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Der Pharmacia Sinica, 2011, 2 (1): 228-238

ISSN: 0976-8688
CODEN (USA): PSHIBD

Study of Scale up parameters of Fluidized bed Coating

Jitendra Chauhan1*and Poonam Yadav1
1

Shri Ramnath Singh Institute of Pharmaceutical Science & Technology, Sitholi, Gwalior(M.P.)
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ABSTRACT
Several investigations have been devoted towards understanding the coating process in fluidized
beds. Most of these studies focused on spraying liquid droplets over the bed. However, due to the
complexity of these systems, more investigations are still required to quantify the effect of
operating conditions on the coating criteria. Fluidized bed processing involves drying, cooling,
agglomeration, granulation and coating of particulates materials. It is ideal for a wide range of
both heat sensitive and heat resistant products. Today fluid bed processors with capacity of
handle a variety of applications using one single mainframe and suitable change parts are
becoming common all over the world. The present work aims at fundamentally understanding
and precisely determining the various key parameters involved in the scale up and coating
process in fluidized bed systems.
Key words: Fluidized bed system, coating process, parameters, scale up.
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INTRODUCTION
During the past decade, the use of fluidized bed systems for coating has developed to a point
where this equipment is now used for applications in industries ranging from chemical to
pharmaceutical to agriculture. The appeal of fluidized beds for coating is due to the high energy
and mass transfer rates that are available in such a system. Fluidized bed processing involves
drying, cooling, agglomeration, granulation and coating of particulates materials. It is ideal for a
wide range of both heat sensitive and heat resistant products. Fluidized bed coating is a process
that takes place inside a fluidized bed whereby a coat is introduced to cover the intended object
in order to protect it or modify its behavior [1-3]. Today modify fluidized beds are used for

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coating because of their high energy and mass transfer [4,5]. The improvements made in the
original fluid bed dryers led to the following machines based on fluid bed technology
1) Spiral Granulator
2) Bottom spray coating
3) Tangential spray roto processor

Figure 1. Types of fluid bed dryers

1. Instrumentation and Operation [6]

a. Incoming Air: It should be direct contact with the product and be free from air born dust, oily
particles and other impurities. The air should be filtered through both coarse and fine dust filters
and also from HEPA filters if required. Cooling with cool water or refrigeration agents or
passing through adsorptive agents should dehumidify it.
b. Product Container: The product container should be made up of high quality polished
stainless steel having suitable shape and size. The bottom part should hold a screen of the correct
size required to catch the product. It may also be equipped with discharge pneumatic devices,
choppers to break lumps of granules during processing, special film-coating partitions and
nozzles to spray fluid from below.
c. Filter Bag Housing: The filter bag & housing are very important parts of fluidized bed
equipment. Manufacturers patent the no, design, size, shape and other characteristics of filter bag
housing. The filter shaking device and filter below off device are used for cleaning the filters.

Figure-2. Characterisation of fluidized bed coating

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d. Spray Device: This device used to distribute the firmly atomized and homogenized
granulating or coating liquid on to the fluidized product. One fluid nozzle, which atomize liquid
by its own pressure against the nozzle tip, and two fluid nozzles where high-pressure air is
introduced at the nozzle tip to break the liquid into fine droplets. The latter one is most widely
used since it places, much finer droplets.
2. Types of Fluidized Bed Coater
a. Top Spray Pellet with Particle Coating Option:
The expansion chamber is lengthened allowing powder to remain fluidized longer and to move
with a higher velocity so that agglomeration is minimized. The expansion chamber is conical
shaped allowing uniform deceleration of the air stream. The filter housing is larger. Its design
allows shaking the fines back into then bed without interrupting fluidization, this reduces
tendencies of agglomeration. The nozzle is kept low in the expansion chamber, so that coating
materials impinge on the fluidized particles a short distance from the nozzle, this reduces droplet
spray drying and provides for longer subsequent drying of the coated particles.
It is used to apply aqueous and organic solvent based film coating, controlled release coating,
hot melts on granules & small particles

Figure 3. Top spray coating

b. Fluid Bed Bottom Spray Pellet with Particle Coating Option:

This coater employs a cylindrical product container with perforated plates. In the container, there
is a second cylinder (coating partition), which is raised slightly above the perforated plate.
Centrally, in the plate below this partition, there is a nozzle used to dispense the coating solution.
The perforated plate is designed with large holes in the area under the coating partition & smaller
holes in the remainder of the plate, excluding the one ring, of larger holes at the perimeter.
Bottom-spray coating provides a highly organized particle flow & high quality reproducible film
so this system is used extensively for sustained release coating. This process is capable of
handling solvents, Aqueous Solutions, emulsions, suspension, films & hot melts. It is used for
coating small particles, pellets & tablet with batch size from a few hundred gm to 600 kg.

