October 2012

TABLE OF CONTENTS

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DRUG DEVICES – The Rise of the Bolus Injector – A New Device Class Enabling Long-Duration Subcutaneous Administration of Large-Dose Volume Biologics

Alan Shortall reviews Unilife’s bolus injectors for large-dose volume injectable therapies, and how Unilife is already working with a number of companies to customize each device to address the specific needs of a series of pipeline and approved molecules.

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BIOAVAILABILITY ENHANCEMENT – Overcoming Poorly Soluble Pharmaceutical Formulations With Hot Melt Extrusion

INTRODUCTION Solubility is an essential characteristic of active pharmaceutical ingredients (APIs), with profound effects on process and clinical development, formulation, and commercialization. Higher-solubility drugs dissolve more completely and are generally..

FORMULATION DEVELOPMENT – Recombinant Human Albumin: Delivering the Future of Type 2 Diabetes Medication

Mark Perkins, PhD, discusses the application of human serum albumin as a half-life extension technology for GLP-1 therapeutics and how further developments in recombinant human albumin technology may further change the dosing paradigm.

DRUG DEVICES – The Rise of the Bolus Injector – A New Device Class Enabling Long-Duration Subcutaneous Administration of Large-Dose Volume Biologics

Alan Shortall reviews Unilife’s bolus injectors for large-dose volume injectable therapies, and how Unilife is already working with a number of companies to customize each device to address the specific needs of a series of pipeline and approved molecules.

FORMULATION DEVELOPMENT – Dry Eye Syndrome: A Review & Novel Formulation Approach

David M. Kleinman, MD; Andrew Loxley, PhD; Gillian M. Tocci, PhD; George Ngwa, PhD; William Gensheimer, MD; and Robert W. Lee, PhD; indicate PEGPLUS, a multifunctional graft copolymer, can be used in a host of topical ophthalmic applications.

EXCIPIENT UPDATE – Addressing Challenges With Low-Solubility Compounds: The Importance of Functional Excipients in the Formulation of Amorphous Dispersions

Rod Ray, PhD, explains that because more than half of the compounds in early development are considered poorly soluble, improving oral bioavailability represents a significant challenge to the pharmaceutical industry.

MANAGEMENT INSIGHT – Formulating Happiness

Derek G. Hennecke concludes his 6-part series on lessons learned from other industries.

FORMULATION DEVELOPMENT – Formulation & Evaluation of Atorvastatin-Loaded ER Tablets

N.V. Satheesh Madhav, PhD, MPharm; and Pranshu Tangri, MPharm; formulate and evaluate sustained-release tablets of atorvastatin using a biomaterial isolated from unripe fruit pulp as a novel biobinder for the formulation of tablets.

EXECUTIVE INTERVIEW – Hovione: New technologies in Particle Design

Dr. Colin Minchom, VP of Hovione’s Particle Design business unit, discusses how the company is evolving and adapting in the current market and reviews its new Particle Design offering.

DRUG DELIVERY – Innovative Formulation Technology Protecting Intended Drug Action

Johannes Bartholomäus, PhD; Judy Ashworth, MD; Hans-Jürgen Stahlberg, MD; Eric Galia, PhD; and Kai Strothmann, PhD; examine an innovative drug delivery platform that can significantly raise the hurdle for misuse or abuse of tablets by routes of administration that require the product to first be crushed.

LYOPHILIZATION – Making Formulations More Efficient Using the Freeze-Dry Microscopy Pre-Lyophilization Method

Jeffrey McGinn says to minimize cost and streamline this process, many companies developing new parenterals are finding it in their best interest to optimize their lyophilization cycles by looking at pre-lyophilization methods such as freeze-dry microscopy.

DRUG DELIVERY – OraGuard(TM): A Tampering-Deterrent & Alcohol-Resistant Extended-Release Technology

Dinesh Haswani, PhD; John Nagel, MBA; Derek Moe, PhD; and Ehab Hamed, PhD; say formulations developed using OraGuard technology provide overlapping resistance against various tampering methods, such as crushing and ingestion, chewing, small-volume extract

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