Tablet manufacturing process

and operations

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 Tablet manufacturing process/operations

 The manufacturing process of tablets principally

consists of three stages:
 filling the die with the powder,
 compressing the powder,
 ejecting the tablet from the die.

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Tablet manufacturing…

I. Filling
 Die filling a tableting machine is a volumetric
process.
 the die is filled to the upper edge of the die
 The filling depth is determined by the height of the
die cavity
 the filling volume is determined by the diameter of
the die hole and the filling depth. 3
 Tablet manufacturing…
II. Compression
 the central stage of tablet production
 Two different possibilities of compression
 the lower punch is closing the die from the bottom
side and the upper punch moves downward for
compression
 Both upper and lower punches move
simultaneously toward each other 4
 Tablet manufacturing…
III. Ejection
 During ejection usually the lower punch moves
upward to eject the tablet from the die and the
upper punch has already left the die when the
process of ejection starts.
 After ejection from the die the tablets are collected.

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Tablet manufacturing…
Common stages occurring during compression

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Tableting machines

There are a number of tableting machines

 each vary in productivity
 similar in basic operation
Two types of tablet press
 Single punch and rotary tableting machines
 Today, single punch tableting machines are only
used for research, in early development
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 Tableting machines…
General parts of tablet machine
 Die- define the sizes and shape of tablet
 Punches: for compression of granulation within the
die
 Hopper:
 usually made of stainless steel
 has the shape of a funnel to contain and deliver
the product to be compressed.

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Tableting machines…
 be provided with low – level sensors that signal an
alarm, shut off the engine, or activate the feeding
mechanism to deliver the product
 Feeder system
 Moves granulation from hopper to die
 Usually consists of different sections
Spread the granulation over wide area
 is ideal for press performance at high speed. 9
 Tableting machines…
 Cam tracks: guides the movements of punches

1.The upper cams

 responsible for guiding the upper punches around the
circumference of the turret head.
 Comprises:

 The filing stage track

 the upper lowering cam

 the upper compression roller

 the upper filling cam

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Tableting machines…
11.The lower cams
 located in the lower section of the press
 Comprise:
 the pre weight control (or fill cam),
 the weight adjustment cam,
 the lower compression cam,
 the ejection cam.

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Tableting machines…

Machine types and their working principles

1 Single - Punch Tableting Machines
 were the first tableting machines used at the end of
the nineteenth century.
 Eccentric tableting machines are still used in
research, in early development, and for material
characterization.

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 Tableting machines…
 they work with one pair of punches.
 In principle, they have a mobile upper punch and a
lower punch which is fixed during compression.
The lower punch only moves for ejection of the tablet.

 An eccentric valve is driven by a motor

 responsible for the movement of the upper punch

The eccentric movement determines the operation

and speed of the upper punch.

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Tableting machines…
 The punch forces for compression evolve due to
contact with the powder.
 the measured punch forces at the upper and
lower punches result from the movement of the
upper punch and the resistance of the powder
bed toward deformation.

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 The measured upper punch force is usually higher
than the lower punch force
 the upper punch force is the main force used
for material characterization.

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 Tableting machines…
 The tablets show different hardness on upper and
lower surfaces
 In eccentric machines, die filling is performed by a
filling shoe which moves back and forth above the
die.
 When the upper punch moves upward above the
die, the die is filled
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Tableting machines…

 During this filling process with a moving filling

shoe, demixing of the product mixture is more
easily possible than with a fixed filling shoe. (a
major problem)
 The production rate varies usually between 10
and 60 tablets/min

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Tableting machines…

Figure Operation of single punch tableting machine: (a) filling; (b)

compression; (c) ejection; (d) pushing from die table.
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2 multi station rotary press

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Fig. The compression cycle of a rotary tablet press machine
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 Multi-station rotary presses
 The head of the tablet machine that holds the upper punches, dies and
lower punches in place rotates
 As the head rotates, the punches are guided up and down by fixed cam
tracks, which control the sequence of filling, compression and ejection.
 The portions of the head that hold the upper and lower punches are
called the upper an lower turrets
 The portion holding the dies is called the die table
 The pull down cam guides (C) the lower punches to the bottom,
allowing the dies to overfill
 The punches then pass over a weight-control cam (E), which reduces
the fill in the dies to the desired amount

