If you want to improve the formulation of pallets and beads in pharmaceutical industry, then try extruder Spheronizer.
You’ll achieve better site-specific drug delivery, bioavailability, more balanced, predictable and transportation within the gastrointestinal tract.
The good news…
You can manufacture multi-particulates, such as beads and pellets, for an oral controlled drug delivery system.
Today’s guide looks at the details of extruder spheronizer – including how it works, its main components, its application in the pharmaceutical industry, among other essential information.
Let’s dive right in…
- What is an Extruder Spheronizer?
- Types of Extruder Spheronizer
- Parts and Components of an Extruder Spheronizer
- How Extruder Spheronizer Works
- Important Factors to Consider when using Extruder Spheronizer
- Beneficial Alternatives for Spheronizer Configuration
- Advantages of Extruder Spheronizer
- Advancement of Extruder Spheronizer in Pharmaceutical Industry
- Applications of Extruder Spheronizer
Gastrointestinal tract – Photo courtesy: University of Missouri
Chapter 1: What is an Extruder Spheronizer?
Extruder Spheronizer has wide use in the pelletization, granulation of spherical particles and granules.
More particularly the sustained release oral solid dose types.
Using the extruder spheronizer entails four major steps:-
- formulation of the wet mass (granulation)
- Molding the wet mass into cylinders (extruder)
- Disintegrating the extrudate and shaping of the fragments into spheres (spheronizer) and
- Drying of the pellets
Even before we continue, you can watch this video (it will help you get a clear picture of what we are about to discuss here):
Production of the pellets using extruder spheronizer begins by blending and wet mixing the ingredients.
The extruder having defined die sizes generates extrudates.
You then feed into the spheronizer that shapes them into spheroids (beads or pellets) with uniform size and desirable flow features.
The pellets go through further processing to form capsules or tablets.
Extruder and Spheronizer
Normally the process of extrusion is instrumental in the densification of the wet mix to saturation point.
Whereas spheronization is basically a shaping operation which sustains the hydro-textural state.
At the same time, the drying phase completes the textural features of the product by densifying them by induced shrinkage.
Chapter 2: Types of Extruder Spheronizer
Extrusion-spheronization is a multistep procedure entailing several unit operations and machines.
The most crucial processing machines are extruders and spheronizers.
In pharmaceuticals production, extrusion is an initial step in the process of extrusion-spheronization.
Nevertheless, you can use extrusion to get rid of dust in formulations even if spheronization is not the ultimate objective.
Section of extruder
The choice between the screen and gear extruders depends on the desired density of the extrudate.
Of course, the characteristics of your formulation also plays a critical role.
Therefore, your choice of the right extruder depends on the specific requirements of your application.
An extruder comprises of two distinct parts:
- A delivery system– which helps in the transportation of the material and at times offers a degree of distributive mixing, and
- A die system–which assists in forming the material into the needed shape
Part of extruder system
Types of Extruders
When you’re out there shopping for the best extruders, you can consider any of the following:
- Screw extruders
- axial extruder
- radial extruder
- Gravity-fed extruders
- rotary gear extruders
- rotary cylinder extruders
- Ram extruder
- Screen (or) Basket extruder
- Roll extruder
Now, let’s briefly explain each type of extruder.
Extruder spheronizer part
i. Screw extruder
A screw extruder uses a screw to generate the pressure needed to thrust the material to flow.
Depending on the design, material will flow via equal openings, forming identical strands, commonly referred to as extrudates.
It employs a screw fed equipment comprising of single or twin helical screws spinning in a barrel.
So, it transfers the damp mass material from a feeder hopper to the die section.
The die comprises of a thin steel plate punctured with numerous holes.
And, you can position them either axially or radially to the screw feed.
Hence, you call them axial or radial screw extruders respectively.
ii. Gravity-fed extruders
It consists of the rotary gear and rotary cylinder extruders.
Normally, it differs primarily in the model of the two counter-rotating cylinders.
iii. Rotary cylinder extruder
In this type of extruder, one of the counter-rotating cylinders empty and perforated.
