October 2013

COVER

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.

FEATURES

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.

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.

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.

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.