❑ SOLID TABLETS

DOSAGE
FORMS

---ANISHA CHAKRABARTY.
ASSISTANT PROFESSOR,
BENGAL SCHOOL OF TECHNOLOGY.
 INTRODUCTION

Tablets are unit solid dosage form which are made by compression & mainly intended for
oral administration.

Ideal properties of tablets:

• It Should be free from discolouration & any Contamination.
• It should release the active ingredients at the site of action with
a predictable manner.
• It Should maintain the physical & Chemical Stabiles during
storage Condition.
• It should have sufficient Strength during packaging &
Dispensing.
.
 ADVANTAGES DISADVANTAGES
Better physical & chemical stability Not suitable for infants, children, &
unconscious patient
Cost effective Delayed action compared to liquid orals
& parenterals
Large scale production is possible Bio availability is less than the
parenterals.
They are easy to carry, easy to swallow Coating is required for the drug with
and they are attractive in appearance. unpleasant taste & odor .
They are in general the easiest and Oxygen sensitive drugs are not Suitable
cheapest to package and ship among all for the tablets
oral dosage forms.
 Types of tablets

Tablets used in the Tablets administered Tablets used to

Tablet ingested orally oral cavity by other routes prepare solution
• Standard • Buccal & Sublingual • Implantation • Dispensing tablets
compressed tablets tablets tablets • Effervescent tablets
• Multiple • lozenges • Vaginal tablets • Hypodermic tablets
compressed tablets • Dental canes • Tablet triturates
• Chewable tablets
• Sugar coated
tablets
• Film coated tablets
• Enteric coated
tablets
• Sustained action
tablets
• Controlled release
tablets
Standard compressed tablets:
• These tablets are formed by compression and contain no special
coating.
• They are made from powdered, crystalline or granular materials,
alone or in combination with suitable excipients.
• These tablets contain water soluble drugs which after swallowing
get disintegrated in the stomach and its drug contents are
absorbed in the gastrointestinal tract and distributed in the
whole body.
• e.g. Aspirin (Dispirin) paracetamol tablets (Crocin).
Multiple compressed tablets:
• These are compressed tablets made by more than one
compression cycle.
• Such tablets are prepared by compressing additional tablet
granulation on a previously compressed granulation. The
operation may be repeated to produce multilayered tablets of
two or three layers.
They are two types-
• Layered tablets
• press coated tablets
❑ Layered tablets:
• they are prepared by compressing additional granules on
previously compressed granules.
• It contain two or more layers (bi-layer, three layers)
• Example: Glimepiride and Metformin bi-layered tablet.
❑ press coated tablets:
• These are made by compressing additional granules around
the previously compresses granules.
• Example: Aceclofenac press coated tablet.
Chewable tablets:
• These tablets should be chewed in the mouth.
• These tablets are disintegrate & dissolve in mouth.
• Chewable tablets are useful for administration of large tablet to
the infant & aged patient.
• Ex- Antacid tablets (Digiene).

Sugar coated tablets:

• these are compressed tablets with or without colored sugar
coating.
• Tablets are coated with sugar solution by spray coating
apparatus or coating pan.
• Such coatings are done to mask the bitter and unpleasant odor
and the taste of the medicament.
• These are mainly used in preparation of multivitamin &
multimineral tablets.
• Example: Reasulf tablets – dried ferrous sulphate
Film coated tablets:
• These are the compressed tablets coated with a thin layer of
water soluble & insoluble polymer.
• hydroxy propyl cellulose, hydroxy propyl methyl cellulose and
ethyl cellulose etc. act as film coating polymer.
• Film coated tablets are generally tasteless.
• Example: Metronidazole film coated tablets.

Enteric coated tablets:

• These tablets are coated with materials resistant to acidic pH (like
cellulose acetate phthalate, CAP) of the gastric fluid but get
disintegrated in the alkaline pH of the intestine.
• These tablets are unchanged in stomach but drug release occurs
in intestine.
• Example :Erythromycin enteric coated tablet.
 Sustained action tablets:
• These are the tablets which after oral administration release the drug is slow and
prolong the effect of the medicament.
• e.g. Diclofenac SR tablets.
• Controlled release tablets:
These tablets release the active ingredients into the body with a specific amount over
a specific period of time.
• Example: Pregabalin CR (pain reliever)

