Abstract

This research explores the development and assessment of polyherbal lozenges aimed at relieving oral discomfort and enhancing respiratory health. Lozenges are solid, flavored forms of medication that dissolve in the mouth, making them ideal for patients, particularly children and the elderly, who may struggle with swallowing pills. The rising interest in natural remedies has led to the incorporation of herbal ingredients, such as liquorice, clove, ginger, long pepper, honey, and turmeric, each recognized for their health benefits. The preparation process involved creating a base using sugar and jaggery, which was then mixed with filtered herbal extracts and heated to form the lozenges. Evaluation techniques included tests for hardness, thickness, friability, disintegration time, dissolution rate, moisture content, and pH level to ensure the product's stability and effectiveness. Findings showed a mean pH of 6.2, with disintegration times ranging from 7 to 10 minutes and satisfactory hardness and friability metrics. These results suggest that polyherbal lozenges can serve as effective, natural alternatives for throat and cough relief, offering ease of use and improved bioavailability. The study concludes that these lozenges represent a safe and effective option for managing respiratory discomfort, catering to consumers seeking herbal alternatives.

Keywords

Lozenges, Polyherbal. Respiratory, Natural.

Introduction

The French word "Losenge," which denotes a diamond-shaped geometry with four equal sides, is whence the word "Lozenge" originates. Since the 20th century, pharmacists have developed lozenges and pastilles, which are currently produced commercially. Lozenges are solid mixtures that dissolve in the mouth or throat. They might have one in them or more medications in a flavored and sweetened basis that are meant to alleviate oral irritation or infections also for systemic medication absorption through the pharynx. The flavored medicinal dose forms are called lozenges.  Lozenges are frequently made with medications such as analgesics, anesthetics, antimicrobials, antiseptics, and antitussives corticosteroids, aromatics, astringents, decongestants, and demulcents.

The lozenges are supposed to progressively crumble or disintegrate in the mouth. They have one or more active ingredients and are flavored and sweetened for flavor. The solid blend of sugar and gum that makes up lozenges gives the drug a slow release while also giving the lozenges solidity and cohesiveness.

The increased desire for safe and natural treatments for various conditions has led to a rise in the usage of herbal components in lozenges. Numerous natural materials, including essential oils, plant extracts, and other natural substances, can be used to produce herbal lozenges. Because they are thought to be safe and effective, herbal lozenges are becoming more and more well-liked as a natural substitute for pharmaceuticals. Because they are less likely to have side effects or interfere with other treatments, they are frequently chosen over pharmaceuticals. Herbal lozenges are also seen to be a more environmentally friendly choice because they are frequently created with natural materials that may be found locally and don't hurt the environment as much. Additionally, herbal lozenges are thought to be a more environmentally friendly option because they typically contain natural product like ginger, honey, clove, turmeric etc
ADVANTAGES OF LOZENGES

1. It can be given to those patients who have difficulty in swallowing.
2. Easy to administer to geriatric and paediatric population
3. Systemic absorption of drug can be possible through buccal cavity.
4. Taste of drug can be masked by sweeteners and flavors used in formulation.
5. It can increase in bioavailability.
6. It can reduce dosing frequency.

TYPES OF LOZENGES

There are three types of lozenges:

1. Hard lozenges
2. Soft lozenges
3. Chewable Lozenges
   1. Hard lozenges: The method of creating hard lozenges, which provide an amorphous glassy material that has hardened, usually involves the use of sucrose or other sugars. HPMC and PEGs are examples of polymers that can be added to delay the rate of dissolution. It is possible to create a different kind of hard lozenge by compressing powder. Troches (lozenges) of clotrimazole, which are created as big, compressed tablets that dissolve gradually in the mouth, are an illustration of this. Povidone, MCC, and dextrose make up the tablet's base substance.

