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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
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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 Lozenge can be withdrawn if dose is not needed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
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
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.
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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
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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.
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)
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)
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.
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.
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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)
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Umashankar M S et al. Int. Res. J. Pharm. 2016, 7 (4)
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and toxicological evaluation of Joshanda lozenges, Journal of
Applied Pharmaceutical Science Vol. 5 (07): 064-070. Umashankar M S, Dinesh S R, Rini R, Lakshmi K S,
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-
8407.07432
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