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Lozenges Detail

This document reviews chewable lozenge formulations. Lozenges are a popular oral dosage form that are meant to dissolve slowly in the mouth or throat. They can provide local effects in the oral cavity or act systemically after absorption. Lozenges offer advantages like increased retention time in the mouth, bypassing first-pass metabolism, and relief of throat symptoms. They can incorporate a wide range of active ingredients for local or systemic delivery. However, lozenges also have some disadvantages. The review discusses the development, types, advantages and applications of lozenge formulations.

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0% found this document useful (0 votes)
241 views9 pages

Lozenges Detail

This document reviews chewable lozenge formulations. Lozenges are a popular oral dosage form that are meant to dissolve slowly in the mouth or throat. They can provide local effects in the oral cavity or act systemically after absorption. Lozenges offer advantages like increased retention time in the mouth, bypassing first-pass metabolism, and relief of throat symptoms. They can incorporate a wide range of active ingredients for local or systemic delivery. However, lozenges also have some disadvantages. The review discusses the development, types, advantages and applications of lozenge formulations.

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CHEWABLE LOZENGE FORMULATION- A REVIEW

Article  in  International Research Journal of Pharmacy · May 2016


DOI: 10.7897/2230-8407.07432

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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

INTERNATIONAL RESEARCH JOURNAL OF PHARMACY


www.irjponline.com
ISSN 2230 – 8407

Review Article
CHEWABLE LOZENGE FORMULATION- A REVIEW
Umashankar M S *, Dinesh S R, Rini R, Lakshmi K S, Damodharan N
SRM College of Pharmacy, SRM University, Kattankulathur, India
*Corresponding Author Email: [email protected]

Article Received on: 11/02/16 Revised on: 13/03/16 Approved for publication: 28/03/16

DOI: 10.7897/2230-8407.07432

ABSTRACT

Development of lozenges dated back to 20thcentury and is still remain popular among the consumer and hence it has continued commercial
production. Lozenges are palatable solid unit dosage form administrated in the oral cavity. They meant to be dissolved in mouth or pharynx for its
local or systemic effect. Lozenge tablets provide several advantages as pharmaceutical formulations however with some disadvantages. Lozenge as a
dosage form can be adopted for drug delivery across buccal route, labial route, gingival route and sublingual route. Multiple drugs can also be
incorporated in them for chronic illness treatments. Lozenge enables loading of wide range of active ingredients for oral systemic delivery of drugs.
Lozenges are available as over the counter medications in the form of caramel based soft lozenges, hard candy lozenges and compressed tablet
lozenges containing drugs for sore throat, mouth infection and as mouth fresheners. The rationale behind the use of medicated lozenges as one of the
most favored dosage form for the delivery of antitussive drugs. This review focuses various aspects of lozenge formulation providing an insight to the
formulation scientist on novel application of lozenge drug delivery system.

Keywords: Lozenges, antitussive, mucosal effect, local and systemic drug delivery