        
           
       
Figure 1: Hard lozenges

1. 2.  Soft lozenges: High molecular weight polyethylene glycols (PEGs) are commonly used in the formulation of soft lozenges to facilitate a gradual dissolving in saliva. To increase the consistency and stickiness of the lozenge, hydrocolloids such as acacia might be used as adhesive agents. To make soft clotrimazole troches, for instance, the medication and acacia are combined with a melted PEG 1450 base, and the mixture is then poured into troche molds. This technique makes it possible to deliver the drug gradually as the lozenge dissolves.

Top of Form

Bottom of Form

       
           
       
Figure 2: Soft lozenges

4. Chewable lozenges: Chewable are usually made of glycerinated gelatin, which is a mixture of water, gelatin, and glycerin. Acacia, medication, and appropriate flavoring and sweetening additives can be used with this base.  Chewable lozenges are frequently used as supplements or for sore throats and coughs since they are made to act more quickly when swallowed. These dissolve more quickly and are usually more appetizing than regular lozenges, which dissolve more slowly. They mix the ease of use with nutritional advantages or efficient alleviation.

       
           
       
Figure 3: chewable lozenges

Top of Form

Bottom of Form

HISTORY OF LOZENGES

Lozenges date back thousands of years, to 1000 BC. Back then, they were frequently flavored with honey and anything from citrus to spices. However, in the 19th century, doctors started adding morphine and heroine to pills in an attempt to treat coughs and colds before they started, giving lozenges a significantly more complicated recipe. The first advertisements for cough drops date back to 1850, while ludens were invented in 1880. Concerning the illness an often occurring viral infection of the throat and nose. A common cold, as opposed to the flu, can be brought on by a wide variety of viruses. The illness is usually not harmful, and the symptoms go away in two weeks on average. Similar flu symptoms include fever, headaches, and painful muscles.

Sneezing, coughing, and congestion are signs of a cold. Prevalent colds: among the most prevalent infections affecting people, they cause significant morbidity and financial loss. Evidence points to a number of potential processes via which polyherbal remedies may be beneficial for the common cold, but no consistently successful cure has been thoroughly studied. A common viral infection, the flu can be fatal, especially to high-risk individuals because it affects the throat, nose, and lungs. Those with weakened immune systems, chronic illnesses, pregnant women, and small children are particularly vulnerable. And readily spreads                              

HYPOTHESIS:
H1: It can be used as a mouth and throat medicant for cough cures or for the gradual delivery of digestive aids.

H2:-It quickly relieves discomfort, coughing, and sore throats.

H3:-In addition to its calming impact on respiratory problems, its delicious flavor, lack of negative effects, and incredibly low cost are rapidly gaining popularity.

H4:-Adults and children alike can utilize it.

H5: It contains no chemical additions and is only made of natural substances with established medical benefits.

1. Liquorice   

 Glycyrrhiza glabra, a member of the Leguminosae family, is the source of the sweet flavor.

A perennial herb, liquorice grows wild in southern Europe and several Asian nations, including India.

 It is demulcent and expectorant. Glycyrrhenic acid is the source of these properties.

Liquorice is also known as sweet root.

       
           
       
Figure 4: Liquorice

2. Clove       

• Eugenia caryophyllus, or the Syzygium aromaticum tree (Myrtaceae), is the source of cloves.
• Their origins are in Indonesia's Maluku (or Moluccas) Islands.
• Applied as a pain reliever and antiviral.
Laung is another name for clove.

       
           
       
Figure 5 :( clove)

C] Ginger

. Comprised of Zingiber officinale (Family: Zinziberaceae) rhizomes that have been scraped to remove the brown outer skin and sun-dried.
. Oleoresin, the primary compound in ginger, has expectorant, carminative, and fragrant qualities.
. Fresh ginger contains an active ingredient called gingerol, which is typically found as yellow, strong oil with a spicy-sweet aroma.
. Adrak is an additional name for ginger.

