Early Stage Oral Development
Your drug development challenge. Our comprehensive solutions. Fast, Flexible, Proven.
To successfully develop increasingly complicated molecules faster it’s often important to supplement innovator’s expertise with broader experience in formulation and specialized drug delivery technologies. Working with the #1 global leader in drug development who shares your passion for unlocking the potential of your molecule is the best way to accelerate development, avoid costly rework and improve the quality of your future treatments. Catalent has the specialized capabilities and experience to supplement your expertise. We help accelerate your development process, which may reduce risk and improve clinical outcomes through our superior formulation technologies and rigorous data-driven scientific approach which has evolved by our 20 global research and development teams from a successful track record of optimizing thousands of molecules. We can help solve your most complex challenges with comprehensive development, analytical and bioavailability enhancement from pre-formulation to fully integrated solutions to get your drug to market faster.
For a free development consultation, please click here.
Pre-Formulation and Formulation Development
A robust early phase development program that applies a broad range of pre-formulation testing and formulation strategies will help bring better treatments to patients faster. Our proven data-driven approaches speed drug candidates into first-in-man studies, then quickly advance them to formulated products.
Our small molecule drug development capabilities and expertise can help overcome solubility challenges, optimize your API, improve timelines and help advance your molecule to clinic.
We can help improve solubility early on with our proven and award-winning Optiform® Solution Suite an integrated offering designed to efficiently and rapidly help solve complex bioavailability challenges for early stage molecules using a unique toolkit of bioavailability enhancing technologies. OptiForm Solution Suite matches the best formulation technologies to your molecule, and utilizes an accelerated parallel screening and development approach, based on rigorous science and best-in-class scientific expertise, all in 12 weeks!
We provide studies necessary to elucidate the drug substance candidate with optimal physicochemical.
- Salt synthesis and salt form selection
- Polymorph screening
- Solid and solution state stability
- pH/temperature degradation rate profile
- pKa determination
- pH/solubility profile
- Excipient compatibility studies
- Container/closure compatibility
- Extensive analytical capabilities for research and development
With more than 80 years of experience, our extensive range of formulation capabilities can help solve the most complex bioavailability, solubility, and permeability challenges. We provide a full-range of formulated study supplies and services:
- Preclinical (GLP toxicology)
- Prototype formulation screening studies
- “First in Man” studies
- Phase I – Phase III clinical trial materials support
- Formulation/process optimization
- Scale-up/technology transfer
- Commercial manufacturing technical support
We have 20 R&D teams with development and formulation expertise to help solve some of the most complex bioavailability challenges. With over 80 years of experience and multiple, proven and innovative formulation technologies to help you deliver more effective treatments that can improve the performance of your product.
Bioavailability Enhancement Platform
The fastest and most effective way to unlock the potential of your molecule is to follow a rigorous, data-driven, parallel screening of appropriate available formulation technologies. We developed Optiform® Solution Suite to do this quickly and efficiently for small molecules and OptiForm® Solution Suite Bio for your large molecules.
- Optiform Solution Suite - a data-driven parallel screening approach to quickly and efficiently solving complex bioavailability and formulation challenges for poorly soluble compounds.
- OptiForm Solution Suite Bio - an integrated parallel screening for macromolecule oral delivery
For a free development consultation, please click here.
Bioavailability Enhancement Technologies:
- OptiForm® API Salt Form Optimization
- Catalent Micron Particle Size Reduction
- Pharmatek™ SD Spray Drying Technology
- OptiMelt® Hot Melt Extrusion
- Lipid-based Drug Delivery
Superior Enabling Formulation Technologies
We help solve your toughest formulation challenges with our wide array of proven and innovative technologies which can help to enhance solubility, bioavailability, stability, scalability and ability to manufacture. We create tailored solutions to drive faster development timelines and help you meet your target product profile. Our deep scientific, regulatory, and product development expertise helps improve the performance of your products. Our Technologies:
- RP Scherer Softgel Delivery Technologies
- Zydis® Fast Dissolve Delivery Technology
- OptiPact™ Roller Compaction
- Fluid-bed Processing
- Liquid & Sterile formulation and development
Comprehensive Analytical Services
Analytical Research and Development is key to understanding your molecule. Finding a partner that has a complete set of analytical testing and methods is vital for efficient product development. Catalent utilizes a step-wise approach for analytical testing and has tailored and integrated analytical services tied into pre-formulation and formulation development to assist with your development strategy. Services include:
- Compendial Testing
- Microbiology Testing
- Method Development/Validation/Transfer
- Structure Characterization
- Release & Stability Testing
- Specialized Testing
We have 20+ years of experience supporting rapid product development including PK/PD studies, method development and validation expertise and phase specific stability studies that can be applied to formulation and packaging strategies. Learn more.
Accelerated Development Solutions
On the path to successful drug development, optimal formulation technologies can improve patient treatments, and expedited regulatory pathways can shave years off the approval process. To support an accelerated development path, it is important to have formulation and process development approaches that can speed drug candidates into first-in-man studies while establishing a composition and process basis. Integrated development approaches and solutions can accelerate your product and speed the path to clinic and market.
Catalent's Accelerated Development Solutions are ideal for your breakthrough designation or orphan drug candidate. Learn more.
Why Catalent for Your Early Development Needs?
We've worked with thousands of molecules over 80 years of drug development, and have been involved in over 50 of the new molecular entity approvals by the FDA since 2004. Catalent can also partner with you through the clinic and all the way to market, ensuring robust and scalable formulations, and integrated clinical manufacturing to accelerate your program with full clinical packaging and distribution services as well as scale-up and commercial supply. Catalent under the lens.