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1.CAPPING: 1.

CAPPING
Capping is the term used, when the upper or lower segment of the tablet separates
horizontally, either partially or completely from the main body of a tablet and
comes off as a cap, during ejection from the tablet press, or during subsequent
handling. Reason : Capping is usually due to the air entrapment in a compact durin
g compression, and subsequent expansion of tablet on ejection of a tablet from a
die.
REMEDIES: REMEDIES S.No . Causes Remedies 1. Fines in granulation Remove some or
all fines through 100-200 mesh screen. 2. Too dry or very low moisture content
(leading to loss of proper binding action). Moisten the granules suitably. Add h
ygroscopic substance e.g.: sorbitol , methyl- cellulose or PEG-4000. 3. Not thor
oughly dried granules Dry the granules properly.
REMEDIES: REMEDIES S. No. Causes Remedies 4. Insufficient amount of binder or im
proper binder. Adding dry binder such as pre-gelatinized starch, gum acacia, pow
dered sorbitol, PVP, hydrophilic silica or powdered sugar. 5. Insufficient or im
proper lubricant. Increase the amount of lubricant or change the type of lubrica
nt.
REMEDIES: REMEDIES S. No. Causes Remedies 6. Granular mass too cold to compress
firm. Compress at room temperature. 7. Deep concave punches or beveled-edge face
s of punches. Use flat punches. 8. Poorly finished dies Polish dies properly. In
vestigate other steels or other materials.

2.LAMINATION: 2.LAMINATION
Lamination is the separation of a tablet into two or more distinct horizontal laye
rs. Reason: Air entrapment during compression and subsequent release on ejection.
The condition is exaggerated by higher speed of turret.
REMEDIES: REMEDIES S.No . Causes Remedies 1. Oily or waxy materials in granules.
Modify mixing process. Add adsorbent or absorbent. 2. Too much of hydrophobic l
ubricant e.g.: Magnesium- stearate . Use a less amount of lubricant or change th
e type of lubricant. 3. 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°.

3.CHIPPING: 3.CHIPPING
Chipping is defined as the breaking of tablet edges, while the tablet leaves the
press or during subsequent handling and coating operations. Reason: Incorrect ma
chine settings.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Sticking on punch faces. Dry the g
ranules properly or increase lubrication. 2. Too dry granules. Moisten the granu
les to plasticize. Add hygroscopic substances. 3. Too much binding causes chippi
ng at bottom. Optimize binding, or use dry binders.

4.CRACKING: 4.CRACKING
Small, fine break marks observed on the upper and lower central surface of tabl
ets, or very rarely on the sidewall are referred to as Cracks . Reason: It is obser
ved as a result of rapid expansion of tablets, especially when deep concave punc
hes are used.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Large size of granules. Reduce gran
ule size. Add fines. 2. Too dry granules. Moisten the granules properly and add
proper amount of binder. 3. Tablets expand. Improve granulation. Add dry binders
.
REMEDIES: REMEDIES S.No . Causes Remedies 4. Granulation too cold. Compress at r
oom temperature. 5. Tablet expands on ejection due to air entrapment. Use tapere
d die.

5.STICKING: 5.STICKING
Sticking refers to the tablet material adhering to the die wall. Filming is a slo
w form of sticking and is largely due to excess moisture in the granulation. Rea
son: Improperly dried or improperly lubricated granules.
REMEDIES: REMEDIES S.No . Causes Remedies 1. Granules not dried properly. Dry th
e granules properly. Make moisture analysis to determine limits. 2. Too little o
r improper lubrication. Increase or change lubricant. 3. Hygroscopic granular ma
terial. Modify granulation and compress under controlled humidity.
REMEDIES: REMEDIES S. No. Causes Remedies 4. Oily or waxy materials. Modify mixi
ng process. Add an absorbent. 5. Too soft or weak granules. Optimize the amount
of binder and granulation technique. 6. Too much binder Reduce the amount of bin
der or use a different type of binder.

6.PICKING: 6.PICKINg
Picking is the term used when a small amount of material from a tablet is stickin
g 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. Reason: Picki
ng is of particular concern when punch tips have engraving or embossing letters,
as well as the granular material is improperly dried.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Excessive moisture in granules. Dry
properly the granules. 2. Too little or improper lubrication. Increase lubricat
ion; use colloidal silica so material does not cling to punch faces. 3. Too much
amount of binder. Reduce the amount of binder, change the type or use dry binde
rs.
REMEDIES: REMEDIES S. No. Causes Remedies 4 Low melting point substances, may so
ften from the heat of compression and lead to picking. Add high melting-point ma
terials. Use high meting point lubricants. 5. Low melting point medicament in hi
gh concentration. Refrigerate granules and the entire tablet press.

7.BINDING: 7.BINDING
Binding in the die, is the term used when the tablets adhere, seize or tear in
the die. A film is formed in the die and ejection of tablet is hindered. With ex
cessive binding, the tablet sides are cracked and it may crumble apart. Reason:
Binding is usually due to excessive amount of moisture in granules, lack of lubr
ication and/or use of worn dies.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Too moist granules and extrudes aro
und lower punch. Dry the granules properly. 2. Insufficient or improper lubrican
t. Increase the amount of lubricant or use a more effective lubricant. 3. Too co
arse granules. Reduce granular size, and increase the quantity of lubricant.

