Pharmaceutical Technology-10-02-2018

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.

Innovative technologies, such as drug-loaded devices and 3D printing, enable advances in implantable devices and other novel dosage forms.

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.

Integration of new modeling and analytical tools with flow chemistry are notable trends.

Efforts strive to harmonize bioanalytical method validation for non-clinical and clinical studies.

Industry experts discuss the formulation and development issues that should be considered when addressing scale up from small-scale batches to commercial production.

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.

A European task force outlines its upcoming efforts to combat drug shortages.

This article applies the basics of stability, performance, and capability to modern process performance and capability indices.

Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.

Click to view Pharmaceutical Technology North America, October 2018 (PDF).

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.

Non-destructive surface area measurement can improve stability testing.

Flexicon’s new range of stainless steel connection boxes are suited for applications requiring high levels of hygiene and ingress protection.

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.

Ross, Charles & Son added a custom 150-gallon Triple Shaft Mixer, the Ross VersaMix Model VMC-150, with elaborate automation and safety functions.

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.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.