8.9.

TABLET COATING
Tablet coatings are essential to achieve certain tasks,
as follows:
• An enteric coating is used to protect the drug from
GI irritation and from acidic degradation in the
stomach.
• Film and sugar coatings are used to mask
unpleasant taste and improve pharmaceutical
elegance of the tablet.

• A film coating can be used to protect the drug from

environmental degradation and to provide
sustained action dosage forms.
• Special tablet coatings may help in targeting the
drug to a certain area of the GI tract (e.g., colon
delivery).
Four different coatings are commonly used in
tablets: sugar coating, film coating, compaction coating,
and air suspension coating.

8.9.1 Sugar Coating

Sugar is one of the oldest forms of tablet coatings.
In this process, successive layers of sugar coatings are
applied by spraying sugar solution into pans in which
tablets are rotated and tumbled. Coating pans are supplied
with air blowers to admit cold or hot air as
needed during the coating operation. Exhaust ducts
are attached to these pans to remove dust and moisture.
For this type of coating, a convex surface tablet is
preferred because flat tablets are difficult to coat. The
following steps are commonly used in sugar coating
operations:
• Dusting of tablets to remove excess dust
• Application of a waterproofing seal (shellac,
ethylcellulose, silicones)
• Subcoating to fill the edge (heavy sugar solutions
containing acacia with occasional dusting with
starch and powder sugar)
• Smoothing (addition of heavy syrup followed by
drying with warm air)
• Application of color coat
• Polishing

8.9.2 Film Coating

Sugar coatings are time consuming. To avoid the
extra time required for sugar coatings, formulation
scientists introduced film coatings. A polymer solution
is sprayed on the tablet surface with constant rotation
and tumbling. Film coatings avoid the need for the
subcoating and smoothing operations needed for sugar
coating. Similar coating pans that are used for sugar
coating are used for film coating. The polymers used for
this coating operation include carboxymethylcellulose,
ethyl cellulose, hydroxyl propyl methylcellulose, cellulose
acetate phthalate, povidone, and acrylate polymers.
8.9.3 Compression Coating
Compression coating is also termed dry coating. In
this process, very fine coating materials are compressed
over the tablet surface by compression in a die with the
aid of punches.This coating process is beneficial for
those drugs that cannot withstand heat and moisture
during the coating operation. Multiple layer tablets can
also be produced by this compression coating to separate
two incompatible drugs. Repeat action and sustained
action tablets are produced by this coating method.

8.9.4 Air Suspension Technique

The air suspension technique is a very rapid and
efficient method of coating tablets or granules. The
tablets to be coated are suspended in a vertical chamber
with an upward stream of warm air. A coating
solution is spread from the bottom of the fluidized-bed
coating chambers. This process is repeated until a uniform
coating is achieved. In this coating, operation efficiency
and quality are controlled by fluidized air
volume, specific humidity of the warm air chamber,
solvent evaporation rate, and the coating spray rate
and duration.

8.9.5 Enteric Coating

Enteric coating of tablets starts with a waterproof
coating with shellac in a coating pan, followed by several
coats with the enteric-coated material. In some
instances, a sugar coat is applied over the enteric coating.
Materials that are used in enteric coating include
shellac, cellulose acetate phthalate, cellulose acetate
butyrate, lipids (mixture of myristic acid, hydrogenated
castor oil, castor oil, cholesterol, and sodium
taurocholate), hydroxypropylmethyl cellulose succinate,
and methacrylic acid co-polymers (Eudragit).
Problems associated with coating of tablet formula-
tions may include poor adhesion of coating material to
the tablet surface, blistering, color variation, cracking,
abrasion, roughness, and filling of tablet markings.
Quality control of coated tablets must include testing
of their appearance and performance. Checking for
color, size, appearance, and physical defects in coating
that can affect the release or stability of the drug in
the dosage form is essential for quality assurance. The
in vitro disintegration and dissolution methods of the
coated tablets in appropriate media need careful evaluation.
Other tests such as evaluation of mechanical
strength and resistance to chipping and cracking during
handling need careful evaluation.

