Mohammad Sarowar Uddin

Lecturer
Submitted To Department of Pharmacy
NSTU
Name Roll
Md. Murad ASH1803019M
Submitted By Shahadul Islam ASH1803020M
Subrina Chowdhury BKH1803022F
Morsheda Khanam Sinthia MUH180323F
A.S.M Asif Khan ASH1803024M

Deadline: 15th July, 2020

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 Content

Name Page No
Introduction …………………………………………………………..……….03

Classification ………………………………………………………….….. 03-04

Typical formulation…………………………………………………....…..04-05

Method of preparation and compression sequence ……………………..05-06

Formulation and processing of different types of medicated……...……07-12

lozenges

Advantages and disadvantages……………………………………………….13

Quality control procedure…………………………………...……………14-19

Application…………………………………………………………………19-20

Conclusion…………………………………………………………………..…20

References………………………………………………………………….21-22

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Introduction:

Lozenges are various-shaped, solid dosage forms usually containing a medicinal agent and a
flavoring substance, intended to be dissolved slowly in the oral cavity for localized or systemic
effect. They are also called troches or pastilles.

The word “lozenge” is derived from French word “lozenge” which means a diamond shape
geometry having four sides Lozenges are solid preparations that are intended to dissolve in
mouth (or) pharynx. Lozenges & pastille have been developed since 20th century in pharmacy &
still under commercial production.

A medicated lozenge has drawn attention to the researchers as potential drug delivery system.

Examples of medicated lozenges include commit (nicotine) and capacol (benzocaine).

Classification:

Types of medicated lozenges:

Lozenges can be classified into various classes based on various methods like:

A) According to the site of action:

1) Local effect

Example: Antiseptics, Decongestants

2) Systemic effect

Example: Vitamin,Nicotine

B) According to texture and composition:

1) Chewy or Caramel based medicated lozenges

Example:Caramel,Toffee

2) Compressed tablet lozenges

Example: Troches

3) Soft lozenges

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 Example: Bentasil

4) Hard Candy lozenges:

Example: Lollipops

center filled hard candy lozenges: liquid filled, fruit centers, paste centers, fat centers.

Shapes of lozenges:

These are available in following shape

A) Flat

B) Circular

C) Octagonal

D) Biconvex

E) Cylindrical

Formulation of Lozenges:

Lozenges are formulated in such a way that they are stable; provide a good medium for
administration of drugs. The ingredients which are used for formulation of Lozenges are as
shown in the table.

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Formulation of lozenges (Example):

Method of Preparations:

For compressed tablet lozenges: -

1. There are 2 types. They are:

A) Direct compression:

Hard candy lozenges are mixtures of sugar and other carbohydrates in an amorphous or glossy
state. They can also be regarded as solid syrups of sugars. In the direct compression the all
ingredients can be thoroughly mixed and directly compressed to form a lozenge.

B) Wet granulation:

In this sugar is pulverized by mechanical comminution to a fine powder (40 – 80 mesh).

 Medicament is added and mass is blended.

 The blended mass is subjected to granulation with sugar or corn syrup and
screened through 2 – 8 mesh.
 This is followed by drying and milling to 10 – 30 mesh.
 Flavor and lubricant are added prior to compression

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2. For soft lozenges:

 These can be hand rolled and then cut into pieces or the warm mass is poured into
a plastic mold.
 Mold cavity should be overfilled if PEG is used.

3.For hard candy lozenges:

The Candy base is cooked by dissolving desired quantity of sugar in 1/3

amount of water in a candy base cooker.

This is continued till the temperature raises into 110 degree celcius.

Corn syrup is added and cooked till the temperature reaches to 145-156
degree celcius.
The candy mass is removed from the cooker and transfered into a lubricateed
transfer container.

This is followed by color addition in the form of solutions,pastes or color tubes

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 poured in mold

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Different Types of Lozenges:
1.Chewy or Caramel Based Medicated Lozenges:

Chewy or caramel based medicated lozenges are the dosage form in which medicament is
incorporated into a caramel base which is chewed instead of being dissolved in mouth.

Soft, chewable, gummy type candies have been on the market for a number of years. They are
specially used for pediatric patients and are a very effective means of administering medications
for gastrointestinal absorption and systemic use. Most formulations are based on the glycerinated
gelatin suppository formula which consists of 70% glycerin, 20% gelatin and 10% purified
water. They are very highly flavored and many often contain a slightly acidic taste. They are an
excellent way of administering drug products as the taste of the drug often can be masked very
effectively with fruit flavored products.

