June 2015

COVER

SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs

Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.

FEATURES

THERAPEUTIC FOCUS - Direct Effects(TM) Diabetic Neuropathy Therapy: Treating Symptoms & Modifying Disease

Ronald Aung-Din, MD, reports that by using a unique methodology, symptomatic and neural restorative therapies treat DPN in preparations applied directly to areas of pathology, and therapeutic benefit is obtained in much shorter time than through blood flow.

CLINICAL TRIALS - Accelerating the Clinical Trials Process

Tom Johnson says by improving the collaborative experience without sacrificing control or security of sensitive information or intellectual property, identity hubs and their providers help pharmaceutical companies minimize the time and cost of clinical trials and the drug R&D process as a whole.

IONTOPHORESIS - Captisol-Enabled(TM) Lipophilic Drug Complex Delivered Transdermally by Iontophoresis

Abhishek Juluri, PhD, Fahimeh Ghasemi, MS, Horacio Pérez-Sánchez, PhD, et al provide results obtained from in vitro studies clearly demonstrating the transport enhancement ability of CAP in solution as well as in gel formulations.

CAPSULE TECHNOLOGY - Enteric Capsule Drug Delivery Technology - Achieving Protection Without Coating

Hassan Benameur, PhD, says ECDDT represents a new, faster, and easier means for oral delivery of labile entities, such as peptides, nucleotides, live biopharmaceutical products, and vaccines.

PLASMA-DERIVED BIOLOGICS - New Fractionation Process to Expand Availability of Plasma-Derived Treatments

Jeffrey B. Davis, MBA, explains how his company has initiated a three-phase process of scaling up the Salt Diafiltration Process, validating it for required FDA filings, and ultimately running the process at production scale to enable the clinical trial product to be produced.

FORMULATION DEVELOPMENT - Overcoming Early Phase Development Challenges & Optimizing Formulations With a Minimal Amount of API

ABSTRACT Softgel is a proven and effective delivery technology for poorly soluble drugs and can incorporate a wide range of fill formulations to optimize the bioavailability of active pharmaceutical ingredients..

MANAGEMENT INSIGHT - Homeopathy & Other Irrational Things People Believe

Derek Hennecke provides an interesting perspective on how pseudoscience kills. And yet, so many people – even smart people like those in the military and government leaders – believe it. Why do smart people believe stupid things?

EXECUTIVE INTERVIEW - Patheon: Comprehensive Development & Manufacturing Solutions for the Entire Drug Development Cycle

Franco Negron, Patheon’s Senior VP of Drug Product Services, discusses his company’s business strategy, two recent acquisitions and integration plans, the role biosimilars play in Patheon’s business, and significant trends driving the pharmaceutical industry over the next few years.

EXTERNAL DELIVERY - Perfuming the Pig

My apologies to the swine lovers of the world for the title to my column this month. I like pigs. They’re cute, smart, have a nose way more sensitive than..

SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs

Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.