Tablets used in the oral cavity

Buccal & Sublingual tablets:
• Buccal tablets are to be placed in the side of the
cheek (buccal pouch) where they dissolve and
absorbed directly in the buccal cavity. e.g.
Progesterone buccal tablets.
• sublingual tablets are to be placed under the
tongue where they dissolve or disintegrate
quickly and are absorbed directly without
passing into GIT. e.g. tablets of nitroglycerin
sublingual tablets.
lozenges:
• These tablets are designed to produce local
effect in the mouth or throat.
• They are prepared by compression or candy
molding process.
• These are generally contain a sweetening
agent, flavouring agent and a substance
which produces a cooling effect.
• e.g. Vicks lozenges, Strepsils.
Dental cones:
• These are compressed tablets meant for
placement in the empty sockets after tooth
extraction. They prevent the multiplication
of bacteria in the socket or reduce bleeding
by containing antibacterial compounds or a
astringent.
• These tablets contain an excipient like
lactose, sodium bicarbonate and sodium
chloride
Tablets administered by other routes:
Implantation tablets:
• These tablets are small cylindrical, will be placed below
the skin or inserted subcutaneously
• It provide prolong action
• Special injector is required for the implantation.
• Tissue toxicity can occur
• Surgery may be needed to remove the tablet.
• Eg: Naltrexone implantation tablet.
Vaginal tablets:
• These tablets are inserted in the vagina.
• Vaginal tablets may contains steroids & antibacterial
agent .
• Eg: clotrimazole vaginal tablet.
Tablets used to prepare solution
Dispensing tablets:
• They are also called compounding tablets because the pharmacist used them to
compound prescription .
• These tablets are intended to be added to given volume of water to produce a
solution.
• Eg: The drugs commonly incorporated are mild silver potentiate, bichloride of
mercury merbromin an quaternary ammonium compounds.
Effervescent tablets:
• These tablets contain sodium bi carbonate & a organic acid such as citric acid &
tartaric acid, which presence of water, it releases carbon dioxide which acts as
disintegrator & produce effervescence.
• Eg: Dispirin tablet
Hypodermic tablets:
• Hypodermic tablets contain one or more drugs with water soluble ingredients &
these are added to sterile water to prepare sterile solution & introduced into the
body by injection.
• Eg: Dilaudid hydrochloride Hypodermic tablet

