Chapter-2 Tablets

Tablets

Fig: 2.0 Tablets

Definition:-

Tablets are solid unit dosage form prepared by compressing a drugs or a mixture of drugs
with or without diluents. They vary in shape and differ greatly in size and weight, depending
on amount of medicinal substances and the intended mode of administration.

It is the most popular dosage form and 70% of the total medicines are dispensed in the form
of Tablet. All medicaments are available in the Tablet form except where it is difficult to
formulate or administer.

Advantages:-

1. They are unit dosage form and offer the greatest capabilities of all oral dosage form
for the greatest dose precision and the least content variability.
2. Cost is lowest of all oral dosage form.
3. Lighter and compact.
4. Easiest and cheapest to package and strip.
5. Easy to swallowing with least tendency for hang-up.
6. Sustained release product is possible by enteric coating.
7. Objectionable odour and bitter taste can be masked by coating technique.
8. Suitable for large scale production greatest chemical and microbial stability over all
oral dosage form. Product identification is easy and rapid requiring no additional steps
when employing an embossed and/or monogrammed punch face.
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Disadvantages:-

1. Difficult to swallow in case of children and unconscious patients.

2. Some drugs resist compression into dense compacts, owing to amorphous nature, low
density character.
3. Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT
may be difficult to formulate or manufacture as a tablet that will still provide adequate or
full drug bioavailability.
4. Bitter testing drugs, drugs with an objectionable odour or drugs that are sensitive to
oxygen may require encapsulation or coating. In such cases, capsule may offer the best
and lowest cost.
Types according to routes of administration:-

(A) Tablets ingested orally:-

1. Compressed tablet, e.g. Paracetamol tablet

2. Multiple compressed tablet
3. Repeat action tablet
4. Delayed release tablet, e.g. Enteric coated Bisacodyl tablet
5. Sugar coated tablet, e.g. Multivitamin tablet
6. Film coated tablet, e.g. Metronidazole tablet
7. Chewable tablet, e.g. Antacid tablet
(B) Tablets used in oral cavity:-

1. Buccal tablet, e.g. Vitamin-c tablet

2. Sublingual tablet, e.g. Vicks Menthol tablet
3. Troches or lozenges
4. Dental cone
(C) Tablets administered by other route: -

1. Implantation tablet
2. Vaginal tablet, e.g. Clotrimazole tablet
(D) Tablets used to prepare solution: -

1. Effervescent tablet, e.g. Dispirin tablet (Aspirin)

2. Dispensing tablet, e.g. Enzyme tablet (Unienzyme)
3. Hypodermic tablets
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4. Tablet triturates e.g. Enzyme tablets (Digiplex).

Formulation:-
Conventional oral tablets for ingestion usually contain the same class of components in
addition to the active ingredients which are diluents, binders, disintegrate, lubricants, coloring
agent, flavoring agents and sweetening agents.

1) Active Ingredients- The dose of a drug to be administered has a profound affect on the
design and formulation of a dosage form. Content uniformity and drug stability become
very important issues when the dose of the drug is very small.
2) Diluents- Diluents are fillers designed to make up the required bulk of the tablet when
the dosage itself is inadequate. Commonly used diluents are lactose, mannitol, sorbitol,
dextrose, calcium carbonate, glucose, lactose, sucrose, microcrystalline cellulos
3) Binders- These materials are added either in dry or liquid form during wet granulation to
form granules and to promote cohesive compact for directly compressed tablets. The
substances mainly used as a binders are acacia, gelatin, starch, tragacanth, liquid glucose,
polyvinyl pyrrolidone, sucrose, cellulose derivatives and alginate derivatives
4) Glidants, antiadherents and lubricants- Glidants are intended to promote flow of the
tablet granulation or powder materials by reducing friction between the particals. Eg.talc,
corn starch, colloidal silicates.
Antiaderents have tablet friction during tablet ejection between the walls of the tablet
and the walls of the die cavity in which the purpose of reducing sticking of tablet
granules or powder to the faces of the punches or to the die wall. E.g. talc, magnesium
stearate, starch derivatives.
Lubricants are intended to reduce the tablet is formed. E.g. talc, stearic acid, magnesium
stearate.
5) Disintegrants- For most tablets it is necessary to overcome the cohesive strength
introduced into the mass by compression. This process will be done by drawing water
into the tablet swelling and causing to burst apart. Commonly used disintegrants are
starch and its derivatives, clays and microcrystalline cellulose.
6) Coloring agents-The use of colors and dyes in a tablet has three purposes:
1) Masking of off color drugs
2) Product Identification
3) Production of more elegant product

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All coloring agents must be approved and certified by FDA. Two forms of colors are used in
tablet preparation – FD &C and D & C dyes. These dyes are applied as solution in the
granulating agent or Lake Form. Lakes are dyes absorbed on hydrous oxide and employed as
dry powder coloring.

