1 Pharmaceutics

Problems in Tablet Manufacturing and Tablet

Coating

Tablet Mfg Sugar Coating Film Coating

Binding Chipping of coating Pickings
Sticking Cracking Orange
peel( Roughness)
Picking Twinning Edge wear- Chipping
Filming Mottling-Uneven color Film Cracking
Capping Blooming Intagliations
Lamination Sweating Film peeling
Chipping Marbling In filling of logos
Cracking Blistering
Weigh variation Hazing dull/ dull film
Blushing
Cratering
Pitting

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
2 Pharmaceutics

Sugar Coating
1] CHIPPING OF COATINGS:
• Sugar coating are inherently brittle and thus prone to chipping if
mishandled.
• Addition of small quantities of polymers(such as cellulosic, polyvinyl
pyrrolidone, acacia, or gelatin) to one or more of the various coating
formulations often help to improve structural integrity, and thus
reduces chipping problems.
• Excessive use of insoluble fillers and pigments tends to increase the
brittleness of sugar coatings, and thus should be avoided where
possible.

2] CRACKING OF THE COATING:

• Tablet cores that expand, either during or after coating, are likely to
cause the coating to crack.
• Such expansion may result from moisture absorption by the tablet
core, or may be caused by stress relaxation of the core after
compaction (a phenomenon which is known to occur, for example, with
ibuprofen).
• Moisture absorption can be minimized by appropriate use of a seal
coat, whereas expansion due to post compaction stress relaxation can
be resolved by extending the time between the compaction event and
commencement of sugar coating.

3] NONDRYING COATINGS:
• Inability to dry sugar coating properly special those based on sucrose
is often an indicator that excessive levels greater than 5% of invert of
invert sugar is present.
• Inversion of sucrose is exacerbated by keeping sucrose syrups at
elevated temperatures under acidic conditions for extended period of
time.
• Such conditions occur when sugar coating solutions containing
aluminum lakes are kept hot for too long or such sugar coating
formulations are constantly being reheated to redissolve sugar that is
beginning to crystallize out

4] TWINNING (OR BUILD UP OF MUTIPLES) .

• Sugar coating formulations are very sticky, particularly as they begin
to dry and allow adjacent tablets to stick together.
• Buildup of multiples really becomes a problem when the tablets being
coated have falt surfaces which can easily come into contact with one
another.

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
3 Pharmaceutics

• This can be particularly troublesome with high dose, capsule shaped

tablets that have high edge walls.
• Appropriate choice in tablet punch design can be effectively used to
minimize the problem.

5] UNEVEN COLOUR.:
Because it has a major impact on final tablet appearance, the color coating
stage of the sugar coating process is critical to ultimate tablet quality.
Uneven distribution of color, particularly with darker colors, is often visually
apparent, and thus a major cause of batch rejection. Many factors may
contribute to this type of problem, including:
• Poor distribution of coating liquids during application. This may be
caused by poor mixing of tablets in the coating process, failure to add
sufficient liquid to coat completely the surface of every tablet in the
batch.
• Color migration of water soluble dyes while the coating is drying.
• Unevenness of the surface of the sub coat when using dye colored
coatings. This unevenness causes a variation in thickness of the
transparent color layer that is perceived as different color intensities.
• “Washing back” of pigment colored color coatings. While pigments do
not migrate on drying, if excessive quantities of coating liquid are
applied during the coloring process, there is a tendency for the
previously applied(and dried) color layers to be redissolved and
distributed non uniformly; thus giving rise to no uniform appearance.
This problem is particularly noticeable for formulations predominantly
colored with aluminum lakes where the level of pacifying pigments
(such as titanium dioxide) is low.
• Excessive drying between color applications. This can cause erosion of
color layer and contributes to unevenness in color coat.
•
Sr.
CAUSE REMEDY
No.
Improper mixing, uneven spray pattern, Go for geometric mixing, reformulation
1. insufficient coating, migration of soluble dyes- with different plasticizers and additives or
plasticizers and other additives during drying. use mild drying conditions.

