Tableting Granulation - How it works
Summary
TLDRThis video from LFA explores granulation in pharmaceutical tablet production, highlighting three key reasons: improving flowability, compressibility, and API distribution. It explains the angle of repose test for assessing flowability and the option of direct compression for sensitive APIs. The video delves into dry and wet granulation methods, including slugging, roller compaction, and fluid bed granulation, emphasizing the importance of milling for granule size standardization. It concludes with the addition of lubricants for easier tablet pressing and offers resources for further information.
Takeaways
- 🌟 Granulation is a process used to improve the flowability, compressibility, and uniform distribution of the active pharmaceutical ingredient (API) in a formulation.
- 📏 The angle of repose is a key test to determine the flowability of a powder; a low angle indicates good flowability, while a high angle suggests the need for granulation.
- 💊 Direct compression is a cost-efficient method for tableting where a formulation can be compressed without granulation, suitable for heat and moisture-sensitive APIs.
- 🔄 Mix validation is crucial to ensure the correct and consistent mixing of the tablet formulation, especially when direct compression is used.
- 🌡️ Dry granulation is preferred when a formulation is sensitive to moisture or heat, and it involves combining granules without the need for any liquid.
- 🔩 Slugging is a technique where large tablets are formed and then granulated to improve flowability before final compression.
- 🌀 Roller compaction is a method where a formulation is compacted into a ribbon by rollers and then granulated to create the desired granule size.
- 💧 Wet granulation involves the use of a binder in a liquid solution or suspension to cause aggregation of particles and improve flowability.
- 🌬️ Fluid bed granulation is a form of wet granulation where hot air and binder spraying within a unit help form granules by creating bridges between particles.
- ⚙️ After granulation, milling is necessary to standardize the granule size distribution, and lubricants are added to facilitate easier flow through the tablet press.
Q & A
What are the three main reasons for granulation in pharmaceutical formulation?
-The three main reasons for granulation in pharmaceutical formulation are to improve the flowability of the formulation, to make the formulation more compressible, and to ensure a consistent spread of the active pharmaceutical ingredient (API) throughout the formulation.
How can you test the flowability of a tablet formulation?
-The flowability of a tablet formulation can be tested by measuring the angle of repose. A small angle indicates good flowability, which is suitable for direct compression, while a high angle suggests that granulation is needed as the formulation may not flow well and could cause issues like arching, bridging, or rat holing during tablet compression.
What is direct compression in tableting and why is it cost-efficient?
-Direct compression in tableting is a process where the API and excipients are mixed and then directly compressed into tablets without any further steps like granulation. It is cost-efficient because it simplifies the manufacturing process, reducing the need for additional equipment and steps, and is also suitable for sensitive APIs that may be affected by heat and moisture.
Why is mix validation important in tablet formulation?
-Mix validation is important in tablet formulation to ensure that the API and other components have been mixed correctly and uniformly. This prevents issues like segregation and ensures consistent dosage and quality of the final product.
What is dry granulation and when is it used?
-Dry granulation is a process that combines granules without the need for any liquid. It is generally used when the formulation is sensitive to moisture or heat, as it avoids the use of solvents that could degrade the API or cause other issues.
What is slugging and how does it relate to dry granulation?
-Slugging is a process where a tablet press is used to form large tablets that vary in weight due to poor flowability of the formulation. These 'slugs' are then passed through a granulator to break them down into granules, which are then compressed again to form the final tablets. This is related to dry granulation as it is an alternative method to improve the flowability of the formulation.
What is roller compaction and how does it differ from other granulation methods?
-Roller compaction is a process where the formulation is fed through a roller compactor, where two rollers compact the powder to form a ribbon. This ribbon then passes through a granulator where it is forced against a mesh to create granules of the desired size. It differs from other granulation methods as it uses mechanical pressure to form the ribbon before granulation, and it's often used for formulations that are sensitive to the addition of liquids.
How does wet granulation work and what is its purpose?
-Wet granulation involves the use of an adhesive, often a binder, which is incorporated into the formulation as a solution or suspension in a suitable liquid. The purpose of wet granulation is to cause aggregation of particles, forming solid bridges between them to create granules of a consistent size. This process is popular as it is applicable to most formulations and can improve the flowability and compressibility of the final product.
What is the role of a fluid bed granulator in wet granulation?
-A fluid bed granulator is used in wet granulation to facilitate the binding of granules. Hot air is fed into the bed, lifting the granules while they are sprayed with the binder solution. This causes the granules to bind together, forming bridges between them. The fluid bed granulator allows for a controlled environment where the granulation process can be easily monitored and adjusted.
Why is milling necessary after granulation?
-Milling is necessary after granulation to break down large granules and create a standardized granule distribution. This ensures uniformity in the final product, which is important for consistent tablet weight and dissolution properties.
What is the purpose of adding a lubricant after the granulation process?
-The purpose of adding a lubricant after the granulation process is to coat the final granules. This coating allows the formulation to flow more easily through the tablet press, reducing friction and preventing the tablets from sticking to the press or each other.
