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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 NF O

Recei ved 19 J ul y 2013
Recei ved i n r evi sed f or m24 J ul y 2013
Accept ed 10 Aug 2013


Keywor ds:
Lozenge,
Over The Count er medi cat i on,
Tr oches,
Past i l l es,
Mol di ng.










Correspondi ng author: Mahakal I nst i t ut e
of Phar maceut i cal St udi es, I ndi a
Tel . +91- 9617383196
E- mai l address:
vi kasj ai n11118059@r edi f f mai l . com

A B S T R A C T


Lozenges are solid, unit dosage formof medicament which are
meant to be dissolved in mouth or pharynx. Development of
lozenges dates back to 20
th
century and is still in commercial
production. Most of the lozenge preparations are available as Over
The Counter medications. Lozenge provide a palatable means of
dosage form administration and enjoy its position in
pharmaceutical market owing to its several advantages but it
suffers formcertain disadvantages too. The dosage formcan 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
evaluation parameters adopted for the dosage form. Furthermore,
it throws light on the applications of lozenges.
2013 British Biomedical Bulletin. All rights reserved









Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
Introduction
The word "Lozenge" is derived from
French word "Losenge" which means a
diamond shaped geometry having four equal
sides. Lozenges and pastilles have been
developed since 20
th
century in pharmacy
and is still under commercial production.
1

Lozenges are solid preparations that
are intended to dissolve in mouth or
pharynx. They may contain one or more
medicaments in a flavored and sweetened
base and are intended to treat local irritation
or infection of mouth or pharynx and may
also be used for systemic drug absorption.
They can deliver drug multi directionally
into the oral cavity or to the mucosal
surface.
2,3
Lozenges are placed in oral cavity.
Since the sublingual lozenges may be
impractical due to their size, buccal lozenges
are formulated and have been extensively
used and are intended to be placed between
the cheek and the gums. Though the lozenge
dissolution time is about 30 minutes, it also
depends on the patient, as patient controls
the rate of dissolution and absorption by
sucking on lozenge until it dissolves. The
consequence of this can be high variabilities
in amounts of drug delivered each time the
lozenge is administered. Sucking and the
subsequent production of saliva may also
lead to increased dilution of the drug and
accidental swallowing.
4

Depending on the type of lozenge,
they may be prepared by molding or by
compression. Molded lozenges are called
pastilles while compressed lozenges are
called troches.
3

Lozenges should dissolve slowly in
mouth and possess some degree of
smoothness, with their shape being without
corners.
5
Lozenges may be formulated with
various shapes, like flat, circular, octagonal,
biconvex or bacilli, meaning short rods or
cylinders.
2
Most of the lozenge formulations are
available as Over the Counter (OTC)
products where there is no need of
prescription from a medical practitioner
while some are prescribed by the medical
practitioners.

Advantages

Can be given to those patients who have

difficulty in swallowing.
4
Easy to administer to geriatric and
pediatric population.
Has a pleasant taste.
It extends the time of drug in the oral
cavity to elicit a specific effect.
Easy to prepare, with minimum amount
of equipment and time.
6

Do not require water intake for
administration.
Technique is non invasive, as is the case
with parenterals.

Disadvantages
It could be mistakenly taken as candy
by children, hence should be kept out of
the reach of children.
6

The non ubiquitous distribution of drug
within saliva for local therapy.
Possible draining of drug from oral
cavity to stomach along with saliva.

Medicaments
Drug candidates which can be
incorporated in lozenges, belong to one of
the following categories:
Antiseptics
Local anesthetics
Antibiotics
Antihistaminics
Antitussives
Analgesics
Decongestants
Demulcents.
2


Classification
According to the site of action-

Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
Local effect. Ex. Antiseptics,
Decongestants.
Systemic effect. Ex. Vitamins, Nicotine.

