Featured Articles
MANAGEMENT INSIGHT - Up Against the Wall: What You Need to Know Before Digging Into Your Next Building Expansion
Derek G. Hennecke continues his series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
MARKET BRIEF - Financial Performance Benchmarking & Competitive Landscape Assessment of Leading CROs
Adam M. Dion, MS, summarizes GlobalData’s recent CRO Benchmark Report and believes the dynamics of pharmaceutical outsourcing and location decisions in emerging markets are changing. Cost reduction is being augmented and will gradually be eclipsed by footprint growth as a major factor shaping decisions, and CROs are realizing that the ability to be on the ground closer to their customers is a key building block to establishing sustainable, long-term relationships with clients.
PACKAGING SOLUTIONS - Overcoming the Challenges of Child-Resistant/Senior-Friendly Closure Development in Today’s Changing World
Steve Stalions and Kurt Attermeier say that as the demand for better CR/SF packaging is on the rise, so too is the market demand for greater cost effectiveness, sustainability, and value-added end-user benefits, and explain how these challenges can be overcome.
ABUSE DETERRENT TECHNOLOGY - New Abuse Deterrent Formulation Technology for Immediate-Release Opioids
Johannes Bartholomäus͛, PhD; Sebastian Schwier, PhD; Martin Brett, et al, review how the INTAC technology platform has been extended to IR formulations with the intention to deter non-oral routes of abuse.
SPRAY-DRIED DISPERSIONS - Efficient Scale-Up Strategy for Spray-Dried Amorphous Dispersions
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.
INTRADERMAL DELIVERY - Advances in Intradermal Drug Delivery
Zach Marks, MS, RPh, believes efficiency of vaccine use will be critical as the world population continues to grow and vaccine prices continue to rise, and ID administration can help reduce dose cost while potentially improving immunogenicity in traditional and hard-to-treat populations.
SOLID DOSAGE FORMS - Better Treatments Through Innovative Solid Oral Drug Release Technologies
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.
FORMULATING PEPTIDES - Novel Formulations for Non-Invasive Delivery & Stabilization of Peptides
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.
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.
ADVANCED DELIVERY DEVICES - The Reconstitution Revolution
Alan Shortall believes with dual-chamber syringes and other emerging device technologies now addressing key market requirements for intuitive reconstitution and injection, the pharmaceutical market for therapies suitable for reconstitution and mixing at the point of delivery is poised for significant rates of growth.
EXECUTIVE INTERVIEW - Ligand: Effective Drug Delivery Solutions With Captisol
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.
BUSINESS DEVELOPMENT - Growing Your Business: A Stage-by-Stage Analysis of Your Company’s Growth & the Challenges it Faces
Derek G. Hennecke continues his series offering an overview of this year’s best business books with insights into what they can teach the Pharma industry.
SPECIAL FEATURE - Hand Held Devices: New Technologies Right the Wrongs of Earlier Devices
Contributor Cindy H. Dubin highlights in this annual report that new devices are coming to market that not only address the trends of home care and a need for delivering larger doses, but are also cleaning up the spotty reputation of early stage devices.
THERAPEUTIC FOCUS - New Therapeutics for Aggressive Brain Cancers
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.
BUSINESS DEVELOPMENT - The 5 Whys
John A. Bermingham says one of the key business success factors he has followed throughout the years is that of always trying to determine the root cause of any problem.
EXECUTIVE INTERVIEW - Capsugel DFS: Integrating Technology for Innovative Finished Dosage Forms
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.
ADVANCED DELIVERY DEVICES - Nanocomposites for Drug Delivery Catheters
Lawrence Acquarulo, PhD, indicates an increased availability of certain medical materials could create a new wave in the development of precision devices to reach smaller areas deeper within the body.
EXCIPIENT UPDATE - Maximizing the Stability of Therapeutic Proteins Using Recombinant Human Albumin
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…
TOPICAL TRENDS - Trends in Skin Medication Dispensing
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.