       
           
       
Figure 6:(Ginger)

     D] Long pepper

• Consists of dried unripe or almost ripe fruits of vine piper nigrum  (family: Piperaceae).
• It is also called long native pepper and pipli in Hindi.
• Pippali, another name for long pepper, is a decongestant that is mostly used to treat respiratory issues during colds.    

       
           
       
Figure 7: (long pepper )

E] Honey

• The comb is filled with a saccharine liquid that is derived from flower nectar and is placed there by Apis smallifera, Apisdorsata, and other Apis species (Apidae family).
• Honey is a well-known home cure for coughs, both wet and dry, because of its consistency.

. Has a soothing effect, helps relieve throat irritation.

. Honey is also called madhu.

       
           
       
Figure 8: (Honey)

Bottom of Form

Turmeric

• They are dried rhizomes of Curcuma longa (Zingiberaceae).
• It has antiseptic properties and is therefore used in respiratory ailments such as common cold, bronchitis, cough and other upper respiratory problems.
• Turmeric is also called haldi

       
           
       
       Figure 9: (Turmeric )

GENERAL METHOD OF PREPARATION

 • A tiny amount of water was used to dissolve the sugar and jaggery until a suitable consistency was reached. Another container was filled with a little amount of water, to which all the herbs were added, well mixed, and then filtered.

 

• The filtered herbal juice was placed in a beaker together with sugar and jaggery syrup.

• Honey was included. 150 °C was attained by heating the mixture while stirring continuously

 

• To create lozenges the perfect size, the mixture was then taken off the heat and poured into a mold.

 

• Room temperature was used to allow the mold to cool and cure.

 To keep the hard lozenges from sticking in the liquid, they were covered in powdered sugar after chilling.
• The powdered sugar-tossed lozenges are kept in an airtight, wide-mouthed

Ingredients:

Equipment:

 1. Soxhlet extractor

2. Heating mantle or hot plate

3. Glassware (round bottom flask, Condenser)

4. Glass wool or cotton

 5. Filtration apparatus

GENERAL METHODS FOR EVALUATION OF LOZENGES  

 Hardness test: A tablet's hardness level reveals how well it can tolerate handling-related mechanical shocks. The Monsanto hardness tester was used to measure the tablets' hardness. It is stated as kg/cm^2.The tablets' hardness was assessed after three were chosen at random.

1.  Place the lozenge between the spindle and anvil. 
2. Apply pressure to hold the lozenge in place. 
3. Turn the screw knob clockwise until the lozenge breaks. 
4. Note the reading in kilograms per square centimeter (kg/cm2), which indicates the   pressure required to break the lozenge.  

       
           
       
Fig ure10 :(Monsanto Hardness Tester)

Determination of Thickness: A vernier caliper was used to measure the lozenges thickness.

.It is measured in mm. The thickness of lozenges was almost uniform in all formulations and was found to be in the range of 3.0 mm to 3.28 mm.

Average thickness = Total 5 lozenges thickness ×100                   

                                              5

       
           
       
Figure 11: (VERNIER CALIPER)

Friability test:

The friability test evaluates a tablet or granule's ability to withstand handling, packing, and transportation.

The Roche Friabilator is used to assess a lozenge's friability. The apparatus rotates for four minutes at 25 rpm. Lozenges are weighed out initially and put in the friabilator.

The lozenges were reweighed and de-dusted following the revolution. The value that was seen is not surpass 1%.

Friability= (Initial Weight -Final Weight) X 100

                                Initial Weight

       
           
       
Figure 12 (Friability test apparatus)

Disintegration test:

The disintegration test calculates how long it will take a solid dosage form submerged in a liquid medium to disintegrate entirely or break down into smaller pieces. Five randomly chosen herbal lozenges and five randomly chosen lozenges were subjected to the disintegration test in accordance with USP30. The test was performed using a disintegration tester with a basket rack assembly that rotates at 30 rpm through the disintegration medium of phosphate buffer with pH 6.2 maintained at 37°C. The duration required for every lozenge to fully dissolve was noted. The lozenges from batch A took an average of seven minutes to dissolve. The average disintegration time of the lozenges from batch B was 10 minute. The results of the disintegration test indicate that both batches of herbal lozenges.