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Figure 4.Wurster process

c. Fluid Bed Roto Processor with Drug Loading & Coating Option:
This is the technique in which fluid bed system utilizes rotating disk to add centrifugal force to
the forces of fluidization and gravity and offers very rapid mixing. The particles cycling time in
tangential spray fluidized bed equipment is very rapid so the films are uniform in thickness.
d. Rotoprocessor insert (Tangential spray insert)
Principle of operation: The principle of operation is that tangential nozzles are fixed on the
rotating plate such as to do different operation using the same insert. The rotating plate is a
specially designed perforated plate such that the powder does not fall down and at the same time
air can come through the plate creating fluidized effect in the processor. The uniformity is well
and the wastage is the minimum as the spray nozzle is embedded within the bed.

Figure 5. Rotoprocessor

Operations possible: Tangential coating, Tangential granulation, Pellet

formation, Pellet drug loading on dummy beads. Concave tablet coating.

formation, Pellet

e. Huttlin Kugel Coater:

It does not consist of a central processor. The product container of kugel coater is spherical.
Fluidized air is introduced by tube that passes down the center of the product container. A series
of spray nozzles are also located at the bottom of the product container in such a way that
fluidizing air creates a balloon effect to keep the product being coated away from the spray
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nozzles. Addition of multiple spray nozzles intended to maximize uniformity of distribution of
coating.

Figure 6. Huttlin kugel coater

Fluidized bed coaters are used widely for coating of powders, granules, tablets, pellets, beads
held in suspension by column of air. The three types (Top spray, Bottom spray, Tangential spray)
are mainly used for aqueous or organic solvent-based polymer film coatings. Top-spray fluidized
bed coating is used for taste masking, enteric release and barrier films on particles/tablets.
Bottom spray coating is used for sustained release and enteric release and Tangential spray
coating is used for SR and enteric coating products.
Table 1 Feature and Uses of the Three Concepts for Fluid Bed Film Coating

3. Characteristics of fluid bed processes

Some characteristics may feature strongly in the scale-up process include the facts that:
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Nozzle positions (with the possible exception of the top-spray process) are somewhat
fixed, and the distances between the nozzle tips and product being coated are often quite
small and unlikely to change on scale-up.
Spray patterns are always round, and thus pattern air is not a factor in the atomizing
process or in defining the spray characteristics.
Although fluid bed machines have optimal operating capacities, they often have much
more flexibility in accommodating a range of batch sizes within a given process,
especially those based on the tangential-spray concept. Although there is a certain
minimum requirement in order to facilitate appropriate fluidization of the product, this
flexibility is often a requirement when one considers that the amount of coating material
that is often applied may range from 1 to 50% (and even broader if one includes the druglayering process).
Nozzle (atomizing) air can contribute significantly to product movement and can also be
a source of a significant increase in product attrition.
Drying air is also the main source of power for creating product movement. Thus the
needs of the drying process and that required to create motion are interdependent, adding
complexity in terms of meeting (and optimizing) the requirements of each.

4. Key processing parameters:

a) Considerations for Batch Size: For fluid bed processes, a useful limit to consider is working
capacity, which essentially refers to the final batch weight. The minimum starting batch size for
the Wurster process is usually approximately 40% of its working capacity.
For the Wurster process, calculating batch volume on scale-up can be calculated using Eq.

where:
B = batch volume, or working capacity (liters)
r12 = radius of the product (Wurster) chamber (cm)
r22 = radius of each inner partition (cm)
n = number of inner partitions
L = length of each inner partition (cm)
If the batch volume is multiplied by the bulk density of the product to be coated, then the batch
load, by weight, can be determined.
When dealing with the tangential-spray process, the quantity of product that is sufficient to
ensure that the spray nozzles are completely immersed when the product is in motion will define
the minimum starting batch weight.
b. Drying/Fluidizing Air Volumes: Keeping the product moving in an appropriate manner and
maintaining the volume of air required to do that may well depend on:
The mass of material inside the machine.
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The tackiness of the coating being applied.

