Pharmaceutical Technology, Mar 2, 2014 - Pharmaceutical Technology

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PharmTech Europe

Pharmaceutical Technology, Mar 2, 2014
Cover Story
Optimizing Solid Dosage Manufacturing
By Jennifer Markarian
Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.
Special Report
Control Strategies for Synthetic Therapeutic Peptide APIs— Part I: Analytical Consideration
By Aleksander Swietlow , Harold Rode , Anita Szajek , Michael Verlander , Ivo Eggen , Brian Gregg
USP evaluates quality attributes for synthetic peptides.
Peer-Reviewed Research
Comparing Drug Layering and Direct Pelletization Processes
By Ed Godek
The extended-release performance of drug-loaded pellets manufactured by two methods, drug layering and direct pelletization, was compared.
A New Approach to Forced Degradation Studies Using Anhydrous Conditions
By Elizabeth Hewitt , Laila Kott , Jun Wang , Nick Yankauskas , Christopher L. Franklin
In this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.
Drug Delivery
Current issues with nanomedicines
By Adeline Siew, PhD
Despite the progress made in nanomedicine development, there are several issues that remain unresolved. Raj Bawa, PhD, provides insight.
Nanosimilars and follow-on nanomedicines
By Adeline Siew, PhD
With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.
Perspectives and Challenges of Nanomedicine in Gene Silencing
By Nidhi Gupta , Surendra Nimesh
Advances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.
Characterization of nanomedicines
By Adeline Siew, PhD
Nanomedicines can offer promising benefits in the diagnosis and treatment of diseases but there are still concerns about the safety and quality of these therapeutics partly because of the lack of clear regulatory guidance. Scott McNeil, PhD, director of the Nanotechnology Characterization Laboratory (NCL), spoke with Pharmaceutical Technology about nanomedicine characterization.
API Synthesis & Manufacturing
Synthetic Biology: The Next Frontier in Chiral Chemistry for API Synthesis
By Cynthia Challener, PhD
The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.
Featured Content
A Survey of Postapproval CMC Changes to Generic Drugs
By Geoffrey Wu , Lane Christensen , Andrew Zhang , Zhaoxin Yang , Andrew Tran , David Holovac , Benjamin Danso , Larisa Wu , Paul Schwartz , Lawrence Yu
A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.
Trends and Best Practices in Visual Inspection
By Hallie Forcinio
Using best practices for manual or automatic inspection can improve the inspection process.
Regulatory Watch
European Union Packaging Safety Features Come into Effect
By Sean Milmo
Manufacturers are taking measures to comply with new package safety rules.
Manufacturers Struggle with Breakthrough Drug Development
By Jill Wechsler
Accelerated testing and production create challenges in documenting product quality.
Packaging Forum
Eight Trends to Watch in 2014
By Hallie Forcinio
Trends driving pharmaceutical packaging include product protection, productivity boosters, and patient adherence improvement.
Best Practices in Adopting Single-Use Systems
By John Schmitz
Bioprocessors should understand the key factors associated with implementing single-use components or platforms, which include materials of construction, components, system design, and vendor support.
Separation of Compliance and Performance Under FDASIA
By Jason J. Orloff
The root cause of drug shortages is mismanagement of variation.
Global Feature
Regulators Get Tough on Corruption in China
By Jane Wan
China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.
Outsourcing Outlook
Under New Ownership
By Jim Miller
Changes in company ownership shake up the CMO industry.
Product Spotlight
ACQUITY QDa Detector Increases Productivity
By Melanie Sena
ACQUITY QDa Detector Increases Productivity
Compact Mass Spectrometer Improves Analysis
By Melanie Sena
Compact Mass Spectrometer Improves Analysis
SALD-7500nano Expands Measurement of Nanoparticles
By Melanie Sena
SALD-7500nano Expands Measurement of Nanoparticles
7900 ICP-MS Increases Efficiency
By Melanie Sena
7900 ICP-MS Increases Efficiency
Guest Editorial
INTERPHEX 2014: New Partners, New Programs
By RJ Palermo
Conference sessions from PDA and PharmTech expand educational opportunities at INTERPHEX 2014.


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Finance development of drugs to treat/prevent disease.
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Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
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All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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