Granulation with Dow Cellulosic Polymers II. High Shear Granulation

Properties of the Granulation
The complete granulations (including
the disintegrant and lubricant) were
characterized by a number of simple
techniques. The apparent and tap
densities of the granulations were
determined using simple
weight/volume measurements and a
Vanderkamp tap density tester (500
taps). From the apparent and tap
densities, one can calculate the socalled
compressibility index (I) given
by the equation
va
I = [ 1 – x 100,
vt
]
where va is the apparent density and
vt is the tapped density. I can be used
as a rough indication of the flow
Table 1
BINDERS IN SOLUTION
Apparent Tap
Density Density I(%)
3% A15P LV 0.62 0.72 15
6% A15P LV 0.59 0.70 16
3% E5P LV 0.62 0.77 20
6% E5P LV 0.61 0.75 19
3% E15P LV 0.60 0.76 20
6% E15P LV 0.62 0.71 12
3% F4P LV 0.60 0.78 23
6% F4P LV 0.58 0.78 24
3% K3P LV 0.59 0.75 21
6% K3P LV 0.57 0.74 24
3% HPC-EF 0.59 0.73 19
6% HPC-EF 0.62 0.76 18
3% HPC-LF 0.63 0.81 22
6% HPC-LF 0.62 0.76 18
3% PVP (K29-32) 0.58 0.75 22
6% PVP (K29-32) 0.57 0.74 22
3% PVP (K90) 0.53 0.71 25
6% PVP(K90) 0.51 0.70 26
6% Acacia 0.57 0.74 23
10% Pregel. starch 0.57 0.68 16
properties of a material, where I
values of less than 15% are indicative
of good flow characteristics, while
values above 25% are indicative of
poor flow properties. The data for the
acetaminophen granulations are
presented in Table 1, in the case
where the binder was applied from a
solution, and in Table 2, where the
binder was added in a dry state to
the mixer-granulator followed by
granulation with water. The densities
are in units of g/cm 3 .
In this acetaminophen model
system, because of composition
differences (3% binder/50% drug and
6% binder/75% drug), comparisons
are made only between similar
binder levels.
Table 2
BINDERS DRY
For the "solution" method, there were
only small differences in the apparent
densities between the binders except
for the PVP (K90) binder, which
exhibited a little lower density at both
the 3% and 6% levels. The values for
I varied from 15-25% at the 3% level,
and from 12-26% at the 6% level, the
highest values in both cases
occurring with the PVP (K90). With
the "dry" binder addition method, the
densities at both binder
concentrations tended to be very
similar to those obtained by the
solution method. The lowest densities
and highest I values resulted from the
use of PVP (K90) as a binder in this
case as well.
Apparent Tap
Density Density I(%)
3% A15P LV 0.64 0.77 17
6% A15P LV 0.57 0.69 16
3% E5P LV 0.56 0.74 24
6% E5P LV 0.60 0.76 21
3% E15P LV 0.65 0.76 14
6% E15P LV 0.59 0.73 19
3% F4P LV 0.61 0.78 22
6% F4P LV 0.57 0.75 24
6% K3P LV 0.59 0.75 22
3% HPC-EF 0.61 0.74 18
6% HPC-EF 0.56 0.73 24
3% HPC-LF 0.58 0.70 17
6% HPC-LF 0.57 0.72 20
3% PVP (K29-32) 0.58 0.75 23
6% PVP (K29-32) 0.54 0.70 22
3% PVP (K90) 0.53 0.71 25
6% PVP(K90) 0.51 0.70 27
High Shear Granulation: Acetaminophen Model
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