Report on Compression
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Transcript of Report on Compression
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Fig 1
2.Angle of Repose:It is the maximum angle that can be obtained between freestanding surface of a powder heap and
the horizontal plane.
Such measurements give at least a qualitative assessment of the internal cohesive and frictional
effects under low levels of external loading, as might apply in powder mixing, or in tablet die or
capsule shell filling operations.
Angle of Repose Type of Flow40 Very Poor
3.Flow Rates:A simple indication of the ease with which a material can be induced to flow is given by
application of a compressibility index (I) given by the equation:
[
]Where, v is the volume occupied by a sample of the powder after being subjected to a
standardized tapping procedure, and vo is the volume before tapping.
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Compressibility Index (I) Flow
5-15 Excellent
12-16 Good
18-21 Fair to passable
23-35 Poor
33-38 Very Poor
>40 Very very Poor
4.Mass-Volume Relationships:Volume:
Measurement of the powder volume is more complicated because of the presence of air spaces or
voids. Air spaces or voids can be distinguished as follows:
1. Open Intraparticulate voids: those within the single particle but open to the externalenvironment.
2. Closed Intraparticulate voids: those within a single particle but closed to the externalenvironment.
3. Interparticulate voids : the air spaces between individual particles.Therefore, atleast three interpretations of powder volume may be proposed:
1. The true volume (vt): the total volume of the solid particles, which excludes all spacesgreater than molecular dimensions, and which has a characteristic value for each material.
2. The granular volume (vg): the cumulative volume occupied by the particles, including allintraparticulate (but not interparticulate) voids.
3. The bulk volume (vb): the total volume occupied by the entire powder mass under theparticular packing achieved during the measurement.
Relative volume (vr) can be defined as:
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The relative volume decreases and tends toward unity as all the air is eliminated from the mass.
This phenomenon occurs in compressional processed such as tableting.
Porosity is the another parameter which is often selected to monitor the progress of compression.
[ ]
Methods to measure the volume of powder
Helium Pycometer Liquid displacement method (Specific gravity bottle method)
Density:
The ratio of mass to volume is known as the density of the material. Three different densities for
powdered solids, based on the following ratios, may be defined.
1. 2. 3.
Where M is the mass of the sample.
Relative density is given as During compressional processes, relative density increases to a maximum of unity when all air
spaces have been eliminated.
5. Effect of Applied Forces:
i. Deformation:When any solid body is subjected to opposing forces, there is a finite change in geometry,
depending upon the nature of the applied load. The relative amount of deformation produced by
such forces is called strain. Three commonest kind of strains are shown in the figure below:
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Fig 2: Diagram for three kinds of strain
ii. Compression:When external mechanical forces are applied to a powder mass, there is normally a reduction in
its bulk volume as a result of one or more of the following effects.
a. Repacking: the onset of loading is usually accompanied by closer repacking of thepowder particles. It is the main mechanism of initial volume reduction as shown in the
figure below.
b. Particle Deformation: As the load increases, rearrangement becomes more difficult andfurther compression involves particle deformation.
Elastic Deformation: if on removal of the load, the deformation is to a large extent spontaneously reversible then the deformation is said to be elastic. For e,g,
Acetylsalicylic acid, MCC etc
Plastic Deformation: if an elastic limit or yield point is reached and load abovethis level result in deformation not easily reversible on removal of applied force,
then such deformation is said to be plastic.
c. Brittle Fracture: when the shear strength is greater, particles may be preferentiallyfractured, and the smaller fragments then help to fill up any adjacent air space. This is
known as Brittle fracture and it occurs in hard, brittle particles. For e.g Sucrose.
d. Microsquashing: Irrespective of the behavior of large particles of the material, smallparticles may deform plastically. This process is known as Microsquashing. Hence the
proportion of fine powder in a sample may be significant.
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Fig 3: Diagram of the effect of compressional force on a bed of powder
iii. Consolidation:When the surface of two particles approach each other closely enough (e.g at a separation of less
than 50 nm , their free surface energies result in strong attractive force, which is known as Cold
welding. This is supposed to be a reason for increasing the mechanical strength of a bed of
powder when subjected to rising compressive forces.
