October 2008

TABLE OF CONTENTS

Formulating Compositions to Achieve Enhanced Oral Bioavailability Through Supersaturation
James C. DiNunzio, MS; Dave A. Miller, PhD; James W. McGinity, PhD; and Robert O. Williams III, PhD; describe the underlying mechanisms for solubility enhancement from supersaturatable systems, as well as current applications of solid dispersion systems for bioavailability enhancement. 

 

Transdermal Delivery of Various Molecules In Vivo Using Alpha-tocopheryl Phosphate

Paul Gavin, PhD; Annike Griffey, Robert Gianello, PhD; et al investigate whether alpha-tocopheryl phosphate’s ability to enhance transdermal penetration also enables it to transdermally deliver drugs of interest.         

 

BIOROD: Bioadhesive-Based Oral System for Targeted Delivery

Avinash Nangia, PhD, explains how the bioadhesive rate-controlled oral delivery system provides controlled and customized release as well as retains the drug at its preferred absorption site in the GIT over an extended duration.

 

Proof of Electro-Osmotic Drug Delivery: A Prejudiced Clinical Trial, Delivering From Mouth to Nose

Nicholas A. Sceusa, PharmD, and Paul M. Ehrlich, MD, present the results of an IRB-approved, GCP-compliant, controlled human clinical trial submitted as proof-of-concept that electro-osmotic delivery exists and can be induced by the dosage form.

 

Pulmonary Drug Delivery: Technology, Regulation & Testing

Mark Copley, MEng, reviews current inhalation technology, the associated regulatory framework, and the test methods specified by the regulatory bodies for approval: delivered dose uniformity and aerodynamic particle size measurement.

 

Taste Optimization of a Model Oral Spray Drug Product

Jeffrey H. Worthington, MBA; David A. Tisi, MS; Frank E. Blondino, PhD; and Foyeke O. Opawale, PhD; review a unique and successful staged approach for developing a palatable oral spray for a model API.

 

Pharma Polymers: New Solutions for the Drug Development Value Chain

Drug Delivery Executive: Randy Bull, PhD, Global Business Director EUDRAGIT Polymers, discusses how Pharma Polymers is working with customers to meet drug delivery challenges in the global market.

 

Isis Biopolymer, Inc.: Iontophoretic Patches in Patient-Friendly Packages

Drug Delivery Executive: Emma Durand, President and CTO of Isis, talks about how the Isis Patch can deliver the clinical benefits of iontophoresis with the convenience and cost effectiveness of a transdermal drug patch.

 

BioPharma Contract Manufacturing: Growth Opportunities & Strategies

Frost & Sullivan Analyst Barath S. Shankar explains that as biopharmaceutical companies increasingly focus on innovation, revenues, and lowering overall cost, the importance of CMOs in achieving these objectives continues to rise.

 

Targeted Tumor Therapy Using Alpha-Particle Emitters

Thomas Ramdahl, PhD, believes that due to their ability to deliver lethal doses of radiation selectively to individual tumor cells while minimizing damage to neighboring normal tissues, alpha-particle emitters are expected to have a significant role in the future treatment of cancer.

 

Training & Testing: The Keys to Driving Study Site Performance in Clinical Trials

Bill Cooney says a comprehensive training/testing program represents a major opportunity for drug developers to significantly improve study site performance, leading directly to faster, higher quality, lower cost clinical trials.

 

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