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Submitted by
D. Srinivasa RaoM.Pharmacy- Pharmaceutics
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TABLET COMPRESSION
BySrinivas
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• Introduction• Different types of tablet compression machines• Punches and dies• Different shapes of tablets• Compaction profile• Effect of compaction on hardness• Effect of compaction on friability• Effect of compaction on lamination• References
CONTENTS
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• What is a TABLET ?A tablet is a pharmaceutical unit dosage form. It comprises a mixture of active substances and excipients, usually in powder form, pressed or compacted from a powder into a solid dose.
INTRODUCTION
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• It is defined as the reduction in volume of a powder owing to the application of a forces.
• Because of the increased proximity of particle surfaces accomplished during compression, bonds are formed between particles which provide coherence to the powder i.e. compact is formed.
Powder compression
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• When external mechanical forces applied to a powder mass there is reduction in bulk volume as follows– Repacking– Particles deformation
• Elastic deformation-e.g. acetyl salicylic acid, MCC• Plastic deformation-at yield point of elastic.
– Brittle fracture – e.g. sucrose– Microquashing-irrespective of larger particles,
smaller particles may deform plastically.
Effect of compression
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Compaction• It is defined as the
formation of solid specimen of defined geometry by powder compression.
• The compression takes place in a die by the action of two punches, the lower and the upper by which compression force is applied.
Consolidation • It is in increase in
mechanical strength of material from particle particle interactions.
Difference
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• Powders intended for compression into tablets must possess two essential properties– Powder fluidity
• The material can be transported through the hopper into the die
• To produce tablets of a consistent weight• Powder flow can be improved mechanically by the use
of vibrators, incorporate the glidant– Powder compressibility
• The property of forming a stable, intact compact mass when pressure is applied
Tablet production
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Filling By gravitational flow of powder from hopper via the die table
into die. The die is closed at its lower end by the lower punch.Compression
The upper punch descends and enters the die and the powder is compressed until a tablet is formed.
During the compression phase, the lower punch can be stationary or can move upwards in the die.
After maximum applied force is reached, the upper punch leaves the powder i.e. the decompressed phase.
EjectionDuring this phase, the lower punch rises until its tip reaches the
level of the top of the die. The tablet is subsequently removed from the die and die table by a pushing device.
Compression process
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• Hopper for holding and feeding granulation to be compressed
• Dies that define the size and shape of the tablet• Punches for compressing the granulation within
the dies• Cam tracks for guiding the movement of the
punches• Feeding mechanisms for moving granulation
from the hopper into the dies
Tablet compression machine
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Upper andLower Collar
Collar locker
Single Punch Machine (Tablets)
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• Dry methods– Direct compression– Dry granulation
• Wet methods– Wet granulation
Tablet production methods
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Process Route for Tablet Manufacture
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• Tablets are compressed directly from powder blends of the active ingredient and suitable excipients
• No pretreatment of the powder blends by wet or dry granulation procedures is necessary
• Advantages – Economy
• Machine: fewer manufacturing steps and pieces of equipment
• Labor: reduce labor costs• Less process vallidation• Lower consumption of power
Direct compression
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Advantages Elimination of granulation process
Heat (wet granulation)Moisture (wet granulation)High pressure (dry granulation) Processing without the need for moisture and heat which is
inherent in most wet granulation proceduresAvoidance of high compaction pressures involves in producing
tablets by slugging or roll compactionElimination of variabilities in wet granulation processing
Binders (temp, viscous, age)Viscosity of the granulating solution (depend on its temp), How long it has been prepared,
Cont..
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Advantages Rate of binder addition and kneading can affect the
properties of the granules formedThe granulating solution, the type and length of mixing and
the method and rate of wet and dry screening can change the density and particle size of the granules, which can have a major effect on fill weight and compaction qualities
Type and rate of drying can lead not only to critical changes in equilibrium MC but also to
unblending as soluble active ingredients migrate to the surfaces of the drying granules
More unit processes are incorporated in production, the chances of batch-to-batch variation are compounded
Cont..
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• Advantages – Prime particle dissociation
• Each primary drug particle is liberated from the tablet mass and is available for dissolution
• Disintegrate rapidly to the primary particle state– Uniformity of particle size– Greater stability of tablet on aging
• Color• Dissolution rate• Fewer chemical stability problems would be encountered as
compared to those made by the wet granulation process
Cont..
