Coating of Tablets
Definition of Coating:
Coating is a process by which an essentially
dry, outer layer of coating material is applied
to the surface of a dosage form in order to
confer specific benefits that broadly range
from facilitating product identification to
modifying drug release from the dosage form.
Reasons for Coating:
1. Providing a means of protecting the drug
substance from the environment particularly light
and moisture, and thus potentially improving
product stability.
2. Masking the taste of drug substances that may
be bitter or otherwise unpleasant.
3. Improving the ease of swallowing large dosage
forms, especially tablets. Tablets that are coated,
are considered by the patients to be somewhat
easier to swallow than uncoated tablets.
4. Masking any patch differences in the
appearance of raw materials and hence allaying
patient concern over products that would
otherwise appear different each time a
perception is dispensed or product purchased, in
the case of over-the-counter products.
5. Providing a means of improving product appearance
and aiding in brand identification.
6. Facilitating the rapid identification by the
manufacture, the dispensing pharmacist and the
patient. In this case the coating would almost
certainly be coloured. It is important hare to
emphasize that efficient labeling and associated
procedures are the only sure way of identifying a
product.
7. Enabling the coated product (especially tablets) to
be more easily handled on high speed automatic
filling and packaging equipment. In this respect the
coating often improves product flow, increases the
mechanical strength of the product and reduces the
risk of cross-contamination by minimizing dust
problems.
8. Imparting modified release-characteristics that allow
the drug to be delivered in a more effective manner.
Types of Coating Process:
1.Film Coating.
2.Sugar Coating.
3.Compression Coating.
Film Coating:
It is the most popular technique and involves the
deposition usually by a spraying method, of a thin film of
polymer formulation surrounding a tablet, capsule or
multi particulate core. Film coating may be either(1)
Immediate- release Film Coating (non-functional
Coating) which means that the Coating has no effect on
biopharmaceutical properties but it has many other
properties but it has many other properties and
functions or (2) Modified-release Film Coating
(Functional Coating) which may be further categorized
as either delayed release (or enteric) or extended
release coating.
The coating liquid (Solution or Suspension) contains a
polymer in a suitable liquid medium together with other
ingredients such as pigments and plasticizers.
This solution in sprayed on to a rotating, mixed tablet
bed or fluidized bed. The drying conditions result in the
removal of the solvent, leaving a thin deposit of Coating
material around each tablet core.
Types of Film-Coating Polymer:
Immediate- release Coatings:
Cellulose derivatives.
(Substituted ethers of cellulose) e.g. hydroxy
propyl methyl cellulose (HPMC) and methyl
cellulose (MC) and hydroxypropyl cellulose
(HPC), Polyvinyl Pyrrolidone (PVP).
Amino-alkyl methacrylate Copolymers
Modified- Release Coating:
EC (ethyl cellulose), CA (cellulose acetate)
here the degree of Substitution in the ether is
more rendering the polymer insoluble in water.
Phthalate ethers.
e.g. hydroxy propyl methyl cellulose
Phthalate (HPMCP)
Sugar Coating:
This involves the successive
application of sucrose-based coating
formulations to tablet cores in a
suitable coating equipment.
Conventional panning equipment with
manual application of syrup has been
extensively used, although mere
specialized equipment and automated
methods are now making an impact on
the process.
Steps of Sugar- Coating:
1.Sealing of the tablet core.
2.Sub-coating
3.Smoothing
4.Colouring
5.Polishing
6.Printing
1. Sealing:
Sugar coatings are aqueous formulations that may penetrate
directly into the tablet cores thus affecting product stability
and possibly may cause premature tablet disintegration. To
prevent these problems, the cores are usually sealed
initially with a water-proofing or sealing coat.
Traditionally, alcoholic solutions of shellac were used but
now synthetic polymers as cellulose acetate Phthalate
(CAP) a polyvinyl acetate Phthalate (PVAP) are now
favoured.
2. Sub Coating:
Sugar coating are usually applied in quite Substantial
quantities to the tablet core (typically increasing the
weight by as much as 50-100%) in order to round off the
tablet edges. This is achieved by adding bulking agent such
as calcium carbonate to the sucrose solutions. In addition,
anti adherents such as talc may be used to prevent tablets
sticking together, and polysaccharide gums such as gum
acacia may also be added as a binder in order to reduce
brittleness.
3. Smoothing:
To facilitate the application of the colouring layer
(which requires a smooth surface), the subcoated tablets
are usually smoothed out by applying a sucrose coating
that is often coloured with titanium dioxide to achieve
the desired level of whiteness.
4. Colouring:
Nearly all Sugar-Coated tablets are coloured, since
visual elegance is usually considered to be of great
importance with this type of coated dosage forms.
Colour coatings usually consist of sucrose syrups
containing the requisite coloring materials. Colorants
may be either water-soluble or water-insoluble pigments.
Traditionally, water-soluble dyes have been used in
order to speed up the coating process and minimize
colour migration problem, dyes are now replaced by
pigments. These colorants must comply with the
regulations of the national legalization of the country
where the products are to be marketed.
5. Polishing:
Once the colour coating layers have been applied and
dried, the tablet surface tends to be smooth but
somewhat dull in appearance. To achieve the glossy
finish that typifies sugar-coated products, a final stage
involving the application of waxes is employed.
Suitable waxes include bees wax, Carnauba wax, or
Candelila wax, applied as finely ground powders or a
suspension / solutions in an appropriate organic
solvent.
6. Printing:
It in common practice to identify all oral solid dosage
forms with a manufacture's logo, product name, dosage
strength or other appropriate code. For sugar coated
products such identification can only be achieved by
means of a printing procure, which is typically an effect
gravure process using special edible inks. However,
alternative printing processes, such as inkjet and pad-
printing processes, have also gained acceptance.
Compression Coating:
This process involves the compaction of
granular material around preformed tablets
cores using specially designed tabletting
equipment. Compression coating is essentially a
dry process (although the coating formulation
may have been produced by a wet granulation
process).
Tablet cores are first prepared and then
mechanically transferred on the same machine,
to another slightly larger die that has partially
been filled with the coating powder. The tablet
core is positioned centrally into this partially
filled die, more coating powder is filled on top
of the core and the whole composite mass
undergoes a second compaction event.
Traditionally, it has been used to separate incompatible
materials (one contained in the tablet core and the second
in the coating). With the traditional coating process, there
in still an interface layer (between the two layers) that
may potentially compromise product stability. Thus it is
also possible to apply two coating layers where the first
coating layer is an inert, placebo formulation that
effectively separate the core and the final coating layer,
each of which contains a drug substance that is
incorruptible with the other.
Compression coating is a mechanically complex process
that requires careful formulation and processing of the
coating layer. Large or irregularly shaped granules will
cause the core to tilt in the second die used for
compression of the coating, thus an uneven or incomplete
coating, with the core occasionally being visible at the
tablet surface.