8.10. CONCLUSIONS
The solid dosage form, the most established and
most preferred route of administration, still offers
many opportunities and challenges for a future formulation
scientist. Some of the recent innovations in solid
dosage form development include use of novel pharmaceutical
excipients obtained from innovative material
science research, more efficient ways of
manufacturing, and advancement of oral sustainedrelease
formulations. The availability of quick disintegrants
and taste-masking technology has made orally
disintegrating tablets (ODT) more cost effective and an
attractive alternative. Although the solid dosage form
still has a promising future, it is not free from many
challenges and hurdles. Some of these challenges may
include improving the oral bioavailability of poorly
soluble drugs, oral delivery of biologics, and size limitation
of oral dose via a tablet or a capsule and controlling
the release characteristics of the active drug from
the dosage form and site-specific delivery of the drug
to a definite part of the GI tract. Some of these challenges
will be overcome in the future by innovative
drug delivery, which may require an interdisciplinary
approach of many fields, including material science,
molecular biology, biochemistry, physiology, computer
technology, and pharmaceutics.

CASE STUDIES
Case 8.1 (Capsules)
In a rural community pharmacy, you receive a prescription
for an older patient for 0.2 mL of peppermint
oil to be dispensed as a solid dosage form. What do
you, as the only pharmacist in the pharmacy, decide
regarding this prescription?
Approach: Peppermint is available in the pharmacy
as a viscous oily liquid. To dispense oil as a solid dosage
form, you need to dispense it in a soft gelatin capsule.
This approach is not feasible in a pharmacy. The
other possible alternative is dispensing 0.2 mL of oil
via a syringe into the body of an appropriately sized
hard gelatin capsule, followed by sealing and locking
the cap of the capsule carefully with a thin band of
water near the outer rim of the body and replacing the
cap for sealing.
You must address the following concerns regarding
quality assurance:
1. The weight of oil dispensed in capsule should be
carefully determined and documented.
2. Leakage of oil, if any, from the filled capsule should
be evaluated by placing the filled capsules on a
Kimwipe.

Case 8.2 (Powder)

An herbal resinous product is supposed to be
diluted with an appropriate filler and dispensed as
divided powder for a patient who is lactose intolerant.
What do you do?
Approach: Since the patent is lactose intolerant, you
cannot use lactose as a diluent. The other alternatives
are microcrystalline cellulose (MCC) or calcium phosphate.
Since calcium phosphate is too granular, you
may have a problem mixing it with resinous material
in a pestle and mortar. Therefore, MCC may be a better
choice. If the patient is not diabetic, dextrose or
mannitol can be the other alternatives.

Case 8.3 (Tablets)

As the director of clinical pharmacy, you are discussing
with a pharmacy intern the reported in vitro
dissolution profile of an investigational drug from the
pharmaceutical literature. Following is some of the
information available for this new drug:
In vitro dissolution data:
Solubility of drug in simulated gastric fluid is
100 µg/mL.
Concentration of the drug in the dissolution
medium at the end of 4 hours 534 mg/mL.
In vivo data:
Concentration of drug in the blood after 4 hours
of oral administration 56 µg/mL.
Total volume of blood in the patient 54.8 L.
Solubility of the drug in the plasma at body
temperature 5100 µg/mL.

At the end of 4 hours, does the dissolution follow

the sink condition? At the end of 4 hours, does the oral
absorption follow the sink condition?
Approach: To answer the first question, you have to
understand the concept of the sink condition. At the
sink condition, the concentration of drug in the release
medium at any time during dissolution should not
exceed 10%_15% of the solubility. Since the concentration
at 4 hours of dissolution is 34 mg/mL, which is
34% of the solubility (100 mg/mL), the concentration
exceeds 15% of the solubility limit; therefore, it does
not maintain the sink condition.
The second part of the in vivo question can be
answered similarly. The solubility of drug in the
plasma is 100 µg/mL and the drug concentration is
6 µg/mL 5(6/100) 3 100 56%. Concentration of the
drug is below 10%_15% of the solubility limit; therefore,
absorption happens under the sink condition.