8.MOTTLING: 8.MOTTLING
Mottling is the term used to describe an unequal distribution of colour on a table
t, with light or dark spots standing out in an otherwise uniform surface. Reason
: One cause of mottling may be a coloured drug, whose colour differs from the co
lour of excipients used for granulation of a tablet.
REMEDIES: REMEDIES S.No . Causes Remedies 1. A coloured drug used with white or
colourless excipients Use appropriate colourants. 2. A dye migrates to the surfa
ce of granulation while drying. Change the solvent system, Change the binder, Re
duce drying temperature. 3. Improperly mixed dye, during Direct Compression . Mix p
roperly and reduce size if it is of a larger size to prevent segregation.

9.DOUBLE IMPRESSION: 9.DOUBLE IMPRESSION


Double Impression involves only those punches, which have a monogram or other eng
raving on them. Reason: At compression, the tablet receives the imprint of the p
unch. On some machines, the lower punch freely drops and travels uncontrolled fo
r a short distance before riding up the ejection to push the tablet out of the d
ie, 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 Impres
sion .
REMEDIES: REMEDIES S.No . Causes Remedies 1. Free rotation of either upper punch
or lower punch during ejection of a tablet. Use keying in tooling, i.e. insert
a key alongside of the punch, so that it fits the punch and prevents punch ro
tation. Newer presses have anti-turning devices, which prevent punch rotation.

PROCESSING PROBLEMS & REMEDIES FOR TABLET COATING: PROCESSING PROBLEMS & REMEDIE
S FOR TABLET COATING Blistering. Chipping. Cratering . Pitting Blooming Blushing
. Picking. Colour variation. Orange peel / Roughness.

1.BLISTERING: 1.BLISTERINg
It is local detachment of film from the substrate forming blister. Reason: Entr
apment of gases in or underneath the film due to overheating either during spray
ing or at the end of the coating run.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Effect of temperature on the streng
th, elasticity and adhesion of the film. Use mild drying condition.

2.CHIPPING: 2.CHIPPING
It is defect where the film becomes chipped and dented, usually at the edges of
the tablet. Reason : Decrease in fluidizing air or speed of rotation of the dru
m in pan coating.
REMEDIES: REMEDIES S. No. Causes Remedies 1. High degree of attrition associated
with the coating process. Increase hardness of the film by increasing the molec
ular weight grade of polymer.

3.CRATERING: 3.CRATERING
It is defect of film coating whereby volcanic-like craters appears exposing the
tablet surface. Reason: The coating solution penetrates the surface of the tabl
et, often at the crown where the surface is more porous, causing localized disin
tegration of the core and disruption of the coating.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Inefficient drying. Use efficient a
nd optimum drying conditions. 2. Higher rate of application of coating solution.
Increase viscosity of coating solution to decrease spray application rate.

4.PICKING: 4.PICKING
It is defect where isolated areas of film are pulled away from the surface when
the tablet sticks together and then part. Reason: Conditions similar to crateri
ng that produces an overly wet tablet bed where adjacent tablets can stick toget
her and then break apart.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Inefficient drying. Use optimum and
efficient drying conditions or increase the inlet air temperature. 2. Higher ra
te of application of coating solution. Decrease the rate of application of coati
ng solution by increasing viscosity.

5.PITTING: 5.PITTING
It is defect whereby pits occur in the surface of a tablet core without any visi
ble disruption of the film coating. Reason: Temperature of the tablet core is gr
eater than the melting point of the materials used in the tablet formulation.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Inappropriate drying (inlet air ) t
emperature. Modifying the drying (inlet air) temperature such that the temperatu
re of the tablet core is not greater than the melting point of the batch of addi
tives used.
6.BLOOMING: 6.BLOOMING
It is defect where coating becomes dull immediately or after prolonged storage
at high temperatures. Reason: It is due to collection on the surface of low mole
cular weight ingredients included in the coating formulation .
REMEDIES: REMEDIES S. No. Causes Remedies 1. High concentration and low molecula
r weight of plasticizer. Decrease plasticizer concentration and increase molecul
ar weight of plasticizer.

7.BLUSHING: 7.BLUSHING
It is defect best described as whitish specks or haziness in the film. Reason:
It is thought to be due to precipitated polymer exacerbated by the use of high c
oating temperature at or above the thermal gelation temperature of the polymers.
REMEDIES: REMEDIES S. No. Causes Remedies 1. High coating temperature. Decrease
the drying air temperature.
REMDIES: REMDIES S. No. Causes Remedies 2. Use of sorbitol in formulation which
causes fall in the thermal gelation temperature of the Hydroxy Propyl Cellulose,
Hydroxy Propyl Methyl Cellulose, Methyl Cellulose. Avoid use of sorbitol with H
ydroxy Propyl Cellulose, Hydroxy Propyl Methyl Cellulose, Methyl Cellulose and C
ellulose ethers.

8.COLOUR VARIATION: 8.COLOUR VARIATION


A defect which involves variation in colour of the film. Reason : Alteration of
the frequency and duration of appearance of tablets in the spray zone or the si
ze/shape of the spray zone.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Improper mixing, uneven spray patte
rn, insufficient coating, migration of soluble dyes-plasticizers and other addit
ives during drying. Go for geometric mixing, reformulation with different plasti
cizers and additives or use mild drying conditions.

9.ORNAGE PEEL / ROUGHNESS: 9.ORNAGE PEEL / ROUGHNESS


It is surface defect resulting in the film being rough and non glossy. Appearanc
e is similar to that of an orange. Reason: Inadequate spreading of the coating s
olution before drying.
REMEDIES: REMEDIES S. No. Causes Remedies 1. Rapid Drying. Use mild drying condi
tions. 2. High solution viscosity. Use additional solvents to decrease viscosity
of solution.

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