Example:-

FD & C yellow 6-Sunset yellow

FD & C yellow 5- Tartrazine

FD & C green 3- Fast Green

FD & C blue 1- Brilliant Blue

FD & C blue 2 - Indigo carmine

D & C red 3- Erythrosine.

D &C red 22 – Eosin Y.

7) Flavoring agents: For chewable tablet- flavor oil are used.

8) Sweetening agents: For chewable tablets: Sugar, mannitol. Saccharine (artificial): 500
times sweeter than sucrose.
Disadvantages:-

i. Bitter after taste and carcinogenic Aspartame (artificial)

ii. Lack of stability in presence of moisture.
Equipment used:-

Table:2.0 List of Tablet Machinery

S.No. Equipment/Instrument Made by Capacity & Description

1 R.M.G (Rapid Mixing Tapasaya engg. Pvt. 600 Lt.

Granulator) Ltd.

2 F.B.D Alliance 120 kg

3 Blender C.P.K engg 1000Lt

4 Compression machine Cadmach Double hopper fluid pack

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Chapter-2 Tablets

35 Punch(B Tooling),
27,24Punch (DTooling)

5 Sifter Magumps 36 inch

6 Multi Mill Sai nath Engg. Two H.P. for sizing wet
and dry granules

7 Dust Extractors Cadmach 60kg

8 Auto coater Chamunda Engg. 145kg

Works

Tablets manufacturing process:-

The tablets manufacturing process can be broadly classified as-

a) Granulation
1. Wet granulation
2. Dry granulation
3. Direct compression.
b) Compression
c) Coating

a) Granulation:-
Granulation is an agglomeration process to improve the flow, density and
compressibility of particulate material by size enlargement and densification.
Granulation can be achieved by the use of binder solution (wet granulation) or dry
binder (dry granulation)

1. Wet granulation method:-

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Chapter-2 Tablets

Drug Sifting or Milling

Filler

Dry mixing
Binder addition

Wet Granulation

Wet Milling (If required) done in multimill

Drying

Dry Milling & Sizing

Lubricants
Glidants Blending

Compression

2. Dry granulation method:-

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Drug

Filler Shifting or Milling

Lubricant
Dry mixing

Slugging

Precompression Repeat whole

Comminution

Sifting

If % of granules not achieved

If % of granules or fine achieved
Glidant
Lubricant
Disintegrant Compression

3. Direct compression method:-

Drug
Filler
Disintegrants Blending Compression
Lubricants
Glidants

Tablets granulation methods:-

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Table: 2.1 Method of granulation

Method Advantages Limitations

Direct Simple, economical process. Not suitable for all API,

compression
No heat or moisture, so good generally limited to lower dose
compounds.
for unstable compounds.
Segregation potential.

Expensive excipients.

Wet granulation Robust process suitable for Expensive: time and energy
consuming process.
most compounds
Specialized equipment required.
Imparts flowability to
Stability issues for moisture sensitive
a formulation
and thermo labile API with aqueous
Can reduce elasticity problems granulation.

Coating surface with hydrophilic

polymer can improve wettability

Binds API with excipient, thus

reducing segregation potential

Wet granulation Suitable for moisture sensitive Expensive equipment.

API.
(non-aqueous) Needs organic facility.
Vacuum drying techniques can
Solvent recovery issues.
remove/reduce need for heat.
Health and environment issues.

Dry granulation Eliminates exposure to moisture Dusty procedure.

(slugging or roll and drying. Not suitable for all

compaction) Compounds, Slow process.