When scaling up the fluid bed process, a major requirement is to produce fluidization behavior
on the larger machines equivalent to that used on the scale that provided the basis for process
development. To achieve this goal and to minimize attritional effects, the same air velocities for
each scale of equipment are required. Thus the overall increase in air volume required during
scale-up will be related to the increase in area of the perforated base plate and, in the case of the
Wurster process, the open area of the partition plate immediately beneath each of the inner
partitions.
c. Spray Nozzle Dynamics: Spray nozzle dynamics often prove to be a more challenging subject
when dealing with fluid bed processes, because:
Often the product being coated is a multiparticulate ranging in size from approximately
50 _m up to about 23 mm in size.
In order to coat each particle in a discrete manner and avoid agglomeration, the coating
fluid must often be atomized more finely and in a more controlled manner than in the
case where tablets are coated in a typical pan process.
In order to maintain fineness of atomization at the higher spray rates typically required in
the larger-scale processes, atomizing air pressures may often have to be increased to
levels where atomization air velocity can seriously increase product attrition.
In order to meet the atomization constraints required, it is almost always necessary to
change the model of spray gun used in order to achieve the effective levels of atomization
at the increased spray rates required during the scale-up process.
Atomization of the coating solution provides an ideal solution to the problem of introducing the
solution to the bed. It solves the problem of local wet quenching which may be a result of
excessive wetting of particles by large coating droplets.
The position of the spray nozzle in a fluidized bed depends on the construction of the equipment,
the material to be processed and obtain the desired product. A assortment of nozzle positions
have been adopted in particle granulation, resulting in different products. The nozzle may be
positioned above the bed (top spraying), inside the bed (submerged spraying) or at the bottom
next to the distributor plate (bottom spraying). If the bottom spraying is employed in a fluidized
bed, there is an increasing danger of defluidization by wet quenching. The bottom spraying
design is normally modified to move particles through the spraying zone as quickly as possible.
This is accomplished in a variety of ways, including the use of a draft tube and unequal
fluidization in the wurster design as well as using spouting gas in a spouted fluid bed. Recent
developments allow the use of multiple nozzles bottom spraying. The top spraying can easily be
accompanied by extreme spray-drying and elutriation of the coating material. However, this may
be preferable to the increased danger of wet quenching associated with submerged spraying. The
particle wet ability and coat drying varies with different coating materials. Nozzle diameter plays
a important role on coating, the increase in load in fluidized bed coater require an increased
diameter of nozzle and for more viscous solutions, need to use bigger nozzle diameter [7].

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d. Spray/Evaporation Rate: The spray rate that can be achieved in a given process is related to
the volume of air that passes through the machine and to the temperature and humidity of that
air. Clearly, therefore, spray rate will be governed to some extent by the rate at which the solvent
(aqueous or otherwise) can be removed. Spray rate will also be influenced by:
The behavior of the coating fluid.
The inherent tackiness of the coating, especially during the critical time immediately after
deposition onto the surface of the substrate.
The rate at which the product being coated moves through the spray zone.
Generally, the faster that product moves through the spray zone, the lower is the dwell time,
the less coating that is captured during that time, resulting in a faster dry time for the coating. As
the rate at which the applied coating dries (so that particle-to-particle contact no longer carries
the risk of interparticulate adhesion, resulting in agglomeration) has a direct influence on the
ultimate spray rate that can be achieved, rapid particle movement through the spray zone
increases the potential to spray faster.
e. Feed particle dimension
Particle size of pellets should be ideal for fluidization and coating. The very small or too large,
give makes disorganized fluidizing. If too small, twinning and agglomeration of multiparticulates
may occur [8].
f. Coating solution
In the early days organic solvents were used in the preparation of coating solution. They allowed
fast coating at relatively low fluidization gas rates and temperatures, but their use has declined
because of the stringent regulations on industrial hygiene, the working environments and safety
measures required during their use. Now, there has been an increasing use of aqueous solutions
to replace the organic solvents and these require higher fluidizing air capacities and heating
systems. The concentration of the coating solution is limited to the range where the solution
remains spray able [9].
g. Coating thinness and consistency
Coated particles used in controlled release application, the quality of the coating must be strictly
controlled. This is done by establishing the most advantageous operating condition for a
particular coating material and seed particle. An ability to monitor the thinness and consistency
of the coating between particles and within an individual particle is crucial in assessing the
suitability of any position of process conditions.
h. Particle circulation
Fluidized-bed coating machine had an inner cylinder (known as draft tube) to expand the particle
movement inside the bed. The spray nozzle is located at the bottom centre of the distributor
plate. The movement of the coated particles is in the same direction as the fluidizing gas. The
congregation resulted in a draft movement of particles which improved particle circulation but
reduced the overall assimilation.

