Devon DuBose, Dana Settell, and John Baumann focus on the methodologies for efficient scale-up of the spray-drying process while maintaining the critical-to-quality attributes of the SDD.
Steven Hamlen, MBA, and Nicholas Johnson, PhD, MBA, discuss recent technology innovations in controlled-release solid oral dose functions and forms as well as more established methods for altering release profiles of molecules, and provide a real-world case study in which applying alternative formulation technology significantly improved an existing therapy and delivered patient and payer benefits.
BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part II of III
Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., continues his multiple-part series discussing today’s most challenging issues in solubility.
Drug Development Executive: Vincent D. Antle, PhD, Senior Director of Technical Operations, and James D. Pipkin, PhD, Senior Director, New Product Development talk about how the company works closely with pharmaceutical and biotechnology companies offering drug delivery solutions that significantly improve stability, solubility, bioavailability, safety, and dosing of APIs.
Edward T. Maggio, PhD, examines how alkylsaccharides offer exciting prospects for novel formulations, providing non-invasive delivery, stabilization, and immunogenicity reduction for biotherapeutic products, resulting in broader patient acceptance and compliance and an increase in their acceptance as viable commercial pharmaceuticals.
Jeffrey Bacha, MBA, says glioblastoma is one of the most common and fatal brain cancers, and new therapies to treat this disease are urgently needed. New approaches, such as vaccines and immunotherapies, have promising results, and to be most effective, will need to be used in combination with a chemotherapeutic.
Drug Development Executive: Amit Patel, President of Capsugel’s Dosage Form Solutions business unit, speaks about the formulation challenges facing the industry and the increasing pressure on companies to remain competitive in today’s dynamic marketplace.
Mark Perkins, PhD, reviews some of the important factors involved, and highlights the advantages of including recombinant human albumin to stabilize protein therapeutics with reference to a recent case study.
BIOAVAILABILITY ENHANCEMENT – Navigating a Broad Spectrum of Solubilization Technologies: Part I of III
In the past two columns, The Second Quadrant focused on excipients and the roles they play in the quest to overcome bioavailability challenges of poorly…
Stefan Hellbardt, PhD, and Degenhard Marx, PhD, focus their review on the trends in topical skin medication, the impact on primary packaging, and possible dispensing solutions.
EXCLUSIVE ONLINE CONTENT
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
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