Constituents or, Ingredients:

Candy base: The candy base consists of a mixture of sugar and corn syrup in a ratio of 50:50 to
75:25 sugar to corn syrup.

Whipping agent: The whipping agents 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 improve chew and mouth feel 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 crystal: 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: Raspberry, Chocolate, Mint, Lemon, Orange etc are used as flavoring agent.

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Manufacturing of Chewy or Caramel Based Medicated Lozenges:

1. The candy base is cooked at 95-125℃ and transferred to planetary or sigma blade
mixer.

2. Mass is allowed to cool to 120℃. This is followed by the addition of whipping agent
below 105℃.

3. The medicaments are then added between 95-105℃.

4. Color is dispersed in humectant and added to the above mass at a temperature above
90℃.

5. Seeding crystals and flavor are then added below 85℃ followed by lubricant addition
above 80℃.

6. Candies are then formed by rope forming.

Example of Caramel Based Medicated Lozenges Formulation:

Formula for 40 lozenges has given below:

Ingredient Amount
Drug 0.5gm
Glycerin 70ml
Gelatin 18gm
Water 12ml
Methylparaben 0.4gm
Flavoring color 3-4 drops
Color q. s

2. Compressed tablet lozenges:

Compressed lozenges are tablet that dissolve slowly in the mouth and so release the drug
dissolved in the saliva. When the active ingredients are heat labile, lozenges are made by
compression.

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The granulation method used for making lozenges are as similar to that used for normal
compression tablet. The compressed lozenges are harder enough so that it slowly dissolves in the
mouth. They have flat faced with sizes 5/8-3/4-inch, weight 1.5-4g, hardness 30-50kg inch 2 and
erosion time ranges between 5-10min

Ingredients used in compressed tablet lozenges:

1. Tablet base or vehicles:

 Sugar: Dextrose, sucrose
 Sugar free: Mannitol, Polyethylene glycol 6000 and 8000
 Other fillers: Dicalcium phosphate, Calcium carbonate, Calcium sulphate, Lactose
2. Binder: These are used to hold particles of mass as discrete granules. Example: Acacia,
Tragacanth, Methylcellulose, gelatin.
3. Lubricant: These are used to improve flow of final troche mixture. Example: Calcium
stearate, Magnesium stearate, stearic acid and PEG.

4. Coloring Agent: Water soluble and Lacolene dyes.

5. Flavoring agent:

Manufacturing process:

 Direct compression-In this process, ingredients are thoroughly mixed and directly
compressed
 Wet granulation- In this process.
 Sugar is pulverized by mechanical comminution to a fine powder
 Then the medicament is added and the mass is blended mass
 The blended is subjected to granulation with sugar or corn syrup
 and screened through 2-8 mesh screen followed by drying and
 milling to 10-30 mesh size
 Flavors and lubricants are then added

Example: Clotrimazole and piroxicam troches. Clotrimazole has been used to treat fungal
infection and piroxicam has been used to treat migraine headache.

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Formulation of piroxicam 40mg troche:

For 24 troches:

Ingredient Amount
Piroxicam 960mg

Silica gel 240mg

Acacia 400mg

Stevia 200mg

Citric acid 240mg

Flavor q.s

Polyethylene glycol 1540 q.s

3.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 5-10 mins
and should not disintegrate. The temperature requirements for their preparation is usually high
hence heat labile materials cannot be incorporated in them.

Ingredients:

1. Bodying agent or base:

This includes Corn syrup which is available on Baume basis. A 43° Baume corn syrup is
preferred in hard candy lozenges.

2. Sweetening agent:

It includes sucrose, dextrose, maltose, lactose.

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 3. Acidulants:

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.

4. Colors:

FD & C colors, orange color paste, red color cubes, etc.

5. Flavors:

It includes menthol, eucalyptus oil, spearmint, cherry flavor, etc.

6. Medicaments:

Medicaments up to 2-4% can be incorporated in the hard candy lozenges.

7. Salvage:

Salvage can be liquid or solid.

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°C. Corn syrup is added
and cooked till the temperature reaches 145-156°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.