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Compression:-
Tablets are made by compressing a formulations containing a drug or drugs with excipients
on stamping machines called presses. Tablet compression machines or tablet presses are
designed with the following basic components-
1. Hopper(s) for holding and feeding granulation to be compressed.
2. Dies that define the size and shape of the tablet.
3. Punches for compressing the granulation within the dies.
4. Cam tracks for guiding the movement of the punches.
5. A feeding mechanism for moving granulation from the hopper into the dies.
6. Tablets presses are classified as either single punch or multi-station rotary presses

Fig.2.1 Tablets compression cycle

3 Tablets coating:-
Historical perspective:-

1. One of the earliest references to coated solid dosage form appeared in early
Islamic drug literature, where coated pills were mentioned by Rhazes(850-
923).
2. The use of coating on drugs was probably an adaptation from early food
preservation methods, and French publication in the 1600s described coating
as a means of masking the taste of medicine.
3. Sugar coating of pills was developed to a considerable extent by the French in
the mild 1800s, and patents issued in 1837 and 1840 utilized sugar
composition for coated pills of cubeb and copaiba.

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Objectives:-

1. To mask taste, odour or colour of the drug.

2. To provide physical and chemical protection of drug.
3. To control the release of drug from tablet.
4. To protect the drug from gastric environment of the stomach with an acid
resistant enteric coating.
5. To incorporate another drug or formula adjuvant in the coating to avoid
chemical incompatibilities or to provide sequential drug release.
6. To improve the pharmaceutical elegance by use of special colour and
contrasting printing.
Components:-

There are three primary component involved in tablet coating-

 Tablets properties
 Coating process
1) Coating equipments
2) Parameter of coating process
3) Facility and ancillary equipment
4) Automation in coating processes
Coating composition

Coatings are necessary for tablets that have an unpleasant taste, and a smoother finish makes
large tablets easier to swallow. Tablet coatings are also useful to extend the shelf-life of
components that are sensitive to moisture or oxidation.

The most common forms of tablet coating are sugar coating and film coating. In comparison
to sugar coating, film coating is more durable, less bulky, and less time consuming. But it
creates more difficulty in hiding tablet appearance. One application of film-coating is for
enteric protection, termed enteric coating. The purpose of enteric coating is to prevent
dissolution of the tablet in the stomach, where the stomach acid may degrade the active
ingredient.

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Chapter-2 Tablets

Opaque materials like titanium dioxide can protect light-sensitive actives from
photodegradation. Special coatings (for example with pearlescent effects) can enhance brand
recognition.

If the active ingredient of a tablet is sensitive to acid or is irritant to the stomach lining, an
enteric coating can be used, which is resistant to stomach acid and dissolves in the high pH of
the intestines. Enteric coatings are also used for medicines that can be negatively affected by
taking a long time to reach the small intestine where they are absorbed. Coatings are often
chosen to control the rate of dissolution of the drug in the gastro-intestinal tract.

Processing problems of tablets:-

1. Capping and Lamination

 Capping:- Partial or complete separation of top or bottom crowns of

tablets from the main body of tablets.

 Lamination:- Separation of a tablet into two or more distinct layers.

 Friability test can be used to reveal these problems

Fig.2.2 Tablets showing capping

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Chapter-2 Tablets

2. Picking & Sticking

 Picking:- Surface materials from a tablet that is sticking to the punch

and being removed from the tablet surface is picking.
 Sticking:-Sticking refers to tablet materials adhering to the die wall.
When sticking occurs, additional force is required to overcome the
friction between the tablets and die wall during ejection.
 Cause: Picking occurs when punch tips have engraving or embossing
having small enclosed areas like “A”,” B”,”D”,”O”,”Q”
3. Mottling:
It is an unequal distribution of colors on a tablet with light and dark areas on tablet
surface.
Cause:
i. Use of a drug whose color differs from tablet excipients
ii. Use of a drug whose dehydration products are colored
Remedy:
i. The use of colorant may solve the problem but can create another Problem. A dye can
cause mottling by migration to the surface of a Granulation during drying to
overcome this difficulty. Change the Solvent system, reduce drying temperature.
ii. Disperse a dry color additive during powder binding steps.
4. Weight Variation:
Variation of tablet weight also causes variation of active medicament which changes the
bioavailability.
Cause:
a) Granule size & size distribution:
b) Poor Flow:
c) Punch Variation:
d) Poor Mixing
5. Hardness Variation: Hardness depends on the weight of materials and space between
upper and lower punch at the moment of compression. If the volume of materials and
distance between the punches varies hardness also alters.
6. Double Impression: This involves only punches that have monogram or engraving. If
the monogram present in upper punch, slight rotation of punch after precompression
produce double impression. If monogram present in lower punch after compression is
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Chapter-2 Tablets

over lower punch move slightly downward to free the tablet and produce double
impression.
Equipment used:-

1) Coating pan:-

Fig.2.3 Coating pan

Coating Pans are used mostly in the pharmaceutical industry for coating tablets and
confectionaries. For this, it is essential that the machines supplement the personal skills of the
coater with its correct design and versatile coating pan.