Whereas the second cylinder is solid and functions as a pressure roller.
Feed the material you want to extrude into the section above the two cylinders.
Pressure builds up in the perforations, which compresses the wet mass and pushes the extrudate to the inside of the cylinder.
To minimize the temperature rise in the extrudate, you circulate cool water across throughout the pressure cylinder.
iv. Rotary gear extruder
It comprises of two hollow counter-rotating gear cylinders.
Having counter-bored dies functioning as dies, which you drill into the cylinders between the teeth.
The toothed cylinders draw in the raw material, which the hopper feeds through gravity.
Pressure forces the materials via the nozzles into the cylinders, where the extrudate gets cut by the scrappers.
As the product passes through the nozzles, it gets compacted thereby forming a dense extrudate.
You can vary the diameter of the holes from 1 – 10 mm to create a variety of pellet sizes.
v. Ram extruder
This is the oldest type of extruder.
A piston dislodges and pushes the material across a die at the end.
vi. Screen or Basket extruder
- Sieve or Screen extruders
This extruder type has a chamber that holds materials you are to extrude and a screen or plate.
A rotating arm moves the wet material through a perforated screen or sieve to create short or long extrudates.
It depends on the moisture content.
Material leaving extruder spheronizer machine
vii. Basket-type extruders
They are the same as sieve extruder.
The only difference is the screen or sieve being part of a vertical, cylindrical wall.
A basket-type extruder forms the extrudate in the horizontal plane as it produces them via the vertical holes.
Whereas, in a sieve-type extruder, the extrudates fall vertically from the sieve plate.
viii. Roll extruder
Roll extruder also referred to as pellets mills, functions by feeding materials between a ring die or perforated plate and a roller.
The basic designs include:
A ring die plate spins about one or more rollers mounted inside the cylindrical die compartment, with each rotating on its stationary axis.
All spinning parts turn in a similar direction.
You introduce the feed material onto the interior surface of the ring die, and the rollers press them outwards.
Mounting of the rollers is on the exterior of the die and feeding of the material is through a hopper.
Sometimes with a screw, into the section between the die and the roller.
It extrudes materials into the middle of the ring die and releases it out through one end.
The die and the roller go in opposite directions.
Also known as marumerizer, a spheronizer comprises of a static stator or cylinder and a rotating disk or friction plate at the bottom.
You can jacket the stator to help control temperature.
The friction plate, a spinning disk having a grooved surface, is the most crucial part of the machine.
It is what initiates the spheronization process.
An ordinary friction plate has a cross-hatch design, with the grooves intersecting at a right angle.
You will choose the groove width depending on your desired pellet diameter.
Typically, you should use groove diameter which is 1.5-2 times the target pellet diameter.
The friction plate diameter is about 20 cm for laboratory-scale machines or up to 1 m for production-scale equipment.
These are the new versions of spheronizers that were introduced into the market.
Air assisted Spheronizer
They are alike to the standard spheronizers in most aspects.
So, what’s the difference?
Air-assisted spheronizer design enables it to allow a conditioned air stream into it from below the rotating disk.
The permitted air flows through the slit or gap between the rotating friction plate and the cylindrical wall.
Chapter 3: Parts and Components of an Extruder Spheronizer
As you can see from the image below, an extruder Spheronizer is an assembly of different parts and components.
Obviously, each part and component perform different functions as you will learn shortly.
Extruder Spheronizer machine
Let’s get to the main subject of this section.
I. Main Parts of an Extruder
i. Feed Hopper
You feed the raw materials into the conical-shaped hopper that delivers the ingredients into the barrel section.
Mostly, the location of the hopper is above the barrel, and a section of the screw is as well present at the bottom end of the hopper.
Speed of the screw, Cross-sectional area of the die, and flow characteristics of the material determine how you adjust the feed rate.
ii. Barrel with Screw Auger
The barrel is an empty cylindrical steel bodywork having the screw auger that drives the loaded materials through the feed hopper.
In most cases, the barrel consists of the feed unit, a compression unit, and a metering unit.
