ailments. They typically contain active pharmaceutical ingredients that offer soothing, analgesic, or antiseptic properties. Common ingredients include menthol, which provides a cooling sensation; honey and herbal extracts that soothe irritation; and local anaesthetics like benzocaine that numb pain. ^[9]

Nutritional lozenges

Nutritional lozenges are specialized dietary supplements designed to provide essential vitamins, minerals, and other nutrients in a convenient and palatable form. These lozenges cater to individuals seeking to enhance their nutritional intake without the need for traditional pills or liquids, making them particularly appealing to those who may have difficulty swallowing. Commonly enriched with vitamins such as Vitamin C, B vitamins, or minerals like zinc, nutritional. ^[10]

Herbal lozenges

Herbal lozenges are formulated with natural plant-based ingredients designed to provide soothing relief for various throat and oral conditions while promoting overall health. Typically containing extracts from herbs such as echinacea, licorice root, marshmallow root, and ginger, these lozenges capitalize on the therapeutic properties of their constituents.¹⁶ For example, Echinacea is often used for its immune boosting effects, while licorice root is known for its antiinflammatory and soothing qualities. ^[11]

AIM AND OBJECTIVES:

AIM

“To explore the effectiveness of Aegle marmelos lozenges.”

OBJECTIVES: -

? Lozenges are designed to provide various health benefits in the form of a small tablet that slowly dissolves in the mouth

? Provide natural relief for sore throat and cough symptoms

? Offer a soothing sensation through herbal ingredients like

? Deliver a convenient and portable solution for on-the-go relief.

? Promote overall wellness by using natural, plant-based ingredients.

? Ensure efficacy and safety through rigorous quality control and testing processes.

? Cater to specific preferences and needs by offering a variety of flavors and formulas.

? Educate consumers about the benefits of herbal remedies and their role in health practices. ^[12]

? Bael leaf lozenges are cost effective & safe.

Plant Profile:

Aegle Marmelos Powder:                                                                                                                            

English Name: Beal fruit, Bengal quince, Golden apple.

Tamil Name: Vilvam, Vilva-pazham, Bilvam

Telugu: Bilvamu.

Kingdom: Plantae.

Order: Sapindales.

Family: Rutaceae.

Sub family: Aurantioideae

Genus: Aegle.

Species: A. marmelos Habitat

Aegle marmelos treating fever, nausea, vomiting, swellings, dysentery, dyspepsia, seminal weakness, and intermittent fever. ^[13]

Fig 1: Agele Marmelos Extract Powder

MATERIAL AND METHOD:

All ingredients were purchased from trusted supplier. All others are purchased from, Local Suppliers, Washim.

Table no 1: Formulation Table

Procedure:

Preparation Images

Fig no 3: - Mixing

Fig no 4: - Final Product

Evaluation of Formulation

Formulation developed was sampled and evaluated for different parameters such as organoleptic properties, weight variation, friability, hardness, dissolution test, disintegration test.

1. Organoleptic parameters-

The lozenges were found to be oval in shape with smooth texture. This oval shape was due to molds used for preparation. The taste of the lozenges was sweet and acrid in taste. The sweet taste could be attributed to the use of sugar as base and acrid tast due to Aegle Marmelos Macerated extract. ^[14]

2. Weight variation-

The USP weight variation test is done by weighing 20 lozenges individually and then by taking average comparing it as follows:

Weight variation = (average weight – initial weight) ÷ average weight. ^[15]

Fig no 5: - Weight Variation

3. Friability-

These is carried out for same as hardness testing. Friability testing is carried out by using Roche Friabilator operated at specific speed for specific time such 25 rpm for 4 min. ^[16]

Fig no 6: - Friability

4. Hardness-

The resistance of lozenges to shipping, storage conditions breakage, Transportation and handling, depending upon the hardness. hence it becomes necessary to measure hardness for checking its threshold capacity which can be measured by using Monsanto hardness tester in terms of kg/cmsq. ^[17]

Fig no 7: - Hardness

5. Dissolution time:

Dissolution time is an important parameter to evaluate in herbal lozenges as it can affect the release of active ingredients and the efficacy of the product. The dissolution time of herbal lozenges can be influenced by factors such as the size and shape of the lozenge, the type and number of excipients used, and the environmental conditions during storage. The dissolution time of herbal lozenges can be determined by placing a lozenge in a beaker of water at a specified temperature and measuring the time it takes for the lozenge to completely dissolve. The acceptable dissolution time for herbal lozenges depends on the specific product and its intended use. ^[17,18,19]

Fig no 8: - Dissolution Time

6. Disintegration time:

Ideally this test is not official for the formulation expected to be dissolved slowly in the mouth and hence the limits are not specific. Still the test was performed to find whether the lozenge dissolves in mouth and how much time it takes to dissolve completely so that the faster and localized onset of action can be obtained. The test was performed as per the procedure given in the monograph for uncoated tablets. ^[19]

Fig no 9: - Disintegration Time

7. Packaging:

Hard candies are hygroscopic and frequently prone to absorption of atmospheric moisture. Considerations must include the hygroscopic nature of the candy base, storage conditions of the lozenges, length of time they are stored and the potential for drug interactions. These products should be stored in tight containers to prevent drying. This is especially true of the chewable lozenges that may dry out excessively and become difficult to chew.) If a disposable Mold with a cardboard sleeve is used, it is best to slip this unit into a properly labelled, sealable plastic bag. Packaging should be proper and attractive or colourful. ^[20]

RESULT AND DISCUSSION

Table no 2: Organoleptic Properties

Table no.3: Drug Excipients compatibility study

Weight Variation Test:

20 lozenges are selected for weight variation test. Individual are average weight is calculated and further weight variation is determined.

Table no 4: Weight Variation Test

Total Weight of Tablet = 67.66 ÷ 20 = 3.383

          Average Weight = 3.383

Friability Test

Friability test is determined by using Roches Friabilator.

Table no 5: Friability Test

Initial Weight = 33.83

Final Weight = 33.49

Formula: -Friability =     Initial weight – Final weight            × 100

Initial weight

Harness is checked by Monsanto tester.

Table no 6: Hardness Test

 Dissolution Test

This test is conducted by using Beaker apparatus. The results are shown in following table.

Table no 7: Dissolution Test

This test is conducted by using disintegration test apparatus. The results are shown in following table.

Table no 8: Disintegration Test