Journal Home Page www.bbbulletin.

org

BRITISH BIOMEDICAL BULLETIN

Review

A REVIEW ON LOZENGES
Rachana Maheshwari, Vikas Jain*, Rehana ansari, S.c. Mahajan, Garvita joshi

Mahakal Institute of Pharmaceutical Studies, India

A R T I C L E I N F O A B S T R A C T

Received 19 July 2013

Received in revised form 24 July 2013
Accepted 10 Aug 2013
Lozenges are solid, unit dosage form of medicament which are
meant to be dissolved in mouth or pharynx. Development of
lozenges dates back to 20th century and is still in commercial
Keywords:
Lozenge, production. Most of the lozenge preparations are available as Over
Over The Counter medication, The Counter medications. Lozenge provide a palatable means of
Troches, dosage form administration and enjoy its position in
Pastilles,
Molding. pharmaceutical market owing to its several advantages but it
suffers form certain disadvantages too. The dosage form can be
adopted for local as well as systemic therapy and a wide range of
actives can be incorporated in them. Lozenges currently available
in market are of four types: Caramel based soft lozenges, hard
candy lozenges and compressed tablet lozenges. The present
review covers more or less all aspects associated with lozenge. It
includes various researches performed till date, formulation and
Corresponding author: Mahakal Institute
evaluation parameters adopted for the dosage form. Furthermore,
of Pharmaceutical Studies, India it throws light on the applications of lozenges.
Tel. +91-9617383196
E-mail address: 2013 British Biomedical Bulletin. All rights reserved
vikasjain11118059@rediffmail.com
Jain et al________________________________________________________ISSN-2347-5447
Introduction
The word "Lozenge" is derived from products where there is no need of
French word "Losenge" which means a prescription from a medical practitioner
diamond shaped geometry having four equal while some are prescribed by the medical
sides. Lozenges and pastilles have been practitioners.
developed since 20th century in pharmacy
and is still under commercial production.1 Advantages

Lozenges are solid preparations that Can be given to those patients who have
are intended to dissolve in mouth or difficulty in swallowing.4
pharynx. They may contain one or more Easy to administer to geriatric and
medicaments in a flavored and sweetened pediatric population.
base and are intended to treat local irritation Has a pleasant taste.
or infection of mouth or pharynx and may It extends the time of drug in the oral
also be used for systemic drug absorption. cavity to elicit a specific effect.
They can deliver drug multi directionally Easy to prepare, with minimum amount
into the oral cavity or to the mucosal of equipment and time.6
surface.2,3 Do not require water intake for
Lozenges are placed in oral cavity. administration.
Since the sublingual lozenges may be Technique is non invasive, as is the case
impractical due to their size, buccal lozenges with parenterals.
are formulated and have been extensively
used and are intended to be placed between Disadvantages
the cheek and the gums. Though the lozenge It could be mistakenly taken as candy
dissolution time is about 30 minutes, it also by children, hence should be kept out of
depends on the patient, as patient controls the reach of children.6
the rate of dissolution and absorption by The non ubiquitous distribution of drug
sucking on lozenge until it dissolves. The within saliva for local therapy.
consequence of this can be high variabilities Possible draining of drug from oral
in amounts of drug delivered each time the cavity to stomach along with saliva.
lozenge is administered. Sucking and the
subsequent production of saliva may also Medicaments
lead to increased dilution of the drug and Drug candidates which can be
accidental swallowing.4 incorporated in lozenges, belong to one of
Depending on the type of lozenge, the following categories:
they may be prepared by molding or by Antiseptics
compression. Molded lozenges are called Local anesthetics
pastilles while compressed lozenges are Antibiotics
called troches.3 Antihistaminics
Lozenges should dissolve slowly in Antitussives
mouth and possess some degree of Analgesics
smoothness, with their shape being without Decongestants
corners.5 Lozenges may be formulated with Demulcents.2
various shapes, like flat, circular, octagonal,
biconvex or bacilli, meaning short rods or Classification
cylinders.2 According to the site of action-
Most of the lozenge formulations are
available as Over the Counter (OTC)

BBB[1][1][2013]035-043
Jain et al________________________________________________________ISSN-2347-5447