Compression of the ingredients within the barrel converts them into a homogenous mass prior to entering the die.
To achieve a shearing and compression action within a constant diameter barrel, you need to decrease the screw pitch or adopt a tapered screw.
A metering unit permits uniform blending of the compressed mass by the exertion of uniform pressure.
You can also refer to the metering unit as a cooking section.
This is the restricted opening found at the bottom of the barrel.
It molds the required cross-sectional shape to the product extruded.
After leaving the metering unit of the barrel, the blended mass goes through a drop in pressure on entering the die.
To hinder the clogging of the extruded product.
The die can have one opening or several openings.
To get a good grade of extruded product, it is crucial to use a die with no defects and scratches.
II. Main Parts of a Spheronizer
There are three main parts that make up the spheronizer:
- Circular friction plate
- Vertical cylinder having discharge port
- Variable speed drive train that turns the plate
The figure below shows the detailed parts and components of a spheronizer machine.
Parts of Spheronizer
i. Friction Plate
This is a critical part of the spheronizer that has a grooved surface to intensify the frictional force.
There are two kinds of the geometry of the grooves, namely:
- Radial geometry
- Cross-hatch geometry
The pattern of the friction plate you use in the extrudates spheronization affects the features of the pellets.
This component is useful in cleaning dust particles from the bowl wall and the friction plate.
iii. Water Jacket
The spheronization chamber has a water jacket that facilitates cooling of the equipment.
Of course this is due to the heat generated during the spheronization process.
Chapter 4: How Extruder Spheronizer Works
The process of extrusion-spheronization comprises of four essential steps:-
- Granulation or mixing – requires a granulator or mixer
- Extrusion –requires an extruder
- Spheronization –requires a spheronizer
- Drying and probably coating –may require a drier and coater
Even before we go to the main discussion of this section – watch this video first.
All of these procedures are essential and all can have a substantial impact on the performance of the final product.
A. Granulation and/or Mixing
The impacts of different granulating or mixing aspects can be underrated.
It is a fact that in most instances mixing can have negligible or no impact on the process.
Of course, this may also apply to the performance of the end product.
However, don’t take any assumptions here.
When undertaking development work, it is crucial in maintaining the granulation/mixing variables constant.
This helps to do away with a possible source of variation.
Or, to carry out systematic trials and exhibit the impacts (or lack of impacts) of alterations in the mixing variables.
Extrusion is an important process before spheronization.
The diameter of the extrudate applied during the process of spheronization determines the final size of the pellets.
For instance, to attain spheres having a diameter of around 1 mm, you will have to use a 1 mm screen on the extruder.
However, it is advisable you use screens having slightly larger hole diameters to compensate for shrinkage after drying.
In a spheronizer, it is practical to produce spheres having diameter spanning from around 0.4 mm to around 10 mm.
Currentspheronizers have numerous additions and adaptations based on the requirements of the specific process and product.
Honestly, spheronizer has a relatively simple design concept.
However, the specifics of the design and detailed development of supplementary equipment has changed over time.
Take, for example, it has broadened the diversity of applications and greatly boosted the flexibility of the machines.
A basic spheronizer machine has a circular disc with a revolving drive shaft.
It rotates at high speed at the base of a stationary cylindrical bowl.
The rotating friction plate has a cautiously modeled groove pattern to the bottom.
In most cases, they have a cross-hatched pattern even though numerous sizes and other kinds exist.
These discs are instrumental in increasing friction with the product.
You could be wondering where exactly the spheronization process begins.
It starts by adding extrudates to the Spheronizer, which falls onto the rotating plate.
During the early interaction of the friction plate with the cylindrical granules, the extrudates get cut into fragments.
Their length may stretch from 1 to 1.2 times their diameter.
These fragments then collide with the wall of the bowl which in turn throws them back to the middle of the friction plate.
Centrifugal force pushes the materials to the exterior of the disc.
The movement of the materials causes the extrudate to break down into segments.
It can be about the length of the extrudate diameter.
