Pharmaceutical Technology October 2018

October 2018 | Volume 42, Issue 10
Pharmaceutical Technology October 2018 Issue
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By Pharmaceutical Technology Editors
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Cover Story
Innovative technologies, such as drug-loaded devices and 3D printing, bring patient focus to drug delivery.
The Global Health division of the Bill and Melinda Gates Foundation is seeking solutions for health problems, such as infectious diseases, that impact the developing world, including identifying drug delivery forms to compensate for a lack of infrastructure in these regions.
Barrier materials, scavengers, and good seal integrity maximize shelf life of oral solid-dosage drug packaging.
A twin-screw extruder can be used as a continuous wet granulator.
Engineering controls and safe practices for containment protect both operator and product in tablet and capsule production.
Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.
Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.
Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.
Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.
Non-destructive surface area measurement can improve stability testing.
Peer-Reviewed Research
Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.
API Synthesis and Manufacturing
Integration of new modeling and analytical tools with flow chemistry are notable trends.
Regulatory Watch
A European task force outlines its upcoming efforts to combat drug shortages.
FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.
Guest Editorial
Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.
Statistical Solutions
This article applies the basics of stability, performance, and capability to modern process performance and capability indices.
Ask the Expert
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
Product Spotlight
By Pharmaceutical Technology Editors
Flexicon’s new range of stainless steel connection boxes are suited for applications requiring high levels of hygiene and ingress protection.
By Pharmaceutical Technology Editors
A new Low-Profile, Flo-Thru Sanitary Screener from Kason scalps oversize particles and foreign matter from dry bulk materials and solids-laden slurries at high rates in low headroom areas.
By Pharmaceutical Technology Editors
Ross, Charles & Son added a custom 150-gallon Triple Shaft Mixer, the Ross VersaMix Model VMC-150, with elaborate automation and safety functions.
By Pharmaceutical Technology Editors
The LCMS-9030 quadrupole time-of-flight (TOF) liquid chromatograph mass spectrometer from Shimadzu is a researchgrade mass spectrometer suited to deliver high-resolution, accurate-mass detection with fast data acquisition rates.
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