Local effect. Ex. Antiseptics, Manufacturing

Decongestants. The candy base is cooked at 95-125oC
Systemic effect. Ex. Vitamins, Nicotine. and transferred to planetary or sigma blade
mixer. Mass is allowed to cool to 120oC. This
According to texture and composition- is followed by the addition of whipping agent
below 105oC. The medicaments ane then
Chewy or caramel based medicated added between 95-105oC. Color is dispersed
lozenges in humectant and added to the above mass at
Compressed tablet lozenges a temperature above 90oC. Seeding crystals
Soft lozenges and flavor are then added below 85oC
Hard candy lozenges followed by lubricant addition above 80oC.
Candies are then formed by rope forming.2
Chewy or Caramel Based Medicated
Lozenges Compressed Tablet Lozenges
These are the dosage form in which If the active ingredient is heat labile, it
medicament is incorporated into a caramel may be made into lozenge preparation by
base which is chewed instead of being compression. The granulation is prepared in a
dissolved in mouth. manner similar to that used for any
Ingredients compressed tablet.2 The lozenge tablets differ
Candy Base- It consist of a mixture of from conventional tablets in terms of
sugar and corn syrup in a ratio of 50:50 organolepticity, non-disintegrating
to 75:25 sugar to corn syrup. characteristics and slower dissolution
Whipping agent- These are used to profiles.3 The lozenge is made using heavy
incorporate air in toffee-based compression equipment to give a tablet that is
confections to obtain the desired degree harder than usual, as it is desirable for the
of soft chew. These are exemplified by troche to dissolve slowly in mouth. They are
milk protein, egg albumin, gelatin, usually flat faced with sizes, weight, hardness,
xanthan gum, starch, pectin, algin and and erosion time ranging between, 5/8-3/4
carageenen. inch, 1.5-4g, 30-50kg inch2 and 5-10min,
Humectants- They improv chew and respectively.2
mouthfeel properties and include Ingredients
glycerin, propylene glycol and sorbitol.
Lubricants- These are added to avoid Tablet base or vehicle-
sticking of candy to the teeth while Sugar- Dextrose, sucrose.
chewing. It includes vegetable oils and Sugar-Free vehicles: Mannitol, sorbitol,
fats. polyethylene glycol (PEG) 6000 and
Medicaments- Medicaments up to 35- 8000.
40% can be incorporated. Other fillers- Di calcium phosphate,
Seeding crystals- It involves addition of calcium sulfate, calcium carbonate,
fine powdered sugar at 3-10% to warm lactose, microcrystalline cellulose.
candy mass to speed up the
crystallization and allow the base to be Some commercially available sugar
formed into tablets in a much shorter based vehicles include- Emdex, Nu-tab,
time. Sweetrex, Mola-tab, Hony-tab, Sugartab.
Flavors. Binders- These are used to hold the
particles of mass as discrete granules and

BBB[1][1][2013]035-043
Jain et al________________________________________________________ISSN-2347-5447

include acacia, corn syrup, sugar syrup, contract as they cool. This is not required in
gelatin, polyvinyl-pyrrolidone, tragacanth case of chocolate as it does not shrink.7
and methylcellulose. Phaechamud and Tuntarawongsa
Lubricants- These are used to improve fabricated clotrimazole soft lozenges by
flow of final troche mixture and include molding method and evaluated the
magnesium stearate, calcium stearate, factors that affect the physical properties
stearic acid and PEG. of lozenge. They found that increasing
Colors- Water soluble and lakolene dyes. amounts of PEG1500, xanthan gum or
Flavors. xylitol increased the hardness of the
lozenge. And also disintegration time
Manufacturing was found to be increased on increasing
Direct compression- Ingredients can be amount of actives and hardness.8
throughly mixed and directly
compressed. Hard Candy Lozenges
Wet granulation- In this sugar is
pulverized by mechanical comminution Hard candy lozenges are mixtures of
to a fine powder (40-80mesh). sugar and other carbohydrates in an
Medicament is added and the mass is amorphous (noncrystalline) or glassy state.
blended mass. The blended is subjected They can also be regarded as solid syrups of
to granulation with sugar or corn syrup sugars. The moisture content and weight of
and screened through 2-8mesh screen. hard candy lozenge should be between, 0.5 to
This is followed by drying and milling to 1.5% and 1.5-4.5g respectively. These should
10-30mesh size. Flavor and lubricant are undergo a slow and uniform dissolution or
then added prior to the compression.2 erosion over 5-10min., and should not
disintegrate. The temperature requirements
Soft Lozenges for their preparation is usually high hence
heat labile materials cannot be incorporated in
Soft lozenges are either meant for them.2,6
chewing or for slow dissolution in mouth.
They can be made from PEG 1000 or 1450, Ingredients
chocolate or sugar-acacia base while some Bodying agent or base- This includes
soft lozenge formulations can also contain Corn syrup which is available on Baume
acacia and silica gel. Acacia is used to basis. A 43o Baume corn syrup is
provide texture and smoothness to the lozenge preferred in hard candy lozenges.
and silica gel is used as a suspending agent to Sweetening agent- It includes sucrose,
avoid settling of materials to the bottom of the dextrose, maltose, lactose.
mold cavity during the cooling. The Acidulents- These are added to candy
formulation requires heating process at about base to strengthen the flavor
50oC hence is only suitable to heat resistant characteristics of the finished product.
ingredients.6,7 Commonly used acids are citric, tartaric,
fumaric and malic acid.
Manufacturing Colors- FD & C colors, orange color
On the account of the soft texture of paste, red color cubes, etc.
these lozenges, they can be hand rolled and Flavors- It includes menthol, eucalyptus
then cut into pieces or the warm mass can be oil, spearmint, cherry flavor, etc.
poured into a plastic mold. Mold cavity
should be overfilled if PEG is used, as PEG's

