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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.
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
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.
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.
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.
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.
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:
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.
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.