According to texture and composition-

Chewy or caramel based medicated
lozenges
Compressed tablet lozenges
Soft lozenges
Hard candy lozenges

Chewy or Caramel Based Medicated
Lozenges
These are the dosage form in which
medicament is incorporated into a caramel
base which is chewed instead of being
dissolved in mouth.
Ingredients
Candy Base- It consist of a mixture of
sugar and corn syrup in a ratio of 50:50
to 75:25 sugar to corn syrup.
Whipping agent- These are used to
incorporate air in toffee-based
confections to obtain the desired degree
of soft chew. These are exemplified by
milk protein, egg albumin, gelatin,
xanthan gum, starch, pectin, algin and
carageenen.
Humectants- They improv chew and
mouthfeel properties and include
glycerin, propylene glycol and sorbitol.
Lubricants- These are added to avoid
sticking of candy to the teeth while
chewing. It includes vegetable oils and
fats.
Medicaments- Medicaments up to 35-
40% can be incorporated.
Seeding crystals- It involves addition of
fine powdered sugar at 3-10% to warm
candy mass to speed up the
crystallization and allow the base to be
formed into tablets in a much shorter
time.
Flavors.

Manufacturing
The candy base is cooked at 95-125
o
C
and transferred to planetary or sigma blade
mixer. Mass is allowed to cool to 120
o
C. This
is followed by the addition of whipping agent
below 105
o
C. The medicaments ane then
added between 95-105
o
C. Color is dispersed
in humectant and added to the above mass at
a temperature above 90
o
C. Seeding crystals
and flavor are then added below 85
o
C
followed by lubricant addition above 80
o
C.
Candies are then formed by rope forming.
2


Compressed Tablet Lozenges
If the active ingredient is heat labile, it
may be made into lozenge preparation by
compression. The granulation is prepared in a
manner similar to that used for any
compressed tablet.
2
The lozenge tablets differ
from conventional tablets in terms of
organolepticity, non-disintegrating
characteristics and slower dissolution
profiles.
3
The lozenge is made using heavy
compression equipment to give a tablet that is
harder than usual, as it is desirable for the
troche to dissolve slowly in mouth. They are
usually flat faced with sizes, weight, hardness,
and erosion time ranging between, 5/8-3/4
inch, 1.5-4g, 30-50kg inch
2
and 5-10min,
respectively.
2

Ingredients

Tablet base or vehicle-
Sugar- Dextrose, sucrose.
Sugar-Free vehicles: Mannitol, sorbitol,
polyethylene glycol (PEG) 6000 and
8000.
Other fillers- Di calcium phosphate,
calcium sulfate, calcium carbonate,
lactose, microcrystalline cellulose.

Some commercially available sugar
based vehicles include- Emdex, Nu-tab,
Sweetrex, Mola-tab, Hony-tab, Sugartab.
Binders- These are used to hold the
particles of mass as discrete granules and
Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
include acacia, corn syrup, sugar syrup,
gelatin, polyvinyl-pyrrolidone, tragacanth
and methylcellulose.
Lubricants- These are used to improve
flow of final troche mixture and include
magnesium stearate, calcium stearate,
stearic acid and PEG.
Colors- Water soluble and lakolene dyes.
Flavors.

Manufacturing
Direct compression- Ingredients can be
throughly mixed and directly
compressed.
Wet granulation- In this sugar is
pulverized by mechanical comminution
to a fine powder (40-80mesh).
Medicament is added and the mass is
blended mass. The blended is subjected
to granulation with sugar or corn syrup
and screened through 2-8mesh screen.
This is followed by drying and milling to
10-30mesh size. Flavor and lubricant are
then added prior to the compression.
2


Soft Lozenges
Soft lozenges are either meant for
chewing or for slow dissolution in mouth.
They can be made from PEG 1000 or 1450,
chocolate or sugar-acacia base while some
soft lozenge formulations can also contain
acacia and silica gel. Acacia is used to
provide texture and smoothness to the lozenge
and silica gel is used as a suspending agent to
avoid settling of materials to the bottomof the
mold cavity during the cooling. The
formulation requires heating process at about
50
o
C hence is only suitable to heat resistant
ingredients.
6,7

Manufacturing
On the account of the soft texture of
these lozenges, they can be hand rolled and
then cut into pieces or the warm mass can be
poured into a plastic mold. Mold cavity
should be overfilled if PEG is used, as PEG's
contract as they cool. This is not required in
case of chocolate as it does not shrink.
7
Phaechamud and Tuntarawongsa
fabricated clotrimazole soft lozenges by
molding method and evaluated the
factors that affect the physical properties
of lozenge. They found that increasing
amounts of PEG1500, xanthan gum or
xylitol increased the hardness of the
lozenge. And also disintegration time
was found to be increased on increasing
amount of actives and hardness.
8