BBB[1][1][2013]035-043
Jain et al________________________________________________________ISSN-2347-5447

Medicaments- Medicaments upto 2-4% retention times were found to be 1hr,

can be incorporated in the hard candy <1hr and 4-5hrs, respectively. This
lozenges. formulation has already been used in
Salvage- Salvage can be liquid or solid.2 fuso-spirochaetal infection treatment and
Manufacturing are being studied for hemolytic
The candy base is cooked by streptococcal infection treatment of
dissolving desired quantity of sugar in one- throat.11
third amount of water in a candy base cooker. A multicenter, randomized, double blind,
This is continued till the temperature rises to single dose study was carried out by
110oC. Corn syrup is added and cooked till Wade et al., for assessing the efficacy of
the temperature reaches 145-156oC. The AMC/DCBA warm and cool lozenge for
candy mass is removed from the cooker and the relief of acute sore throat. Analgesic
transferred to a lubricated transfer container and sensorial benefits of AMC/DCBA
mounted onto a weight check scale where the warm and cool lozenge was compared
weight of the mass is checked. This is against unflavored non-medicated
followed by color addition in form of placebo lozenge and significant
solutions, pastes or color cubes. The mass is analgesic, functional sensorial and
then transferred to a water-jacketed stainless emotional effects against the placebo
steel cooling table for mixing and the flavor, were observed. Sore throat relief ,
drug and ground salvage is added. The mass difficulty in swallowing and throat
is either poured in mold or pulled into a numbness were observed, also emotional
ribbon while cooling and then cut to desired benefits included happiness, better feel
length. The obtained lozenges are and less frustration.12
packaged.2,6 Shukla et al., evaluated in vivo behaviour
Cocaine voice tablet lozenges and of controlled and pulsatile release
pastilles were developed in late 1800's pastilles for the treatment of asthma,
and were indicated in Extra COPD and for chrono therapeutic
Pharmacopoeia, 1888. They were used management of nocturnal asthma. They
by singers and public speakers for the found that, enteric coating of pastilles
remedy of vocal huskiness and delayed the in vivo drug release and can
hoarseness.9 be used in nocturnal asthma.13
Esimone et al., formulated and evaluated
antimicrobial activity of herbal lozenge Center Filled Hard Candy Lozenges
of garlic and ginger extract by molding These are the hard candy lozenges
method. The antimicrobial activity was with soft or liquid centers into their main
evaluated against Candida albicans, body.
E.coli and Staphylococcus aureus using
Nystatin as standard. The formulation
inhibited growth of laboratory strains of Quality Control
C.albicans but not S.aureus and E.coli
General Checks- Candy Base Manufacturing
and hence concluded that lozenges can be
As the candy base manufacture is
used in non-resistant oral thrush.10
commenced, a check on following
Greey et al., prepared penicillin agar
parameters is performed: Corn syrup and
pastilles. In order to prolong the retention
sugar delivery gears; Temperature, steam
time they tried gelatin, gelatin+agar and
pressure and cooking speed of precookers
agar combinations with penicillin whose
and temperature, steam pressure, cooking