Section of Spheronizer
These cylindrical fragments gradually get rounded by bumping with each other, the wall of the bowl and the plate.
Continuous collision of the particles with the bowl wall and getting pushed back to the interior of the friction plate develops across the wall of the bowl.
Normally, this collision will progressively change the cylindrical fragments into spheres.
Of course, this will happen so long as the granules are plastic enough to facilitate deformation without them getting destroyed.
Remember, continuous movement is necessary to form optimal spheronization.
As the process goes on, the shape of the fragments steadily changes.
And when they have attained the required shape (typically in approximately 2 to 10 minutes), you can remove the spheroids.
When the segments have attained the required spherical shape, the spheronization chamber opens its discharge valve.
Then, the centrifugal force discharges the granules.
It is possible to obtain very narrow particles distributions in the spheronizer.
Chapter 5: Important Factors to Consider when using Extruder Spheronizer
You can split the process parameters into those associated with:
- Extruder Spheronizer machine
You must consider the two to achieve the best product quality and better process results.
Let’s get to the main subject here.
Some of the most common machine parameters include:
Pellets extruder and Spheronizer machine
· Friction plate pattern
The most popular groove pattern utilized for spheronizer discs is the “waffle-iron” design.
In this pattern, the friction plate is similar to a chessboard of chopped-off pyramids.
Nonetheless, the choice of the best plate is always a challenge.
As a guideline, you should process extrudates up to 0.8 mm in diameter on a 2 mm pitch plate.
On the other hand, process extrudates up to 3 mm in diameter on a 3 mm pitch plate.
You can as well use discs with a radial design since they are gentler on the material you are spheronizing.
· Friction plate speed
The typical speed of rotation for a production size (700 mm diameter) disc varies from 200 to 450 rpm.
Higher speeds mean you will need to exert more energy into the fragments during a collision.
Optimal speed relies on the size of the particles and characteristic of the product you are using.
What does this imply?
Smaller disc diameter requires higher speed.
The critical variable here is the speed at the exterior edge of the disc.
In practice, you can determine the optimum speed with a little experience.
For certain products, it is advisable to begin the process at a high speed.
Then, reduce the speed during the final phase of the process.
You can determine this by simple practical trials.
The process enables a high degree of versatility for perfect formulations.
· Retention time
It is the time it takes for the Spheronizer to process material.
Typically spheronization retention times may vary from 3 to 8 minutes.
This is fairly simple to determine.
You can achieve this by simple tests using distinct products.
At times, the strong cohesive forces in some products can be a problem.
That is, they may hinder the extrudates from disintegrating into smaller fragments.
Remember, the process will depend on your goals.
Take, for example, your goal can be to minimize dust and not to attain ideal spheres.
In such situations, short interaction with the friction plate is adequate to fragment the long extrudates into small pieces and round the margins.
As a matter of fact, margins of cylindrical granules are the most delicate part.
They will produce dust in the course of handling and transportation.
You can minimize the quantity of dust substantially when you apply spheronization with short retention time.
· Charge volume or weight
This is the amount of product you loaded into the spheronizer.
Here, the optimal level relies on the characteristics of the product and the size of the machine.
Remember, there is an optimum amount of product that you should load into the spheronizer chamber.
It is the only way to produce the best spheres and the most narrow segment distribution.
For a machine having a 380 mm disc, the typical charge volume is 4 kg depending on the material density.
Increasing the load per batch strengthens the hardness of the spheres and makes the surface of the granules smooth.
A load of from 2 kg to around 12 kg is acceptable for a larger spheronizer.
Different sides of extruder Spheronizer
Obviously, the outcome you expect will depend on the rheology of the product.
You can easily determine the rheology using a Mixer Torque Rheometer – MTR.
Mixer Torque Rheometer – Photo courtesy: CALEVA
The particles should have sufficient plasticity to facilitate deformation due to the impact they undergo during the process.
In addition, they should be adequately strong to sustain the collisions with each other, bowl wall and the friction plate without breaking up or getting destroyed.
