This document summarizes common tablet processing problems including capping, lamination, cracking, chipping, sticking, picking, binding, and double impression. For each problem, the document identifies potential formulation-related and machine-related causes and recommended remedies. It also discusses problems that can occur during tablet coating like blistering, cratering, picking and sticking, pitting, blooming, and color variation as well as their causes and remedies. The document provides a concise overview of common tablet defects and approaches to address them.
COATING PROCESS : PRINCIPLE : Tablet Coating is the process of a coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of solvent . The distribution of coating is accomplished by the movement of tablets either perpendicular or vertical to the application of the coating composition
COATING PROCESS : PRINCIPLE : Tablet Coating is the process of a coating composition to a moving bed of tablets with the concurrent use of heated air to facilitate evaporation of solvent . The distribution of coating is accomplished by the movement of tablets either perpendicular or vertical to the application of the coating composition
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
Tablets are solid dosage forms usually obtained by single or multiple compression of powders or granules. In certain cases tablets may be obtained by molding or extrusion techniques. They are uncoated or coated. Tablets are normally right circular solid cylinders, the end surfaces of which are flat or convex and the edges of which may be bevelled. They may have lines or break-marks (scoring), symbols or other markings.Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, substances capable of modifying the behaviour of the dosage forms and the active ingredient(s) in the gastrointestinal tract, colouring matter authorized by the appropriate national or regional authority and flavouring substances. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s); there must be no incompatibility between any of the components of the dosage form.
Tablets are single-dose preparations intended for oral administration. Some are intended to be swallowed whole, some after being chewed and some after being crushed, some are intended to be dissolved or dispersed in water before being taken and some are intended to be retained in the mouth where the active ingredient(s) is/are liberated.
Granulation process may be defined as a process wherein small particles adhere together by forming bonds between them , resulting in the formation of large aggregates called granules.
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Capping is one of the most complex phenomena in the pharmaceutical industry it is one of the mechanical defects in the tableting process in which catastrophic failure of the compact can occur. Understanding what influences tablet capping in terms of process variables, material properties, and density/stress distributions in tablets and developing specialized techniques to correlate these variables with mechanical failures are practical interests of the pharmaceutical industry. In this presentation, we describe a nondestructive ultrasonic device/methodology to predict the capping tendencies of tablet formulations based on their manufacturing performances.
Tablet processing problems and their remedies ronit ghosh RONIT GHOSH
This Presentation Mainly Consists Of :--------- INTRODUCTION TO TABLETS ; ADVANTAGES & DISADVANTAGES ; TABLET DEFFECTS DURING PROCESSING TIME WITH REMIDIES ; TABLET PROBLEMS DURING COATING WITH REMEDIES
Tablet defects can come from any of the unit operations upstream and from the tablet press. The raw materials may be of poor quality or do not meet specifications, causing excessive fines that lead to a host of defects. The formulation may be the source of defects if the material does not compress well or the processing step specified within the formulation fail to produce a powder with a good flow, compressibility, and ejection properties. The processing and granulation of powder are often the sources of the defect.
Every product behaves differently on a tablet press, even if it‘s the same product run on a different day. The variation often
stems from changes in the properties of the raw materials—active ingredients and excipients- from batch to batch. Naturally,
the goal is to minimize these changes. Tablet press operators, however, don‘t have any control over formulation and
granulation. Tablet specifications are tight, and the list of possible defects is long: Variable weight, sticking, picking, capping, lamination, variable hardness, among others. This article focuses on these variations. It pinpoints the possible causes of these defects and offers advice on preventing and fixing the source of the problems.
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Tablet processing problems and its remedies for poster presemntation
1. TABLET PROCESSING PROBLEMS
AND ITS REMEDIES
BY-KRISHNA PRIYA JHA & HARISH SHARMA
(B.PHARM 2ND YEAR)
Visual
Defects
Process
Related
Capping
Lamination
Cracking
Chipping
Formulation
Related
Sticking
Picking
Binding
Machine
Related
Double
Impression
•Capping
•Capping is the term used, when the upper or
lower segment of the tablet separates horizontally
during ejection from the tablet press, or during
subsequent handling.
Formulation related Machine related
Causes Remedies Causes Remedies
Large amount of fines in
the granulation
Remove some or all fines
through 100 to 200 mesh
screen.
Poorly finished dies Polish dies properly
Low moisture content. Moisten the granules. Deep concave punches. Use flat punches
Insufficient amount of
binder or improper binder.
Increasing or change the
type of binder.
Lower punch remains
below the face of die during
ejection.
Make proper setting of
lower punch during ejection
Insufficient or improper
lubricant.
Increase or change the
type of lubricant.
High turret speed Reduce speed of turret
• Lamination is the separation of a
tablet into two or more distinct
horizontal layers.
•Lamination
Formulation related Machine related
Causes Remedies Causes Remedies
Oily or waxy materials in
granules.
Modify mixing process.
Add adsorbent or
absorbent
Rapid relaxation of the
peripheral regions of a
tablet, on ejection from a
die.
Use tapered dies, i.e.
upper part of the die
bore has an outward
taper of 3° to 5°.
Too much of
hydrophobic lubricant.
Use a less amount of
lubricant or change the
type of lubricant.
