TABLETS

SOLID DOSAGE FORMS: TABLETS

Tablets are “unit solid dosage form” manufactured either by dry granulation, wet granulation or direct
compression containing medicaments with or without excipients, intended to produce desired
pharmacological response. Various types of tablets are being manufactured according the route of
administration and type of dosage form.
Tablets ingested orally includes
1. Film coated tablet.
2. Sugar coated tablet
3. Chewable tablet
4. Delayed release tablet
5. Compressed tablet like paracetamol
6. Multiple compressed tablet
7. Enteric coated tablets
Sugar coated tablets – These are compressed tablets which are coated with sugar, in order to mask the
bitter taste or odor of the drug.
Film-Coated Tablets (FCT) – These are compressed tablets covered with a thin layer or film of a
water soluble material. A number of polymeric substances may be used for film coating. Film coating
imparts the same general characteristics as sugar coating, in addition it offers reduced time period
required for the coating operation.
Enteric-Coated Tablets (ECT) – these are compressed tablets which are coated with substance, which
disintegrates in intestine.
Compressed Tablets (CT) - these tablets are prepared by compression technique in which tablets are
not coated with any material.
Multiple Compressed Tablets (MCT ) – these tablets are subjected to more than one compression
cycle.
Chewable tablet -these tablets are placed to mouth which are chewed and swallowed.
Tablets used in oral cavity includes
1. Sublingual tablet
2. Buccal tablet
3. Lozenges
Buccal and Sublingual Tablets: These are small flat oval tablets. These tablets are formulated and
compressed with sufficient pressure to give a desired buccal tablet. These tablets are
administered by inserting in buccal pouch which may dissolve slowly.
Sublingual tablets: Sublingual tablets or lozenges may dissolve rapidly and are absorbed readily.
Tablets used to prepare solution includes
1. Effervescent tablet
2. Dispensing tablet
3. Tablet triturates
Effervescent Tablets: They contain sodium bicarbonate and an organic acid such as tartaric or citric
acid along with the drug. In the presence of water, they reacts & liberating carbon dioxide which
acts as a disintegrator and thus produces effervescence.
Molded Tablets: Tablet Triturates are made from moist material using triturate mold, must be
completely and rapidly soluble.
Dispensing tablet: these tablets are prepared by molding or compression.

Tablets which are administered via other route include:

1. Vaginal tablet
2. Implantation tablet Implants-these are small tablets which are prepared for insertion under the
skin.
Tablets preparation: -
Tablets are usually prepared by compression technique, which includes various ingredients like
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diluents, binders, disintegrants, lubricants, glidants, etc

Diluents: Diluents are normally used as fillers, in order to increase the bulk of the tablet. Example
for diluents includes lactose, starch, mannitoletc
Binders and adhesives: Binders are either added in wet form or dry form, which serves as a
binding agent in the formulation. Commonly used binders are starch, carboxy methyl cellulose, and
acacia.The amount and type of binder added in formulation influences the tablet properties.
Disinetegrants: These are added, in order to aid in disintegration or breaking of tablet in GIT.
Disintegrants like starch, clays, cellulose are used.
Lubricants: Lubricants prevents sticking of tablets to dies and punches; talc, stearic acid,
magnesium stearate.
Glidant: They reduce the friction, thus aid in free flow of granules or powder. Commonly used
glidants includes starch and talc
Colouring agents: Helps in elegant appearance of the product. Examples of coloring agents like
brilliant blue
Sweetening agent: Sweetening agents are added in order to mask the bitter taste of the drug. Ex:
aspartame, mannitol, lactose.
Flavouring agent: Added in order to impart flaovour or odour to the table formulation Ex:
Menthol, cloe oil, vanilla

Role of excipients in tablet formulation:

- modify the drug release characteristics
- Enhance the solubility and bioavailability of dosage form
- Imparts weight, volume
- Increases better patient compliance

Tablet preparation methods:

Tablets are prepared by three methods
-wet granulation method
-dry granulation method
-direct compression

Wet granulation method: -

It is the most common and widely used method and involves various steps like weighing of ingredients,
mixing, granulation, screening of damp pass, drying, lubrication and compression of tablets.

The main active ingredient, diluent, disintegrant are blended together, and then it is allowed to pass
through the sieve (sifting). Solutions of the binding agent are added to the initial mixture with stirring.
The amount of binding agent added should be sufficient, in order to avoid over wetting of the tablet. If
the powder is not wetted properly, the granules will be too soft and can be broken down during
lubrication, which is difficult during compression of tablet.

Tray drying is most common method of drying the tablet granules, Tray drying was the most widely
used method of drying tablet granulations in the past, which might be replaced by fluid –bed dryers as a
novel approach. After drying the granules, they are allowed to pass through the screen; usually 60-100
mesh nylon cloth is used. After dry granulation, lubricant is added as fine powder, which is required for
proper filling of the die cavity.