You can change the rheology of the product by changing the liquid constituents of the mix, altering the mixing time, or by using lubricants or binders.
Though the evaluation of the product rheology may appear complicated and probably time-consuming.
With a Mixer Torque Rheometer, you can determine the ideal formulation very fast and easily.
Binders play an important role in reducing the quantity of fine dust produced during spheronization.
Furthermore, it boosts the strength of granules.
When you add too much binder and the granules get very hard, it will become cumbersome to attain good spheres.
It will intensify the plasticity.
Besides, it may as well increase the quantity of fine dust produced during spheronization.
Water can as well act as a lubricant.
If you use too much water, the wet material can stick on the bowl wall and the friction plate.
Remember, granules may also adhere together producing big lumps.
If you produce extrudates that are too dry, there are chances of generating a high quantity of fine dust.
The optimal moisture content for spheronization is moderately lower than for extrusion only.
Chapter 6: Beneficial Alternatives for Spheronizer Configuration
Are you looking for other beneficial alternatives for Spheronizer configuration?
Well, here are some of the few things you should have in mind:
a) Cooling Jacket or Drum Heating
You can introduce cooling or heating water in a jacket about the spheronizer bowl.
Using warm water is beneficial for the wall of the chamber.
It eliminates moisture that would make products adhere to the wall.
Cooling the wall will prevent rises in temperature in heat sensitive products.
Even though the standard temperature rise in a spheronizer is usually negligible (about 2 to 3 °C).
b) Air introduction (Fines air)
You can introduce a modest flow of air in the chamber from below the friction plate.
It will hinder entry of dust between the wall of the chamber and rotating plate.
Furthermore, it helps in removing moisture from granules surface.
The good news?
All these will enhance friction forces and efficiency of the process.
c) Automatic Timer
It is instrumental but not mandatory to have your spheronizer fitted with an automatic timer.
Spheronization is a batch procedure and not a continuous process.
Appropriate timing of the spheronization run time for every batch will aid in maintaining standard operating procedures.
Besides, it will boost product quality and performance standardization.
d) Non-Stick Coatings
For some products, you can coat the plate and the chamber wall using non-stick substances.
It is useful for sticky material. Besides, it makes cleaning easy and simple.
Chapter 7: Advantages of Extruder Spheronizer
The beads or pellets manufactured using the extrusion-spheronization provides the following benefits over conventional drug delivery system.
- Generates spheroids having a high loading capacity of active constituents without creating excessively large particles.
- Manufactures particles of a consistent size having a narrow size distribution and exceptional flow features.
- Allows for the successful coating of the spheroids due to their low surface area to volume ratio and the spherical shape.
- Enables the blending and formulation of pellets made up of different drugs in a single dosage form.
This allows for the delivery of two or more drugs.
Either chemically compatible or incompatible at the same or varying site in the gastrointestinal tract.
- Pellets frequently find application in controlled release delivery system. This is because it enables free spheroids dispersion in the gastrointestinal tract.
Besides, it gives flexibility for further improvement.
- Enhances the safety and effectiveness of the active
- Assists to boost the bioavailability of drugs by regulating or altering the release rate of drugs.
Chapter 8: Advancement of Extruder Spheronizer in Pharmaceutical Industry
Current advancement in pellet technology mainly revolves around the invention of advanced coating techniques.
Currently, researchers are developing new technologies to provide a higher degree of stability and enhance flexibility.
Remember, the thickness of the polymeric film can affect release pattern of pharmaceutical product. Of course, this is one of the main features of polymer coating.
Let’s look at some of the emerging technologies in the extruder spheronizer in the pharmaceutical industry.
i. Hot Melt Extrusion
This is a new modification of the extrusion-spheronization technique.
Hot melt extrusion finds wide application in the pharmaceutical industry.
More specifically, in the manufacture of modified release dosage forms.
Take for example transmucosal drug delivery systems, transdermal implants, tablets, granules, pellets, among others.
It is because the technique does not need supplementary film coating since the release of the drug is diffusion controlled 6-10.