Tablet triturates:
• They are small Cylindrical moulded or compressed tablets contain small amount
of drug.
• These tablets must be completely & rapidly soluble in water.
• Eg: Enzyme tablets
 Tablet INGREDIENTS
Tablets contain two basic groups of ingredients:
(a) The medicament, which are always present.
(b) The excipients, which may or may not be present:
• All non-drug component of a formula are known as excipients.
• These are inert substances and to give tablet a suitable form & consistency.
• Ideal properties of ingredients:
✓ All ingredients should be nontoxic,
✓ Stable
✓ physiologically inert
✓ compatible with medicaments
✓ free form and micro organism
✓ commercially available
✓ low costing
✓ physically & chemically stable.
• The excipients are classified according to the part they play in the finished tablet.
❑ Group I: includes those which help to impart satisfactory compression characteristics
to the formulation, eg. Diluent/filler, binders and adhesives and lubricants, glidants.
❑ Group II: includes substances that help to give additional desirable physical
characteristics to the finished tablet, eg. Disintegrators, colors, flavors and
sweeteners.
▪ Diluents (Fillers): These are also known as bases. They are added to tablet
formulations to increase the bulk of the tablet to a suitable size and to make small
dosages easier to handle. Examples include lactose, mannitol, sorbitol,
microcrystalline cellulose, and dicalcium phosphate.
▪ Binders and Adhesives: These are materials, used to hold powders together to form
granules. Eg: Starch paste (5-15%), gelatin, sugars such as sucrose, glucose, dextrose,
maltose and lactose, natural and synthetic gums (acacia 10-25%) tragacanth.
▪ Glidants: Glidants improve flow of the powder materials or granules by reducing
friction between the particles. Examples colloidal silicon dioxide (silica) and talc.
▪ Lubricants: Lubricants are intended to reduce sticking or adhesion of any of the
tablet granules or powder to the faces of the punches or to the die wall. Examples
of these include stearic acid, calcium and magnesium stearate. Most lubricants are
used in concentration of 1%. Excessive amounts can result in poor water proofing,
disintegration and dissolution of tablets.
▪ Disintegrants:
• These are substances that facilitate break up or disintegration of a tablet when it
comes in contact with water in GIT.
• Disintegrants act by three mechanisms
(a) By swelling (Bursters), e.g., alginates, starch, PVP etc.
(b) By improving penetration of aqueous liquids (Wetting agent), eg SLS. clays.
(c) By liberation of gas from an effervescent base, e.g., sodium bi carbonate, and citric
acid.
▪ Coloring agents: Coloring agents Give the tablets a suitable color and help in product
identification. Examples include iron oxides, titanium dioxide.
▪ Flavoring agents: Flavoring agents Improve the taste of the tablet. Examples include
artificial sweeteners, flavors, and natural sweeteners like sucrose.
 METHODS USED IN TABLET FORMULATION
Tablets are commonly manufactured by-
❑ Wet Granulation
❑ Dry Granulation
❑ Direct Compression
❑Direct Compression:
Direct compression involves compression of powdered materials into tablet
without modifying the physical nature of powder materials.
Method:
• weighing, milling : weighing& milling of the active ingredients & powdered
excipients (without lubricant).
• Mixing: Mix the active ingredients & powdered excipients with lubricants. In
this step the Double cone blender or ribbon blender etc. is used as a mixer.
• Compressing: Compressing the granules into tablet by tablet punching
machine.
Ingredients
ADVANTAGES OF DIRECT COMPRESSION:
• Reduced production cost
• Suitable for Heat sensitive & moisture sensitive drug.
• Tablets are form with Faster tablet disintegration and drug dissolution time.
DISADVANTAGES OF DIRECT COMPRESSION:
• Low-dose drugs may not be uniformly blended.
• Tablets produced by direct compression tend to have lower hardness
compared toothers method.
• Powder with low flowability compressibility are not suitable for this methods.
GRANULES & GRANULATION:
• Granules are aggregation of fine particles in a spherical shaped mass.
The process of formation of granules called granulation.
• It produces granules that have good flowability and uniformity.
• granulation helps to improve the compressibility of the powder mixture,
resulting in tablets with better hardness.
❑ Wet Granulation:
Wet granulation is a widely used method for production of tablets.
Methods:
• weighing, milling & mixing: weighing, milling & mixing of the active
ingredients with powdered excipients (without lubricant). In this step the
Double cone blender or ribbon blender etc is used as a mixer.
• Granulation: Preparing of blinder solution such as starch solution (5-15%).
Mixing the blinder with powders to form a damp mass. Screening the damp
mass into granules using 6-12 mesh.in this step the Tornado mill or rotary
granulator etc is used as a granulator.
• Drying: Drying the moist granules. Tray dyer or fluidized bed dyer is used as
a dyer in this step.
• Screening: Sizing the granules by screening using 14-20 mesh
• Mixing: Mixing of the dried granules with lubricants.
• Compressing: Compressing the granules into tablet by tablet punching
machine.
Ingredients

screen
granulation
Advantages of Wet Granulation
• It is a relatively simple process that is easy to scale up.
• It produces granules that have good flowability and uniformity.
• Wet granulation reduces the generation of dust during processing.
• Wet granulation helps to improve the compressibility of the powder mixture,
resulting in tablets with better hardness.

Disadvantages of Wet Granulation

• Wet granulation involves several steps, whish is time consuming.
• The moisture and heat used in wet granulation . So not suitable for heat-sensitive
or moisture-sensitive active pharmaceutical ingredients (APIs).
• it is a more expensive process compared to other granulation methods.
❑ Dry Granulation:
The formation of granules by compacting powder mixtures into large pieces or
compacts which are broken down or sized into the granules.
Methods:
• Weighing and Milling: Weighing and Milling of
formulation ingredients (drug substance and excipients)
• Mixing: Mixing of milled powders. In this step the
Double cone blender or ribbon blender etc is used as a
mixer.
• Slugging : Compression of mixed powders into slugs.
Roller compactor or chilsonator is used in this step.
• Milling and sieving : Milling and sieving of slugs into
granules.
• Mixing: Mixing of the dried granules with lubricants.
• Compressing: Compressing the granules into tablet by Roller compactor
tablet punching machine.
Ingredients

Slugging
Advantages of Dry Granulation
• Dry granulation does not involve the use of heat or moisture, making it suitable for
heat-sensitive active pharmaceutical ingredients.
• Dry granulation typically requires less processing time compared to wet granulation.
• Dry granulation can be more cost-effective than wet granulation.