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Examples of Hard lozenges formulation:

Formula for 30 lozenges:

Drug 1gm

Powdered 42gm

Sugar 16gm

Corn syrup 24ml

Water 1.2ml

Extracts 1.2ml

Color q.s

4.Center Filled Hard Lozenges:

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

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Advantages:

1.Ease of administration to pediatric and geriatric patients.

2.Local and systemic effect through oral cavity.

3.Increased contact time of the drug.

4.Suitable for patients having difficulty swallowing (Dysphagia)

5.Prolonged drug action.

6.Do not require water for intake.

7. Less production time.

8. Cost of production is less.

9.Avoid first pass metabolism of drug.

10.Modification of formula as per the patients need.

11.Lozenges can be withdrawn if dose is not needed.

12. Technique is noninvasive, as in the case with parenteral.

13.Provied flavor and pleasant taste to the mouth.

14.Better patient compliance.

Disadvantage:

1. Possible draining of drug from oral cavity to stomach along with saliva.

2. Accidental swallowing of entire dosage form.

3. It could be mistakenly used as candy by children. Parents should be cautioned not to associate
medications with candy and to keep the product out of the children.
4. The non-ubiquitous disturbation of drug within saliva for local therapy.
5. Some drug may not be suitable with aldehyde candy bases eg; benzocaine.
6. These drugs should be heat stable.

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Quality Control of Lozenges:
01. In Process Quality Control of Manufacturing:

As the candy base manufacture is commenced, a check on followings parameters is performed:

corn syrup and sugar delivery gears; temperature, steam pressure and cooking speed of
precookers and temperature, steam pressure, cooking speed and vacuum of candy base cookers.

02. Moisture Analysis:

Gravimetric, Karl Fisher titration and Azeotropic distillation methods are used to determine the
moisture content of lozenges.

a) In gravimetric method, sample (1g) is weighed and placed in vacuum oven at 60-70℃
for 12-16hrs. Final weight is subtracted from initial and the difference in moisture content
is calculated.

b) Karl Fischer titration involves calculating a sample to contain 10-250mg water in

titration flask and titrated with Karl Fischer reagent.

c) In 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.

03. Determination of Sugar and Corn Syrup Ratios:

This is performed by "Dextrose equivalent method and Lane Eynon Titration method".

04. Determination to of Percentage of Reducing Sugars:

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

= Reducing sugar factor for 3g Dextrose………….. (1)

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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.

………………….………………………………………….……(2)

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

Forming checks: It involves a check on candy rope diameter.
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.
05.Physical and chemical testing method:
 Thickness & Diameter:

The thickness of the lozenges was meadured using vernier calipers or screw guage.

The lozenges are inserted between the jaws after making sure that the pointer was
sent to zero.

The readings of main scale and vernier scale were measured. This is measured in mm.

The mean thickness and diameter is calculated

Fig: Diameter measurement process by Vernier Calipers

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  Weight Variation:

The 20 lozenges were selected randomly and each of them weighted individually &
collectively on a digital weighted balance.

Average weight per lozenges was calculated from the collective weight..

Then the weights of the individual lozenges were compared with the average weight to
determine the weight variation.

Then the weight variation is calculated using this formula:

Average weight -Initial weight

Weight Variation = × 100
Average weight

Fig: Weight measurement process by Digital balance

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  Friability Test:
Friability is determined by Roche friabilator.

The 20 lozenges were taken on a friabilator and were operated for 4 mins
at 25 rpm.

Then the lozenges were taken after 4 mins & they were then made free
from dust and reweighed.

Then the percentage friability is calculated and % loss is calculated.

The percentage friability was calculated using formula.

Initial weight -Final weight

Percentage friability= × 100
Initial weight

 Drug content:
Appropriate number of lozenges are crushed and dissolved in an appropriate solvent and the
absorbance of the solution is measured spectrophotometrically.
 Hardness:
The hardness of lozenge was measured using MONSANTO HARDNESS TESTER, where the
force required to break the lozenge was noted. 3 lozenges were tested.

