issues

June 2010

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TABLE OF CONTENTS

How to Choose a CRO

Derek G. Hennecke, MBA, continues with part 3 of this 6-part series on business models and best practices for navigating the new normal.

 

Prefilled Syringes Gain Favor With Pharma, Caregivers & Patients

Contributor Cindy H. Dubin speaks with leaders in the prefilled syringe industry to find out how these delivery devices have evolved and what benefits they offer to a range of audiences.

 

Formulation & Evaluation of Time-Controlled Pulsatile-Release Propranolol HCl Pellets Prepared by a Suspension/Solution-Layering Process Using a Fluid Bed System

Himanshu K. Solanki, Bhupendra G. Prajapati, MPharm; and Girish N. Patel, PhD; formulate propranolol HCl pellets using two different viscosity grades of HPMC using a solution/suspension layering process, and then coating the pellets with an aqueous dispersion of EC using a fluid bed system to elucidate the release kinetics of propranolol HCl from the pellets.

 

Forced Degradation as an Integral Part of HPLC Stability-Indicating Method Development

George Ngwa, PhD, says that even though the ICH and FDA guidance documents only call for the inclusion of these studies in Phase III of the regulatory submission process, it is strongly recommended they be started as early as possible to assess the inherent stability of a drug, and to improve formulations and the manufacturing process.

 

Raman Chemical Imaging as a Tool for Measuring Layer Thickness in Sustained-Release Beads

Oksana Klueva, PhD; Ryan J.Priore, PhD; and Brian K. Jensen use Raman Chemical Imaging (RCI) coupled with optical microscopy to investigate API and polymer coating thicknesses in commercial sustained-release beads.

 

Banner Pharmacaps: Innovation in Gelatin-Based Oral Drug Delivery

Drug Delivery Executive: Roger E. Gordon, PhD, President and CEO of Banner, discusses his company’s proprietary technologies and expertise, and the future direction of the oral drug delivery industry.

 

Contract Research & Manufacturing Services: Best Practices, Investment Strategy & Deal-Making

Frost & Sullivan Analyst Barath Shankar Subramanian provides a market brief on the contract research and manufacturing services (CRAMS) market, reporting it is one of the fastest growing segments in the pharmaceutical and

biotechnology industry.

 

DEPARTMENTS

 

Market News & Trends

 

Excipient Update

Evaluation of In Vitro Dissolution Methods for the Assessment of Drug Release

 

Advanced Delivery Devices

A Compact, Controllable, Implantable Delivery Device Driven by Electro-Osmosis

 

Technology Showcase

 

External Delivery

Unethical Ethics

 

COVER

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