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 A swipe off blade (D) at the end of the feed frame removes the excess
granulation and directs it around the turret and back into the front of the
feed frame
 The lower punches travel over the lower compression roll (F) while
simultaneously the upper punches ride beneath the upper compression roll
(G)
 The upper punches enter a fixed distance into the dies, while the lower
punches are raised to squeeze and compact the granulation within the dies
 After the moment of compression, the upper punches are withdrawn as
they follow the upper punch raising cam (H)
 The lower punches ride up the cam (I) which brings the tablets flush with
or slightly above the surface of the dies
 The tablets strike a sweep off blade affixed to the front of the feed frame
(A) and slide down a chute into a receptacle
 At the same time, the lower punches re-enter the pull down cam (C) and
the cycle is repeated

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Tableting machines…

 commonly used for tablet production

 The principle of all rotary machines is the same
Configuration
 work with a number of punch and die sets which
move in a circle.
 The dies are fixed in a round die table and the die
table circulates.
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Tableting machines… . Rotary Tableting …
 Together with the dies the lower and upper
punches circulate on tracks.
 The densification process is bilateral
force is evolving on the upper as well as on the
lower side of the powder bed.
 The produced tablets show the same hardness on
the upper and lower surfaces.
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Tableting machines…
 There are different stages of tablet production
which happen simultaneously for several tablets.
The central stage of tableting occurs when the
punches pass the upper and lower compression
wheels
the compression wheels determine the
movement of the upper punch and the lower
punch 25
Tableting machines…
 The tablet is formed by the resulting punch
forces
 Except for the compression stage the upper
punch is always in an upward position.
 The upper punch is above the die and the lower
punch closes the die, determining the filling
depth

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Tableting machines…

 The dies pass below the filling shoe and the powder
flows into the die up to its upper edge
 the powder bed is leveled off by a scraper.
 the lower punch is lowered slightly on the track to
keep the whole powder volume during compression
and to prevent dusting
 Now the punches start to pass the compression
wheels and the main compression event occurs. 27
Tableting machines…
 Forced by the wheels, both the upper and lower
punches move toward each other
 compress the tablet,
and leave each other again.
 The upper punch lifts into an upward position and
the lower punch moves upward to eject the tablet.
 After ejection the tablet passes a scraper and it is
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pushed down from the die table
Tableting machines…

 Additionally rotary machines are equipped with

precompression wheels.
 Here, the punches pass the precompression wheels
before the main compression events starts
 Precompression has the same stages of compression
as the main compression
the applied forces are lower.
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 Tableting machines…
 Precompression avoids dusting, capping, or lamination
 After precompression only a lower main compression

force is necessary.
 The number of dies and complementary punches of a

rotary machine can vary between one and up to

hundred.
 Tablet production is determined by;

 The number of punches

 the rotation speed of the die table.

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 Tableting machines…
 Fast rotary machines have up to 120 rpm of the die
table.
 In order to increase the production rate of rotary
tableting machines, double-sided rotary machines
were build
 possess two pairs of compression wheels
 Have two filling shoes.
 If these machines are equipped with precompression
wheels one machine contains four pairs of wheels.31
Tableting machines…

Fig. An illustration of the compression cycle

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Tableting machines…
Application of Tableting Machines:
 In summary, the single - punch tableting machines
still being used are mainly eccentric tableting
machines (mostly for research),
 rotary machines with different production output are
predominantly used for production

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 Tableting machines…

Auxiliary Equipments
I. Hopper feeder
 used to feed the main hopper to keep the production
process in progress for long.
Granulation Feeding Device
 the time of die under feed frame is too short to allow
adequate or consistent gravity filling of die with granules
resulting in weight variation and content
uniformity. 34
 Tableting machines…
seen with poorly flowing granules
 Mechanized feeder can employ to force granules into
die cavity to avoid these problems
II. Tablet weight monitoring devices
• High rate of tablet output with modern press requires
continuous tablet weight monitoring with electronic
monitoring devices like:
Thomas Tablet Sentinel,
 Pharmakontroll and Killan control System-MC.
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Tableting machines…
 They monitor force at each compression station by
strain gage technology
then correlated with tablet weight.

III. Tablet Deduster

• In almost all cases, tablets coming out of a tablet
machine bear excess powder on its surface and are
run through the tablet deduster to remove that
excess powder. 36
 Tableting machines…
Tablet press tooling
 Punches and dies are essential tools in the tableting
process
 critical to the quality of the tablets produced.

 Both tools are designed for long life under normal

conditions of working
 In tableting operation, it is important not only to select
the appropriate press tooling in terms of dimensional
data but also to consider the material of which tools
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Tableting machines…
 various types of steel are available for the
manufacture of press tooling.
 The appropriate steel for press tooling should be
selected based upon:
 the toughness
wear resistance required by the application

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 Tableting machines…
 it is mandatory to have satisfactory knowledge
regarding the abrasiveness, corrosiveness, and
lubricity of the product intended for compression
as well as the desired dimensions of the punch tip.
 The toughness of the steel regards its ability to
resist shock and its wear resistance regards the
ability to resist physical damage or erosion due to
product contact.

