Documenti di Didattica
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by
D. Srinivasa Rao
M.Pharmacy- Pharmaceutics
TABLET COMPRESSION
By
Srinivas
CONTENTS
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
INTRODUCTION
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.
Powder compression
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.
Effect of compression
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.
Difference
Compaction Consolidation
It is defined as the It is in increase in
formation of solid specimen mechanical strength of
of defined geometry by material from particle
powder compression. particle interactions.
The compression takes
place in a die by the action
of two punches, the lower
and the upper by which
compression force is
applied.
Tablet production
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
Compression process
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.
Ejection
During 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.
Tablet compression machine
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
Single Punch Machine (Tablets)
Upper and
Lower Collar
Collar locker
Tablet production methods
Dry methods
Direct compression
Dry granulation
Wet methods
Wet granulation
Process Route for Tablet Manufacture
Direct compression
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
Cont..
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 procedures
Avoidance of high compaction pressures involves in producing
tablets by slugging or roll compaction
Elimination 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..
Advantages
Rate of binder addition and kneading can affect the
properties of the granules formed
The 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..
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..
Concerns
Excipient available from only one supplier and often cost more than filler used in
granulation
Procedure conservation
Machine investments
Lack of material knowledge
Physical 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 variability
Dusting problem
Coloring
Direct compression fillers
Common materials
that have been
modified in the Fillers
chemical
manufacturing process
to improve fluidity and
compressibility
Soluble Insoluble
fillers fillers
Soluble fillers
Lactose
Spray dried lactose
Sucrose
Nutab: 95.8% sucrose, 4% convert sugar
Di-Pac: cocrystallization of 97% sucrose and 3% modified dextrin
Dextrose
Emdex: spray crystallized
Sorbitol
Mannitol
Maltodextrin
Maltrin
Insoluble fillers
Starch
Starch 1500
Spray dried starch
Celulose
Microcrystalline cellulose (Avicel)
Inorganic calcium salts
Dicalcium phosphate (Emcompress or DiTab)
Tricalcium phosphate (TriTab)
Heckel equation
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.
DIFFERENT TYPES OF TABLETTING MACHINES
Upper punch
Lower punch
Die
Keying
KEYS ON PUNCHES TERMINOLOGY
Different shapes of tablets
Different Shapes of punches and Dies
Can manufacture
following types of tablets:
Flat Faced Flat with bevel
edges
Concave/Deep/Deep
Concave with bevel edges.
Capsule shape punch die set
Applicable to
pharmaceutical and
ayurvedic industries.
Can manufacture
following types of
tablets:
Concave with Edges
Deep Concave Flat
Faced
Normal concave Flat
with Bevel Edges.
Geometric Shape Punch Die Set
Are applicable to
confectionery
industries.
Available with
different size,
concavity, and flat
in plain or
engraved break
line.
Core Rod Tooling Punch Die Set
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.
Materials For Construction
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.
Coating of Dies and Punches
Why coating is required?
Sticky material
Corrosive material
Abrasive material
Different Types of Coatings
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)
Quality Control
Visual Inspection
Dimensional Dies:
Inspection
Height and outside
Punches: diameter
Overall length Die bore diameter
Working length using expandable,
Cup depth small bore gauges
Tips round and capsule Die bore major and
Tip and Barrel minor axis using
concentricity
Head, Head flat and Neck Vernier caliper and
Barrel expandable, small bore
gauges
Die Bore concentricity
Squareness
Maintenance of Dies and Punches
Why is it required?
To improve the lifespan of toolings.
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 [carrs 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.
References:
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.