INTRODUCTION calorie content, facilitate quick manufacture and modify the


drug release characteristics. The benefits of the medicated
Lozenges dissolve slowly in the mouth or throat which is a lozenges is to increase the retention time of the dosage form in
favored delivery system particularly for drugs meant for oral cavity which increases bioavailability, reduces gastric
relieving sore throats and cold symptoms. The name “troche” irritation and bypasses first pass metabolism. The predilection of
can be applied to compressed lozenges but the term lozenge and lozenge can be attributed mainly to their ability to keep the
troches are used interchangeably. Lozenges are intended to be naso-pharyngeal mucosa moist, enhance the swallowing reflex
held in the mouth or pharynx containing one or more and to provide longer contact time of the drug on the mucosal
medicaments either dissolved or dispersed in a sweetened base1, layer.
2
. Lozenges are used for patients who have difficulty swallowing
of solid oral dosage forms as well as for the drugs which should Lozenge tablets are loaded with analgesics like Codeine,
be released slowly to yield a constant amount of drug in the oral Ketamine, Fentanyl and Paracetamol; antifungal like
cavity or to coat the throat tissues with the solution of drug3. The Ketoconazole, Miconazole, Clotrimazole, Amphoterisin B;
lozenge tablets differ from conventional tablets in terms of anesthetics like lidocaine, benzocaine; antimicrobials like
organolepticity, non-disintegrating characteristics and with Artesunate; anti-emetic like Ginger root extract, Ondansetron
slower dissolution profiles. Commercially lozenges are made by and Promethazine; and Antihistamines like Chlorpheniramine
moulding or by compression they slowly dissolve or disintegrate maleate, Phenyltolaxamine Dihydrogencitrate,
in the mouth sometime they are chewed. Lozenges made by Diphenhydramine HCl; Anti-asthmatics like Salbutamol,
compression are harder than ordinary tablets. Lozenges prepared Theophylline; antimicrobial action egItraconazole, and
using sugars to form a hard lozenges, polyethylene glycol (PEG) Thyrothricin; demulcents action e.g. Zinc gluconate; antiseptics
to form a soft lozenges and gelatin to form a chewable type of action e.g. Chloraseptic; having astringent action e.g herbal
lozenges. A throat lozenge includes cough drop, troche, cachou, pastilles; and having antitussives properties like
or cough sweet which is a small, medicated tablet intended to be Dextromethorphanhydrobromide, Besides, Decongestantants
dissolved slowly in the mouth to temporarily arrest coughs, to like Phenyl propanolamineHCl, d-pseudo ephedrine HCl. steroid
lubricate and to soothe the irritated tissues of the throat like corticosteroids; smoking cessation e.g. Nicotine and some
infections (sore throat) caused due to common cold or influenza. aromatics 5. Traditional drugs used in lozenge dosage form are
Several brands of throat lozenges like halls contain menthol, Phenol, Sodium phenolate, and Cetylpyridinium chloride etc.
peppermint oil, eucalyptus oil and/or spearmint as their active
ingredient(s) and some honey lozenges. Non-menthol throat Lozenge exerts local effect at a particular site in the oral cavity
lozenges generally use either zinc gluconate glycine or pectin as and some systemic effect for which the drug undergoes
an oral demulcent. Chewable lozenges are popular among the circulation in the bloodstream and exhibits its pharmacological
pediatric and geriatric populations. action eg. Some vitamins C and D lozenges and multivitamin
lozenge tablets contains B-Complex and lozenges containing
A number of innovative technologies have been developed to nicotine for smoking cessation. More recently it is proved that
improve the conventional forms of lozenges which include the single or multiple ingredients lozenges may be formulated for
use of novel ingredients and techniques to enhance taste, reduce

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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

chronic ill patient, making a patient’s friendly lozenge dosage 4. Prolonged drug action
form. 5. Avoid first pass metabolism of drugs
6. Do not require water for intake
Types of Lozenge 7. Suitable for patients having difficulty swallowing
(Dysphagia)
1. Based on Site of Action: Local and systemic action lozenges 8. Lozenge can be withdrawn if dose is not needed
2. Based on Texture: Medicated type compressed lozenge 9. Modification of formula as per the patient’s need
tablets, hard candy lozenges, chewy or caramel based 10. Less production time
medicated lozenges, soft lozenges and center filled lozenges 11. Cost of production is less
and non-medicated type lozenge include sugar candies and 12. Provides flavour and pleasant taste to the mouth
lollypops. 13. Better patient compliance

Advantages of Lozenges4-7 Disadvantages of Lozenges4-7

1. Ease of administration to paediatric and geriatric 1. Non-ubiquitous distribution of drug in the saliva for
patients local therapy
2. Local and systemic effect through oral cavity 2. Possible draining of drug into the stomach
3. Increased contact time of the drug 3. Accidental swallowing of entire dosage form

