October 2015

COVER

FORMULATION DEVELOPMENT TECHNOLOGY - A Novel Drug Delivery System That Offers Zero-Order/Near Zero-Order Release Profile of Low-Dosage Strength Tablets Containing Highly Soluble Actives

Thomas B. Gold, PhD, was awarded a US patent; the intellectual property centers on formulation development technology that allows for the steady, continuous release of API over a particular duration of time to mitigate variations or spikes in therapeutic benefit.

FEATURES

ADVANCED DELIVERY DEVICES - Implantable Drug-Eluting Devices: A Novel Approach to Patient Care

Samuel D. Trohman, MBA, Joey L. Glassco, Elena Draganoiu, PhD, and Carey Boyum present developmental and commercial examples of non-biodegradable drug-eluting devices, along with the versatile properties of thermoplastic polyurethanes for the development of effective drug delivery systems.

SOLUBILIZATION TECHNOLOGY - How to Choose the Right Solubilization Technology for Your API

Matt Wessel, PhD, Tom Reynolds, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, present a brief overview of the various solubilization technologies, and a high-level strategy to aid in the selection of an appropriate formulation technology.

PRIMARY PACKAGING - Ophthalmic Squeeze Dispenser (OSD): Does One Size Fit All?

Degenhard Marx, PhD, and Matthias Birkhoff, discuss how the use of preservatives in eye drops is still controversial, but more and more evidence supports the use of unpreserved eye drops for treatment of chronic diseases.

EXECUTIVE INTERVIEW - Vetter: Helping Small Biotech Companies Execute a Successful Drug Development Process

Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.

ORODISPERSIBLE TABLETS - Advanced Drug Delivery for Repositioning Promethazine for Improved Application & Patient Outcomes

Srinivas Tipparaju, PhD, Anastasia Groshev, Danielle Dantuma, et al designed and characterized a formulation of ODTs at three different compression settings to determine the effective formulation for manufacturing rapid-release ODT promethazine tablets.

EXECUTIVE INTERVIEW - ALTHEA: Giving Biopharmaceutical Companies the Power To Make

David Enloe, Althea’s President and CEO, discusses his company’s business strategy, why companies choose Althea, trends in the CMO industry, and how the company is growing since the acquisition of Ajinomoto.

SYRINGE SYSTEM - The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies

John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.

FORMULATION DEVELOPMENT TECHNOLOGY - A Novel Drug Delivery System That Offers Zero-Order/Near Zero-Order Release Profile of Low-Dosage Strength Tablets Containing Highly Soluble Actives

Thomas B. Gold, PhD, was awarded a US patent; the intellectual property centers on formulation development technology that allows for the steady, continuous release of API over a particular duration of time to mitigate variations or spikes in therapeutic benefit.

Patently Disruptive

Derek Hennecke, CEO &President of Xcelience, says Kyle Bass and his hedge fund are challenging pharma patents for the purpose of shorting their stocks and making a fortune and asks is this just industry noise or a true disruption?