For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
FORMULATION FORUM – Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.
FORMULATION FORUM – Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway
Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.
Contributor Cindy Dubin speaks with several leading excipient manufacturers on how their excipient offerings are improving drug release, solubility, taste, physical characteristics, viscosity, and more for a range of molecules.
Jim Huang, PhD, says with ever increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based delivery systems, together with other main delivery technologies, have become an important tool for the development of those compounds.
William Small, PhD, and Arsalan Khan say drug degradation can have toxicological effects in many instances, and it is imperative that this mechanism be minimized as much as possible. The best solution to this is to ensure that appropriate ingredients, both high in quality and purity, are chosen and used throughout the entire drug product lifecycle.
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
EXCLUSIVE ONLINE CONTENT
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