Table 1: Ingredient used in lozenge formulation

Ingredients Examples
Candy Base
1. Sugar Sucrose, Maltose, Lactose, Dextrose.
2. Sugar free vehicles Polyethylene Glycol (PEG) 600 and 800, Mannitol and Sorbitol.
Lactose, Calcium Sulphate, Calcium Carbonate, Dicalcium Phosphate,
3. Fillers Microcrystalline Cellulose.
Binders Acacia, Corn Syrup, Sugar Syrup, Gelatin, Polyvinyl Pyrollidone, Tragacanth and
Methylcellulose (MC).
Lubricants Stearic Acid, Magnesium Stearate, Calcium Stearate, Polyethylene Glycol,
vegetable oils and fats.
Flavouring Agents Menthol, Eucalyptus Oil, Cherry flavour, Spearmint etc.
Colouring Agents Water soluble and Lakolene dyes, Food Drug and Cosmetic Colours, Orange
Colour paste and Red Colour cubes and etc.
Whipping agents Milk protein (Casein), Egg Albumin, Gelatin, Xanthan gum, Starch, Pectin, Algin
and Carrageenan.
Humectants Glycerin, Propylene Glycol and Sorbitol.

Various ingredients of lozenge formulations

Figure 1: Steps Involved in Manufacturing of Lozenges 9, 10

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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

