Pharmaceutical Technology, Sep 2, 2014 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Sep 2, 2014
Cover Story
QbD in API Manufacturing
By Cynthia Challener, PhD
With a quality-by-design approach, robust processes consistently can help deliver quality product.
Featured Content
Modularity Creates Flexible Manufacturing Systems
By Jennifer Markarian
Flexibility, which involves the ability to quickly change product capacity or even product type to meet market demand, is increasingly important. In new construction or renovation, modular process skids and modular buildings create this flexibility. Experts discuss trends and challenges.
Fit for the Lung?
Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.
Investigation of Various Impurities in Febuxostat
By Anand M. Lahoti , Ponnaiah Ravi , Neela Praveen Kumar , V. Innareddy , P. S. Deepthi , V. Shanmugam , M. Sudhakar Rao , Vivekananda Reddy
Febuxostat is a novel, non-purine, selective inhibitor of xanthine oxidase for hyperuricemia in patients with gout. It is the first promising substitute for allopurinol in 40 years. Various synthetic routes to febuxostat, as well as polymorphic forms and impurities of the drug, are reported in the literature. The authors have also identified several impurities that result from the synthesis of febuxostat. This article describes the identification and control of all isomeric, carryover, and byproduct impurities of febuxostat and its intermediates.
Using Quality by Design to Develop Robust Chromatographic Methods
By Melissa Hanna-Brown , Kimber Barnett , Brent Harrington , Tim Graul , Jim Morgado , Stephen Colgan , Loren Wrisley , Roman Szucs , Gregory Sluggett , Gregory Steeno , Jackson Pellett
The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.
API Synthesis & Manufacturing
Asymmetric Synthesis Continues to Advance
By Cynthia Challener, PhD
A survey of the recent literature reveals numerous advances in asymmetric chemocatalysis.
Regulatory Watch
Data Integrity Key to GMP Compliance
By Jill Wechsler
FDA demands accurate manufacturing and test information to ensure product quality.
Extending the Scope of Pharmacovigilance Comes at a Price
By Sean Milmo
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
Using Ultrasonic Cleaning for Equipment and Tooling
By Frank Pedeflous
Ultrasonic cleaning of solid-dosage tooling and other equipment, such as filling-machine valves and nozzles, is more effective than hand cleaning.
Drug Delivery
Exploring Newly Introduced Methods for Testing MDIs with Add-On Devices
By Mark Copley
The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.
Minimizing Variation in Vial Withdrawal Practice
By Zack Marks
Innovations in drug delivery such as needle-free transfer devices and vial adapters can provide consistency when transferring liquid for reconstitution of lyophilized drug products.
Outsourcing Outlook
Targeting Different Off-Shore Destinations
By Eric Langer
Annual study shows geographic proximity not a factor in CMO selection.
Product Spotlight
Thermo Fisher Scientific UHPLC System Improves Productivity
Thermo Fisher Scientific?s Vanquish ultra-high performance liquid chromatography (UHPLC) system is a new design for improved productivity and usability when used as a standalone system or with the latest mass spectrometers.
Waters QTof Mass Spectrometer Detects Low-Level Compounds
The Waters Xevo G2-XS mass spectrometer is a new high-performance benchtop quadrupole time-of-flight (QTof) mass spectrometer that combines the new XS Collision Cell with the technologies of Tof-MRM, StepWave and QuanTof for sensitivity and selectivity that allows detection of low-level compounds.
Excellims Ion-Mobility Separator Interfaces with Mass Spectrometers
The MA3100 high performance ion mobility pre-separator (HPIMS) from Excellims has been built to interface with multiple mass spectrometer (MS) product lines from Thermo Fisher Scientific.
Xylem Polarimeters Measure Chiral Compounds
The ADP600 Series high accuracy Peltier temperature-controlled polarimeters from Xylem?s Bellingham + Stanley brand measure chiral compounds and other optically active substances.
Guest Editorial
The Relevance of Industry Technical Associations
By Hal Baseman
Industry associations play a strong role in helping the pharmaceutical industry meet challenges.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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