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ConcernsExcipient available from only one supplier and often cost more than filler used in
granulationProcedure conservationMachine investmentsLack of material knowledgePhysical limitation of drug
No compressibility No flow ability
Physical characteristics of materials (both drug and excipient) Size and size distribution Moisture Shape and surface Flowability Density
Lot to lot variabilityDusting problemColoring
Cont..
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Common materials that have been modified in the chemical manufacturing process to improve fluidity and compressibility
Direct compression fillers
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LactoseSpray dried lactose
SucroseNutab: 95.8% sucrose, 4% convert sugar Di-Pac: cocrystallization of 97% sucrose and 3% modified dextrin
DextroseEmdex: spray crystallized
SorbitolMannitolMaltodextrin
Maltrin
Soluble fillers
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• Starch– Starch 1500– Spray dried starch
• Celulose– Microcrystalline cellulose (Avicel)
• Inorganic calcium salts– Dicalcium phosphate (Emcompress or DiTab)– Tricalcium phosphate (TriTab)
Insoluble fillers
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Heckel plot is density Vs applied pressure.Follows first order kinetics.As the porosity increases the compression force will increase.The Heckel equation is described as follows. It is based on the assumption
that powder compression follows first-order kinetics, with the interparticulate pores as the reactant and the densification of the powder bed as the product.
Where D= relative density of a powder P=compact at pressure P. Constant k = measure of the plasticity of a compressed material.Constant A =die filling and particle rearrangement before deformation and
bonding of the discrete particles.Thus, a Heckel plot allows for the interpretation of the mechanism of
bonding.
Heckel equation
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• Single punch press• Rotatory tablet press• Computerised tablet press
DIFFERENT TYPES OF TABLETTING MACHINES
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• It posses a die and a pair of punches.• The amount of powder fill in to the die is
controlled by the position of the lower punch.• After ejection of tablet it is displaced by the
shoe of the hopper.as it moves back to the die for next tablet.
• OUTPUT:200 TABS per minute• Used in production of small batches.
Single punch pressSingle punch press
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• Developed to increase the out put.• It operates with a number of dies & sets of
punches which can vary considerably.• Both the dies & punches rotate during the
operation.• The vertical movement of the punches is
controlled by tracks that pass over cams and rolls used to control the volume of powder fed in to the die and the pressure applied during compression.
ROTATORY PRESSROTATORY PRESS
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• In these the movement of the punches can be controlled and varied considerably.
• Thus the tablet can be prepared under controlled conditions with respect to loading pattern and loading rate.
• Applications: to predict the sensitivity of the drug to such variations, to mimic the loading pattern of production presses to predict scale up problems.
• Because of the later application this is also called as compaction simulator
Computerised hydraulic pressComputerised hydraulic press
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Type of Tools Punch Body (mm) Diameter (mm)
D tools 25.35 38.10
B tools 19 30.16
BB tools 19 24
BB toolB toolD tool
International StandardsInternational Standards
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• General Terminology of Tooling• Different shapes of dies and punches• International Standards• Materials For Construction• Coating of Dies and Punches• Quality Control• Maintenance of Dies and Punches• New Developments
PUNCHES AND DIESPUNCHES AND DIES
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• Upper punch
• Lower punch
• Die
• Keying
GENERAL TERMINOLOGY OF TOOLINGGENERAL TERMINOLOGY OF TOOLING
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KEYS ON PUNCHES TERMINOLOGYKEYS ON PUNCHES TERMINOLOGY
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Different shapes of tabletsDifferent shapes of tablets
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• Round shape punch die set
• Oval shape punch die set
• Capsule shape punch die set
• Geometric shape punch die set
• Irregular shape punch die set
• Core rod tooling punch die set
Different Shapes of punches and DiesDifferent Shapes of punches and Dies
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• Used by pharmaceutical and veterinary industry.
• Can manufacture following type of tablets:
Shallow Concave Ball Shape
Deep Concave Flat Faced
Concave with Edges Flat with Bevel Edges
Normal Concave.
Round shape Punch Die SetRound shape Punch Die Set
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Applicable to pharmaceutical and ayurvedic industries.
Can manufacture following types of tablets:Flat Faced Flat with bevel
edgesConcave/Deep/Deep
Concave with bevel edges.
Oval Shape Punch Die SetOval Shape Punch Die Set
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Applicable to pharmaceutical and ayurvedic industries.
Can manufacture
following types of tablets:Concave with EdgesDeep Concave Flat
Faced Normal concave Flat
with Bevel Edges.
Capsule shape punch die setCapsule shape punch die set
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• Applicable to pharmaceutical, confectionery, chemical, industrial powder metallurgy industries.