Manufacturing of Lozenges spearmint, and cherry flavor etc. The moisture content should be
between 0.5 to 1.5% and weight of hard candy lozenge lie
LOZENGE FORMULATIONS between 1.5-4.5g. They undergo slow and uniform dissolution
or erosion over 5-10 min. and it should not undergo
The lozenges are aimed to formulate into a stable dosage form disintegration. The temperature required for the preparation is
and to provide a more promising means of administration of usually high hence heat sensitive ingredients cannot be
variety of drugs. incorporated into them. Then the color is added to it in the form
Criteria for the formulation of lozenges includes8, 9.10 of solutions or pastes or cubes which is then mixed
1. Selection of suitable drug candidate homogenously to get uniformly coloured mass. The weight of
2. Selection of appropriate drug carrier excipients candy mass is checked by mounting the lubricated vessel
3. Selection of appropriate type of lozenge formulation containing the candy mass. This mass is then transferred to a
water-jacketed stainless steel cooling table for mixing of drug
Compressed Lozenge tablets10, 11 and the flavor. The mixed mass is either poured into mould to
get desired and uniform size lozenge. The mass may also be
Compressed lozenges tablets are manufactured either be direct pulled into a ribbon and after cooling it is cut into desired length
compression or wet granulation method. Thermolabile drugs can to obtain lozenges which are packed as single units using
be made into a compressed lozenge tablets. The granulation wrappers.
method used for making lozenge tablets is as similar to that used
for normal compressed tablet. The compressed lozenge is harder Chewy or Caramel based medicated lozenges12
enough so that it dissolves slowly in the mouth. They have flat
faced with sizes of 5/8-3/4 inch, weight 1.5-4 g, hardness 30-50 Chewy or caramel based medicated lozenges contains
kg inch2 and erosion time ranges between 5-10 min. In direct medicament incorporated into a caramel base which is chewed
compression, the compressed lozenge tablets contain sugar instead of being dissolved in mouth. These are made by using
based vehicle like dextrose or sucrose including some sugar free glycerinated gelatin suppository formula containing glycerin,
vehicles like mannitol, sorbitol, polyethylene glycol (PEG) 6000 gelatin, and water. The other ingredients incorporated are candy
and 8000 for the benefit of diabetic patients if anti-diabetic drug base, whipping agent, humectants, lubricants, flavour and the
are loaded as drug in the lozenge formulation. There are some selected medicaments. Caramel based medicated lozengesare
commercially available sugar based vehicles used lozenge manufactured by allowing the caramel base to cool to 120℃ .
formulation in their brand name like Nu-tab, Sweetrex, Emdex, This is followed by the addition of whipping agent at
Honey-Tab, Mola-tab and Sugar tab. In direct compression of temperature below 105℃ . The medicaments are then added
medicated lozenges, dicalcium phosphate, calcium sulphate, between 95-105℃ . Colour is dispersed in humectant and added
calcium carbonate, lactose and microcrystalline cellulose are to the above mass at a temperature at about 90℃ . Seeding
used as diluents in order to facilitate the formulation of crystals and flavour are then added below 85℃ followed by
lozenges. Acacia, corn syrup, sugar syrup, gelatin, polyvinyl- lubricant, added at above 80℃ . These lozenges are fruity
pyrrolidone, tragacanth and methylcellulose are used as binders flavoured and have a slightly acidic taste to mask the acrid taste
to held the particles as discrete granules to make free flow of drug. The candy base contains sugar and corn syrup in two
during compression into lozenge tablets. In the direct ratios either 50:50 or 75:25. The whipping agents used to aerate
compression process, the free flow of mixture is aided by using the toffee-based confections to obtain the desired degree of
lubricants like magnesium stearate, calcium stearate, stearic acid softness to chew. The humectants improves mouth feel includes
and PEG to make lozenges of the required weight. The water glycerin, propylene glycol and sorbitol. Lubricants are added to
soluble colors and lake dyes are usually used to impart color to avoid sticking of candy to the teeth while chewing which
the lozenge tablets.All the selected ingredients are mixed include vegetable oils and fats. Medicaments up to 35-40% can
homogenously and compressed into lozenge tablets. In wet be incorporated. Seeding crystal involves addition of fine
granulation method sugar is ground into a fine powder by powdered sugar at 3-10% to warm candy mass to speed up the
mechanical agitation and passed through sieve 40-80 mesh size. crystallization and allow the base to be formed into tablets more
Medicament is now added to the sugar mass and uniformly quickly. Candies which are formed in the form a long rope of
mixed. These homogenously mixed mass is granulated using suitable thickness cut to a desired size and then packed using
sufficient amount of sugar syrup or corn syrup and passed wrappers.
through 2-8 mesh screen to get wet granules. These wet
granules are dried and once again passed thorough 10-30 mesh Soft Lozenges13, 14
size. Suitable flavor and lubricant are then added before
compression into required size lozenge tablets. Soft lozenges are made by using polyethylene glycol 1000 or
1450, chocolate or sugar-acacia base which gives soft texture to
Hard Candy Lozenges10, 11 the lozenges. They are made by hand rollmethod to a desired
size and thickness and cut into pieces or the warm mass can be
Hard candy lozenges are manufactured by cooking process by poured into a plastic mould to get soft lozenges. The soft candy
dissolving desired quantity of sugar to prepare the candy base lozenge contains silica gel which acts as a suspending agent to
and other carbohydrates if any are then added to get an prevent sedimentation of particles in the moulds during cooling.
amorphous, non-crystalline glassy state in one third amount of The formulation requires heating to about 50℃ it is suitable for
water in the candy cooker at the temperature at about 110oC. If heat resistant ingredients. The soft lozenges are meant for
Baume base, a corn syrup if used in manufacturing of hard chewing and to provide a slow release of drug in the mouth. Soft
candy lozenges, the temperature should be kept in between 145- lozenges contain polyethylene glycol are made by moulding
156℃ .Medicaments up to 2-4% can be incorporated in the hard method. The mass is poured over filling into the mould cavity as
candy lozenges. Sucrose, dextrose, maltose and lactose are the polyethylene glycol shrinks on cooling gives spongy texture
added as sweeteners. citric, tartaric, fumaric and malic acid etc to the lozenge tablets in case of chocolate base no overfilling is
are added as acidulents to strengthening the candy base. Colours required since itself provides a soft texture. Soft lozenge
approved by FD & C are added with shades like orange, red, containing Clotrimazole is made by moulding method in which
green or yellow. Flavours used include menthol, eucalyptus oil, the increasing amount of PEG, Xanthan gum or Xylitol

