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The breadth and range of our bioavailability-enhancing and modified release technologies are critical for efficient product development, with the collective utility of these technologies covering a broad space in terms of drug properties and target performance. Extensive investigation of each technology has resulted in an in-depth understanding of its range and appropriate use. This technology breadth and know-how promotes unbiased assessment and flexibility in selecting the optimum technology for a particular compound.
We use numerous types of information and a variety of specialized tools to ensure the optimum technology is selected for each new compound and associated target product profile.
Product Needs – A detailed understanding of client expectations governing the final dosage form size, shape, appearance, packaging and compliance needs facilitates effective technology selection. Extensive client discussions and involvement early and collaboration throughout the product development process are critical. We leverage the expertise of Capsugel’s global commercial and regulatory team to understand relevant patient preferences and regulatory requirements.
Compound Qualification – We focus on in-depth understanding of the physical, chemical and biological properties of the compound. This fundamental understanding enables the development of tailored problem statements for each compound and guides preliminary decisions on technologies to enhance formulation effectiveness and demonstrate the highest potential for performance, stability and manufacturability.
Absorption Models – Internal predictive physiological-based pharmacokinetic (PBPK) models predicated on modeling mass transport under physiologically relevant conditions are also consulted to predict in vivo performance based on compound and formulation properties. These models are based on the increase in intestinal absorption of a poorly water-soluble drug that will result from an increase in the concentration of all drug species.
Past Project Databases – Conceptual “technology maps” have been developed based on analysis of data from past projects on how key physicochemical drug properties have affected oral absorption. These key drug properties have been mapped from the evaluation of more than 1,000 compounds to craft robust understanding of each technology and their respective feasibility / performance boundaries. A series of maps plotting key parameters are referenced in choosing the optimal enabling technology and limiting the empirical analyses required.
Our Technology Selection process, which includes predictive modeling and technology mapping, allows Capsugel Dosage Form Solutions scientists to quickly identify the right solution for improving bioavailability and formulating a robust, fit-for-purpose dosage form.
This approach offers clear advantages over more empirical approaches that focus on “screening” various technologies—including efficient and successful compound advancement, optimized dosage forms, reduced API usage, and speed to clinic and, ultimately, speed to market.
Empirical approaches may result in development delays and may require a substantial amount of compound to effectively evaluate several technology paths. In addition, these approaches run the risk that a compound fails to perform across all technologies. In many cases, this lack of success may stem from inappropriate or suboptimal formulation design and development or, even more fundamentally, the lack of a drug candidate/technology “match,” rather than fundamental technology ineffectiveness.
The advantages to our technology selection process can be contrasted to instances when a drug has been progressed down a specific technology path, or parallel paths using technologies that aren’t optimally suited to the drug properties and product needs. This approach is common in the industry where a pharmaceutical company, contract research organization (CRO), or contract developer and manufacturer organization (CDMO) has strong expertise and experience in a specific technology that may not be well-suited to the drug properties or product needs for a specific project. Initial selection of a less-than-optimal technology may be revealed early at initial feasibility assessment or later on during development process, but results in wasted time and resources and can halt development of an otherwise promising compound. In contrast, Capsugel Dosage Form Solutions scientists use a wide range of data to ensure impartial selection of the best technology for a given application.