Disadvantages of dry Granulation

• Tablets produced by dry granulation tend to have lower hardness compared to wet
granulation.
• Dry granulation can generate dust and may require additional equipment for dust
control.
• Some binders used in wet granulation may not be suitable for use in dry granulation,
limiting the choice of binders are available.
The talc & lubricants should not be added in initial stage . It should be added
just before the compression. Because-
• Adding lubricants at the initial stage might coat the particles of the API
and excipients & making it difficult for them to mix uniformly.
• Talc absorbs the moisture from atmosphere. So Adding Talc at the initial
stage might absorbs excessive moisture which can causes difficulty in
compression.
 TABLET COATING
Tablet coating is a process in which tablets are covered with one or more layers of mixtures
of various substances to protect the active ingredients or mask the bad taste & odor of
tablets.
OBJECTIVES:
• To protect the components from environment (such as oxidation, absorption of moisture,
light etc.).
• To protects the drug from gastric environment of stomach in case of acid sensitive drug.
• To control the release of the drug.
• To improve the pharmaceutical elegance of use of special colour.
• To mask the bad taste & odor of tablets.

TYPES OF COATING

Sugar coating Film coating Enteric coating Compressed coating

 Sugar COATING

Sugar coating is a process in which tablets are covered with one or more layers of
mixtures of sugar to protect the active ingredients or mask the bad taste & odour of
tablets.

OBJECTIVES
• To protect the components from environment (such as oxidation, absorption of
moisture, light etc.).
• To improve the pharmaceutical elegance of use of special colour.
• To mask the bad taste & odor of tablets.
PROCEDURE:
• The sugarcoating of tablets may be divided into the following steps: (a)
waterproofing and sealing if needed, (b) sub coating, (c) smoothing and final
rounding, (d) finishing and coloring if desired, (e) Imprinting (f)polishing.
• The sugarcoating process is conducted in a coating pan made up by iron, stainless
steel, or copper.
Waterproofing and Sealing:
• the tablets which containing components that may be affected by moisture, one or more
coats of a waterproofing substance, such as pharmaceutical shellac or a polymer are
applied to the compressed tablets before the sub coating .
• The waterproofing solution (úsually alcoholic) is sprayed on the compressed tablets in a
rotating coating pan.
• Warm air is blown Into the pan during the coating to drying the tablets.
Sub coating:
• three to five surcoats of a sugar-based syrup are applied.
• The sucrose and water syrup also contains gelatin, acacia, or PVP to enhance coating.
• The process is done in a a rotating coating pan.
• Warm air is blown Into the pan during the coating to drying the tablets.
• When the tablets are partially dry, they are sprinkled with a dusting powder, usually a
mixture of powdered sugar and starch.
• the process is repeated until the tablets are of the desired shape and size
• After drying The sub coated tablets are then removed from the coating pan, and the
excess powder is removed by gently shaking the tablets on a cloth screen.
Smoothing and Final Rounding:
• After the tablets are sub coated, 5 to 10 additional
coatings of a thick syrup are applied to complete the
rounding and smooth the coatings. This syrup is
sucrose based, with o without additional components
such as starch and calcium carbonate.
• As the syrup is applied, the operator moves his or her
hand through the rolling tablets to distribute the
syrup and to prevent the tablets from sticking to one
another.
• A dusting powder is often used between syrup
applications. Warm air is applied to hasten the drying
time of each coat.

Finishing and Coloring :

To attain final smoothness and the appropriate color to
the tablets, several coats of a thin syrup containing the
desired colorant are applied.
Imprinting:
Solid dosage forms may be passed Waterproofing and Sealing
through a special imprinting machine to
print the identification codes and other
distinctive symbols to the tablets. Sub coating
Polishing:
• Coated tablets may be polished with
carnauba wax or beeswax. Smoothing and Final Rounding
• pieces of wax may be placed in a
polishing pan, and the tablets allowed
to tumble over the wax. Finishing and Colouring
• Two or three coats of wax may be
applied, depending upon the desired
gloss. Imprinting

Polishing
 Film coating
• These are the compressed tablets coated with a thin layer of water soluble &
insoluble polymer.
• hydroxy propyl cellulose, hydroxy propyl methyl cellulose and ethyl cellulose etc. act
as film coating polymer.
• Film coated tablets are generally tasteless.
Enteric coating
• These tablets are coated with materials resistant to acidic pH (like cellulose
acetate phthalate, CAP) of the gastric fluid but get disintegrated in the alkaline pH
of the intestine.
COMPREESION coating
• Compressed coated tablets having an inner core of medicaments & outer shell of
coating materials.
• The coating materials are compressed around the tablet core with a special tablet
press.
 Defects of tablets
Problems Definition picture Reason Solution
Capping separation of • Poor Powder Flow • Ensure that the formulation has good
the top or • Insufficient compression flow by adding glidant.
bottom crown force applied during tablet • Adjust compression force and speed
(caps) of a formation during compression
tablet form the • Excessive Moisture Content • Maintain optimal moisture levels
main body of • Improper lubrication of the during the manufacturing process.
tablet. tablet formulation & • Adjusting the formulation to include
Insufficient or improper use appropriate binders and lubricants
of binders