Hard Candy Lozenges
Hard candy lozenges are mixtures of
sugar and other carbohydrates in an
amorphous (noncrystalline) or glassy state.
They can also be regarded as solid syrups of
sugars. The moisture content and weight of
hard candy lozenge should be between, 0.5 to
1.5% and 1.5-4.5g respectively. These should
undergo a slow and uniform dissolution or
erosion over 5-10min., and should not
disintegrate. The temperature requirements
for their preparation is usually high hence
heat labile materials cannot be incorporated in
them.
2,6


Ingredients
Bodying agent or base- This includes
Corn syrup which is available on Baume
basis. A 43
o
Baume corn syrup is
preferred in hard candy lozenges.
Sweetening agent- It includes sucrose,
dextrose, maltose, lactose.
Acidulents- These are added to candy
base to strengthen the flavor
characteristics of the finished product.
Commonly used acids are citric, tartaric,
fumaric and malic acid.
Colors- FD & C colors, orange color
paste, red color cubes, etc.
Flavors- It includes menthol, eucalyptus
oil, spearmint, cherry flavor, etc.
Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
Medicaments- Medicaments upto 2-4%
can be incorporated in the hard candy
lozenges.
Salvage- Salvage can be liquid or solid.
2

Manufacturing
The candy base is cooked by
dissolving desired quantity of sugar in one-
third amount of water in a candy base cooker.
This is continued till the temperature rises to
110
o
C. Corn syrup is added and cooked till
the temperature reaches 145-156
o
C. The
candy mass is removed from the cooker and
transferred to a lubricated transfer container
mounted onto a weight check scale where the
weight of the mass is checked. This is
followed by color addition in form of
solutions, pastes or color cubes. The mass is
then transferred to a water-jacketed stainless
steel cooling table for mixing and the flavor,
drug and ground salvage is added. The mass
is either poured in mold or pulled into a
ribbon while cooling and then cut to desired
length. The obtained lozenges are
packaged.
2,6
Cocaine voice tablet lozenges and
pastilles were developed in late 1800's
and were indicated in Extra
Pharmacopoeia, 1888. They were used
by singers and public speakers for the
remedy of vocal huskiness and
hoarseness.
9

Esimone et al., formulated and evaluated
antimicrobial activity of herbal lozenge
of garlic and ginger extract by molding
method. The antimicrobial activity was
evaluated against Candida albicans,
E.coli and Staphylococcus aureus using
Nystatin as standard. The formulation
inhibited growth of laboratory strains of
C.albicans but not S.aureus and E.coli
and hence concluded that lozenges can be
used in non-resistant oral thrush.
10

Greey et al., prepared penicillin agar
pastilles. In order to prolong the retention
time they tried gelatin, gelatin+agar and
agar combinations with penicillin whose
retention times were found to be 1hr,
<1hr and 4-5hrs, respectively. This
formulation has already been used in
fuso-spirochaetal infection treatment and
are being studied for hemolytic
streptococcal infection treatment of
throat.
11

A multicenter, randomized, double blind,
single dose study was carried out by
Wade et al., for assessing the efficacy of
AMC/DCBA warmand cool lozenge for
the relief of acute sore throat. Analgesic
and sensorial benefits of AMC/DCBA
warm and cool lozenge was compared
against unflavored non-medicated
placebo lozenge and significant
analgesic, functional sensorial and
emotional effects against the placebo
were observed. Sore throat relief ,
difficulty in swallowing and throat
numbness were observed, also emotional
benefits included happiness, better feel
and less frustration.
12

Shukla et al., evaluated in vivo behaviour
of controlled and pulsatile release
pastilles for the treatment of asthma,
COPD and for chrono therapeutic
management of nocturnal asthma. They
found that, enteric coating of pastilles
delayed the in vivo drug release and can
be used in nocturnal asthma.
13


Center Filled Hard Candy Lozenges
These are the hard candy lozenges
with soft or liquid centers into their main
body.