11
Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

increases the hardness of the lozenge and hence the and jams where corn syrup or liquid sucrose had modified into a
disintegration time, care must be taken in the quantity of these viscous gel form with a fill weight at about 20-25%. Center
agents. filled hard lozenges are manufactured by forming a candy base
or vehicle comprising sugar, corn syrup and water; the candy
Center Filled Hard Lozenges14 base or the vehicle was heated to remove water therefrom to
obtain a cooked candy base having a residual moisture content
Center filled hard lozenge tablets are hard candy type with a soft ranging from about 0.02% to about 5.0%. Then, subsequent
or liquid filled center containing the active medicament. There cooling the candy base or vehicle to a soft state and forming the
are various types of centre filled lozenges like liquid filled candy base into a rope. The rope is wrapped around a filling
containing fruit juice, sugar syrup, sorbitol solutions or pipe and a powder or semi-liquid center film was prepared
hydroalcoholic solutions at about 10-20 % of fill weight. Fat containing medicament in a stabilizing base including vegetable
filled centre containing medicament or flavour being suspended oil, and optionally sugar and/or gelatin; The semi-liquid or the
or dissolved in hydrogenated fats with a fill weight of 25-32%. powder center filler was dispensed into the center of the candy
Paste centre filled lozenge contains crystals and granules base or vehicle in a ratio of about 2 to 50% by weight of the
formulated as paste with a 40% of fill weight. Fruit centre Jellies medicament.

Table 2: Medicated lozenges and their proven facts

Type Ingredients Effects produced Uses References


Penicillin agar Gelatin and agar Retention time was found to be Spirochaetal infection Greey et al 194515
pastilles 4-5hrs and for hemolytic
streptococcal infection of
throat
Multi-layered Enteric coated controlled Delayed in vivo drug release Asthma, chronic Shukla et al
Pastilles and pulsatile release polymer obstructive pulmonary 200916
like Polyethylene Glycol disease, (COPD) and for
added with colloidal silicon chrono-therapeutic
dioxide management of
nocturnal asthma
Amylmetacresol and Corn syrup mixed with Rapid release of the drug in the Acute sore throat and as Wade et al 201117
2,4 – dichlorobenzyl mucoadhesive polymers mouth analgesic
alcohol Lozenge
Salbutamol sulphate Isomalt a tooth friendly sugar Extended drug release profile Asthma Rajesh Kini
lozenges substitute mixed with corn for 60 minutes 201118
syrup
Ketoconazole Sucrose, Citric Acid, Reduces gastric irritation by Fungal infections in NagobaS.N
lozenges Hydroxy Propyl methyl passing first pass metabolism pediatric and geriatrics. 201119
cellulose and Hydroxy Ethyl
Cellulose
Paracetamol lozenges Paracetamol, Sucrose, Slow release of medicament Fever and pain Dharmajit
Sodium Carboxy Methyl Pattanayak 201120
Cellulose, Methyl Cellulose
Clotrimazole Sugar base, acacia/ Guar Prolonged oral retention time Pediatric and geriatric Shivappa N.
lozenges Gum/ Methyl Cellulose citric dysphagia Nagoba, 201221
acid artificial flavours and
colours
Artesunate oral Mucoadhesive polymer like Prolonged retention of the Malaria in paediatric Edward K
retentive lozenges sodium hydroxyl ethyl lozenges patient kamamia 201322
cellulose is used
Montelukast Sodium Montelukast Sodium, Prolonged retention in the Asthma Walia Mandeep,
lozenge glucose, Hydroxy Propyl mouth K.
Methyl Cellulose (HPMC) PurushothamRao,
201323

