Author Archive

Spot Shortages and New Approvals for US Influenza Vaccine

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages. Read more »

Real-time Data Aids Continuous Manufacturing

How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. Real-time devices for continuous feeding processes, among many other topics, were discussed at a seminar I attended last week. The seminar, “Advances in Pharmaceutical Processing”, was sponsored by K-Tron, which supplies material handling and feeding systems. Read more »

Non-Profit Research Organization’s Mission Includes Hot-Melt Extrusion Studies

markarian online portraitThe Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion. I recently visited with the PPI researchers and toured their facilities. Read more »

Color-Changing Sealant Technology Enhances Package Security

Rollprint Packaging Products’ new, patent-pending, color-changing sealant technology is appropriately named Chameleon; it enhances product security with a color change indicating that a pouch or tray lid has been opened. Read more »

2012 European Outsourcing Award Winners

The 2012 European Outsourcing Awards—what some call the “Outsourcing Oscars”—were presented on October 10, 2012 during the CPhI Worldwide/iCSE show and included awards to Vetter for a high-speed filling line and to Catalent for updates to its controlled-release facility. Read more »

New USP Standards for Prescription Container Labels

Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US.  It seems that, despite the efforts of regulators, industry, and medical professionals, patients continue to misunderstand dosage instructions. Read more »

Hot Melt Extrusion Research Continues

markarian online portraitResearch into hot melt extrusion (HME) as a solution to improve solubility continues to expand with a partnership between Encap Drug Delivery, a contract development and manufacturing organization in the UK, and the School of Pharmacy at the Queen’s University Belfast (QUB), announced in a press release this week. Read more »

Odorous Taints Linked to Treated Wood Pallets

It is amazing what the human nose knows.  Well, those who originally detected a musty, moldy odor in pharmaceutical and healthcare products didn’t know where it came from.  But the odorous taints that resulted in product recalls were found to come from tribromoanisole (TBA) and trichloroanisole (TCA), and have been linked to treated wooden pallets from sources outside the US, the Parenteral Drug Association (PDA) reported in a September PharmTech article, which summarizes the findings of the recent PDA Technical Report No. 55 on detecting and mitigating taints and odors from TBA and TCA. Read more »

Researchers Investigate Raw Materials for Drug-Delivery Polymers

Researchers are trying to find better, cheaper ways to produce biodegradable and bio-based polymers.  Although one of the main drivers for this research is to compete with fossil-fuel-based polymers in large-volume, consumer plastics applications, medical applications, such as microcapsules for drug delivery, may also benefit.  While it seems odd, the researchers found that waste oil from cooking fried food can be used as a raw material in the polymer production process.  Read more »

Winds of Change at the International Society of Automation Summit

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release. Read more »

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