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 preformulation to fully integrated solutions to get your drug to market faster.
For a free development consultation, please click here.
Catalent Reinforces Early Phase Development: Catalent Completes Tender Offer For All Outstanding Shares Of Juniper Pharmaceuticals, Inc.
PRECLINICAL FORMULATIONS
Moving More Molecules into Development
Formulations for Preclinical Efficacy Testing
Formulations for GLP Toxicology Studies
Thousands of drug candidates are abandoned annually due to solubility and bioavailability issues, but advanced formulation technologies can profoundly impact ADME and improve the fate of many of these candidates, improving PK profiles and PD responses.
With specialized capabilities and experience, Catalent offers comprehensive evaluations of compounds from formulation through preclinical in vivo proof-of-concept, and can provide you with preclinical formulations to help you move more molecules from discovery to development.
- OptiForm® Select solubility screening
- DMPK in silico modeling
- GLP formulations for toxicity assessments
OptiForm® Select Formulation Screening
Formulation Screening for Preclinical Efficacy Testing Coupled with DMPK Modeling Lets Data Drive Your Decisions
OptiForm® Select formulation screening, formerly known as Hot Rod Chemistry®, is a preclinical formulation screening tool designed to help solubilize your molecule for preclinical efficacy testing. Built off of more than 30 years of formulation know-how, OptiForm Select formulation screening improves lead candidate selection and enables continued development of promising, yet challenging, molecules, with more meaningful data by maximizing exposure with minimal material usage.
Once you have tested your molecule, Catalent will also provide guidance for your preclinical and clinical study design through a better understanding of your molecule’s developability and insights into drug absorption, metabolism and distribution. We will analyze your PK results using our DMPK modeling software. The data from DMPK analysis help direct human dosing strategies, leading to improved development decisions going forward.
Formulations for GLP Toxicology Studies
Formulation development can play an important role in providing maximum exposure of your drug candidate during toxicology studies. The challenge sometimes requires much higher exposure levels than clinical studies. A lack of exposure can severely trip up your GLP toxicology study. Investment in formulation upfront can help avoid costly delays. Therefore, formulation expertise with these studies is essential.
Catalent prepares formulations based on our extensive knowledge of vehicle suitability in preclinical models. We support development of preclinical drug formulations for various routes of administration. Our goal is to develop a formulation for toxicology studies that can help optimize exposure, while:
- Conserving API
- Ensuring quick turnaround to meet aggressive timelines
- Targeting a formulation that is transferable and easy to administer for your preclinical testing site
- Building upon the development of a human formulation
If needed, Catalent can produce non-clinical formulations for shipment to testing facilities. We can also analyze your formulation by HPLC to determine chemical and physical stability. If you don’t have an HPLC method appropriate for this use, our experienced team can develop a “fit for purpose” method at this stage of development.
PREFORMULATION AND FORMULATION DEVELOPMENT
A robust early phase development program that applies a broad range of preformulation 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.
Preformulation Studies
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
- Adsorption/desorption
- Excipient compatibility studies
- Container/closure compatibility
- Extensive analytical capabilities for research and development
Formulation Services
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 Human” studies
- Phase I – Phase III clinical trial materials support
- Formulation/process optimization
- Scale-up/technology transfer
- Commercial manufacturing technical support
BIOAVAILABILITY ENHANCEMENT
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
- Nano-milling
- Catalent Spray Drying Technology
- OptiMelt® Hot Melt Extrusion
- Lipid-based Drug Delivery
CLINICAL TRIAL MANUFACTURING
Our clinical trial manufacturing services complement our established formulation development expertise and are supported by our analytical and materials characterization capabilities. Our clinical manufacturing capabilities and technologies include:
- Tableting
- Encapsulation (powders, pellets, liquid fill, softgel)
- Granulation (dry, high shear, wet, melt)
- Fluid-bed granulation (Aqueous and solvent)
- Coating (multiparticulate and film coating)
- Spray drying (Aqueous and solvent)
- Hot melt extrusion
- Particle size reduction (micronization and nano-milling)
- Oral liquids and suspensions
Our clinical trials service offering also integrates:
- Primary packaging (e.g. HDPE bottles/blistering)
- Clinical Supply Services
- Assembly of patient supplies – Label design (inc. language translation) and printing, randomization
- Distribution of patient supplies
- QC release analytical testing
- Stability studies (in accordance with ICH guidelines)
- QP release
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
- Inhalation
- 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 preformulation 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.
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.