2) Sifter:-

Fig.2.4 Sifter
 Easy dismantling and cleaning.
 High degree of surface finish.
 Double Deck arrangement can be provide
 Mechanical shifter also available.

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Chapter-2 Tablets

3) Fluidized bed dryer

Fig.2.5 Fluidized bed dryer

Features:-

 All stainless steel cGMP models and basic models with only product contact parts
and air  path in stainless steel
 Pneumatic lifting & locking for product container with retarding chamber * Fully
automatic bag shaking
 Intrinsically safe earthing arrangement
 Inlet air filtration system with 0.3 micron hepa filters
 Rear chambers with heating coils and air inlet filter modules to be mounted in remote
areas
 Fan motor unit to be mounted in remote areas
 Noise level below 90 DB with specially designed silencer
4) Wet mass mixer:-

Fig.2.6 Wet mass mixer

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Chapter-2 Tablets

 Used for mixing of material uniformly

 Functions as a lump and agglromerate breaker
 A high speed mixer blade revolves around the bottom of the bow

5) Vaccum tray dryer:-

Fig.2.7 Vaccum tray dryer

 Available in 36 & 48 Tray

 Chamber walls are heated externally to prevent condensation 
 Unique single chamber & multi chambers design.
 Lowest leakage rate of vacuum.
 Surface contact between tray & shelf
 Heavy duty hollow shelf design with all connection outside the chamber

6) Double cone blender:-

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Chapter-2 Tablets

Fig.2.8 Double cone blender

 Ideal for mixing of powders and homogeneous lubrication of granules.

 Safety guards provided with limit switch interlock to motor higher capacity
model.
 Available capacities 1000 kg.
 Automatic loading & unloading facilities provided
7) Multimill:-

Fig.2.9 Multimill
 Multispeed drive for various product grading.
 Easy dismantling and cleaning.
 Low energy consumption.
 High degree of surface finish.
 Easy portabl

8)  Compression machine:-

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Chapter-2 Tablets

Fig.2.10 compression machine

9) Rapid mixer granulator:-

Fig.2.11 rapid mixer granulator

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In-process test:- Tablets must comply with the following requirements-

1. Appearance:- The general appearance of a tablet, its visual identity and overall
elegance is essential for consumer acceptance, for control of lot-to-lot uniformity
and general tablet-to-tablet uniformity, and for monitoring trouble-free
manufacturing.

2. Size and shape:- The size and shape of the tablet can be dimensionally described,
monitored, and controlled. Tablet thickness should be controlled within a 5%
variation of a standard value.

3. Uniformity of weight:- For uncoated tablets-weigh 20 tablets and determine the

average weight. Not more than two of the individual weights deviate from the
average weight by more than the % deviation shown in table, and none deviates by
more than twice that percentage according to IP.

Table: 2.2 Uniformity of weight

Average Weight of Tablet Percentage deviation

80 mg or less 10%
More than 80 mg or less than 250 mg 7.5%
250 mg or more 5%

4. Hardness and friability:- Tablets requires a certain amount of strength, or hardness

in resistance to friability, to withstand mechanical shocks of handling in
manufactured, packaging and shipping. Several devices are used to test tablet
hardness:
 Monsanto hardness tester
 Strong cobb tester
 Pfizer tester
 Erweka tester
 Schleuniger tester.

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Chapter-2 Tablets

5. Disintegration:- uncoated tablets except for chewable tablets, comply with the
disintegration test for tablets. The tablets disintegrate within 15 min unless
otherwise indicated in the monograph. Remove the assembly from the liquid. The
tablets pass the test if all six have disintegrated. The apparatus being operated for 30
min. If any of the tablets have not disintegrated repeat the test on a further six
tablets, replacing the water in the beaker with 0.1N hydrochloric acid. The tablets
then pass the test of all the six tablets have disintegrated in the acid medium.

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