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Granulation Process Parameters

Impeller Speed

.1

.1

Higher Impeller speeds generally results in denser and smaller granules. Low impeller
.speeds generally result in more porous, large granules
Chopper Speed

.2

Generally Chopper speed has no significant effect on granule size and density
Water Addition Rate and Method
.(mins for water addition 52~)
Massing Time

.3

Massing time is normally in the order of 1 to 10 minutes. Long massing times (> 20
mins) may lead to decreased dissolution rates due to decreased disintegrant function
.or due to the formation of denser granules
Load of the Mixer

.4

Generally, the load of the mixer is less than two-thirds the volume of the mixer
2. Granulation end point measurement:
1.

Torque impeller method and power consumption are still the best methods for highshear and planetary mixer-granulators.

2.

Near Infrared (NIR) spectroscopy: It is used efficiently in fluid-bed granulation.

3.

Types of glass

Type I- Borosilicate Glass: In this highly resistant glass, a substantial part of the alkali and earth
cations are replaced by boron and/or aluminum and zinc
Type IITreated Soda-Lime Glass:
Type IIIRegular Soda-Lime Glass: Containers are untreated and made of soda-lime glass It is
used for non aqueous vehicle parenterals.
Type NPGeneral-Purpose Soda-Lime Glass. Containers made of soda-lime glass are supplied
for non-parenteral products, those intended for oral or topical use.
4. Steam dryer depends on the fact that steam rapidly changes its direction when it become in
contact with a surface, while water is left behind or deposited on the surface
5. The optimum speed of rotation is about 75% of the critical speed, which is defined as
the speed which causes the steel balls to centrifuge.
6. Mechanism of Mixing of Solids

Convective mixing During convective mixing, transfer of groups of particles takes place
from one location to another by means of blades or paddles of the machine. Convective mixing
is referred to as macromixing.
Shear mixing During shear mixing, shear forces are created within the mass of the material
by using agitator arm or a blast of air.
Diffusive mixing During this mixing, the materials are tilted so that the gravitational forces
cause the upper layers to slip and diffusion of individual particles take place over newly
developed surfaces
7. Physical properties affecting mixing
Material density: If the components are of different density, the denser material will sink
through the lighter one, the effect of which will depend on the relative positions of the material
in the mixer.
Particle size: Variation in particle size can lead to segregation also since smaller particles can
fall through the voids between the larger particles.
Particle attraction: Some particles exert attractive forces; this may be due to adsorbed liquid
films or electrostatic charges, such particles tending to aggregate.
Proportions of materials to be mixed
it is difficult to mix small quantities of powders with large quantities of other ingredients or
diluents. The practical method for mixing such quantities is named the geometric dilution.

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