6] “BLOOMING AND SWEATING”:

• Residual moisture (in finished sugar coated tablets) can often be a
problem. Over a period of time, this moisture can diffuse out and
affect the quality of product. Moderate levels of moisture egress cause
the polish of product to take on a fogged appearance, a phenomenon
often termed as blooming.

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
4 Pharmaceutics

• At higher levels the moisture may appear like beads of perspiration on

the tablet surface. This second phenomenon, often called sweating,
can be much more serious, since tablets stored in closed containers
will ultimately stick together.

7] “MARBLING”:
• One of the secrets of achieving a high quality, sugar coated product is
to assure that color is uniformly distributed in the color layer, and at
the same time at the end of the application of the color coating that a
smooth coating surface is obtained.
• Failure to achieve the requisite smoothness often results in marbled
appearance on polishing. This problem occurs as a result of collection
of wax in the small surface depressions of a rough coating and is
particularly evident with darker colors.
FILM COATED TABLETS
1] PICKING:
Picking results when, for example the coating on two adjacent tablets is not
sufficiently dry before contact between them occurs. Because the partially
dried coating can be extremely tacky, once the two tablet make contact they
adhere to one another only to break apart later (under the influence of
attrition ) once the coating has dried. In extreme cases, tablets with flat
faces or flat edges (as with capsule shaped tablets that have thick side walls)
may become permanently glued together so that twinning (or the build up of
multiples) occurs.

Certain types of coating formulations (e.g. those based on

hydroxypropylcellulose, many of the enteric-coating formulations, and
several of the acrylic aqueous latex-coating system) are inherentely tackier
during application, and are thus more likely to create the conditions under
which picking occurs.

Sr.
CAUSE REMEDY
No.
Use optimum and efficient drying conditions or
1. Inefficient drying.
increase the inlet air temperature.
Higher rate of Decrease the rater of application of coating
2. application of coating solution by increasing viscosity of coating
solution solution.

2] “Orange peel” (Roughness):

• For a successful film coating process, it is critical that the droplets of
coating liquid dry (at least to the point of being tack-free) very soon
after they make contact with the surface of the product being coated.

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
5 Pharmaceutics

• Consequently, almost all film-coated tablets exhibit a characteristic

known as orange peel (so-called because of a resemblance to skin of
an orange). Optimized coating processes will allow this characteristic
to keep to a minimum such that it is not readily visible to the naked
eye.
• Certain process conditions, however, are likely to cause this inherent
roughness to become visible. Such process conditions include low
spray rates coupled with excessive drying conditions (high processing
temperatures and air flows) and use of excessive atomizing air
pressures (for air sprays system) which accentuate premature drying
of the droplets of coating liquid.
• The problem may also be compounded by attempting to spray coating
liquids with excessively high viscosities such that optimal atomization
is difficult to achieve.

Sr.
CAUSES REMEDIES
No.
1. Rapid Drying Use mild drying conditions
High solution Use additional solvents to decrease viscosity
2.
viscosity of solution.
3] Edge Wear (chipping)
Since Tablet edges are often exposed most to the attritional effects, fracture
at this point is common and results in parts of the tablet surface being
exposed. Cause of this problem includes:
• Tablets core having high friability values.
• Worn tablet punches (that produce “flashing” on the tablet edges).
• Minor lamination problems (with the tablet cores) that exacerbate
edge erosion problems.
• Brittle film coatings that offer insufficient protection to tablet edges.

4] Film Cracking\Splitting:
• Cracking of film coatings occur when the internal stress (that develops
within the coating on drying) exceeds the tensile strength of that
coating.
• These problems are totally unacceptable for products where the
applied coating is a major factor in modifying drug-release
characteristic.
• While cohesive failure is often associated with brittleness of the
coating, the problem is certainly exacerbated by thermal expansion
effect particularly when significant differences exist between the
thermal expansion coefficients for core and coating respectively.

5] Bridging of Logos (Intagliations):

• Internal stress is also a major causative factor in logo bridging.

