Industry estimates indicate that between 60-90% of new chemical entities exhibit poor solubility or dissolution rate. Effectively addressing these issues is essential for the development of drugs with adequate bioavailability, which is crucial if a drug is to provide the desired therapeutic benefit to patients.
Capsugel is a leader in drug solubility and enhancement of solubility or dissolution rate. Our depth of bioavailability enhancement technologies and their application enables us to work collaboratively with our customers to advance compounds with a range of properties and delivery challenges. Rather than relying on trial and error, we use a fundamental, model-based approach to select the best technology for each of our customers’ compounds. We build on that approach with formulation optimization, process development, and scale-up to advance medicines first to the clinic and then to commercialization.
We provide customers with integrated product development services, from defining the problem to clinical and commercial scale production of micronized APIs / drug product intermediates, using enabling technologies such as spray drying, and/or finished dosage forms.
In addition to significant intellectual property, Capsugel has extensive capabilities, and experience with the key technologies used to address bioavailability challenges:
- High-energy crystals / salt forms
- Micronization and nano-milling
- Solid amorphous dispersions
- Spray-dried dispersions (SDDs)
- Hot-melt extrusion (HME)
- Lipid- / Liquid-based formulation (LBF) approaches
- Liquid-filled hard capsules
- Soft gelatin capsules
- Nanocrystalline technologies
- Specialized spray-dried nanoadsorbates (SDNAs)
- Solid nanocrystalline dispersions (SNCDs)
- Specialized lipid multi-particulate (LMP) technology, used to combine bioavailability enhancement with extended release and/or taste masking
This technology depth allows our product development teams to efficiently select the most suitable technology, demonstrate formulation feasibility, optimize formulations, and advance product concepts to clinical trials and commercial manufacture. Using our collective expertise in formulation science, we focus on the key physical and chemical properties of a compound and its dosage form requirements, working collaboratively with clients to develop tailored problem statements specific to each compound. These problem statements are used to guide preliminary decisions regarding selection of the best technology (i.e. drug-delivery platform) that offers the highest potential for performance, stability and manufacturability.
Our Technology Selection Methodologies – developed over years as we formulated and advanced more than 4,000 compounds – enable Capsugel product development teams to rapidly select the optimal technology and avoid or minimize trial-and-error approaches. Models and other tools have been developed to guide us in the design process, resulting in accelerated and optimized product performance, while minimizing program cost and complexity. Incorporation of Quality-by-Design (QbD) principles early in the product design phase ensures ultimate manufacturability of the formulation design.
In addition, specialized lab-scale equipment has been developed that allows us to rapidly assess formulation performance with minimal API requirements. Our lab-scale process modeling capabilities and extensive experience in advancing compounds also facilitate rapid and efficient scale-up.