Manufacturing, Solid Dosage Drugs

Engineering controls and safe practices for containment protect both operator and product in tablet and capsule production.

3D printing is being explored as a manufacturing method for on-demand, personalized medicine.

Coperion’s ZSK 18 MEGAlab extruder fulfills requirements for both wet extrusion and hot-melt extrusion pharmaceutical processes.

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

A twin-screw extruder can be used as a continuous wet granulator or as a continuous mixer for a wet gelatin mass.

A process control system based on PAT can compensate for variations in particle size, resulting in more consistent coating thickness in a Wurster coating process.

Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology about the ins and outs of multilayer tableting.

Increasing dwell time can improve tablet production.

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.

Bosch Packaging Technology’s GKF 720 capsule filling machine for small batches of hard capsules uses a fully automated, washable containment process.

The acquisition expands Micromeritics’ portfolio of products and solutions.

Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.

The UK’s University of Sheffield opened a new chemical engineering teaching plant for continuous oral solid-dosage pharmaceuticals using GEA’s multipurpose platform.

Glatt Ingenieurtechnik has added compact continuous agglomeration equipment and new control systems to its "modular plant engineering" portfolio.

GEA and Perceptive Engineering will collaborate to promote and deploy multivariate monitoring and advanced process control (APC) solutions for batch and continuous pharmaceutical process units.

Netzsch will present a new compact grinding/separating system, LabCompactPlus, for chemical, pharmaceutical, and cosmetic laboratories at Achema 2018.

As more continuous processes move toward commercialization, users and equipment vendors are working to speed changeovers and address other needs.

Bosch’s Industry 4.0 solutions deliver full transparency for all process and machine data.

Romaco will display the IHD series for processing hot melt coatings at Achema 2018.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

Colorcon Inc. and Applied DNA signed a supply agreement granting Colorcon exclusive right to use Applied DNA’s SigNature molecular tags in film coatings for solid oral dosage forms, and non-exclusive rights to use it in inks and colorants for SOD pharmaceuticals.

Process analytical technology and advanced process control strategies can be applied to either batch or continuous manufacturing of solid-dosage drugs.

The Natoli AIM Data Acquisition and Analytical Software for Natoli’s NP-RD10A single-station tablet press speeds research and development.

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

A systematic framework and software are needed to implement material traceability in continuous pharmaceutical tablet manufacturing.

New technologies, such as NIR and Raman, enable online measurements of blending and content uniformity in the production of solid dosage forms.

Colorcon's Opadry SGR, Rapid Sugar Film Coating System, is an aqueous, high-gloss sugar film coating system for pharmaceutical products.