Marshmallow root Xanthan gum as a gummy Increased the disintegration Irritated oropharyngeal Bistra Kostova
extract Lozenges base time over 30 min and retain in mucosa and associated 201324
vitro drug release rate 40% for dry cough
30 min of the lozenges
Garlic and ginger Sucrose, sodium chloride, Taste masking with good Inhibitory activity Charles
Lozenges poly vinyl pyrollidone, release matrix type lozenge against non-resistant C. O.Esimone 201325
sodium carboxy methyl albicans infections, non-
cellulose resistant oral thrush
Itraconazole topical Rolled into lozenges using 90% drug release by the end of Topical application Deepika Modyala
delivery Lozenges PEG base 60 min. and remain stable 201426

Ondansetron Sucrose as base and Eudragit Increase in bioavailability, Chemotherapy induced Suchita Pundir
hydrochloride E100, sodium carboxy reduction in gastric irritation by nausea and vomiting. 201427
lozenges methyl cellulose, hydroxy passing of first pass
propyl methyl cellulose K4M metabolism and increase in
and methyl cellulose as onset of action
binder are used
Fluconazole tablet Maize starch, acacia, HPMC Increased bioavailability, Oral thrush V.B. Bharkad
lozenge E50. sucrose as base and reduction in gastric irritation, 201428
gelatin as a binder by passing first pass

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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

metabolism, provide slow


release medicament
Joshanda, polyherbal Conventional decoction form Slow dissolution in the mouth, Cold, cough and Monika Bansal,
lozenge of Joshanda prolonged effect associated allergic July 201529
reactions

Formulations proved to be effective as Lozenges

Table 3: List of marketed lozenges30, 31

S.N. Products Ingredients Other Ingredients Indication Marketed By


1. Cepacol Menthol, Cetylpyridinium Chloride, glucose, Sore Throat Combe
Benzocaine peppermint oil, propylene glycol, sucrose, incorporated
yellow 10
2. Chloraseptic Benzocaine Corn Syrup, FD&C Red #40, Flavor, Relief of minor Prestige Brands
Glycerin, Soy Lecithin, Sucrose, Water sore throat and lnc.
mouth pain
3. Clotrimazole Clotrimazole Croscarmellose Sodium Dextrates, Oral thrush Perrigo company
lozenge magnesium stearate, Cellulose
Microcrystalline, Povidone
4. Koflet-h Madhu Haritaki, Trikatu, Kulanjana Alleviate cough Himalaya Herbal
(Alpiniagalanga) Khadira (Acacia Catechu) and quickly Healthcare
Oils. Lavanga, Sukshmaila (Elettaria relieves throat
cardamomum), Darusita irritation
(Cinnamomumzeylanicum), Sugar base
5. Lockets Eucalyptus Sugar, Glucose syrup, Honey, Glycerol, Nasal Wrigley
and menthol Citric Acid, Vitamin C, Monopropylene congestion and Company
Glycol, Colors E122 and E142. sore throat
6. Nicorette Nicotine Aspartame, calcium polycarbophil, Smoking Perrigo company
flavor, magnesium stearate, cessation
mannitol, potassium bicarbonate,
sodium alginate, sodium carbonate,
xanthan gum
7. Strepsils Amylmetacr Hexylresorcinol, sucrose, glucose, Sore throat and Reckitt Benkiser
esol, levomenthol, blackcurrant flavour blocked nose
dichlorobenz (contains propylene glycol),
yl alcohol carmoisineedicol (E122), patent
blue V (E131)
8. Sualin Glycyrrhiza Aadhatodavasica, Ocimum sanctum, Influenza, Hamdard
Glabra Menthaarvensis, bronchitis, sore (WAKF)
Pimpinellaanisum, Eucalyptus Citriodora, throat, cold and Laboratories
Cinnamon zeylanicum, Piper cubeba. cough,
congestion of
head and lungs
9. Sucrets Dextrometho Corn Syrup, D&C Yellow, Hydrogenated Sore throat Insight
rphan Palm Oil, Menthol, N&A Honey Lemon Pharmaceuticals
Hydrobromide Flavor, Sugar
10. Therazinc Zinc Vitamin A (Acetate) 500 IU, A proprietary Common cold Quantum Health
Gluconate blend of Slippery Elm Bark of UlmusFulva and flu care
(4:l), Propolis, Elderberry, Larch and
Mullein, natural flavors
11. Vicks Menthol Ascorbic acid, citric acid, eucalyptus oil, Sore throat Procter and
FD&C Blue No. 1, FD&C Red No. 40, Gamble
flavor, liquid
glucose, sucrose.
12. Vigroids Liquorices Maize starch, menthol, kaolin, tragacanth, Expectorant Ernest Jackson
eucalyptus oil, peppermint oil, tolu tincture

