April 2015

COVER

MANAGEMENT INSIGHT – Peak Drugs: Have We Passed the Peak of New Drug Discoveries? Are the Best Days Behind Us?

WHATEVER HAPPENED TO PEAK OIL? Since the 1970s, we have been told with varying degrees of certainty that we are about to run out of oil. We are at —..

FEATURES

SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products

Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.

LIPID-BASED DELIVERY SYSTEMS – New Approaches for Macromolecule Oral Delivery, Abuse Deterrence & Bioavailability Enhancement

Julien Meissonnier reviews the development of a broad range of advanced oral drug delivery technologies, including a toolkit of technologies based upon the broad application of lipid-based drug delivery systems for optimum solubility enhancement.

THE SECOND QUADRANT – The Birth of Drug Solubilization: 1840 Through 1920

Marshall Crew, PhD, indicates that while it may seem as if today’s technologies for dealing with solubilization challenges have emerged throughout the past 2 decades, their maturation took over a century, and this process itself is an interesting study in innovation diffusion.

FORMULATION DEVELOPMENT – A QbD Approach to Develop Extended Release Softgels

INTRODUCTION Soft gelatin capsules (softgels) continue to be the oral solid dosage form preferred by consumers.1 Understandably, as they are easy to swallow and digest, effectively mask unpleasant tastes and..

EXECUTIVE INTERVIEW – Croda: Understanding & Addressing the Purity Needs of the Pharmaceutical Market

Dr. Andrew Kaziska, Health Care Applications Manager at Croda Inc, discusses his company’s Super Refining technology and the benefits of excipient purity in drug formulations.

GASTRORETENTIVE DELIVERY – Box-Behnken-Designed Gastroretentive Floating Tablets of Famotidine

Mohit Kumar, MPharm, Parijat Pandey, and Harish Dureja, PhD, develop and characterize a single-unit, floating controlled drug delivery system of famotidine hydrochloride using a blend of natural polymer and synthetic polymer along with a gas-generating agent by applying Box-Behnken design.

ADVANCED DELIVERY DEVICES – Self-Administration Device Training: Incorporating New Technologies to Reduce Device Errors

Craig Baker says at its core, the ultimate goal of device training is to improve the patient experience and create value for HCPs and industry stakeholders, and improved training technologies can allow brands to engage patients and provide personalized training content based on individual patient needs and performance.

EXTERNAL DELIVERY – The Glamour of Air Travel

I have been traveling by air for all of my business life, and throughout the years, I have been both a victim of and a witness to a certain group..

PARTICLE AGGREGATION ANALYSIS – Biologics & Particulates: Identification & Control in the Product Lifecycle

Zabin Younes says that traditional tools, such as SEC and DSC, have been used in formulation screening; however, to ensure a control of particulate counts, it is important to use the full range of tools to ensure all types and sizes of particles and aggregates are assessed and accounted.

NANOSCALE PARTICLES – VAULT: A Novel Nanofrontier in Drug Delivery

ABSTRACT Novel nanoscale particles (Vaults) as first described in 1986, exist in the multiples of thousands in most eukaryotic cells. Having an intricate shape composed of multiple curves evocative of..