Fusion bonding is caused due to generation of considerable frictional heat when any applied load
to the bed is transmitted through the particle contacts. This fusion bonding also increases the
mechanical strength of the mass.
In both cold and fusion welding, the process is influenced by several factors, including,
The chemical nature of the materials The extent of the available surface The presence of surface contaminants The intersurface distances
Initial
Repacking
Deformation
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Fig 4: The effect of increasing compressional force on specific surface area of powder.
When a powder mass is subjected to increasing compressional force there is initial
particle fracture, which gives rise to increase in surface area (from O to A). At point A,
particle rebonding occurs, causing decrease in surface area
iv. Role of Moisture:Moisture concentration well below the 1% level can dramatically affect the behavior of the feed
materials and that of the finished products. As little as 0.02% moisture can affect the proportion
of the applied force transmitted to the lower punch, and at 0.55% moisture, the behavior is
actually the reverse of that for totally dry material.
III. Decompression:
As the applied force is removed, a new set of stresses within the tablet gets generated as a result
of elastic recovery. The tablet must be mechanically strong enough to accommodate these stress,otherwise the structure failures occur. The degree and rate of relaxation within the tablet is the
characteristic of a particular blend. Recording of this phase provides insights into tableting
problems. For example, if the degree and rate of elastic recovery are high, the tablet may cap or
laminate. If the tablet undergoes brittle fracture during decompression, the compact may form
failure planes as a result of fracturing of surfaces. Tablets that do not cap or laminate are able to
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relieve the stresses by plastic deformation. Since the plastic deformation is time dependant,stress
relaxation is also time dependant. The tablet failure is affected by rate of decompression
(machine speed). Addition of a plastically deforming agent (e.g., PVP, MCC) is advisable to
reduce the risk of such structure failures.
IV. Ejection:
The last stage in compression cycle is ejection from die. Ejection phase also requires force to
break the adhesion between die wall and compact surface and other forces needed to complete
ejection of tablet. Radial die wall forces and die wall friction also affect the ease with which the
compressed tablet can be removed from the die. The force necessary to eject a tablet involves the
distinctive peak force required to initiate ejection, by breaking of die walltablet adhesion. The
second stage involves the force required to push the tablet up the die wall, and the last force is
required for ejection. Variation in this process are sometimes found when lubrication is
inadequate and a slip-stickcondition occurs between the tablets and die wall, with continuing
formation and breakage of tablet diewall adhesion. Heat is generated during ejection as a result
of friction from shear between the compact and the die wall, and absorption of this heat can aid
in bond formation. The shear forces during ejection can produce additional plastic flow and
afford consolidation not achieved during the compaction event. Lubrication usually assists in
reducing the ejection forces, however it also has the negative effect on compact strength because
of reduction in cohesion characteristics. The unequal stress exerted on the compact during
ejection can cause stress planes that break bonds and result in compact capping or laminating.
V. Energy involved in Compaction:
It requires high input of mechanical work which is converted to other form of energy. Any
protection of applied energy stored in a product such as tablet retains a destructive property. The
work involved in various phases of tablet or granule compaction operation includes
i. Work necessary to overcome friction between particles.ii. Work necessary to overcome friction between particles and machine parts
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iii. Work that is required to induce elastic or plastic deformationiv. Work required to cause brittle fracture within the materialv. Work associated with mechanical operation of various machine parts.
Total work involved is
(1)
Then, .(2)
Where,
WF = workdone in overcoming the friction depends upon properties of tablet mass
WN = Net mechanical energy actually required to form the tablet
WD = Elastic deformation energy that is stored in the tablet.
Fig 5: Force Displacement Curve
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2.Rotary Tablet Press:
Fig 6: Multi station Tablet Press
It is also called multi station tablet press. The steps involved are:
Over fill Corrected Fill Compression Ejection
Multi station presses are termed rotary because the head of the machine that holds the upper
punches, dies and lower punches in place rotates. As the head rotates the tablet granulation runs
from the hopper through the feed frame into the dies. Feed frame promotes a uniform fill of the
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die. Compression takes place as the upper and lower punches pass between a pair of rollers. The
up and down movement of the punches are guided by fixed cam tracks. The portion of the head
that holds the upper and lower punches are called upper and lower turrets and the portion holding
the dies is called the die table.