The technique is important in various interesting aspects such as:
- Nanoparticles liberated from molecular dispersions
- Rapid dispersion systems having foam-like structures
- Complex formation in the melt, and
- In-situ salt formation
In a nutshell, it is a simple, effective, solvent-free method that needs fewer processing steps.
Besides, it does not require long drying stages.
Some of the main advantages of these methods include:
- Continuous production of spherical shaped pellets having narrow range particle size distribution
- Minimized loss of coating material in the course of the coating process related to the process of wet mass extrusion
- Continuous manufacturing of drugs that exhibit symptoms of degradation in the course of processing and storage because of residual water
- Development and delivery of poorly dissolvable drugs to the solid solution and solid dispersion for enhanced rate of dissolution and bioavailability
- Masking the harsh flavor of the active ingredient
- Inclusion of poorly compatible substances into tablets manufactured by slitting an extruded rod
- Regular dispersion of fine particle
- Good stability at different moisture levels and pH
ii. Freeze Pelletization
This is an enhanced and most simple method of manufacturing spherical pellets.
You simply introduce droplets of immiscible molten solid carrier.
Or, introduce matrix having the additives listed below with or without drug into the inlet column of an inert liquid:
- Release modifiers
You can introduce the droplets into the liquid inlet column using an atomizer, nozzles, or needles.
And more importantly, introduce the droplets from a specific height.
This ensures they remain intact as they drop into the liquid column.
It is possible to scale-up the process by increasing the nozzles number to several hundred.
Normally, this will depend on the required rate of production. You can have them as either static or vibrate electrically.
It is a method where you produce lyophilized or freeze-dried pellets by solidifying the droplets of:
- Organic or aqueous emulsions
- Solutions or,
Obviously, you will use liquid nitrogen as the fixing medium.
Initially, the technology was widely applied in the nutrition sector to lyophilize viscous bacterial suspensions.
The pharmaceutical industry has adopted it for the production of drug loaded pellets for controlled and immediate release formulations.
Here, the key advantage of this method is the formulation of highly porous pellets.
The technique facilitates uniform and instantaneous freezing of the processed material.
This courtesy of the fast transfer of heat that takes place between the liquid nitrogen and the droplets.
iv. Melt agglomeration
In this process, the solid particles go through a steady change in size and shape.
It results in agglomerates having molten binding liquid.
This melts because of temperature rise due to the heat of friction from the high shear mixer.
You may add the binder as a dry powder, molten liquid, or flakes.
Then you can heat it using a heating jacket or hot air above its melting point.
Dry agglomerates form as the molten binder solidifies due to cooling.
Binders applied in melt agglomeration usually have melting points ranging from 50ᵒC to80ᵒC.
Temperatures below this range will result in softening of the binders.
This will impact on quality of the product during production and storage.
Agglomerates formation using this method entails agitation, kneading, and layering.
v. Complex Perfect Spheres CPS™ Pelletizing Technology
This is a direct pelletization and an advanced fluid bed rotor technology.
You can use it to manufacture matrix type pellets and micropellets.
It was invented in 2000.
The process machine comprises of a modified fluid bed rotor system.
The system has conically shaped spinning disc and supplementary gadgets for direct movement of particles.
It is a batch process appropriate for drug layering by solution, emulsion, suspension, among others on starter cores.
Of course, this is, in addition, to dry powder layering to attain a specific quality of drug layering.
You can use either an organic or aqueous layering liquid with or without functional compounds.
As an alternative, you can feed dry powder into the process.
In the case of powder layering, you can measure the end point of pelletization with the assistance of torque at the CPS™ rotor.
You achieve densification of the particles by way of a characteristic motion of particles.
The particle movement applies various forces on the rising pellet cores by the speed and form of the rotating disc.
Centrifugal force plays a major role here.
This procedure is appropriate for drug dose varying from low to high.
It is perfect for masking coating and functional coating applications.