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Fig. Compression cycle of rotary machine 40
Problems in tablet
manufacturing

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42
 Introduction

 An ideal tablet should be free from any visual

defect or functional defect.
 The advancements and innovations in tablet
manufacture have not decreased the problems
often encountered in the production, instead
have increased the problems, mainly
because of the complexities of tablet presses
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 Introduction

 An industrial pharmacist usually encounters

number of problems during manufacturing.
 Majority of visual defects are due to:
 inadequate fines
 inadequate moisture in the granules
ready for compression
 due to faulty machine setting.
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 Problems in tablet processing

 Problems in tablets are either related to

imperfection in any one or more of the
following factors:
 tablet process
 Excipients
 machine

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 Problems in tablet processing

 Tableting Process related problems

 Capping: due air-entrapment in the granular
material.
 Lamination: due air-entrapment in the
granular material.

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 Problems in tablet processing

 Excipient related problems

 Chipping: it is due to very dry granules
 Sticking: due to excess moisture present in
the granule
 Picking: due to Improper drying of granules
 Binding: due to more amount of binder in
the granules or wet granules.
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 Problems in tablet processing

 Defect related to more than one factor:

 Mottling: It is either due to any one or more of
these factors:
 Due to a coloured drug, which has different
colour than the rest of the granular material.
 improper mixing of granular material
 dirt in the granular material or on punch faces
 The defect related to Machine
 Double impression: due to free rotation of
the punches, which have some engraving on
the punch faces. 48
 Problems in tablet processing….
 Capping
 Capping’ is the term used, when the upper
or lower segment of the tablet separates
horizontally, either partially or completely
from the main body of a tablet and comes off
as a cap, during ejection from the tablet
press, or during subsequent handling

 Reason: usually due to the air–entrapment

in a compact during compression, and
subsequent expansion of tablet on ejection of
a tablet from a die. 49
 Problems in tablet processing….
Lamination / Laminating
 Definition: ‘Lamination’ is the separation of a
tablet into two or more distinct horizontal
layers.
 Reason: Air–entrapment during compression
and subsequent release on ejection.
 The condition is exaggerated by higher
speed of turret.
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 Problems in tablet processing….

 Chipping

 Definition: ‘Chipping’ is defined as the

breaking of tablet edges, while the tablet
leaves the press or during subsequent
handling and coating operations.
 Reason: Incorrect machine settings, specially
mis-set ejection take-off.
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 Problems in tablet processing….

Sticking / Filming
Definition:
Sticking refers to the tablet material
adhering to the die wall.
Filming is a slow form of sticking and is
largely
due to excess moisture in the
granulation.
Reason: Improperly dried or improperly
lubricated
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granules.
 Problems in tablet processing….
Picking
 is the term used when a small amount of material
from a tablet is sticking to and being removed
off from the tablet-surface by a punch face.
 more prevalent on the upper punch faces than
on the lower ones.
 The problem worsens, if tablets are repeatedly
manufactured in this station of tooling.

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 Problems in tablet processing….

Reason: Picking is of particular concern

when punch tips have engraving as well
as the granular material is improperly
dried.

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 Problems in tablet processing….
Binding

‘Binding’ in the die, is the term used when the

tablets adhere, seize or tear in the die.
 A film is formed in the die and ejection of
tablet is hindered.
 With excessive binding, the tablet sides are
cracked and it may crumble apart.

Reason: usually due to excessive amount of

moisture in granules, lack of lubrication. 55
 Problems in tablet processing….

Mottling
 is the term used to describe an unequal
distribution of color on a tablet, with light or
dark spots standing out in an otherwise
uniform surface.

Reason: One cause of mottling may be a

colored drug, whose color differs from the
color of excipients used for granulation of a 56
 Problems in tablet processing….

Double impression

 Double Impression’ involves only those

punches, which have a monogram or other

engraving on them.

 Reason: At the moment of compression, the

tablet receives the imprint of the punch.

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 Problems in tablet processing….

 on some machines, the lower punch freely

drops and travels uncontrolled for a short

distance before riding up the ejection cam to

push the tablet out of the die, now during this

free travel, the punch rotates and at this

point, the punch may make a new impression

on the bottom of the tablet, resulting in 58

 Problems in tablet processing….

 If the upper punch is uncontrolled, it can

rotate during the short travel to the final
compression stage and create a double
impression.

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