Shenyang Pharmaceutical University LAB 15: FILM COATING PHARMACEUTICS III

LABORATORY 15: Film coating and evaluations of film-

coated tablets

1. LABORATORY OBJECTIVES
a) To learn the film coating of tablets using the coating pan method.
b) To know how to prepare the coating material.
c) To know the evaluation methods for film coated tablets.

2. INTRODUCTION
Tablets are usually coated for different purposes such as masking of unpleasant taste,
protecting from moisture or light, stability enhancement, achieving targeted release or
controlled drug release rate, avoiding drug degradation in the stomach, and improving the
appearance of the tablets. Coated tablets can be classified into sugar-coated tablets and
film-coated tablets. Recently, sugar-coated tablets are not often considered favorably
during the development of new drug products and many sugar-coated tablet products have
been gradually replaced by film-coated tablets. Based on the properties of the filming
coating, film-coated tablets can be further classified as general film-coated tablets, enteric
film-coated tablets, and pH independent film-coated tablets.
The tablets, which are used for film-coating, are called the plain tablets. The plain
tablets should possess adequate hardness allowing the tablets to withstand the stresses
during the coating process without mechanical failure such as high friability, chipping, and
capping. In addition, the plain tablets should possess the required disintegration
characteristics so that the coated tablets will meet the final product disintegration
requirements.
Nowadays, film-coating technologies have been widely used for the manufacturing of
coated tablets showing a tendency to replace the sugar-coating technology. Film-coating
materials can be classified as water soluble and alcohol soluble materials which can also
impart different functionalities to the final coating such as soluble in gastric pHs, intestinal
pHs, or independent of pHs. Film coating materials are mainly composed of polymeric
film formers, plasticizers, solubilizers, and pore-forming agents.
The advantages of film-coating include less coating materials, less weight change,
easy to operate, high automation, good controllability, and short production time. However,
there are also a few disadvantages such as the flammable and explosive nature of the
solvents as well as the environmental pollution caused by the solvents used. In recent
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years, the newly developed aqueous film coating technology with the use of latex and
pseudo-latex materials has shown great promise in replacing the solvent-based technology.
Methods for tablet coating include rotary pan coating, fluidized bed coating, and
compression coating. Commonly used methods for film-coating are rotary pan coating and
high performance pan coating. Sugar coating can also be carried out by the rotary pan
coating method.
If film-coating is performed in a sugar coating pan, several pieces of baffles should be
installed in the coating pan in order to improve the tablet flow patterns, leading to
enhanced contact between the tablets and the atomized coating liquid. The procedures for
the use of a sugar coating pan for tablet film coating are listed below.
1) Install 3-5 pieces of baffle in the coating pan.
2) The temperature of the plain tablets is controlled at 40-60ºC.
3) Spray the coating liquid onto the tablets in the coating pan which is in continuous
motion. When the required level of coating is achieved, remove the coated tablets
followed by additional drying.
During film-coating, several important aspects should be emphasized.
1) The hot air exchange efficiency should be sufficient to provide adequate heating.
2) The delivery rate of the sprayed coating liquid should be controlled and adjusted to
achieve the maximum coating efficiency and shortest processing time.
3) The atomization performance of the spray gun should be adequate and consistent.
4) The rotation speed of the coating plan should be controlled.
The above operation parameters may be different for different equipment and are to
be optimized during the process development phase. The general rule is that the adhesive
force of the atomized droplets to the plain tablets should be stronger than the abrasion
force generated between different plain tablets and between the tablets and the pan wall so
that an intact film can be formed by the coating liquid droplets being deposited on the
surface of the plain tablets.
The key factors affecting the outcomes of a film-coating operation include the
hardness of the plain tablets, the penetration and absorption of water into the tablets, and
the extent of swelling after moisture absorption which is a function of the hydrophobicity
of the tablet surface. Operation parameters including the hot air exchange efficiency,
atomized pressure, the distance between the spray gun and the coating pan, and rate of
spraying of the coating liquid will also affect the quality of the film coating.

3. METHODS
3.1 Formulation for the film-coating

Components Amount

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HPMC (low viscosity) 2g

95% alcohol 50 g (or 70-75 mL)
H2O 40 g (or 40mL)
Castor oil 1 mL
Talc 3g
PEG 400~6000 1 g (PEG 4000)
*Diethyl phthalate 1 mL
Titanium 2g
*Water soluble pigment q.s.
*Silicon oil 1 mL
Note: the component with * mark are optional.

