OptiForm® Solution Suite
ENHANCE BIOAVAILABILITY IN 12 WEEKS
According to industry reports1 only "1 in 10 new molecules in active clinical development are readily bioavailable" and even those that are, may not be sufficiently absorbed when dosed at escalated levels. We know, that in addition, limited amounts of material are available for the determination for formulation pathways that would result in speedy execution of product development.
OptiForm® Solution Suite is a ‘molecule centric’ integrated offering designed to efficiently, flexibly and rapidly solve complex bioavailability and formulation challenges for early stage compounds. OptiForm Solution Suite matches the best formulation technologies to your molecule, and utilizes an accelerated parallel screening approach, based on rigorous science and best-in-class scientific expertise, all in 12 weeks! OptiForm Solution Suite provides great flexibility in test and technology selection, to give your molecule better chance to succeed in PK studies and a viable path to Phase I.
Because Catalent’s product development network comprises leading scientists with deep experience with a wide array of technologies, we can offer OptiForm® Solution Suite at a single fixed price, enabling our partners to better manage the risk/spend ratio on a molecule.
If you're ready to get started today, we encourage you to try the "patent pending" OptiForm® Pro Web Tool which will enable you to learn more about the possible formulation approaches that may be suitable for your unique molecule.
Minimal material needed
Dedicated scientific expert
Accelerated parallel process
Optimized animal PK materials in 12 weeks
Fast path to Phase I after PK studies
Customized chemical and stability analyses
Flexible technology screening options
Data driven, ‘molecule-centric’ choices
For early stage molecules to accelerate development and reduce risks, it is essential to:
- Assess the properties and challenges specific to each molecule
- Apply known industry models and evaluate in parallel multiple delivery options
- Use scientifically rigorous data to rank development options
Let's look at each in detail.
By applying proven high throughput screening tools, Catalent's team assists you by providing detailed pre-formulation data in order to characterize the molecule’s potential challenges. Typical assessment includes:
- Molecule physicochemical characterization
- Solid state characterization and stability evaluation including polymorph screening
- Solubility in bio-relevant media and in selective formulation components (e.g., polymers, surfactants, lipids)
- Chemical compatibility with major excipient groups and stability in bio-relevant media
- Ability to reduce particle size
- Salt form benefits
Catalent's formulation technology experts efficiently determine the feasibility of the proposed formulation approaches using parallel path processing which results in recommend candidate formulations. In addition, our experts are able to provide you preliminary stability data in order for you to make better decisions about the candidates. The typical program includes:
- Development of lipid-based formulation under a solution and/or dispersion form
- Amorphous solid dispersion, including Pharmatek™ SD and OptiMelt® HME
- Particle size reduction
- Short-term preliminary stability data
- Built-in risk assessment to rank formulation options per physical, chemical and processing stability risk and to provide directional ranges of dose escalation limits (Acceptable Daily Intake and exposure driven)
In 12 weeks, a dedicated adviser will provide a recommended path forward based on rigorous data, shipping to your facility the necessary animal PK study materials for you to enter animal trials with an optimal product faster. The typical program includes:
- Development report showing summary of studies conducted, results,recommendations, and risk assessment for each dose form option to yield better bioavailability, including operational considerations,regulatory approval risks, and patient specific considerations.
- PK study materials: lipid solution and/or suspensions, milled solid dispersion, micronized/milled salt form if applicable.
- Protocol to administer formulation in animal PK studies.
- Your dedicated scientific adviser will review all the data and recommendations with you.
A number of recent webinars provided more details to the structured approach for parallel formulation feasibility assessment that is designed to reveal the most suitable pathway to enhance bioavailability and accelerate development. Learn more by viewing:
- Early Technology Selection For Optimized Drug Development
- Accelerated Bioavailability Enhancement For Early Phase Molecules
- Novel Technologies To Deliver Oral Oncology Therapies
After Your OptiForm Program
After your successful animal PK trial we can help you develop Phase I enabling dose and partner with you through the process in order to deliver optimized therapeutic, delivery, layer, provider and patient requirements.
For molecules with more available clinical data that have other bioavailability hurdles beyond exposure, Catalent has additional solutions.
The largest and broadest set of technologies designed to deliver the best form of your molecule:
- Bioavailability Solutions - We have a team of over 1,000 development and formulation scientists that have the talent and expertise to solve some of the most complex bioavailability challenges.
- Better Treatments - We have deep scientific, regulatory, and product development expertise that will help improve the performance of your products.
- OptiForm® API - high throughput screening platform that has been applied to more than 500 compounds, spanning from early-stage lead compounds through launched products.
- Catalent Micron Technologies - particle size engineering technology for enhanced bioavailability, stability and manufacturability.
- RP Scherer Softgel - the most successful bioavailability solution that enables optimized delivery profile.
- OptiShell™ Technology - solves bioavailability challenges for a wider range of molecules, and accommodates semi-solid formulation for modified release.
- OptiMelt® Hot Melt Extrusion - unique ability to formulate, develop and commercialize hot melt extrusion processes.
- Pharmatek™ SD - spray drying technology for bioavailability enhancement of your poorly soluble API.
- Zydis® ODT - world’s best orally dissolvable tablet – about 3 seconds, now with taste-masking and higher dose options.
- OptiGel™ Bio Technology - enhances bioavailability for macromolecules, potentially enabling the oral delivery of biotherapies.
Depth of Supporting Expertise
Our focused studies and extensive analytical offerings provides best in class support that will help ensure your project's success.
- Method Development and Validation
- Drug Substance, Drug Product Release and Stability Testing
- API Product Characterization
- Drug Excipient Compatibility
- Product Optimization
- Scale Up and Validation
- Regulatory Consulting
1. R. Lipp; The Innovator Pipeline: Bioavailability Challenges and Advanced Oral Drug Delivery Opportunities, Am. Pharm. Rev., 2013