BBB[1][1][2013]035-043
Jain et al________________________________________________________ISSN-2347-5447

speed and vaccum of candy base Reducing sugar factor x 100

cookers.2 Sample weight/250 x Volume of
Moisture analysis- sample solution consumed by Fehling's
Gravimetric method- 1g sample is solution.
weighed and placed in vaccum oven = Percent reducing sugar.
at 60-70oC for 12-16hrs. Final weight
is subtracted from initial and the Salvage solutions- Solid contents of
difference in moisture content is salvage solutions is determined using a
calculated. refractometer.2
Karl Fisher titration- A sample Forming checks- It involves a check on
calculated to contain 10-250mg candy rope diameter.2
water is taken in titration flask and Cooling checks- Visual inspection is
titrated with Karl Fischer reagent. performed in order to analyze any stress
Azeotropic distillation method- 10- cracking due to rapid cooling, air bubble
12g candy is pulverized and placed formation, surface cracking and black
in 500ml flask to which 150-200ml specks.2
toluene is added. Flask is connected Physical and Chemical Testing-
to a reflux condenser and is refluxed Hardness- This is determined by
for 1-2hrs. Water collected gives the Pfizer or Monsanto hardness
amount of water present in the tester.14,15
sample.2 Diameter and thickness- This is
Determination of sugar and corn syrup determined by vernier calipers.
ratios- Drug excipient interaction studies-
This is performed by "Dextrose Determined by FTIR.14
equivalent method: Lane Eynon Titration Friability - Determined by Roche
method".2 Friabilator operated at 25rpm for
Percentage reducing sugars- 4min.
Standard- 3g anhydrous dextrose is Weight variation- 20 lozenges are
dissolved in 500ml water. The solution is weighed and average weight is
boiled for 2min and 2 drops of methylene determined. Individual weight is
blue is added and titrated against 25ml of compared to the average weight.
alkaline cupric tartrate solution (Fehling's In-vitro drug release- This is carried
solution) to a yellowish red end point.2 out in USP II paddle type dissolution
apparatus.15
(3g) x (volume of standard dextrose solution Drug content- Appropriate number
Consumed by Fehling's solution) of lozenges are crushed and
500 dissolved in an appropriate solvent
= reducing sugar factor for 3g dextrose and the absorbance of the solution is
measured spectrophotometrically.
Sample- 10g sample of candy base is Microbial Check
dissolved in 250ml of water and titrated with In this, the presence of any bacterial,
25 ml of Fehling's solution in the same mold or spore contamination is checked in
manner as the standard. raw materials, finished products, machinery,
cooling tunnels, environmental conditions and
storage drums. Laboratory microbial testing
should include the following counts:

BBB[1][1][2013]035-043
Jain et al________________________________________________________ISSN-2347-5447

Total plate A variety of drug candidates can be

Total coliform incorporated in them for the treatment of and
Yeast and mold relief from conditions of oral as well as throat
E.coli infections such as oral thrush, sore throat,
Staphyllococcus cough, gingivitis, pharyngitis, decongestant,
Salmonella.2 etc. Moreover these also have been used to
Stability Testing deliver the drug systemically for smoking
Stability testing of product- Lozenges are cessation and pain relief.
subjected to stability testing under
following conditions- Conclusion
1-2months at 60oC
3-6months at 45oC Lozenges are medicated confections
9-12months at 37oC designed for local as well as systemic therapy.
36-60months at 25 and 4oC.2 A wide range of actives can be incorporated
Stability testing of product in package- within their structure. Most of the
Lozenges in their final packs are preparations are available as OTC products
subjected to following conditions for and are very economic dosage forms. These
stability testing: have been developed about 20th century ago
25oC at 80%RH for 6-12months and are still under commercial production.
37oCat 80%RH for 3 months Lozenges enjoy an important position in
25oC at 70%RH for 6-12 months.2 pharmacy and will continue to remain at the
same in future.
Packaging
Authors' Contributions
Since the lozenges are hygroscopic in
nature a complex and multiple packaging is Rachana Maheshwari has contributed
adopted. The individual unit is wrapped in to the acquirement of data and drafting of the
polymeric moisture barrier material which are manuscript.
then placed in tight or moisture resistant glass, Rehana Ansari has contributed in data
polyvinyl chloride or metal container that is acquisition. Dr. Vikas Jain has guided as well
over wrapped by aluminum foil or cellophane as reviewed and approved the version to be
membrane.3 published. Dr. S.C. Mahajan and Mrs. Garvita
Joshi have reviewed and approved the article
Storage for publication.

Lozenges should be stored away from Acknowledgement

heat and out of reach of children. They should
be protected from extremes of humidity. I would like to extend my gratitude
Depending upon the storage requirements of towards my guide and our Head of
both, the drug and the base, either room Department, Dr. Vikas Jain and our Director
temperature or refrigerator temperature is of college, Dr. S.C. Mahajan who guided me
usually indicated.2 and provided me moral support throughout
the preparation of manuscript. I would also
like to thank my family, brother and my
Applications colleagues who provided me their full support
for the same.
Lozenges are employed for the
treatment of local as well systemic disorders.

