roller compaction - pharmaceutical outsourcing · roller compaction is a granulation process that...
TRANSCRIPT
Roller compaction is a granulation process that turns
powders into densified sheets using the pressure
from two compacting rollers. These sheets can then be
granulated to any desired mesh size.
Compared to wet granulation, roller compaction can save
you money, material, and time on your next project.
Patheon’s Whitby facility has utilized roller compaction for
pharmaceutical manufacturing for over 20 years. This site
has a roller compaction output of several hundred metric tons
of prescription and over-the-counter medications per year.
Roller Compaction
Ability to handle moisture sensitive products
Greater throughput rate
Automated material handling
Material recycling
Bulk density control
Better flow properties
Key Benefits
dev
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For more information, email us at [email protected]
roller compaction CASE STUD IES
development services
For more information on our Roller Compaction, contact your Patheon representative or email us at [email protected]
Overcoming Unique ChallengesThe Challenge
The content uniformity of capsules with a 2% API loading that
were manufactured by conventional direct blending did not meet
specification. The API was free-flowing and had a wide particle size
distribution. Blend homogeneity was satisfactory, but segregation
occurred during the encapsulation process. The capsules were urgently
needed for a Phase I clinical study and IND submission.
The Solution
The manufacturing process was redesigned to include milling to reduce API
particle size variation and roller compaction to “lock in” homogeneity after
blending. Encapsulation was completed as before.
The Outcome
The capsules complied with content uniformity limits. Process redesign,
manufacturing and testing were completed within one week enabling the
client to achieve their clinical study and IND submission timelines.
Optimizing ProcessesThe Challenge
An API with low density and cohesive properties exhibited poor flow, resulting in
processing difficulties and out-of-specification product content uniformity. The product
was required for Phase II clinical studies.
The Solution
A roller compaction process design study was carried out at lab scale using Statistical Design
of Experiments to optimize the process for the clinical supply and subsequent scale-up.
The Outcome
The product was manufactured successfully and complied with specification, enabling clinical
supply on time. The process is very robust and is being used at a 150 kg scale for Phase III
clinical supplies.
Published 4/12 PATH0046R2
US Headquarters
Patheon Inc.4721 Emperor Blvd, Suite 200Durham, NC 27703-8580USAP: +1 919 226 3200F: +1 919 474 2269
European Headquarters
Patheon UK Ltd.Kingfisher DriveCovingham, SwindonWiltshire SN3 5BZUKP: +44 1793 524411F: +44 1793 487053www.patheon.com