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i. Temperature and wetness distributions
In fluidized bed coating process heat and mass transfer must take place for the particles to be
coated. The temperature and wetness readings are indicators of these transfers. The variety,
superiority and thinness of any coating are resolute by among other factors. The temperature and
wetness in the spraying section and in the rest of the bed there was an inverse proportionality between the
size of the agglomerates and difference between the inlet dry bulb temperature and the outlet wet bulb
temperature.

j. Spray velocity
The spray velocity at which the polymer solution or dispersion is functional to a solid substrate is
crucial and important processing factor. Aqueous film coating requires the uniform application
of a polymeric film to the substrate surface and a well-controlled evaporation of water from that
surface. The air quantity, temperature and dew position will combine to decide the drying ability.
k. Dewdrop magnitude
The crucial processing feature to control in the application of polymeric film coats is the mean
dewdrop magnitude. In order for consistent, accurate and emaciated film formation to occur on
the substrate surface, the polymer solution or dispersion must contact all surfaces consistently
and evaporate quickly. This can be proficient by breaking the liquid into small droplets, with the
use of two-fluid atomizers, hydraulic nozzles or ultrasonic nozzles. The dewdrops are formed by
the shearing action of pressurized air on an emerging column of polymer liquid. These dewdrops
are sprayed in either a conical pattern into the fluidized air or onto the tablet bed from the
atomizing nozzle onto the substrate surface where they spread and evaporate to their solid
constituents. Some dewdrops may contact the multiparticulates and dry before complete
coalescence or film formation occurs. Large droplets will devastate the evaporative aptitude of
the system causing over wetting. This may lead to sticking of multiparticulates in pans or
agglomeration or loss of fluidization in air suspension coaters. As a result, it is enviable to
control droplet diameter to optimize the process. The atomization air pressure delivered to the
nozzle determines the dewdrops size of the liquid spray [10,11].
5. Scale up factors in Wurster Coating
a. Critical Parameters
Air flow - CFM
Air velocity ft./min
Air temperature - degrees F or C
Total amount of liquid - kgs
Spray rate - g/min
Atomizing pressure - psi
Distributor plate configuration (% open inside and % open outside partition)
Partition gap - inches or mm (distance between distributor plate and bottom of partition)
Product Characteristics
b. Theoretical Scale Up
Use same inlet temperature
Use same velocity - velocity calculation
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Calculate total amount of liquid per kg of product processed and maintain

Calculate spray rate per CFM and maintain
Maintain same liquid droplet size by adjusting air pressure as required
Maintain same distributor plate configuration (% open inside and % open outside
partition)
Maintain same partition gap

c. Practical Tips
Visually achieve same fluidization level inside and outside the partition. Fluidization
levels should primarily be adjusted by changing the plate pattern. Total airflow and
amount of product allowed inside the partition (partition gap) can also be varied but may
require an adjustment of the spray rate.
Somewhat higher fluidizing airflows may be needed inside the partition in larger
machines as the atomizing airflow is a lower percentage of the total airflow through the
partition.
CONCLUSION
The characteristics of pharmaceutical coating processes sets them apart from most, if not all,
other pharmaceutical unit operations, not only in terms of issues that need to be understood
during process development, but also when it comes to scaling up those processes. This is
especially true when dealing with the number of process variables that have to be considered.
Spraying of coating liquids, ensuring that effective and consistent drying takes place, achieving
appropriate uniformity of distribution of the coating, and enabling final coating structure and
functionality to remain consistent with the intended purpose of that coating are all events that
must well defined if successful process scale-up is to be accomplished. Coming to grips with the
multiplicity of parameters that commonly define such a process is clearly facilitated when
employing statistical techniques exemplified by the design of experiments approach. Technology
transfer on a global scale is equally well facilitated by access to expert systems that capture all of
the relevant process and formulation events that have been used to define the final coated dosage
form. Finally, in the long run, the best approach to troubleshooting such a complex process to
avoid trouble altogether.
REFERENCES
[1] K.W. Olsen, Marcel Dekker Inc., New York. 1989, pg. 39-70.
[2] Niro, Fluid bed process, GEA powder technology division.2009, pg.1-15.
[3] R.Gulwady, Pharma business and technology part-I., 1997, pg. 22
[4] R. Gulwady, Pharma business and technology part-II, 1997, pg. 50
[5] D.M. Jones., Marcel Dekker Inc., New York, 1989, pg. 113-142
[6] J. Swarbrick, J.C. Boylan, Encyclopedia of pharmaceutical technology, Marcel Dekker INC,
New York, 1992, 6, pg. 171-173
[7] M. Barletta and V. Tagliaferri, Surf. Coat. Technol., 2006, 200, pg. 4619
[8] M. Barletta, A. Gisario, S. Guarino and V. Tagliaferri, Eng. Appl. Artificial Intelligence,
2008, 21, pg. 1130.
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[9] C. Nastruzzi, R. Cortesi, E. Esposito, A. Genovesi, A. Spadoni, C. Vecchio, E. Menegatti
AAPS Pharm Sci Tech., 2000, 1, pg. 9.
[10] V. Saini, Rasayan J. Chem., 2009, 2, pg. 447-450.
[11] S.M. Alavi and L. Mirmomen, Iran. J. Chem. Chem. Eng. 2007, 26(3), pg. 37-44

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