3.2 Preparation of the coating liquid

3.2.1 Transfer the accurately weighed quantity of HPMC in a clean beaker and add the
95% alcohol followed by gentle stirring for 5~10 min to yield a clear solution.
3.2.2 PEG 4000 is dissolved in distilled water and incorporated into the above solution
under continuous stirring.
3.2.3 The remaining formulation components are added in the above solution under
constant stirring and the final mixture is mixed well by continuous stirring for 15~20
min.

3.3 Coating operations

200 g of plain tablets are placed in the coating pan with three pieces of baffles installed.
The plain tablets are heated to 40~60 °C by applying hot air. Adjust the air pressure and the
spraying speed of the spray gun to produce properly atomized coating liquid. Turn on the
coating pan and change the rotation speed to 30~50 rpm. Spray the coating liquid onto the
plain tablets until a uniform film coating is formed. Stop spraying and keep the coating pan
running for an additional few minutes to avoid sticking between the coated tablets.
Remove the coated tablets followed by drying at 60 °C.

3.4 Notes
3.4.1 The plain tablets should be produced with adequate hardness and be resistant to
abrasion. The plain tablets should be dedusted by sieving to remove any fine powder
adhering on the tablet surface.
3.4.2 During the coating process, the selection of the spraying rate of the coating liquid and
the air blowing speed should be made with the aim not to over-wet the tablets and to
prevent sticking. The temperature should not be too high or too low. If the
temperature is too high, the coating film formed will not be uniform; on the other

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hand, if the temperature is too low, drying will be very slow and the coated tablets
may stick to each other.
3.4.3 Air bubbles should be avoided during the coating process.
3.4.4 The coating materials should be passed through a 150~200-mesh sieve if particle
agglomeration is present (or homogenized by using a homogenizer).
3.4.5 If the viscosity of the coating liquid is too high, it can be diluted with 60~70%
alcohol before use (the solid concentration of the coating liquid is generally in the
range of 3~8％).
3.4.6 The coating liquid should be stirred throughout the coating process to avoid
sedimentation.

*Attention: While using ethanol, all equipments using electrical power should be grounded
and preferably an explosion proof design should be applied. Do not spray the coating
liquid onto the pan wall and clean the spray gun immediately after use to prevent clogging.

4. RESULTS AND DISCUSSION

4.1 Appearance of the coated tablets: 20 coated tablets are examined visually. Acceptable
tablets should show uniform color, the surface should be smooth and glossy, and the
film coating should be formed without any cracks and dark marks. Calculate the
percent of acceptable coated tablets in the batch.
4.2 Compare the hardness and weight of the coated and the plain tablets: 20 tablets are
weighed before and after coating to calculate the amount of coating in terms of %
weight of the tablet; the tablet hardness before and after coating is also tested (n=6).
The results are recorded.
4.3 Compare the disintegration time of the coated tablets and the plain tablets: determine
the disintegration time of the tablets before and after coating using the compendial
disintegration test. Record the results.
4.4 Draw conclusion based on the results obtained in the experiment.

5. QUESTIONS
a) What are the requirements for the coating materials? Which factors have significant
influence on the coating quality and how to control and optimize these factors?
b) When should tablet coating be considered for a tablet product?

Appendix

The film-forming mechanism of an aqueous dispersion

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The coating process starts with a wetting phase when a dispersion of the coating
material is sprayed onto the surface of the tablets; the polymer particles are first deposited
on the surface of the tablets giving rise to a discontinued layer. The subsequent coalescence
of the polymer particles is achieved primarily by the capillary forces generated during the
evaporation of water, which causes the formation of menisci of very small radii of
curvature between the particles. The mutual inter-diffusion of the free polymer chain ends
through the particle-particle interface also facilitates the formation of the final homogenous
and cohesive film.

Phaseⅰ. Water evaporation

Phase ⅱ. Polymer particles approaching each other

Phase ⅲ. Deformation of polymer particles

Phase ⅳ. Inter-diffusion of polymer chains and film formation

Fig.1 Film-forming mechanism of aqueous dispersion.

As shown in Figure 1, the film-forming process from individual polymer particles to a

continued film can be divided into four phases. The first phase is the evaporation of water;
the second phase is the close contact of the polymer particles, which could be dramatically
accelerated by the capillary forces exerting on the particles; the third phase is the
deformation of the particles; and in the final phase, a continuous film is formed through the
inter-diffusion of the free polymer chains.
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(Liqiang ZHANG)

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