At the start of a compression cycle, granulation from the hopper empties into the feed frame (A),
which has several interconnected compartments. These compartments spread the granulation
over a large area to provide time for the dies (B). Pull down cam (C) guides the lower punches to
bottom of their vertical travel, allowing the die to the cam (E), which reduces the fill in the dies
to the desired amount. A wipe-off blade (D) at the end of the feed frame removes the excess
granulation and backs it into the front of the feed frame. Next, the lower punch travels over the
lower compression roll (F) and upper punches rides below the upper compression roll (G) The
upper punch enters a fixed distance into the dies, while the lower punches are raised and hence
compacts the granulation within the dies. To regulate the upward movement of the lower
punches, the height of the pressure roll is changed. After compression, the upper punches are
withdrawn by upper punch raising cam (H) and lower punch ride up by the cam (I), which brings
the tablet above the surface of the dies. The tablets strike a sweep off blade attached at the front
of the feed frame and slide down to the receiver. At the same time, the lower punch re-enters the
pull down cam (C) and cycle is repeated.
VII. Common Processing Problems
1.Capping & Lamination:Capping is the complete or partial loss of top and bottom crowns of a tablet from the main body;
lamination is the separation of a tablet into two or more distinct layers. These problems generally
occur immediately after compression; however they may occur after several hours or days.
Lamination is often blamed on over compressing - too much compression force flattens out the
granules, and they no longer lock together. Lamination can also occur when groups of fine and
light particles do not lock together. These groups of fine and light particles simply will not
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compress well. Lamination could also occur due to defects in the machinery, such as deep
concave punches, claw formation in the punch, ring formation in the die wall.
These problems could be remedied by precompression, by slowing the tabletting rate, or by
using flat punches. Adding a taper into the die will also help eliminate lamination.
Punch head flat diameter is often overlooked. As punches wear, the punch head flat usually
becomes smaller and smaller and worn. Dies (dies with a wear ring) will make the tablet split
during ejection which gives the tablet the appearance that capping has occurred (replace the
dies).
Cams are made of Phosphor Bronze, Teflon and OHNS. This Phosphor Bronze is a special grade
PB2 with excel lent lubricating characteristics, longer life and more acoustic absorbency, when
compared with the normally available PB2 Grade bronze. Constant Amount Feeder has special
paddles to take up greater volume with better powder traction ability.
2. Picking & Sticking:
Surface materials from a tablet that is sticking to the punch and being removed from the tablet
surface is picking. 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.
Picking occurs when punch tips are of engraving or embossing types e.g. small enclosed areas in
letter A.
The source of the problem may relate to the product, the tooling, the upstream processes, or the
operation of the tablet press. It might also be a combination of these factors.
During the compression, air entrapment occurs in the concave cup of the punch face. The deeper
the cup, the more likely it is to trap air. This trapped air creates a soft area on the very top of the
tablet.
New punches are more likely to entrap air than used punches simply because of their tighter
clearances. Tight clearances are good, but they can cause air to escape more slowly during
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compression. With the old tooling, air escapes more quickly so particle to- particle bonding is
more likely.
Sticking occurs when granules attach themselves to the faces of tablet press punches. Picking is a
more specific term that describes product sticking only within the letters, logos, or designs on the
punch faces. Regardless whether it's sticking or picking, the result is a defective tablet.
Sticking and picking can be prevented by appropriate use of lubricants and binders.
3. Mottling:
It is an unequal distribution of colors on a tablet with light and dark areas on tablet surface. This
could be due to use of a drug whose color differs from that of the tablet excipients, or use of a
drug whose dehydration products are colored. Colorants or dry colour additives could be added
to remedy the problem. Alternately, the solvent system could also be changed if necessary.
4. 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.