The typical properties of pellets obtained by this process constituent:-
- A spherical shape having an average particle size range between 100 to 1500 μm
- Narrow particle size distribution of > 90% between 700 to 900 μm
- Yield typically > 90 %
- Smooth surface-an ideal substrate for coating applications
- Drug loading from < 0.1% -90%
- Low attrition and friability
- High density and low porosity
- Dust free surfaces
Particles densification is through rolling particle movement.
Figure 18 Modern Spheronizer
vi. ProCell™ Technology
This is a spouted-bed kind of continuous agglomeration technology.
Here, a vertical airflow process fluidize particles in the ProCell™ spouted bed.
System air gets into the processing chamber via slots located at the side.
This is not by the usual inlet air distribution plate or bottom screen as in ordinary fluid bed processing.
Here, processing chamber cross-section gets significantly wider towards the top.
Consequently, this leads to a sharp reduction in the fluidizing speed of the process air.
This effect results in a controlled circulation and flow pattern of fragments in the processing chamber.
The system has spray nozzles installed in the bottom spray position; precisely between the two inlet air openings.
In this position, the nozzles spray at the place of highest energy input within the equipment.
The technology is a direct granulation and pelletizing procedure.
You do not require inert starting beads.
Besides, you can process solutions, emulsions or suspensions comprising of the API.
ProCell™ Technology works in the most efficient way when you process melt of material.
Because you need to evaporate neither organic solvents nor water.
The production of granules and pellets happens by way of spray solidification and agglomeration.
Due to this fact, cost-effective and high through-puts processes are possible.
You can fractionate the continually increasing amounts of products offline by way of a sieving unit or online by using a zig-zag sifter.
In any case, you are able to re-circulate the separated material into continuing to reduce product losses.
ProCell™ technology helps in the production of highly concentrated, nearly spherical pellets having low porosity and high density.
This leads in matrix type granules and micropellets having low friability and attrition.
You originally use the technology as a hot-melt granulation process.
It offers an interesting and economical alternative without the necessity to evaporate organic solvents or water.
Drug loading is up to 100%.
Implying, you will not require extra excipients for the generation of ProCell™ particles.
This is because of its unique processing features and the design of the process chamber.
You can adjust the mean particle size range over a wide extent from 50-1500 μm.
The process of agglomeration is specifically appropriate for pellets with inherent stickiness.
vii. MicroPX™Fluid Bed Technology
This is a continuous fluid bed pelletizing technique
Here, you can process aqueous-based liquids, leading to matrix type, onion-like micropellets through solidification and agglomeration.
MicroPX™ Fluid Bed Technology is most suitable for the following uses:-
- Taste-masking applications
- Controlled release formulations
- Compression of pellets into tablets
- Manufacturing of spherical, high density, low porosity, smooth surfaced, high drug-loaded segments (> 90%) having a particle size range of 100 to 500 μm with low friability and attrition.
With technology, you do not need starter cores.
A spraying liquid (emulsion, solution or suspension) contain the Active Pharmaceutical Ingredients, pharmaceutical binders, and other functional constituents.
You can feed them into MicroPx™ process through spray guns.
The procedure is a high-throughput, economical process.
There are minimal product losses due to recirculation of substances into the continuing process.
Chapter 9: Applications of Extruder Spheronizer
The wet extrusion process, followed by extrusion-spheronization, is instrumental in the production of a broad range of engineered, controlled release pharmaceuticals.
Interestingly, these solid dosage forms commonly come in the form of capsules or tablets comprising of high amounts of an Active Pharmaceutical Ingredient (API).
· Pharmaceutical industry
Some of the most common applications include:
- Controlled release pellets
- Sustained release polymer coated pellets
- Multi-particulate systems
- Enteric coated pellets
Here, you need this machine to make:
Clearly, with extruder Spheronizer, you can easily achieve advanced flow, more even and foreseeable distribution, delivery in the gastrointestinal tract, etc.
Although there are many methods to manufacture pellets, extrusion-spheronization arguably offers the greatest advantages.
You can only achieve this using modern extruder Spheronizer, which guarantees fast processing and high efficiency.
So, if you’re planning to manufacture multi-particulate oral controlled release dosage forms; SaintyCo is here to help.