Few lozenge formulations available in the market Moisture Analysis

EVALUATION TEST FOR LOZENGES Gravimetric method: Weigh 1g of sample and noted as its
initial weight, it is then placed in a vacuum oven at 60-70oC for
Quality Control32, 33 12-16 hours. After specified intervals of time, once again weigh
Candy Base- For the candy base it is essential to check for corn the sample and moisture content can be calculated using the
syrup and sugar delivery gears; temperature, steam pressure, following formula.
cooking speed, temperature and vacuum of candy based cooker. Moisture Content =Initial weight – final weight

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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

Azeotropic Distillation Method

Figure 2: Azeotropic distillation method - Moisture Analysis

Karl Fisher titration- A sample of the prepared lozenge is calculated to obtain 10-250mg of water which is then titrated with Karl
Fischer reagent.

Determination of sugar and corn syrup ratio


The test is carried out by Lane Eynon Titration method which is a Dextrose equivalent method.
1. Percentage Reducing Sugar

Figure 3: Percentage Reducing Sugar

1. Determination of salvage solutions using a refractometer.


2. Rope forming test involves checking of the rope diameter of the candy.
3. Cooling checks is done on visual inspection to analyze any stress cracking occurs due to rapid cooling, bubble formation,
surface cracking and black spots.

Physical and Chemical Testing34, 35 3. Friability of the prepared lozenges can be determined
by Roche Friabilator operated at 25rpm for 4mins.
1. Hardness of the lozenges is determined by Pfizer or 4. Weight variation test is done on 20 lozenges, initially
Monsanto hardness tester. they are weighed and average weight is determined.
2. Diameter and thickness of the lozenges are determined Individual weight is compared with the calculated
by using Vernier callipers. average weight.

14
Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)

5. Drug and the excipients interaction can be determined REFERENCES


by FTIR.
6. In vitro drug release is carried out using USP II paddle 1. Panati, Charles, Panati's Extraordinary Origins of Everyday
type dissolution apparatus. Things. New York: Harper & Row. ISBN 0060964197, 1989,
7. Drug content is done by taking an appropriate number pp. 258–260.
of lozenges being crushed and dissolved in a suitable 2. M.E.Aulton, Pharmaceutics the Science Of Dosage Form
solvent and the resultant absorbance of the solution is Design. 2nd edition p.no. 416.
measured spectrophotometrically. 3. The Pharmaceutics & Compounding Laboratories at the UNC
Eshelman School of Pharmacy. [Cited 2015 December 29];
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2(1): 13-26.
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per the prescribed conditions either 1-2 months at 60o C or 3- Chem.Pharmaceuticals. 2002; 24-27
6months at 45o C or 9-12 months at 37o C and or 36-60 months 9. H.A. Shojaei. Development of medicated Lozenges. J Pharm
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ACKNOWLEDGMENT 22. Edward K Kamamia et al., Formulation development of
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The authors wish to convey gratitude to our respectful Dean, Journal of Medical Research and Practice 2013, 2(7): 197-202.
SRM College of Pharmacy, SRM University, who gave us
constant support to complete this review article.

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and toxicological evaluation of Joshanda lozenges, Journal of
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30. James MD. Medicated Lozenges. British Medical Journal. Damodharan N. Chewable lozenge formulation: A review. Int.
1880: 880. Res. J. Pharm. 2016;7(4):9-16 http://dx.doi.org/10.7897/2230-
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