Quality Control
General Checks- Candy Base Manufacturing
As the candy base manufacture is
commenced, a check on following
parameters is performed: Corn syrup and
sugar delivery gears; Temperature, steam
pressure and cooking speed of precookers
and temperature, steam pressure, cooking
Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
speed and vaccum of candy base
cookers.
2

Moisture analysis-
Gravimetric method- 1g sample is
weighed and placed in vaccum oven
at 60-70
o
C for 12-16hrs. Final weight
is subtracted from initial and the
difference in moisture content is
calculated.
Karl Fisher titration- A sample
calculated to contain 10-250mg
water is taken in titration flask and
titrated with Karl Fischer reagent.
Azeotropic distillation method- 10-
12g candy is pulverized and placed
in 500ml flask to which 150-200ml
toluene is added. Flask is connected
to a reflux condenser and is refluxed
for 1-2hrs. Water collected gives the
amount of water present in the
sample.
2

Determination of sugar and corn syrup
ratios-
This is performed by "Dextrose
equivalent method: Lane Eynon Titration
method".
2

Percentage reducing sugars-
Standard- 3g anhydrous dextrose is
dissolved in 500ml water. The solution is
boiled for 2min and 2 drops of methylene
blue is added and titrated against 25ml of
alkaline cupric tartrate solution (Fehling's
solution) to a yellowish red end point.
2


(3g) x (volume of standard dextrose solution
Consumed by Fehling's solution)
500
=reducing sugar factor for 3g dextrose

Sample- 10g sample of candy base is
dissolved in 250ml of water and titrated with
25 ml of Fehling's solution in the same
manner as the standard.


Reducing sugar factor x 100
Sample weight/250 x Volume of
sample solution consumed by Fehling's
solution.
=Percent reducing sugar.

Salvage solutions- Solid contents of
salvage solutions is determined using a
refractometer.
2

Forming checks- It involves a check on
candy rope diameter.
2

Cooling checks- Visual inspection is
performed in order to analyze any stress
cracking due to rapid cooling, air bubble
formation, surface cracking and black
specks.
2

Physical and Chemical Testing-
Hardness- This is determined by
Pfizer or Monsanto hardness
tester.
14,15

Diameter and thickness- This is
determined by vernier calipers.
Drug excipient interaction studies-
Determined by FTIR.
14

Friability - Determined by Roche
Friabilator operated at 25rpm for
4min.
Weight variation- 20 lozenges are
weighed and average weight is
determined. Individual weight is
compared to the average weight.
In-vitro drug release- This is carried
out in USP II paddle type dissolution
apparatus.
15

Drug content- Appropriate number
of lozenges are crushed and
dissolved in an appropriate solvent
and the absorbance of the solution is
measured spectrophotometrically.
Microbial Check
In this, the presence of any bacterial,
mold or spore contamination is checked in
raw materials, finished products, machinery,
cooling tunnels, environmental conditions and
storage drums. Laboratory microbial testing
should include the following counts:
Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
Total plate
Total coliform
Yeast and mold
E.coli
Staphyllococcus
Salmonella.
2

Stability Testing
Stability testing of product- Lozenges are
subjected to stability testing under
following conditions-
1-2months at 60
o
C
3-6months at 45
o
C
9-12months at 37
o
C
36-60months at 25 and 4
o
C.
2

Stability testing of product in package-
Lozenges in their final packs are
subjected to following conditions for
stability testing:
25
o
C at 80%RH for 6-12months
37
o
Cat 80%RH for 3 months
25
o
C at 70%RH for 6-12 months.
2


Packaging
Since the lozenges are hygroscopic in
nature a complex and multiple packaging is
adopted. The individual unit is wrapped in
polymeric moisture barrier material which are
then placed in tight or moisture resistant glass,
polyvinyl chloride or metal container that is
over wrapped by aluminum foil or cellophane
membrane.
3


Storage
Lozenges should be stored away from
heat and out of reach of children. They should
be protected from extremes of humidity.
Depending upon the storage requirements of
both, the drug and the base, either room
temperature or refrigerator temperature is
usually indicated.
2

Applications
Lozenges are employed for the
treatment of local as well systemic disorders.
A variety of drug candidates can be
incorporated in themfor the treatment of and
relief from conditions of oral as well as throat
infections such as oral thrush, sore throat,
cough, gingivitis, pharyngitis, decongestant,
etc. Moreover these also have been used to
deliver the drug systemically for smoking
cessation and pain relief.

