Excipients
2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM – Age-Appropriate Pediatric Formulation Development
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.
PEGYLATION – PEGylation – Three Decades of Product Approvals & Technology Development
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.
FORMULATION DEVELOPMENT – Formulating Immediate-Release Tablets for Poorly Soluble Drugs
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.
SPECIAL FEATURE – Excipients: Matching Ingredients to Molecules Improves Functionality
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.
FORMULATION FORUM – Rational Design & Development of Lipid-Filled Hard Capsules
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.
HIGH PURITY EXCIPIENTS – A Simple Solution to a Complex Problem
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.
DEVELOPMENT TIMELINES – Drug Development Times, What it Takes – Part 1
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
MilliporeSigma Launches Excipient Technology Platform for Viscosity Reduction of Protein-Based Therapeutics
MilliporeSigma has recently launched a new Viscosity Reduction Excipient Platform to reduce the viscosity and help overcome manufacturing and formulation challenges associated with….
ABITEC Corporation & Larodan AB Announce Brand Refresh After Successful Integration of the Two Companies
ABITEC Corporation, an ABF Ingredients company, recently announced in July 2020 the acquisition of Swedish manufacturer and international marketer of state of the art, high-purity research grade lipids, Larodan AB….
Dotmatics to Deliver the Foundation for Croda’s R&D Digital Program: Artificial Intelligence & Data Mining
Dotmatics Ltd, a scientific informatics software and services company that is driving the automation of laboratory data workflows for scientific discovery and innovation research, recently announced it has been selected….
Roquette Boosts Customer Support With New Digital Pharma Marketplace
Roquette recently announced the opening of its new pharma online marketplace, powered by Knowde. The e-commerce platform will provide users….
Evonik Markets New Enteric-Protected Ready-to-Fill Capsules for Fast, High-Performance Drug Development
Evonik recently launched the EUDRACAP platform of easy-to-handle capsules to help the pharmaceutical industry accelerate speed to market for complex oral drug products in early development stages…..