Outlines
💊 Granulation in Tablet Formulation
This video by LFA discusses granulation, a critical process in tablet formulation. Granulation serves three main purposes: improving the flowability of the formulation, enhancing its compressibility, and ensuring a uniform distribution of the active pharmaceutical ingredient (API). The video introduces a method to test flowability by measuring the angle of incidence of the powder. A low angle indicates good flowability, suitable for direct compression, while a high angle suggests the need for granulation to prevent issues like arching or bridging during tableting. Direct compression is highlighted as a cost-efficient method when neither dry nor wet granulation is required, and it's particularly suitable for heat and moisture-sensitive APIs. The video also mentions the importance of mix validation to ensure proper blending of the formulation. Granulation techniques, both dry and wet, are explained, with dry granulation being preferred for formulations sensitive to moisture or heat. Wet granulation involves the use of a binder in a liquid solution to aggregate particles, and the video describes the process of fluid bed granulation, which includes spraying, wetting, and drying stages. After granulation, milling is necessary to standardize granule size, and lubricants are added to facilitate the flow of the formulation through the tablet press. The video concludes with a resource for recommended suppliers and further information.
Mindmap
Keywords
💡Granulation
💡Flowability
💡Compressibility
💡Angle of Incidence
💡Direct Compression
💡Dry Granulation
💡Wet Granulation
💡Binder
💡Fluid Bed Granulator
💡Milling
💡Lubricant
Highlights
Three main reasons for granulation: improving flowability, compressibility, and ensuring consistent API spread.
Testing flowability through angle of incidence measurement.
Direct compression as a cost-efficient process for sensitive APIs.
Importance of mix validation for correct API and excipient blending.
Granulation process overview, including wet and dry methods.
Dry granulation for formulations sensitive to moisture or heat.
Slugging as a method to form large tablets with varying weights.
Roller compaction as an alternative to granulation.
Wet granulation for most formulations using an adhesive or binder.
Fluid bed granulator as an easy form of wet granulation.
Process of wet granulation including spraying, wetting, and drying phases.
Milling as a necessary step after granulation to standardize granule distribution.
Final blend completion with the addition of lubricants for easier tablet pressing.
LFA's recommendation of suppliers for granulation equipment.
Visit www.imtcva.org for more information on granulation and related equipment.
Transcripts
[Music]
welcome to LFA's video on granulation
there are three reasons to granulate
your formulation one to improve the flow
ability of your formulation two to make
your formulation more compressible and
three to ensure a consistent spread of
API throughout the formulation one way
to test if your tablet formulation is
granulation is to check your
formulations flowability
a way to do this is to test the angle of
incidence a small angle on the powder
will show good flow ability meaning it's
suitable for direct compression a high
angle means your formulation mainly
granulation as it would not flow well
and may potentially cause arching
bridging or rat holing but in your
tablet press we have a video on the
angle of incidence which we'll link in
the description below direct compression
in tableting sometimes your tablet
formulation needs neither dry
granulation or wet granulation and can
be directly compressed this is the most
cost-efficient process within tableting
your api and your exhibits needed are
taken and added to a mixer once blended
they can be compressed in your tablet
press with no further steps this is a
great option for sensitive api's that
may be sensitive to both heat and
moisture however an Lisa you've
mentioned that you should consider mix
validation to ensure your tablet
formulation has been mixed the correct
amount and not too much please see our
video on mixed validation in description
below
granulation granulation is the process
to produce larger granules remove fines
and to improve the flow ability within
your formulation there's both wet
granulation and dry granulation but
before granulation you first have to
complete your formulation including both
API and exits - the lubrication dry
granulation is a combination of granules
without the need of any liquid dry
granulation is generally used if your
formulation is sensitive to moisture or
heat let's look at slugging which is
using your tablet press to form large
tablets that are varying weights due to
poor flow ability of the formulation the
slush creators are then put through your
granulator to be broken down into
granules and then compressed once again
for your final tablets
whilst reading about dry granulation you
may have also heard of roller compaction
brawler compaction is where your
formulation is fed through a roller
compactor your mix is fed through the
top hopper where our two rollers will
compact the powder to form a ribbon this
would then pass for a granulator where
the powder is forced against the mesh
which creates the granules of the
desired size what's been one of the most
complex forms of granulation where
granulation is one of the most popular
due to it being applicable to most
formulations with a purpose to cause
aggregation of particles the adhesive
usually called a binder is incorporated
in the form of a solution in suspension
in the suitable liquid liquid should be
non-toxic and is preferably water
although other solvents are sometimes
used the fluid baked granulator is one
of the easiest forms of wet granulation
as it all happens within the same unit
hot air is fed into the bed lifting the
granules whilst they are sprayed the
granules bind together to form bridges
between themselves the initial phase of
wet granulation is the spraying of the
granules the spray rate is dependent on
your formulation
next is the wetting of the powder begins
to form liquid bridges between the
granules the process is continued until
the required size granule was formed
with solid bridges between the granules
once complete your granules will go to
the drying process the spraying process
has turned off and the hot air will
continue to flow through the bed drying
the granules there's many different
machines and processes for wet
granulation such as fluid bed granulator
x' planetary mixer granulator and rapid
high shear granulator x' after both wet
and dry granulation milling is needed to
deal umph and create a standardized
granule distribution after milling
complete your final blend was adding
lubricant the lubricant is added after
to coat the final granule which allows
the formulation to float easier through
your press whilst LF a doesn't supply
all of the equipment mentioned in this
video we do have a list and recommended
suppliers that would be happy to put you
in contact with more information on
anything covered in this video or
questions about the equipment please
visit us at www.imtcva.org
description below
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