Modified Release
Local targeting, Extended duration of action, reduced peak to trough, and more convenient for patients
When you need a modified release formulation to enable your molecule, careful design for the dosage form, release profile, and manufacturing process is critical.
With over 35 years of experience developing and manufacturing oral-controlled-release products including design, development and commercial production of multple products with complex release profiles, we have the expertise and organizational knowledge to design, develop, and deliver your modified-release product.
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What We Do
Our site in Georgia launched its first commercial multiparticulate modified release capsule in 1990. We have been developing, manufacturing, testing, and delivering OCR products ever since.
We understand the need for strategic CMC pathway planning for modified release dosage forms so that you do the right work at the right time to avoid both unnecessary work and technical gaps that could create downstream delays.
With modified release dosage forms, it’s not enough to have a skilled scientist. That’s why our extensive organizational experience with a wide variety of modified-release dosage forms matters. We have knowledgeable regulatory, quality, and safety teams supporting excellent facilities with superior compliance records. Our expert scientists, engineers, analysts and operators have broad knowledge and experience with modified release dosage forms, and our dedicated professional project managers work to keep everything on track.
What We Offer
- Modified-release product design – sustained, extended, delayed, or pulsatile-release
- Tablets – hydrophilic matrix, MUPS tablets, bilayer tablets, enteric coating
- Capsules – pellet, granule, minitablet, and multicomponent fills
- Pellets – Wurster processing, rotor processing, or extrusion spheronization
- Direct collaboration with your biopharmaceutics/pharmacokinetics experts
- Preformulation
- Prototype formulation screening
- Process design and optimization
- Phase 1 – 3 clinical supplies
- Commercial manufacturing
Processing Options
We offer a wide range of processing options for small molecule modified release products from design to commercial scale:
- Direct powder blending
- Bin and V-blending
- Granulation
- High-shear, fluid-bed, roller compaction; Freund-Vector, Glatt, Alexanderwerk, Gerteis
- Pellet coating
- Wurster, fluid bed, rotor; Glatt, Freund-Vector
- Tablet Compression
- Natoli, Korsch, Fette
- Encapsulation
- Two-piece gelatin or HPMC capsules, powders, granules, pellets, and/or minitablets; MG, Bosch
- Tablet coating
- Bohle, Freund-Vector, Thomas Engineering
- Highly potent compound handling
- OEL > 0.1 mcg/m3
- DEA controlled substance
- Schedule I - V
- Solvent handling
Design • Develop • Manufacture
Let’s build something remarkable