5. Double Impression:
This involves only punches that have monogram or engraving. If the monogram is present in
upper punch, slight rotation of punch after precompression produces double impression. If
monogram present in lower punch after compression is over lowered punch moves slightly
downward tofree the tablet and produces doubleimpression. This problem can be overcomeby
using non-rotating cam track.
6. Weight Variation:
Variation of tablet weight also causes variation of active medicament which changes the
bioavailability.
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Causes:
(a) Granule size & size distribution: Variations in the ratio of small to large granules and
difference in granule size determines how the void spaces between particles are filled. Since
volume of die cavity remains same, different proportions of large and small particles may change
the weight of fill in each die.
(b) Poor Flow: The die fill process is based on a continuous and uniform flow of granules from
the hopper through the feed frame. When the granulation does not flow uniformly some dies are
incompletely filled. Dies are also not filled properly when machine speed is in excess of
granulations flow capability. With poor flow the addition of a glidant such as talcum or colloidal
silica may be helpful. Cams are made of Phosphor Bronze, Teflon and OHNS. This Material of
Construction of various cams are carefully chosen to take into consideration the forces acting on
the punch head.
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VIII. Recent Advances:
The market for tablet compression technology and demands placed on equipment manufacturers
have changed quite significantly in recent years. Although the operating principle and
fundamental design of the rotary tablet press have not changed for decades, multiple machine
design improvements have been developed and implemented by various suppliers.
Advancements are basically focused
To reduce cost and lead time To increase productivity, flexibility and safety performance
1.Exchangeable Turret:Initial emphasis of innovation was on reducing the amount of time for machine cleaning and
product changeover. The first significant change was the exchangeable turret introduced to the
market by Fette in the early 1990s.
The entire turret, including punches and dies, can be easily removed from the machine and
replaced with a duplicate turret.
Benefits of Exchangeable turret:
Offers great flexibility with regard to tooling types that can be used in the same machineLimitations:
The complex inside of the tablet press still needed to be cleaned.Therefore, openness of structure and accessibility were further improved by Korsch in its XL
ranges.
2.Centrifugal Die Filling:IMA came up with a revolutionary design without exchangeable turret but with centrifugal die
filling and Clean-In-Place capability.
Main Features were
Complete separation between Mechanical parts and processing areas. Accurate feeding of the dies through specially shaped radial channels. Maximum protection of product against any variation and maximum operator safety.
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3.Exchangeable Compression Module (ECM):In early 2000, GEA Courtoy introduced the Exchangeable Compression Module (ECM), a
concept that made extremely fast product changeover possible. Exchangeable CompressionModule (ECM) concept is a tremendous improvement on the exchangeable turret concept It
offers very high containment with incomparable productivity and flexibility for tablet
compression.No machine cleaning is required, as all product contact parts and powder residues
are encapsulated in and removed with ECM. A duplicate clean ECM can be installed in the
machine in just 15 minutes.
Fig 7: Exchangeable Compression Module
4.Exchangeable Die Disc:The middle part of the turret holding the dies are removed manually and quickly replaced by a
duplicate die disc. It takes less than 30 minutes. This is a more economical alternative to the
exchangeable turret. Only the die disc needs to be duplicated instead of Sthe entire turret.
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Fig 8: Exchageable Die Disc
5.Exchangeable Die Disc with Die Shells:The die shells have extremely simple cylindrical design. The die shells are locked in the die disc
with a simple conical clamping mechanism. A dedicated tool allows installing and dismantling of
die shells.
Benefits:
Increased output up to 50% due to increased numbers of punch positions Increased yield Reduced damage to the tooling Reduced tooling investment and maintenance design of die shell
6.Compression to Equal Force Technology:Compression to equal force (EF) is a new concept that allows tablets to be compressed at the
same peak compression force, independent of tablet weight. This method relies on air
compensator. The air compensator is installed at the precompression and main compression
stations. Because the surface of the cylinder and the air pressure are constant, the force is also
constant. Tablets compressed under equal force technology has the benefit of more consistent
density, tensile strength and disintegration rate than tablets compressed to equal thickness.
