Pharmaceutical Technology, Mar 2, 2008 - Pharmaceutical Technology

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Pharmaceutical Technology, Mar 2, 2008
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Innovation at Interphex
By Patricia Van Arnum
A preview of some product enhancements and launches for Interphex 2008, the large trade show being held Mar. 26–28 in Philadelphia.
SAFC Sets Forth an Ambitious Growth Strategy
By Patricia Van Arnum
SAFC is delivering on its plan for double-digit annual growth by increasing its businesses through organic growth and targeted technology acquisitions.
Special Report
New Dimensions in Tablet Imaging
By Maribel Rios
Chemical imaging of solid dosage forms has become a powerful analytical tool for the development of solid dosage forms.
Pharmaceutical Technology's Equipment and Machinery Trends Survey
By Patricia Van Arnum
The pharmaceutical industry plans moderate increases in spending for equipment and machinery in 2008. Investments include equipment for solid-dosage manufacturing, active pharmaceutical ingredients, and parenteral manufacturing.
Innovation in Equipment and Machinery
By Patricia Van Arnum
Results from Pharmaceutical Technology's Equipment and Machinery Trends survey and industry members provide insight into product innovation
Peer-Reviewed Research
Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations
By John Y. Lee , John G. Grazal
There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.
Packing-Line Improvement Based on a Fault-Tree Analysis Approach
By Arturo Toledo Rivero , Nelson Sierra Prado , Yohann Pérez Molina , Ian Toledo de Zayas
This article focuses on upgrading and improving a packing process to comply with current good manufacturing practices. The authors sought to maintain proper quality assurance for finished products.
Salt Selection in Drug Development
By Lokesh Kumar , Aeshna Amin , Arvind K. Bansal
The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.
Raw-Material Authentication Using a Handheld Raman Spectrometer
By Robert L. Green , Christopher D. Brown
Using a handheld Raman spectrometer, the authors developed methods for 28 commonly used excipients and active ingredients.
The Importance of Quality in Corrosion-Resistant Alloys
By Hira Ahluwalia , Brian J. Uhlenkamp
In this topical review, the authors discuss the rationale behind microstructural requirements for biopharmaceutical equipment and problems that may be encountered during the fabrication of high-performance corrosion-resistant equipment.
Peer-Reviewed Technical Note: Influence of Common Excipients on the Crystalline Modification of Freeze-Dried Mannitol
By Stefan Schneid , Xenia Riegger , Henning Gieseler, PhD
Mannitol is the most commonly used bulking agent in freeze-drying formulation design. The benefit of using mannitol is that it crystallizes during freezing and permits drying processes at higher product temperatures, and thus with higher sublimation rates relative to purely amorphous systems (1). Mannitol, however, is known to form different crystalline modifications which compromises reproducibility of product characteristics and storage stability due to phase transformations (2, 3).
Packaging Forum
Containers Insulate Companies from Product Loss
By Hallie Forcinio
New packaging options monitor and protect temperature-sensitive products.
Outsourcing
Outsourcing Outlook: API Manufacturers Go From Grams to Tonnes
By Jim Miller
CMOs have positive outlook for 2008 but are wary of competitive pressures.
Ingredients Insider
A Changing Path in Global Sourcing
By Patricia Van Arnum
The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.
Washington Report
FDA Seeks Regulatory Flexibility
By Jill Wechsler
Quality-by-design submissions may reduce supplements and improve change management.
Inside USP
Inside USP: Metrology and USP Dissolution
By Thomas S. Foster , Darrell R. Abernethy , William F. Koch , Walter W. Hauck, PhD
The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
Agent-In-Place
Holding Back
By Control, a senior compliance officer
If not properly monitored, filters and plastic bags can keep back more than they should.
Guest Editorial
Guest Editorial: Interphex Focuses on Evolution of the Life Sciences
By RJ Palermo
Show blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.
PharmTech Talk
Changing Fortunes for CMOs
By Patricia Van Arnum
Contract manufacturers of APIs and intermediates are cautiously optimistic.
Viewpoint
Time for a World Tooling Standard
By Dale Natoli
After two centuries, there's no reason to maintain two tablet compression tooling standards.
News
Report from: India
By A. Nair
A. Nair discusses patent disputes in India.
Coming Down the Pike: HDAC inhibitors
By Michelle Hoffman
New research and ideas for March 2008
In the Field: News
A news roundup for March 2008.
In the Spotlight
In the Spotlight
Editors' Picks of Pharmaceutical Science & Technology Innovations; Analytical system provides multiuser capability; Encapsulator aids dosage design; Versatile drive offers quick setup
Pharma Capsules
Pharma Capsules
Brief pharmaceutical news items for March 2008.

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Survey
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
27%
Breakthrough designations
9%
Protecting the supply chain
41%
Expedited reviews of drug submissions
9%
More stakeholder involvement
14%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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