Pharma Polymers 01/2005 1/6 2.

2e
Coating Formulation Calculations
(1) Calculation of Polymer Quantities
Since a certain layer thickness has to be achieved in film coating, the amount of coating material must be
related to the surface area of the substrate. For this reason it is expressed in mg of dry polymer substance
per cm
2
of surface area.
If we divide the surface area of a substrate A (mm
2
) by its weight w (mg), we immediately obtain the
requisite coating quantity in %, i.e. the polymer consumption in kg of dry polymer substance per 100 kg
of substrate for a coating of 1 mg of dry polymer substance per cm
2
. If lower or higher coating weights
are specified for certain dosage forms, we must multiply by this factor l = mg polymer per cm
2
.
Coating weight (%) =
Note that A in this formula refers to the surface area and mg per cm
2
to the amount of film former. Both
quantities are linked by the factor 100, which leads to the result in percent.
Depending on the desired function of a coating, the following values can be used for the calculation of
the required amount of polymer:
Enteric coatings: 4 6 mg for round tablets
5 10 mg for oblong-shaped tablets
5 20 mg for gelatin or HPMC capsules
Taste-masking coatings: 1 2 mg for round tablets
1 4 mg for oblong-shaped tablets
Moisture protection: 1 6 mg for round tablets
2 10 mg for oblong-shaped tablets
5 10 mg for gelatin or HPMC capsules
A(mm
2
) l(mg/cm
2
)
w(mg)
Pharma Polymers 01/2005 2/6 2.2e
(2) Calculation of Surface Area
(2.1) Simplified Calculations
The surface areas of some pharmaceutical dosage forms can be calculated according to the following
simplified formulas, assuming that the tablet has the shape of a circumscribed cylinder:
A = surface (mm
2
), D = diameter (mm), H = overall height (mm),
L = length (mm), Bw = band width (mm)
Tablets: A= ! (D H + 0.5 D
2
)=mm
2
Capsules, oblongs: A=! L Bw=mm
2
Spherical shapes (microtablets, pellets, granules): A= ! D
2
=mm
2
Following the simplified calculations, the following values for the surface area of tablets and capsules
can be used:
Tablets
Diameter [mm] 5 6 7 8 9 10 12 14
2 70 95 120 150
3 85 115 145 175 210 250 340
4 100 130 165 200 240 280 380 485
5 185 225 270 315 415 530
6 300 345 450 570
7 505 615
H
e
i
g
h
t

[
m
m
]
8 660
Surface
area
[mm
2
]
Capsules
Capsule size 5 4 3 2 1 0 00 000
Surface area [mm
2
] 175 235 290 350 410 500 610 800
Pharma Polymers 01/2005 3/6 2.2e
(2.2) Exact Calculations
The following formulas can serve for the exact calculation of the tablet surface (Bauer et. al.
Coated Pharmaceutical Dosage Forms, medpharm GmbH Scientific Publishers, Stuttgart, 1988)
a)
Round Biconvex Tablet
(A=2 ! (rB+r
2
+Ch
2
)
CH can be calculated by means of the following formula: Ch =
A = Surface area
D = Diameter
r = Radius
Ch = Curvature height
B = Band height
H = Overall height
WR = Curvature radius
BW = Band width
b) Oblong-Shaped Tablets
X= 2 ! (rB +r
2
+ Ch
2
)
Z=2B (L-2r)
A=X+Y+Z
The individual calculation steps are based on the hatched areas in the schematic drawing:
X = round ends
Y = 2x top-hat segment
Z = band (2x faces)
Top view
Side view
B H
r
D
X X
Y
Y
Z
B
Side view Side view
Top view
BW
L
Ch
}H
H B
2
Ch
Pharma Polymers 01/2005 4/6 2.2e
(3) Estimating the Surface Area of Small Particles
Where irregularly formed crystals or granules have to be evenly coated, their surface area has to be
estimated with sufficient accuracy to permit calculation of the polymer requirement and the requisite
layer thickness of the diffusion shell. It is then also easier to obtain a consistent release rate when the
particle size distribution and surface texture have changed.
A fast and simple approach is the permeability method
according to Blaine (ASTM Des. C 205-55), whereas both
nitrogen adsorption and mercury intrusion are much more
complicated and time-consuming.
Blaine's method serves for quick routine assessment of the
specific surface area (in cm
2
or cm
2
of core volume) of small
particles. It is based on the mathematical model of laminar
flow through capillaries arranged in parallel, as established
by Kozeny-Carman. This model states that the time taken by
a constant air volume to flow through a defined product bed
is proportional to the square of the specific surface area of
this powder, i.e. inversely proportional to the diameter of the
equivalent sphere.
The apparatus, originally developed by Blaine for measuring
micronized ceramic powders, had to be modified for
pharmaceutical purposes to serve for larger particles as well.
Air volume (Friedrich manometer) and powder bed (granulate attachment according to Gupte) were
increased to extend the measuring range to specific surface areas up to about 100 [cm
2
/cm
3
].
Pharma Polymers 01/2005 5/6 2.2e
Of critical importance for accurate measurement is a defined porosity of the core bed, which should be
kept constant if a particular product is measured several times. This is most easily achieved by tapping
the sample in a granulate attachment fastened to a tapping volumeter by means of an adapter.
The vacuum required for the airflow is produced by keeping a fluid of known density (e.g. water) out of
equilibrium in a U-shaped tube, using a rubber bulb or automatic pipette. For calculation, the measured
airflow time has to be corrected by subtracting the no-load value of the apparatus.
For better reproducibility, time should be measured electronically with the aid of light barriers activated
by the liquid meniscus.
The following values can be used to estimate the surface for spherical particles:
Spherical Particles
Diameter [mm] 0.5 0.8 1 2 3 4 5 6
Surface area mm_] / piece 0.8 2 3 12.5 30 50 80 120
For spherical particles with diameters in a range of 0.5 1.2 mm the following % polymer weight gains
can be used as a guideline:
Enteric coatings: 10 30%
Sustained-release coatings: 5 20%
Taste-masking coatings: 5 10%
Moisture protection: 10 30%
Depending on the solubility of the active, surface structure, size of the particles and mechanical stability,
quite different amounts may be needed. Therefore it is recommended to start with a coating trial in
which samples at different polymer weight gains should be taken and tested in order to determine the
required amount of polymer.
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to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal sense is intended
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inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole
responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used.
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polymers in compositions, procedures and/or applications which may be subject to license agreements.
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