Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
Prior to use in a continuous manufacturing system for oral solid dosage forms, loss-in-weight feeders need to be tested and validated to understand the performance capabilities of a given material–feeder combination. In this article, the proper strategy for set-up and optimization of a loss-in-weight feeder is demonstrated for a range of materials. The optimized set-up of the feeders was demonstrated to provide suitable performance for even the most challenging, poorly flowing materials.
The company is voluntarily recalling one lot of cefazolin for injection, USP, 1 gram per vial due to customer complaints of the wrong product being included in a carton.
Pharmaceutical Technology® sat down with Stefan Verheyden, Global Vice President Sales Pharma & Biopharma Solutions Injectables at Gerresheimer, to talk about the primary and secondary packaging solutions Gerresheimer and Bormioli Pharma will be showcasing at Pharmapack Europe 2025 in Paris, France from January 22–23.
With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.
Efforts to tackle challenges in tablet manufacture are shaped by quality by design (QbD) and continuous manufacturing.
To ensure the safety and efficacy of biologic drug products, the materials that come in contact with the drug must be fully characterized to determine their impact.
Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.
Innovations in glass and plastic syringes reduce waste and increase safety.
Packaging and packaging line innovations are addressing the industry’s growing use of biologics.
New technologies improve efficiency and remove operator intervention.
As a GMP manufacturing method, 3D printing offers benefits for modified release and personalized dosages.
Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.
This article looks at five of the most common hurdles in packaging and labelling artwork and how to avoid them.
Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.
Hot-melt coating was used to develop taste-masked orally disintegrating granules of acetaminophen and caffeine.
Hot-melt coating was used to develop taste-masked orally disintegrating granules of acetaminophen and caffeine.
Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.
Understanding the impact of API solubility on the performance of a given drug product and determining ways to enhance dissolution rates is critical to ensuring your product makes it to market, into the hands of patients and clinicians, is well absorbed and provides its intended therapeutic effect. Selecting the best formulation strategy to address challenges for each API, however, can be time-consuming, costly and complex.
GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.
As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.
Heightened uncertainty means CDMO executives need to play out planning scenarios.
The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.
FDA and industry face unprecedented political and policy challenges.
FDA is expanding its Emerging Technology Program and providing more support for new drug applications that present advanced manufacturing technologies.