Spheronizer and Marumerisiers and other Specialised granulation and Drying equipment.

Problems Encountered

Prepared by:Nitu Jha Guided by:Dharmang Pandya

Introduction
Granulation may be defined as a size

enlargement process which converts small particles into physically stronger & larger agglomerates. Granulation method can be broadly classified into two types: Wet granulation, Dry granulation.

Ideal characteristics of granules

good flow compactibility. These are usually accomplished through

creation of increased density spherical shape narrow particle size distribution with sufficient fines to fill void spaces between granules, adequate moisture (between 1-2%)

 The effectiveness of granulation depends on the following properties i) Particle size of the drug and excipients ii) Type of binder (strong or weak) iii) Volume of binder (less or more) iv) Wet massing time ( less or more) v) Amount of shear applied to distribute drug, binder and moisture. vi) Drying rate ( Hydrate formation and polymorphism

granulating equipments
1) Spray granulator 2) Fluid bed granulator 3) High shear mixture granulator

Spray granulator

What is Spray Granulation?

Spray Granulation occurs when a liquid solution is rapidly dried over an active ingredient.

This newly encapsulated particle structure is harder and denser, yielding particle properties that are desirable in many applications. The newly formed particle can be sprayed again and again creating larger and larger spherical pellets that form in successive onion like layers.

 In the granulation process, the particles are conveyed through the inner partition into the

expansion chamber by the hot fluidizing air. Gravity overcomes the force of the fluidized air and the particles fall back into the outer partition. The pneumatic atomizing nozzle in the bottom center of the chamber introduces the coating solution. This nozzle sprays upward providing successive applications of coating to the product.

Mechanism
Stages in Spray Granulation: 1.Atomization of granulation liquid 2.Agglomeration of particles 3.Drying

Atomization
It is the process by which a liquid is disintegrated into many fine droplets, thereby yielding a high

surface/mass ratio. This is achieved by supplying energy to the liquid in the form of kinetic energy, pressure energy, centrifugal energy etc. The most common form of atomization is hydraulic pressure nozzle atomization. The differential pressure drop across the orifice determines the mean droplet diameter.

Agglomeration
In this stage, the atomized granulating liquid is

sprayed over the particles to facilitate the agglomeration. At low moisture contents, particles contact each other and adhere due to the formation of liquid bridges. Finally, droplets are formed when the liquid completely surrounds the granule. The strength of the droplet is dependent on the surface tension of the liquid phase.

Drying
In this stage, the agglomerated droplets are

brought into contact with heated gas for the evaporation to take place equally from the surface of all droplets

Why Spray Granulation? Advantages

Some of the desirable product properties of

the spray granulation process are: Dust-free granules Spherical pellets Free flowing properties Good solubility Compact structure Less hygroscopic Less abrasive

applications
Spray granulators are widely used for forming

materials in industries like chemicals, food products and pharmaceuticals. Its main purpose is to convert light, small powders into high-density free-flowing granulates.

Fluidized Bed Granulator

1. Inlet air filter 2. Condenser 3. Humidifier 4. Inlet air Heater 5. HEPA filter 6. Inlet air 7. Inlet air plenum 8. Gas distributor plate 9. Product container 10. Conical expansion zone 11. Filter housing 12. Product filter 13. Outlet air 14. HEPA filter 15. Fan 16. Spray gun

Introduction
The basic concept in granulation (also known as

agglomeration) involves suspending particulates in an air stream and spraying a liquid from the top on to the fluidized bed. Particles in the path of the spray get slightly wetted and become tacky. The tacky particles collide with other particles and adhere to them to form a granule. There are two different mode of fluid bed granulation: 1) Dry stage 2) Wet stage

 In the dry stage granulation , the granulating solution is applied at a rate less than or equal to

the evaporation rate so that the particles are wetted slightly to become tacky and stick to each other. Thus the particles remain dry through the entire process. In the wet stage granulation , the granulating solution is applied at the rate higher than evaporation rate until the particles build up enough moisture to granulate so that particles are wetted significantly before they become tacky enough to stick to each other.

working
A suction fan mounted at the top portion generates

the airflow necessary for fluidization of powders. The air used for fluidization is heated to the desired temperature by an air heater. The liquid granulating agent is pumped from its container & sprayed as a fine mist through a spray head onto the fluidized powder. The wetted particles undergo agglomeration through particle contacts. After appropriate agglomeration is achieved, the spray operation is discontinued and the material is dried and discharged from unit.

Common Problem In Fluid Bed Granulation

Excessive fine Excessive coarse granulation Poor fluidization Finished product non uniformity Low yield

High Shear Granulators

Construction and working

High Shear Granulators series features a cutting chamber

Sound treatment is easily retrofitted whenever desired. The chamber design uses economical flat blade knives in a skewed mount for pointcontact cutting against the two bed knives. This, plus an open segmented rotor, yields cool operation and clean cutting with few fines, while contributing to the low overall operating sound levels. .

Additional feature
Periodic maintenance has been simplified and quickened.

All knife adjustments are accomplished from the top of the chamber after tilting back the hopper. No dead spots or corners are found in the lower chamber or screen area, so dust and fines cannot accumulate, making clean out faster and more thorough. The screen assembly is held in place by two push rods for easy mounting and dismounting without loose hardware, yet is held firmly with positive seating and sealing. Commonly removed cabinet components clamp in place, and can be removed and replaced in moments, without tools.

use
High shear mixture has been widely used in

Pharmaceutical industries for blending and granulation. Blending and wet massing is accompanied by high mechanical agitation by an impeller and a chopper. Mixing, densification and agglomeration are achieved through shear and compaction force exerted by the impeller.