Rapid decompression Use pre-compression
step. Reduce turret
speed and reduce the
final compression
pressure.
•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.
Formulation related Machine related
Causes Remedies Causes Remedies
Large size of granules. Reduce granule size. Add
fines.
Tablet expands on ejection
due to air entrapment
Use tapered die.
Too dry granules. Moisten the granules
properly and add proper
amount of binder.
Deep concavities cause
cracking while removing
tablets
Use special take-off
Tablets expand. Add dry binders.
Granulation too cold Compress at room
temperature
•Chipping
•Chipping‘ is defined as the breaking of tablet edges,
while the tablet leaves the press or during subsequent
handling
Formulation related Machine related
Causes Remedies Causes Remedies
Sticking on punch faces Dry the granules properly or
increase lubrication.
Groove of die worn at
compression point
Polish to open end, reverse
or replace the die.
Too dry granules. Moisten the granules Barreled die (center of the
die wider than ends)
Polish the die to make it
cylindrical
Too much binding causes
chipping at bottom.
Optimize binding, or use dry
binders.
Edge of punch face turned
inside/inward
Polish the punch edges
Concavity too deep to
compress properly
Reduce concavity of punch
faces. Use flat punches.
•Sticking
•Sticking refers to the tablet material
adhering to the die wall.
Formulation related Machine related
Causes Remedies Causes Remedies
Granules not dried
properly
Dry the granules properly Concavity too deep for
granulation
Reduce concavity to
optimum
Too little or improper
lubrication
Increase or change
lubricant
Too little pressure Increase pressure
Too much binder Reduce or use another
binder.
Compressing is too fast. Reduce speed
Oily or way materials Modify mixing process.
Add an absorbent
Too soft or weak granules Optimize the amount of
binder•Picking is a more specific term that describes
product sticking only within the letters, logos, or
designs on the punch faces.
•Picking
Formulation related Machine related
Causes Remedies Causes Remedies
Granules not dried properly Dry the granules properly Rough punch faces Polish faces
Too little or improper lubrication Increase or change lubricant Dividing line is too
deep
Reduce depths
Low melting point substances, may soften
from the heat of compression.
Use high meting point lubricants. Pressure applied is
not enough
Increase
pressure to
optimum
Low melting point medicament in high
concentration.
Refrigerate granules and the
entire tablet press.
Too warm granules when compressing Cool sufficiently before
compression.
Too much amount of binder Reduce or change binder.
•Binding
•Sticking of the tablet to the die and does
not eject properly out of the die
Formulation related Machine related
Causes Remedies Causes Remedies
Too moist granules. Dry the granules properly. Poorly finished dies. Polish the dies properly.
Insufficient or improper
lubricant.
Increase or change
lubricant
Rough dies due to
abrasion, corrosion.
Investigate other steels.
Too coarse granules. Reduce granular size. Undersized dies Rework to proper size.
Too hard granules for the
lubricant to be effective.
Modify granulation. Reduce
granular size.
Too much pressure in the
tablet press.
Reduce pressure.
Granular material too
warm.
Reduce temperature.
•Mottling is the term used to describe an unequal
distribution of colour on a tablet.
•Mottling
Causes Remedies
A coloured drug used along with colourless or white-
coloured excipients.
Use appropriate colourants.
A dye migrates to the surface of granulation while drying.
Change the solvent system, Change the binder,
Reduce drying temperature and Use a smaller particle
size.
Improperly mixed dye, especially during ‘Direct
Compression’.
Mix properly and reduce size if it is of a larger size to
prevent segregation.
Improper mixing of a coloured binder solution.
Incorporate dry colour additive during powder blending
step, then add fine powdered adhesives such as acacia
and tragacanth and mix well and finally add granulating
liquid.
•Problems and remedies for tablet coating
Problem Definition Causes Remedy
BLISTERING It is local detachment of film from
the substrate forming blister.
Effect of temperature on
the strength, elasticity and
adhesion of the film.
Use mild drying condition.
CRATERING
It is defect of film coating
whereby volcanic-like craters
appears exposing the tablet
surface
Inefficient drying.
Higher rate of application
of coating solution.
Use efficient and optimum
drying conditions.
Increase viscosity of
coating solution to
decrease spray application
rate.
PICKING AND
STICKING
It is It is defect where isolated
areas of film are pulled away
from the surface when the tablet
sticks together or to the pan and
then detached from one another
or from the pan.
Inefficient drying.
Higher rate of application
of coating solution.
Increase the inlet air
temperature
Decrease the rate of
application of coating
solution.
PITTING
It is defect whereby pits occur in
the surface of a tablet core without
any visible disruption of the film
coating
Inappropriate drying (inlet
air ) temperature
Increase the drying (inlet
air) temperature
BLOOMING
It is defect where coating becomes
dull immediately or after prolonged
storage at high temperatures
High concentration and
low molecular weight of
plasticizer.
Decrease plasticizer
concentration and
increase molecular weight
of plasticizer.
COLOR
VARIATION
A defect which involves variation in
colour of the film.
Improper mixing, uneven
spray pattern, insufficient
coating, migration of
soluble dyes-plasticizers
and other additives during
drying.
Go for geometric mixing,
reformulation with
different plasticizers and
additives or use mild
drying conditions.