Formulation & Process Development
Get It Right
from the Start
Drug products in today’s pipeline often include complex delivery profiles, including precise release mechanisms, active pharmaceutical ingredient (API) combinations, and poorly soluble or highly varied APIs. At Tedor, we transparently communicate and collaborate with our clients to address challenges and keep timelines on track. From early clinical phases to commercial scale, we are dedicated to the long-term success of your product.
Tedor Clinical Trial Supply Services At-a-Glance
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Excel at difficult-to-formulate products
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Clinical
to commercial launch
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Specialized dosage form expertise
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Pediatric & geriatric delivery form experience
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Robust analytical capabilities
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Fully equipped pilot lab for robust process development & seamless scale-up
Formulation & Process Development Dosage Form Capabilities
Today’s drug products are often challenging to formulate and manufacture. However, Tedor’s team of experts works to quickly understand the characteristics and objectives of our client’s products, allowing us to tackle the toughest challenges for an incredibly diverse set of product delivery platforms.
- Tablets
- Capsules
- High- and low-potency products
- Modified- and extended-release products
- Powders
- Granulations
- Beads
- By-layer tablets
- Extrusions
- Slugs
- Liquids
- Creams
- Lotion
- Suppositories
- Hollow core
- Multi-fill capsules
- Enteric-coated
- Effervescent
Formulation Development Services
Getting your product’s formulation right from the early phases of development can help save time and money as you advance through each phase of development and ultimately to commercialization. Our formulation development experts support every phase of your project, ultimately creating a stable and efficient drug delivery platform.
- Evaluation of formulation options
- Raw material, excipient, and API sourcing
- Extractables and leachables
- Flowability
- Wettability
- Compressibility
- Particle size
- pH
- Specific gravity
- Intrinsic dissolution
- Design, validate, and implement analytical and process methodologies
- Generation of data required for regulatory filings
Process Development & Optimization Services
Drug product manufacturability challenges often occur in later phases of development as larger-scale production can significantly impact a product’s physicochemical characteristics. The Tedor team works to help our clients avoid these challenges through systematic, risk-based identification and understanding of critical quality attributes (CQAs) and critical process parameters (CPPs). Additionally, Tedor’s fully equipped pilot lab supports robust process design to ensure seamless scale-up. CPPs requiring development and optimization often include:
- Blending
- High shear wet granulation
- Kneading
- Impeller & chopper speed
- Binder addition time
- Fluid bed drying & granulation
- Inlet air temperature
- Fluidization air volume
- Dew point
- Product temperature
- Roller compaction, gap, width & pressure
- Spray rate & volume
- Inlet air temperature
- Milling
- Screen size
- Compression force & speed
- Dwell time
- Coating
- Spray rate
- Inlet air temperature
- Encapsulation
- Tamping pressure