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  Mouth dissolving time test
The time taken by lozenge to dissolve completely was determined by the USP disintegration
apparatus where hard lozenge was placed in each tube of apparatus & time taken for the lozenge
to dissolve was noted by using phosphate buffer of Ph 6.4 at 370 degree Celsius. the test was
performed 3 times and average dissolving time was calculated and presented with standard
deviation.
 Invitro drug dissolution studies
Invitro dissolution studies were carried out using USP dissolution teat apparatus type II (paddle
type) at 100 rpm and 37 ± 0.50-degree Celsius PH 6.8 buffer containing 2% SLS was used as
dissolution medium for in Invitro dissolution studies. A lozenge was placed in each flask of the
dissolution apparatus & samples of 5ml were withdrawn at predetermined time travels for
60minits in order to maintain sink conditions an equal volume of medium was replaced. The
sample were analyzed by using UV. visible spectrophotometer at specific nm & percentage drug
released was calculated. This experiment was done in triplicate and the average percentage
released was calculated.

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6. Microbial Check on Lozenges:
In this microbial check, 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: total plate, total
coliform, yeast and mold, E.coli, Staphylococcus, Salmonella.
7. Stability Testing for Lozenges:
Lozenges are subjected to stability testing under following conditions: 2 months at 60°C, 3-
6months at 45°C, 9-12 months at 37°C, 36-60 months at 25°C. Lozenges in their final packs are
subjected to the following conditions for stability testing: 25°C at 80% relative humidity (RH)
for 6-12 months, 37°C at 80% RH for 3 months, 25°C at 70% RH for 6-12 months.
8. Packaging of Lozenges:
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.
9. Storage of Lozenges:
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.

Applications of lozenges:
Antifungal lozenges: Oral lozenges, such as clotrimazole and nystatin, are used to treat fungal
infections.
Nicotine lozenges: Nicotine lozenges are used as a method to quit smoking. The lozenges
release nicotine into bloodstream when u suck on the lozenges, according to the Mayo clinic.
Nicotine smoking are intended to be used as often as necessary, until the craving to smoke
ceases.
Zinc lozenges: Zinc is used as an antioxidant to help your body fight infections. When contained
in lozenges, zinc is thought to help reduce the duration of colds and symptoms. Yet, the Mayo
clinic notes that there are conflicting studies on whether those zinc claims are accurate.
Throat/cough lozenges: sore throat lozenges contain an anesthetic, such as benzocaine, to soothe
your throat. The anesthetic works by numbing the affected area to provide temporary relief.
Some throat lozenges also might contain an antibiotic to treat diseases of the throat, including
strep throat. Cough lozenges which suppress coughing, can contain ingredients, such as menthol
or eucalyptus.

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Erectile dysfunction lozenges: According to the New Zealand men’s clinic, lozenges are
available to treat erectile dysfunction. The lozenges are administered up to the 30 minutes before
intercourse erectile dysfunction lozenges have fewer side effects than tablet forms.
Morning sickness lozenges: Prenatal lozenges contain pyridoxine, or vitamin B6 helps to
relieve nausea and vomiting symptoms. The use of prenatal lozenges should be taken as directed
by your physician, since high doses of B6 during pregnancy can cause side effects in your
newborn
Marketed Product:

Conclusion:
Lozenges are organoleptically accepted formulations by the pediatric patients and patients
having dysphagia. Lozenges as medicated confections both for local and systemic delivery of
drugs are growing more popular. They are expected to acquire more demand in pharmaceutical
production as innovative dosage forms for potent drugs which seem to be an ideal dosage form.
Lozenges provide easy administration, convenience to patient, large patient compliance and
efficient treatment of low drug dosing, immediate onset of action, reduced dosage regimen and
cost effectiveness. New drug design in this area always benefit for the patient, physician and
drug industries. Lozenges surely will enjoy the most wanted position in pharmacy in the very
near future.

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References:
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2235.
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15.Benbassad N. et al, Development and evaluation of novel lozenges containing marshmallow
root extract Pak. Jornal of Pharma Science., 2013; 26(6): 1103-1107.
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Vol 7, Issue 16, 2018. 322 Rathod et al. World Journal of Pharmaceutical Research
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Technol Today. (3): 138-145.
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Pharmacy, 2017,7(1), 16-22.
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ajmms.20150502
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Mahajan,Garvita Joshi ; Retrieved from:
https://www.academia.edu/7397456/Lozenges_manufacturing_etc_parameters
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Information LLC; Retrieved from: https://www.uspharmacist.com/article/piroxicam-40-mg-
troche

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