       
           
       
Figure 13 (Disintegration apparatus)

Dissolution test:

The rate at which the medicine dissolves in the lozenges tells us how quickly the drug absorbs. Lozenge efficacy is directly correlated with bioavailability and rate of dissolution. The instrument used for this study is a paddle-type USP II Dissolution type device. The USP II paddle method at 100 rpm was used to make artificial saliva or 900 ml of buffer pH 6.4 was used for the dissolution investigation. Spectrophotometric analysis was performed on samples that were taken out at intervals of five minutes and promptly replaced with an equivalent volume of either artificial saliva or fresh buffer. Maintain the temperature between dissolution trials at 37 ± 2 °C.

       
           
       
Figure 14 (Dissolution apparatus)

DETERMINATION OF MOISTURE CONTENT:

The moisture content of a sample is calculated as a percentage by dividing the mass of water by the mass of solids in the sample. This formulation's attribute was determined by weighing the amount, which was then heated to 110 degrees Celsius in hot air for a single night in order to calculate the moisture content.

Moisture balance device is used to determine the final candy's moisture content. [The material was weighed and crushed in a mortar; the moisture balance device measured one gram of the sample and assessed its moisture content.

       
           
       
Figure 15 (Moisture balance)               

PH OF LOZENGES

The pH of the herbal lozenges was measured using a calibrated pH meter following the manufacturer's instructions, and the results showed a mean pH of 6.2 ± 0.3 (n=10) on the pH scale.

To determine the pH of a lozenge, weigh the lozenge and dissolve it in water and then measure the pH by following some steps:

1. Weigh the lozenge
2. Dissolve it in 5 mL of water
3. Place the vial on a horizontal shaker until the lozenge dissolves 

PH meter is use to measure the pH of a sample. A pH meter works by measuring the ion exchange between the sample and the glass electrode's inner solution, which generates an electrical voltage. The pH reading is based on the hydrogen ion concentration and the relation between the electric voltage and the pH reading. 

The pH scale ranges from 0 to 14. A pH lower than 7 indicates an acidic substance, a pH of 7 indicates a neutral substance, and a pH greater than 7 indicates a basic substance. 

       
           
       
Figure 16(pH meter)

Swelling Index: Using p.H6.4 phosphate buffer, the swelling rate is calculated. One establishes the starting weight. After that, the tablet is withdrawn at various intervals (0, 1, 2, 3, etc.) and placed in a Petri dish coated with phosphate buffer and placed in an incubator at 37+/- 1. Filter paper was used to blot and then reweight.

CONCLUSION
Six different herbs were used to create herbal lozenges. The many measurements used for the qualitative Quantitative analysis and physical parameters final products comply with the standard. specified in GMP guidelines and criteria. concurrently supporting the impression of the herb. lozenges can compete with the regular lozenges. Available in the market. These herbal lozenges were Herbs were thoroughly studied, and then Optimal formulation dose and evaluation of qualitative and quantitative analysis by precised Advanced analytical instrumental methods for assessment. The effectiveness was evaluated by a The survey was conducted using a questionnaire. e. The investigation confirmed the purity and efficacy of the herbal lozenges. This study demonstrates that the lozenges are appropriate dosage form for the symptomatic treatment of cold. and flu. The standards offers a specific a quick method for establishing quality standards, identity Superior consistency in herbal lozenges for colds and flu. Consequently, the lozenges passed all of the standards and were It was discovered to be more effective in treating colds and flu. Therefore, this formulation can be recommended for Patients are experiencing cold and flu symptoms.

ACKNOWLEDGMENT

The authors would like to thank the Himalayan Pharmacy Institute for allowing them to conduct this research.

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