Dry granulation method: - This method is used for tablet ingredients, those are highly sensitive to
moisture or unable to with stand elevated temperatures during drying, slugging may be used to form the
granules. Dry granulation or double compression, usually eliminates various steps, which involves
slugging of the powder mass.
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The active ingredient, diluent and lubricant are blended together, to form the slug. Thus, the
compressed slug is passed through the mesh or through the mill, and the remaining lubricant is added to
the granulation, blended properly and compressed to form the tablets.

Direct compression:- It involves direct compressing the powdered material into tablets. Direct
compression is adopted, if drug constitutes major portion of tablet total weight. Tablets containing 25%
or less of drug substances can be formulated, with a suitable diluent which acts as a carrier or vehicle
for the drug.

Tablets prepared by above method are subjected to compression machine which may be single station
or multiple stations.
Tablet should possess following characteristics
- Should be free from defects like cracks, discoloration, chips etc.
- Should able to withstand mechanical stress
- Physically and chemically stable

Problem during tableting: -

During processing of tablets during compression, there several processing problems encountered such
as: -picking, sticking, capping, lamination, mottling
 Picking: The tablet surface material may be removed by a punch during compression.
 Sticking:adhesion of tablet to the die wall, which may occur due to excessive moisture in the
tablet. Capping: it is partial or complete separation of tablet from the top or bottom crowns of the
tablet from the main body.
 Lamination: Segregation of a tablet into two or more distinct layers. Capping and lamination
may occur due to air entrapment during processing
 Mottling: Unequal distribution of color on tablet surface results in mottling.

Advantages:
- Light and compact
- Easy to swallow
- Better patient compliance
- Bitter taste of the drug can be masked by coating
- Cheaper to other solid medication
Disadvantages:
- Difficult to swallow in case of children and elderly patients.
- Drugs with poor wetting, show slow dissolution profile.
- Some drug resists compression, due to their amorphous nature.

Evaluation tests: -
After tablet compression, tablets are subjected various evaluation tests to ensure the tablets withstand
sufficient mechanical strength, etc.
 General appearance
 Weight variation test
 Hardness test
 Friability test
 Disintegration test
 Dissolution test
1. General appearance: it includes overall appearance of the tablet like size, shape, odor,
taste, color, surface, consistency, textures physical flaws. Tablet thickness should be
controlled with ± 5% variation of standard value.

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2. Weight varaiation test: Twenty tablets are weighed randomly in a batch, and the average
weight of the tablet is determined. As per the IP specification,if the tablets weight is
a. < 80mg- deviation upto 10% is allowed
b. 80-250mg - deviation upto 7.5% is allowed
c. >250 mg- deviation upto 5% is allowed
If any tablet deviates from the specification, another 10 tablets are selected from the batch
and the same procedure is repeated. In case of 30 tablets, not more than one tablet should
deviate.
3. Hardness test: It is defined as the force required to break the tablet. This test is performed
in order to ensure that the tablet withstands mechanical shocks during manufacture,
packaging and shipping of tablet.
Various types of hardness testers are the hardness of the tablet like: Monsanto hardness
tester, Strong cobbtester, pfizerused to measure tester etc.The tablet hardness should be 2.5-
5kg/cm2 (for conventional tablets), for extended release tablets hardness should be 5-7.5
kg/cm2.
4. Friability test: Friability test is performed, in order to ensure the mechanical strength of the
tablet during transportation, packing etc. Roche friabilator is the instrument, used to carry
out the friability test, in which tablets are weighed before friabilation, and subjected to
friabilation with a speed of 25 rpm. Thus the tablets are weighed after friabilation and the
percentagefriability is determined. The deviation should be between 0.5-1%.
5. Disintegration test:Disintegration is the breakdown of tablet into finely divided particulates
or granules in GI tract. Disintegration time for uncoated tablets should be 15 minutes,
60minutes for sugar coated tablets, and 30 minutes for film coated tablets.
6. Dissoultion test: the time required for the given percentage of drug in tablet, to go into
solution, under specified set of conditions as in in-vitro test. It can also be considered as
solubilisation of drug in dissolution media. Several dissolution apparatus like paddle over
disk, flow through cell, cylindrical apparatus, paddle over disk, etc. used depending on the
type of dosage form. For tablets rotating
basket and rotating paddle type is most
commonly used.

Tableting Manufacturing: -

Tablet compression machine: -

Design:-
 Hopper ; for holding & feeding granules/ powders,
to be compressed
 Die; for defining shape & size of tablets
 Punch; for compressing granules within dies
 Cam track ; for guiding moment of punches
 Feeding mechanism ; for moving guanules from
hopper to into the dies

Stages of Tablet Formation:

 Collection & Filling
 Compression
 Ejection

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Collection & Filling; by gravitational flow powder moves from hopper to into Die via die table.
Compression; upper punch descends & enter into die, where placed powder is compressed in
between upper & lower punch, within die. Then upper punch ejected upwards &
leaves the die.
Ejection; then lower punch raises upto the top level of die & subsequently tablet is displaced to
bucket from die table with help of a pushing device.

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