Lamination Separation of a • Poor Powder Flow • Ensure that the formulation has good
tablet into two • Insufficient compression flow by adding glidant.
or more force applied during tablet • Adjust compression force and speed
distinct layer formation during compression
• Excessive Moisture Content • Maintain optimal moisture levels
• Improper lubrication of the during the manufacturing process.
tablet formulation & • Adjusting the formulation to include
Insufficient or improper use appropriate binders and lubricants
of binders
 Defects of tablets
Problems Definition picture Reason Solution
Picking & Sticking : adhesion • Improper Drying • Ensure proper drying conditions,
sticking of tablet material to • Improper lubrication of such as air temperature and airflow.
die wall. the tablet formulation • Ensure proper and adequate
Picking: adhesion of • Excessive Moisture lubrication of the tablet
tablet material to Content • Maintain optimal moisture levels
faces of punches. during the manufacturing process.
Mottling It is non-uniformity • uneven drying during • Ensure proper drying conditions,
of color distribution the coating process. such as air temperature and airflow
• High viscosity of the during coating process.
coating solution • Maintain viscosity of the coating
• incompatibility between solution
the colorant and other • Choose a colorant which compatible
ingredients with other ingredients.
 QUALITY CONTROLL TEST OF TABLETS

Hardness:
• Tablet hardness is also known as Crushing Strength.
• The tablet hardness is defined as the force required
to break a tablet in a diametric compression test.
• It ensures that tablets can withstand handling,
packaging, and transportation without breaking.
• Monsato hardness tester, Strong cobb hardness
tester & Pfizer hardness tester etc. are used to
measure the hardness of tablets.
• The test is done by placing a tablet between two
anvils of tester, applying the force to anvils
recording the crushing strength, that just causes,
the tablet to break.
• A hardness of 2 kg-means a soft tablet. A hardness
of 4 kg means satisfactory tablets. A hardness of 6
kg means hard tablets.
Uniformity of thickness:
• Tablet thickness is determined by Calipers scale.
• +- 5 % variation in thickness of the tablets is allowed.

Uniformity of diameter:
• Tablet diameter is determined by Calipers scale.
• For diameter < 12.5 mm +- 5 % variation & > 12.5 mm +- 3% variation in diameter of
tablet is allowed.
Friability/Tumbling test:
• This test is measure the ability of a tablet to withstand
abrasion and edge damage during packaging, handling and
shipping.
• Roche friabilator is mainly used for this purpose
• A number of weighed tablets are placed into the friabilator.
• The friabilator is revolved at 25 rpm for 4 mins (100
revolution) & tablets are dropped from a distance 6 inch.
• Then tablets are removed from the friabilator & reweighed.
• The friability of tablets is calculated by-
𝑊
% ꝭ =100(1 − )
𝑊0
W= weight of tablets after performing the test
w0 =weight of tablets before performing the test

• Weight loss should be with in the range- 0.5-1 %

 Content uniformity test:
• This test is only performed for the uncoated tablet.
• A sample of 30 tablet is randomly selected and 10 of them are individually assayed.
• Nine of the 10 tablets must contain > 85% and <115% of drug content specified in the
individual monograph.
• The tenth tablet must not contain >75% or <125%
Uniformity of weight:
• This test is not performed for the layered & enteric coated tablets.
• Select 20 tablets randomly
• Weigh the tablets individually & calculate it’s average.
• The % weight variation is calculate by-
𝑤2 −𝑤1
% weight variation = x 100
𝑤1
W1 =weight of tablet
W2 = average weight of tablets
Disintegration time:
• Disintegration is a process of breaking down a tablet into small fragments. Time required
to disintegrate a tablet called disintegration time.
• This test is not performed for Chewable tablet & sustained release tablets.
• This test is done by disintegration apparatus.
In vitro dissolution test:
• Dissolution may be defined as the amount of
drug that goes into the solution per unit time
under standardized condition of temperature
& solvent composition.
• The dissolution rate is defined as the rate in
which the drug is release from the tablet.
• The dissolution rate is estimated by the in-
vitro dissolution apparatus.
• As per IP, Apparatus I (Busket type) &
apparatus II (paddle type) are used to study
in-vitro dissolution rate.
• This study ensue that the rate of release is
uniform from batch to batch & the release of
drug from tablets is near to 100%.