Conclusion
Lozenges are medicated confections
designed for local as well as systemic therapy.
A wide range of actives can be incorporated
within their structure. Most of the
preparations are available as OTC products
and are very economic dosage forms. These
have been developed about 20
th
century ago
and are still under commercial production.
Lozenges enjoy an important position in
pharmacy and will continue to remain at the
same in future.

Authors' Contributions
Rachana Maheshwari has contributed
to the acquirement of data and drafting of the
manuscript.
Rehana Ansari has contributed in data
acquisition. Dr. Vikas Jain has guided as well
as reviewed and approved the version to be
published. Dr. S.C. Mahajan and Mrs. Garvita
Joshi have reviewed and approved the article
for publication.

Acknowledgement
I would like to extend my gratitude
towards my guide and our Head of
Department, Dr. Vikas Jain and our Director
of college, Dr. S.C. Mahajan who guided me
and provided me moral support throughout
the preparation of manuscript. I would also
like to thank my family, brother and my
colleagues who provided me their full support
for the same.

Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
References
1. Lozenges and Pastilles, Prolonged
Medication From Palatable Preparations.
Royal Pharmaceutical Society, Information
sheet: 4.
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HA, Lachman L, Schwartz J B, editors.
Pharmaceutical Dosage Forms: Tablets. 2
nd

ed. New York: Marcel Dekker, Inc.; 2005. p.
419-577.
3. Mendes RW, Bhargava H. Lozenges. In:
Swarbick J, editor. Encyclopedia of
Pharmaceutical Technology. 3
rd
ed. North
California, USA: Informa Healthcare Inc.;
2006. p. 2231-2235.
4. Batheja P, Thakur R, Michniak B. Basic
Biopharmaceutics of Buccal & Sublingual
Absorption. In: Touitou E, Barry BW,
editors. Enhancement in drug delivery.
London, New York: CRC Press, Taylor and
Francis Group; 2006. p. 189.
5. James MD. Medicated Lozenges. Br Med J.
1880; 880.
6. Allen LV. Troches and Lozenges. Secundum
Artem. Current & Practical Compounding
Information for the Pharmacist. 4(2).
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Pharmaceutics and compounding
Laboratory. UNC ESHEL MAN/school of
pharmacy.
8. Phaemachud T, Tuntarawongsa S.
Clotrimazol Soft Lozenges Fabricated with
Melting and Mold Technique. Res J Pharm
Biol Chem Sci. 2010; 1(4): 579-586.
9. Developing Treatments with Controlled
Drugs. Part One: Cannabis, Coca, and
Cocaine. Museum of the Royal
Pharmaceutical Society. 2011.
10. Esimone CO, Okoye FBC, Odimegwu DC,
Nworu CS, Oleghe PO, Ejogha PW. In vitro
Antimicrobial Evaluation of Lozenges
Containing Extract of Garlic and Ginger. Int
J Health Res. 2010; 3(2): 105-110.
11. Greey P, Macdonald IB. Penicillin Agar
Pastilles. CMAJ. 1945; 52(4): 327-330.
12. Wade AG, Morris C, Shephard A, Crawford
GM, Goulder MA. A multicenter
randomized, double blind, single-dose study
assessing the efficacy of AMC/DCBA Warm
lozenge or AMC/DCBA Cool lozenge in the
relief of acute sore throat. BMC FamPract.
2011; 12(6).
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Evaluation of in vivo behaviour of controlled
and pulsatile release pastilles using
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techniques. Expert Opin Drug Deliv. 2012;
9(11): 1333-1345.
14. Pattanayak D, Das S. Formulation
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Pharm Sci Res. 2012; 3(1):138-140.
15. Kini R, Rathnanand M, Kamath D.
Investigating the suitability of Isomalt and
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Jain et al_____________________________________________________________________
BBB[1][1][2013]035-043
Table 1. Types of center filled lozenges
2

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

Table 2. Applications of hard candy lozenges
16

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
Menthol
Cough and sore throat relief
Decongestant
Table 2 provides a list of some of the drugs which can be incorporated in lozenge and their area
of applications.