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
6 Pharmaceutics

• This phenomenon occurs when a competent of the internal stress

becomes sufficiently high so as to cause partial or complete
detachment of the coating (from the substrate) in the region of the
logo.
• As a result of detachment, the film is able to “shorten” and thus
partially relieve the stress within the film. In doing so, legibility of the
logo can be significantly reduced. Typically this type of problem
becomes progressively worse as more coating is gradually applied
during the process.
 Solutions to bridging involve improving film adhesion and/or reducing
stress within the film, and usually require some reformation of either
the tablet core or the coating. In addition, appropriate design of tablet
punches (especially with respect to the logo) may help to alleviate the
problem, whereas adjustment of process conditions may prove
beneficial.

6] Film peeling:
On occasion (particularly during application of aqueous coating
formulations), if cohesive failure of the coating occurs, that coating may
subsequently peel back from the surface of the substrate. While both
cohesive and adhesive failures are implicated here, appropriate solutions
typically involve addressing the initial cracking problem by increasing the
mechanical strength of the coating.

7] In filling of logos:
• While visually similar to bridging, in filling of logos typically occurs
during the spray application of aerated aqueous film –coating
solutions.
• When a foaming coating solution impinges on a regular part of the
tablet surface it will, under the shear forces generated, form a film with
“normal “characteristics.
• However those droplets of coating liquid that reside in the logo , being
protected from the shear forces at the surface , gradually dry to form a
solid foam that eventually obliterates the legend .

Sr.
CAUSE REMEDY
No.
Bubble or foam formation because of Add alcohol or use spray nozzle
1.
air spraying of a polymer solution capable of finer atomization.

8] Cratering:

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
7 Pharmaceutics

Definition: It is defect of film coating whereby volcanic-like craters appears

exposing the tablet surface.
Reason: The coating solution penetrates the surface of the tablet, often at
the crown where the surface is more porous, causing localized disintegration
of the core and disruption of the coating.

Sr. CAUSES REMEDIES

No.
Inefficient drying. Use efficient and optimum drying
1.
conditions.
Higher rate of application of Increase viscosity of coating solution to
2.
coating solution. decrease spray application rate.

9] Blistering:
When coated tablets require further drying in ovens, too rapid evaporation of
the solvent from the core and the effect of high temperature on the
strength. elasticity and adhesion of the film may result in blistering.

Sr.
CAUSE REMEDY
No.
Effect of temperature on the strength, elasticity and Use mild drying
1.
adhesion of the film. condition.

10] Blushing:
Definition: 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 coating temperature at or above the thermal gelation
temperature of the polymers.

Sr.
CAUSES REMEDIES
No.
Decrease the drying air
1. High coating temperature
temperature
Use of sorbitol in formulation which causes Avoid use of sorbitol with
largest fall in the thermal gelation Hydroxy Propyl Cellulose,
2. temperature of Hydroxy Propyl Cellulose, Hydroxy Propyl Methyl
Hydroxy Propyl Methyl Cellulose, Methyl Cellulose, Methyl Cellulose and
Cellulose and Cellulose ethers. Cellulose ethers.

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.
8 Pharmaceutics

11] Hazing/Dull film:

• This is sometimes called bloom.
• It can occur when too high a processing temperature is used.
• Dulling is particularly evident when cellulosic polymers are applied out
of aq media at high temperatures.
• It can also occur if the tablets are exposed to high humidity conditions
and partial solvation of film results.

12] Pitting:
Definition: It is defect whereby pits occur in the surface of a tablet core
without any visible disruption of the film coating.
Reason: Temperature of the tablet core is greater than the melting point of
the materials used in the tablet formulation.
Sr.
CAUSE REMEDY
No.
Dispensing with preheating procedures at the initiation
Inappropriate of coating and modifying the drying (inlet air)
1. drying (inlet air ) temperature such that the temperature of the tablet
temperature core is not greater than the melting point of the batch
of additives used.

Parag Mehta, Final yr B.Pharm, MET’s Institute of Pharmacy, Bhujbal Knowledge

City.