• Can manufacture following types of tablet:
Triangular Benzene Rhombus Rectangular Square.
Geometric Shape Punch Die SetGeometric Shape Punch Die Set
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• Are applicable to confectionery industries.
• Available with different size, concavity, and flat in plain or engraved break line.
Irregular Shape Punch Die SetIrregular Shape Punch Die Set
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• Applicable in confectionery and ceramic industries.
• Can manufacture following types of tablets: Tablet with hole in center
& concave rib Tablet with hole in center
& flat rib.
Core Rod Tooling Punch Die SetCore Rod Tooling Punch Die Set
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• Dies- HCHC (High carbon High chromium steel )
• Punches- OHNS (Oil Hardened Nitride steel)
• Different types of steel standards: For dies:- AISI-01
For punches:- AISI-S7, AISI-S1, D2(HCHC-D2), SUS 440C.
Materials For ConstructionMaterials For Construction
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• Why coating is required?
Sticky material
Corrosive material
Abrasive material
Coating of Dies and PunchesCoating of Dies and Punches
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• Titanium Nitride Coating
• Electroless Nickel Plating (ENI)
• Chromium Nitride Coating (CrN)
• Chromium Carbon Nitride (CrCN) Coating
• Diamond Coating of Diamond like Carbon (DLC)
• Cr-CrN-Cr Multilayer Coating (Nano Coating)
Different Types of CoatingsDifferent Types of Coatings
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Visual InspectionDimensional
Inspection
Punches:Overall lengthWorking length Cup depthTips – round and capsuleTip and Barrel
concentricityHead, Head flat and NeckBarrel
Dies:Height and outside
diameterDie bore diameter
using expandable, small bore gauges
Die bore major and minor axis using Vernier caliper and expandable, small bore gauges
Die Bore concentricitySquareness
Quality ControlQuality Control
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• Why is it required?
To improve the lifespan of toolings.
• How are they Maintained?Fitting instructions usually as per the manual
given.Warm soap water and a soft brush are suitable for
thorough cleaning Not to be touched by bare fingers Thoroughly coated with an acid-free oil in order
to prevent corrosion.
Maintenance of Dies and PunchesMaintenance of Dies and Punches
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Toolings should be regularly checked.Polishing –
By hand “Drag Finishing” machine
Storage cabinets for tooling – Clashing Dusting Humidity
Contd..
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• Multi-tip punches
• Development in manufacturing different shapes of tablets Polo Teddy Beer, Lion, etc.
• Tablets which can be broken into 4 equal halves
New DevelopmentsNew Developments
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Multi-tip PunchesMulti-tip Punches
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COMPACTION PROFILECOMPACTION PROFILE
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• It has the same causes as weight variations.• Hardness depends on weight of the material and the
space between the upper and lower punch at the moment of compression.
• If the distance between the punches varies hardness is like in consistent.
EFFECT OF COMPACTION ON HARDNESS OF TABLETEFFECT OF COMPACTION ON HARDNESS OF TABLET
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• When the punches are in poor condition or worn at their surface edges this problem arises.
• Less compression pressure also leads to increased friability.
Effect of Compaction on Friability of TabletEffect of Compaction on Friability of Tablet
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• Rapid relaxation of the peripheral region of a tablet,on ejection from a die.
• This can be prevented by using tappered dies• Rapid decompression also causes lamination.• This can be prevented by doing pre compression
step. And decreasing the final compression pressure.
Effect of compaction on laminationEffect of compaction on lamination
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The Kawakita equation is described as follows. This equation describes the relationship between the degree of volume reduction of the powder column and the applied pressure.
The basis for the Kawakita equation for powder compression is that particles subjected to a compressive load in a confined space are viewed as a system in equilibrium at all stages of compression, so that the product of the pressure term and the volume term is a constant.
where C = degree of volume reduction of a powder compact at pressure P. constants (a and b) =evaluated from a plot of P/C versus P. a= total volume reduction for the powder bed [carr’s index] b= constant that is inversely related to the yield strength of the particles.
The data from this study were modeled via the Kawakita equation in an attempt to evaluate the relationship between the volume reduction and applied pressure for each studied DC binder.
Kawakita equation
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• www.google.com• Parle-Elizabeth Tools Pvt Ltd.• Encyclopedia of Pharmaceutical Technology,
second and third volumes• http//www.thomaseng.compresstooling.pdf• www.vmindustries.com• Pharmaceutics by Aulton• Pharmaceutical technology by Libermann and
laitman.
References:References:
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