TABLET PROCESSING PROBLEMS
AND ITS REMEDIES
Presented By: Sanjay Kumar Yadav
M.Pharm-Pharmaceutics(I/I)
Background
An
ideal tablet should be free from
any visual defect or functional
defect.
With
the
development
of
technology, the production process
had become more simplified and
more mechanized.
Background
In
olden days tablets were initially
punched on small scale with hand
operated machines, which suffered the
problem of varied strength and
integrity.
But now the tablet punching machines
are all mechanized, the mechanical
feeding of feed from the hopper into
the die, electronic monitoring of the
press, but tablet process problem still
persist.
Background
An
industrial
pharmacist
usually
encounters number of problems during
manufacturing.
Majority
of visual defects are due to
inadequate fines or inadequate moisture in
the granules ready for compression or due
to faulty machine setting.
Functional defects are due to faulty
formulation.
Background
Weight Variation
Mechanical
Content
Release
Profile
Uniformity
Strength
Altered
Related
Background
The
Imperfections
known
as:
VISUAL DEFECTS
are either
related to Imperfections in any one or
more of the following factors[1]:
I.
Formulation design
II.
Tableting process
III.
Machine
Capping
Process
related
Lamination
Cracking
Chipping
Visual
defects
Formulatio
n related
Sticking
Picking
Binding
Machine
related
Double
impression
The defects related to Tableting
Process..
CAPPING:
LAMINATION:
Separation of tablet into two or more layers due to airentrapment in the granular material[1,2,5].
CRACKING:
Partial or complete separation of the top or bottom of tablet
due to air-entrapment in the granular material[1,2,3,5].
Small, fine cracks observed on the upper and lower central
surface of tablets, or very rarely on the sidewall[1].
CHIPPING:
Breaking of tablet edges[1].
The defects related to
Formulation..
STICKING:
The adhesion of granulation material to the die
wall[1,2,4,5].
PICKING:
The removal of material from the surface of
tablet and its adherence to the face of punch[1,2,4,5].
BINDING:
Sticking of the tablet to the die and does not
eject properly out of the die[1].
The defect related to Machine..
DOUBLE
Due
IMPRESSION:
to free rotation of the punches,
having some engraving on their faces[1,2].
The defect related to more than one
factor..
MOTTLING:
Unequal
distribution of color on a tablet with
light or dark areas.[1,2]
Further, in
this section, each problem is
described along with its
causes
and remedies which may be related to
either of formulation or of machine.
Capping
The
upper or lower segment of the tablet separates
horizontally, either partially or completely from the
main body and comes off as a cap, during ejection from
the tablet press, or during subsequent handling.
Reason:
Due to the airentrapment in a compact during compression,
and subsequent expansion of tablet on ejection of a tablet
from a die.
Fig: Capping
[1]
The Causes and Remedies of Capping related to
Formulation
The Causes and Remedies of Capping related to
Machine
Lamination
Separation
of a tablet into two or more distinct
horizontal layers.
Reason:
Airentrapment
during
compression
subsequent release on ejection.
The
and
condition is exaggerated by higher speed of
turret.
Fig: Lamination[1]
The Causes and Remedies of Lamination related to
Formulation
The Causes and Remedies of
Machine
Lamination related to
Chipping
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.
The Causes and Remedies of Chipping related to
Formulation
The Causes and Remedies of Chipping related to
Machine
Cracking
Small, fine cracks observed on the upper
and lower central surface of tablets, or very
rarely on the sidewall are referred to as
Cracks.
Reason:
It is observed as a result of rapid expansion of
tablets, especially when deep concave punches
are used.
The Causes and Remedies of Cracking related to
Formulation
The Causes and Remedies of Cracking related to
Machine
Sticking
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
granules.
Fig: Sticking on punch face[6]
The Causes and Remedies of Sticking related to
Formulation
The Causes and Remedies of Sticking related to
Machine
Picking
Small
amount of material from a tablet is sticking to and
being removed off from the tablet-surface by a punch
face.
The problem is more prevalent on the upper punch faces
than on the lower ones.
Fig: Picking[1]
Picking
Reason:
Picking is of particular concern when
punch tips have engraving or embossing
letters.
Granular material is improperly dried.
The Causes and Remedies of Picking related to
Formulation
The Causes and Remedies of Picking related to
Machine
Binding
Sticking
of the tablet to the die and does not eject
properly out of the die.
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 and/or use of worn dies.
The Causes and Remedies of Binding related to
Formulation
The Causes and Remedies of Binding related to
Machine
Mottling
Unequal
distribution of color on a
tablet, with light or dark spots.
Reason:
Colored
drug, whose color differs from
the color of excipients used for
granulation of a tablet.
The Causes and Remedies of
Mottling
Double Impression
Involves
only those punches, which have a
monogram or other engraving on them.
If
the upper punch is uncontrolled, it can
rotate during the short travel to the final
compression stage and create a double
impression.
Double Impression
Reason:
At the moment of compression, the tablet receives
the imprint of the punch.
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 double impression.
The Causes and Remedies of Double Impression
Reference
1.
http://www.authorstream.com/Presentation/sabapathi-369361-problemstablet-manufacturing-science-technology-ppt-powerpoint/2007
2.
Leon lachman, H. A. (2009). The Theory and Practice of Industrial
Pharmacy. New Delhi: CBS Publishers and Distributors, 311-314.
3.
B.C. Hancock, A. M. (2006). Numerical and experimental investigation of
capping mechanisms during pharmaceutical tablet compaction. Science
Direct , 121-128.
4.
Tousey, M. D. (2003). Tablet Press operation. Techceuticals , 1-7.
5.
Tousey, M. D. (2011). The Manufacturing process Tablet and Capsules
Manufaturing. Techceuticals , 10-11.
6.
http://upload.wikimedia.org/wikipedia/en/2/27/Tabletfailure.jpg
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