Advantages:
i) Short processing time ii) Less amount of liquid binders required

compared with fluid bed. iii) Highly cohesive material can be granulated.

Defect
It cant be used for sticky material Can not be used for thermolabile substance

Spheronization
Forming granules with a specific bioconsumable shape Producing a smooth particle surface suitable for thin layer coating. Conditioning particles to prevent generation of dust and fines from usage or shipping.. Increasing flowability by diminution of sticking or bridging points. Increasing the apparent bulk density up to 25 % compared to extruded material.

working
The Marumerizer is comprised of three main components: a vertical cylinder with discharge

port, a circular "friction" plate and a variable speed drive train which turns the plate. The feed material to the spheronizer can be extruded particles or moist granules from a mixer/granulator. Since an extruded particle has at least two dimensions already defined, a narrow final particle size distribution is possible.

 Particles are fed onto the spinning friction plate, which throws them against the inside wall of the

cylinder. Extruded particles are quickly broken into segments approximately one diameter long. Centrifugal and gravitational forces create a mechanically fluidized ring of particles. Collisions with the wall, friction plate and other particles result in the plastic deformation of each granule, quickly creating a spherical shape. ".

Drying
Drying is a process that occurs by effecting

vaporization of the liquid by supplying heat to the wet feedstock. Heat may be supplied by convection (direct dryers), by conduction (contact or indirect dryers),radiation or volumetrically by placing the wet material in a microwave or radio frequency electromagnetic field. Over 85 percent of industrial dryers are of the convective type with hot air or direct combustion gases as the drying medium. Over 99 percent of the applications involve removal of water.

 In Drying Process The following inlet air parameters are critical, and

applicable in all processes of drying, granulation and coating. 1) Temperature As the inlet air temperature increases the rate of drying increases and vice versa. This approach to increase the rate of drying can not be used always because some materials are harmed by high temperature, e.g. Ibuprofen liquefies above 60C temperature of inlet air should be optimized without any impact on product quality. If temperature is high, it leads to blistering. If temperature is low, soft spot can be formed.

Cont.
2) Humidity Humidity in the inlet air should be as low as possible and

ideally dehumidified air should be used for faster drying rate because as the humidity of inlet air decreases the rate of drying increases. 3) Air flow rate Air flow rate should be controlled properly in order to get efficient use of drying air. As the air flow rate increases, the rate of drying increases but the cost of drying also increases. If drying air is allowed for sufficient time to remain in contact with the drying material, proper heat transfer and mass transfer takes place and thus drying cost decreases. Air flow rate should not be too fast or too slow but optimized to have efficient drying.

Fluidised bed dryier

 direct drying where direct contact between a heated gas/air and the product occur to effect

heat and mass transfer. The hot air/gas used for drying can be generated by either steam coils or a combustion furnace. The holes in the perforated plate are covered with caps that prevent material form entering the plenum when the dryer is not in operation. The fan equipped in the upper part of the apparatus induce fluidizing air stream. .

 Hot air is fed in the material layer at rest from the bottom

of gas straightening valve (e.g. perforated plate). The velocity of air is adjusted by means of a damper. When the velocity of hot air accelerates a bit, particle groups gradually come to make active movements gradually resulting in hot air pressure loss due to the material layers comes to be in proportion to the weight of material particles on the unit area of the straightening vane. With further accelerating the velocity of hot air, the particle groups undergo vigorous movement to mix with gas in all directions, resulting in suspension state

 In indirect fluid bed processing, a tube or

series of plates are incorporated into the drying chamber. They are arranged in such a way that products remain in intimately contact with the heated surface. The heat energy is transferred by means of conduction. Here steam is used as a source of energy. The cost of operation is low because steam is low cost energy source

Industrial application
Fluid bed dryer is suitable for powders granules agglomerates pellets having average particle size normally

between 50 and 5000 micron.

Pneumatic/Flash Dryer

working
The pneumatic or flash dryer is used with

products that dry rapidly owing to the easy removal of free moisture or where any required diffusion to the surface occurs readily. Drying takes place in a matter of seconds. Wet material is mixed with a stream of heated air (or other gas),which conveys it through a drying duct where high heat and mass transfer rates rapidly dry the product.

Industrial application
Applications include the drying of filter cakes crystals Granules pastes sludges slurries; in fact almost any material where a

powdered product is required.

Rotary Dryers

Direct Rotary Dryers working

Direct Rotary Dryer comprises of a rotating inclined shell through which a hot stream of air flows. The wet material present in the rotary shell is lifted by means of spiral flights and

showered in hot flowing air. Due to this direct contact, the product is dried. Rotary Dryers are available with co-current or counter current air flow patterns depending on the properties of individual products to be dried

Indirect Rotary Dryers

INDirect Rotary Dryers working

Indirect Rotary Dryers comprises of a rotating

shell having a concentric inner shell. Hot products of combustion passed through the inner concentric shell not coming in contact with the product. The product is dried by radiation and conduction.

Industrial application
Rotary dryers are suitable for a wide variety

of products, from granular, powdered and crystalline materials, to filter cakes and sludges

References
1. The theory and Industrial pharmacy

2.
3.

4.
5.

by Leon Lachman, Third edition Pharmaceutical science by Remington, 20th edition Pharmaceutical engineering-II By DR Girish k.jani Tutorial pharmacy by cooper and gunns ,edited by S.J Carter Ansels pharmaceutical dosage form and drug delivery system,8 edition,by Loyd v. allen,Howard c.Ansel