BBB[1][1][2013]035-043
Jain et al________________________________________________________ISSN-2347-5447

References 9. Developing Treatments with Controlled

Drugs. Part One: Cannabis, Coca, and
1. Lozenges and Pastilles, Prolonged Cocaine. Museum of the Royal
Medication From Palatable Preparations. Pharmaceutical Society. 2011.
Royal Pharmaceutical Society, Information 10. Esimone CO, Okoye FBC, Odimegwu DC,
sheet: 4. Nworu CS, Oleghe PO, Ejogha PW. In vitro
2. Peters d. Medicated Lozenges. In: Lieberman Antimicrobial Evaluation of Lozenges
HA, Lachman L, Schwartz JB, editors. Containing Extract of Garlic and Ginger. Int
Pharmaceutical Dosage Forms: Tablets. 2nd J Health Res. 2010; 3(2): 105-110.
ed. New York: Marcel Dekker, Inc.; 2005. p. 11. Greey P, Macdonald IB. Penicillin Agar
419-577. Pastilles. CMAJ. 1945; 52(4): 327-330.
3. Mendes RW, Bhargava H. Lozenges. In: 12. Wade AG, Morris C, Shephard A, Crawford
Swarbick J, editor. Encyclopedia of GM, Goulder MA. A multicenter
Pharmaceutical Technology. 3rd ed. North randomized, double blind, single-dose study
California, USA: Informa Healthcare Inc.; assessing the efficacy of AMC/DCBA Warm
2006. p. 2231-2235. lozenge or AMC/DCBA Cool lozenge in the
4. Batheja P, Thakur R, Michniak B. Basic relief of acute sore throat. BMC Fam Pract.
Biopharmaceutics of Buccal & Sublingual 2011; 12(6).
Absorption. In: Touitou E, Barry BW, 13. Shukla D, Chakraborty S, Mishra B.
editors. Enhancement in drug delivery. Evaluation of in vivo behaviour of controlled
London, New York: CRC Press, Taylor and and pulsatile release pastilles using
Francis Group; 2006. p. 189. pharmacokinetic and -scintigraphic
5. James MD. Medicated Lozenges. Br Med J. techniques. Expert Opin Drug Deliv. 2012;
1880; 880. 9(11): 1333-1345.
6. Allen LV. Troches and Lozenges. Secundum 14. Pattanayak D, Das S. Formulation
Artem. Current & Practical Compounding Development and Optimization of
Information for the Pharmacist. 4(2). Medicated Lozenges For Pediatric Use. Int J
7. Lozenges and medication sticks. The Pharm Sci Res. 2012; 3(1):138-140.
Pharmaceutics and compounding 15. Kini R, Rathnanand M, Kamath D.
Laboratory. UNC ESHEL MAN/school of Investigating the suitability of Isomalt and
pharmacy. liquid glucose as sugar substitute in the
8. Phaemachud T, Tuntarawongsa S. formulation of Salbutamol sufate hard candy
Clotrimazol Soft Lozenges Fabricated with lozenge. J Chem Pharm Res. 2011; 3(4): 69-
Melting and Mold Technique. Res J Pharm 75.
Biol Chem Sci. 2010; 1(4): 579-586. 16. Michaud J. Pharmaceutical Confectionary.
PharmaChem. Pharmaceuticals. 2002; 24-27.

BBB[1][1][2013]035-043
 Jain et al________________________________________________________ISSN-2347-5447

Table 1. Types of center filled lozenges2

Type of center Fill Weight Shelf life
S.no. Composition
filled lozenge (%) (months)
Fruit juice, sugar syrup, hydroalcoholic solutions or
1 Liquid fill 10-20 6-9
sorbitol solution.
Jams and jellies whose viscosity has been modified
2 Fruit center 20-25 12-15
with corn syrup or liquid sucrose
3 Paste center Granules and crystals formulated as paste 40 24
Medicament or flavor being suspended or
4 Fat center 25-32 36-60
dissolved in hydrogenated vegetable oil
Table 1 provides a concise description on the types of center fills in hard candy lozenges.

Table 2. Applications of hard candy lozenges16

Active Ingredient Applications

Amylmetacresol Throat infection
Phenol Throat infection
Benzocaine Mouth and throat infection
Camphor Sore throat relief
Hexyl resorcinol Sore throat relief
Cetyl pyridinium chloride Pharyngitis
Diphenhydramine Cough suppressant
Cough and sore throat relief
Menthol
Decongestant
Table 2 provides a list of some of the drugs which can be incorporated in lozenge and their area
of applications.

BBB[1][1][2013]035-043