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Fig 9: Compression to equal Thickness versus Equal Force
7.Multi Tip Tooling:Multi tip tooling has the following benefits:
Significantly increases tablet production Decreases press run time Decreases tool cleaning time Minimizes assembly time Reduces operating costs
Fig 10: Multi Tip Tooling
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8.Multi Layer Tablet Press:Multi Layer Tablet press accurately measures low compression forces. It accurately samples
layers and prevents layer contamination.
9.External Spray Lubrication:Lubricants are applied to punch tips and die walls and at the tablet surfaces. Lubricants are
sprayed into the press with compressed air or in a solution. 0.005% - 0.05% typically resolves
picking/sticking problems and die wall friction. This technique has the benefit in reducing
tooling wear and in rapid disintegration and formation of stronger tablets. But the process
becomes less sensitive to changes in API.
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IX. Recommendations:
Pharmaceutical Industry can achieve increase in operational efficiency through higher speeds,
faster cleaning and product changeover, and fully automatic unmanned operation. Flexibility
should also be developed further as the complexity of tablets increases, with the emergence of
special tablets, such as multiple-layer tablets and core-coated tablets.
But most of all, future developments should focus on advanced process control to guarantee
improved and constant tablet quality. This is one of the basic requirements to help realise two
crucially important new concepts, which will shape the future of solid dosage production:
continuous processing and real-time release. The implementation of new control strategies and
the implementation of new types of sensors into tablet presses are vital means to this end. All the
advancements in tablet compression machine should result in tablet of high quality, desired
hardness, friability, weight, disintegration and finally dissolution. With the advent of promising
new devices such as NIR sensors, progress is being made, but these are just the early stages of
the new developments that are required.
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X. Summary:
Compaction is an integral step for the manufacture of tablets, and it is pertinent to understand the
underlying physics of compaction. Complete understanding of compaction physics still eludes
us, many variables such as inherent deformation behavior of drugs/excipients, solid-state
properties, and process parameters are known to affect the final attributes of tablets. A due
consideration to the variables of compaction process, can aid a pharmaceutical scientist to design
optimum formulation devoid of problems such as capping, lamination, picking, and sticking.
Availability of sophisticated tableting instrumentations has catalyzed the understanding of
process, and the generation of compaction profiles such as force-time profile, force-displacement
profile, and pressureporosity relationships can help in deciphering the dynamics of the process.
The compactibility of the drugs, especially in case of high dose systems, is critical for successful
manufacturing of tablets. An appreciation of the contribution of tableting excipients to the
compaction behavior of the tablet-matrix can enable science-based selection of excipients.
Similarly, optimization of process parameters such as granulation, moisture content, and rate and
magnitude of force transfer, can help in achieving satisfactory tensile strength and desired
biopharmaceutical properties in tablet drug products.
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XI. References:
1. Lachman, L., Lieberman, H. A. The Theory & Practice of Industrial Pharmacy, SpecialIndian Edition 2009, 346 - 372.
2. Aulton, M. E., Pharmaceutics: The Science of Dosage Form Design. 3rd Edition.Churchhill Livingstone Elsevier, 2002, 500-513
3. Remington the science and practice of pharmacy , 20 th edition, volume 1 , Indian edition,Lippincott William's & Wilkins
4. S. Patel et.al. Compression Physics in the formulation development, Critical Reviews inTherapeutic Drug Carrier Systems, 23(1):1-65, 2006
5. Mudbidri Ashish, Tablet Compression Principles, Pharma Time- Vol. 42- No.11, Nov.2010
6. Natoli Dale, Progression in Tablet Compression, European Industrial Pharmacy, Issue 11,Dec. 2011
7. Allenspach Carl, Recent Advances in Tablet Compaction Technology, NJPhAST, April,2011
8. Vogeleer Jan, Tablet Compression: Changing trends, more demands, PharmaceuticalTechnology Europe, Jun 1, 2010
9. Evelghem. V. Johan, Improving Tablet Quality with Compression to Equal ForceTechnology, Pharmaceutical Technology, May 1, 2008
10.http://www.gea-ps.com/npsportal/cmsdoc.nsf/WebDoc/webb85zbwt