In order to increase patient compliance and to create improved drug delivery profiles, many of today’s pharmaceutical products benefit from the application of controlled release formulation techniques. These benefits can extend to enhanced intellectual property protection, product differentiation and brand awareness. Patheon has recognized the need for sophisticated controlled release formulation options for a range of product and molecule types.
Patheon offers integrated development services for controlled release products at three sites located in the U.S., Canada, and Europe. Our extensive team of formulation scientists bring a wealth of experience in controlled release formulation development utilizing strategies such as:
- Matrix systems
- Hydrogels
- Polymeric matrix
- Wax matrix
- Multi-particulate systems
- Polymeric Film Coating
- Ion Exchange Resins
- pH dependant release methods such as enteric coating
- laser drilling
Patheon also has experience in the development of complex controlled release systems such as combined Immediate Release and Sustained Released formulations using a loading dose plus a release modified dose in a bi-layer tablet, or as two fractions in a capsule.
These complex formulations are devised quickly and efficiently through the application of Statistical Design of Experiment (DOE) where applicable.
Patheon’s fully equipped formulation laboratories and pilot plants use scalable equipment which allow you to save time and money during the scale-up process. And because Patheon’s development services are integrated with our world-class manufacturing facilities, we can take your controlled release product seamlessly from pre-formulation, through process development and validation, to commercial manufacturing. Our facilities have the necessary equipment to accommodate a variety of processes ideal for controlled release manufacturing including:
- hot melt granulation
- top spray/Wurster spray coating
- tangential granulation
- extrusion/spheronization
Analytical Testing Capabilities
Patheon supports formulation development activities with extensive in-house analytical development and testing capabilities. We can develop and test the dosage form of your controlled release formulation using USP dissolution apparatus 1 through 4 to ensure it meets the required dissolution profile parameters.
Depomed AcuForm™ Controlled Release Technology
Patheon is continually searching for services and technologies which will help us to satisfy our customer’s evolving formulation needs.
Patheon’s Pharmaceutical Development Services (PDS) group can now offer you access to Depomed’s AcuForm™ modified release technology, combined with our extensive controlled release formulation experience and capabilities.
AcuForm™, developed by Depomed Inc., is a proprietary oral drug delivery platform which promotes gastric retention. AcuForm uses a proprietary polymer technology to provide targeted, controlled, and prolonged release options for a wide range of compounds and potentially reduces risk of adverse side effects.
Patheon’s extensive formulation experience and capabilities combined with Depomed’s Acuform™ controlled release technology serve as an example of Patheon’s effort to provide our clients with simple solutions to their formulation challenges. Please contact us for more information about AcuForm™ and Patheon’s controlled release development services.