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Bioavailability Enhancement Suite

More than 60 percent of compounds in early development fall in Class II of the Biopharmaceutical Classification System (BCS), exhibiting low bioavailability driven by limitations in solubility or dissolution rate. With the acquisition of Bend Research and Encap Drug Delivery in 2013, Capsugel Dosage Form Solutions has a premier suite of bioavailability-enhancement technologies with which to address BCS Class II challenges.

Our Capabilities

Capsugel Dosage Form Solutions has extensive capability, intellectual property and experience with the key technologies used to address bioavailability challenges:

This technology breadth allows our scientists to efficiently select technology, demonstrate formulation feasibility, optimize formulations and advance product concepts through clinical trials to ongoing commercial manufacture. Using our collective expertise in formulation science, we focus on key physical and chemical properties of the compound and 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 about selection of the technology (i.e., drug-delivery platform) that offers the highest potential for performance, stability and manufacturability.

Increase Aqueous SolubilityOur Technology Selection Methodology – developed over years of scientific investigation leveraging the experience of formulating and advancing more than 1,000 compounds – allows Capsugel Dosage Form Solutions Scientists to select the optimal technology rapidly, saving valuable time, reducing complexity and lowering costs. Models and conceptual reference maps have been developed that guide scientists in the design process.

During feasibility analyses, our Rapid Advancement Process™ leverages these models to conduct feasibility studies in less than 6 weeks — and often and as little as 2 weeks. Our ability to formulate with minimal quantities of API means we can assist with lead selection by choosing the best compounds to progress at an early stage. First-in-human (FIH) clinical trials can be reached in 6 months or less from project initiation.

Formulation Development – Low-Solubility Compound Example

Low-solubility Compound

Capsugel Dosage Form Solutions utilizes a wide range of complementary technologies to optimize finished dosage forms, including:

Salt Form Selection and Polymorph Screening
Capsugel Dosage Form Solutions offers preformulation services including polymorph identification and salt screen/selection as a complement to our Bioavailability Enhancement suite of technologies. Salt selection for a potential drug candidate can improve the bioavailability, stability and manufacturability of the drug. Considerations include crystalline material, non-hydroscopic, a high single melting temperature and chemical stability in the solid form. Salt forms of a drug have a large effect on the drugs’ quality, safety and performance.

Polymorph screening is done during API selection to determine if the API can exist in polymorphic forms and whether the choice of polymorph will affect the drug’s efficacy and/or safety profile. A polymorph screen of the drug substance is conducted utilizing a selection of possible solvents that have come in contact with or may come in contact with the drug substance during synthesis, purification, process, cleaning, and/or salt formation.

Related Links

Modified-release technology suite
Liquid and semi-solid fill technologies
Multiparticulate formulation options
Abuse-deterrent formulation approaches
Inhalation formulation technologies
Biotherapeutic processing
Health and Nutrition

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