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.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Richard Gray, MA, discusses the use of polymer microparticles for pharmaceutical applications, including specific examples of polylactic-co-glycolic acid (PLGA) encapsulation.
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
EXCLUSIVE ONLINE CONTENT
Gattefossé is investing 30 million euros in its industrial operations and announced the construction of a brand new manufacturing plant in Lufkin, TX. This asset will produce lipid-based….
Croda International Plc recently announced it has entered into an agreement with Pfizer Inc. to supply novel excipients used in the manufacture of a COVID-19….
Evonik Launches New Oral Drug Delivery Technology for Enteric Protection & Rapid Release in the Upper Small Intestine
Evonik has recently launched an advanced oral drug delivery technology that provides enteric protection followed by rapid, homogeneous release for effective….
Evonik recently announced the qualification of an advanced aseptic filling line for complex parenteral drug products at its FDA-inspected Birmingham….
Croda International Plc recently announced it has agreed to acquire Avanti Polar Lipids, Inc., a knowledge-intensive leader in lipid-based drug delivery technologies for next-generation pharmaceuticals…..