Solid/Semi-Solid Dosage

Containment valves and smart monitoring can keep employees safe and improve manufacturing efficiency when handling potent APIs, intermediates, and solid-dosage drugs.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

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

Lipid-based formulations offer a means of addressing the physicochemical and biological challenges of poorly soluble APIs.

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

Senomyx uses an approach, known as taste-blocking, to address the challenges of bitter APIs. Kenneth J. Simone, vice-president of Pharmaceutical Business Development, Senomyx, speaks with Pharmaceutical Technology about this technology.

The level of tastemasking required will depend on the API properties and the dosage form design.

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

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

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.

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.

The acquisition expands Micromeritics’ portfolio of products and solutions.

The tablet tooling manufacturer will showcase its products and services, which include an online training package and a tool management system for proactive monitoring of tooling rotations, inventory, and maintenance.

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.

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.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

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.

The company completed its oral solid dose production facility in Suzhou, China.

The authors offer recommendations for permissible daily exposures and concentration limits of elemental impurities for dermal drug products.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

Ralph Gosden, head of product development at Catalent’s Swindon, United Kingdom site, explains the opportunities of orally disintegrating tablets as a patient-centric dosage form.

Experts from Colorcon share insights on how manufacturers can play a role in minimizing the risk of medication errors by ensuring that the medicines they develop are well differentiated, especially between dosages of the same product.

Pharmaceutical companies are increasingly adopting patient-centric formulation development to ensure that drug products adequately meet the needs of end-users in all target patient populations.

Model-based formulation and technology selection methodologies facilitate rapid product development.

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

The company has passed inspection by the UK Medicines and Healthcare products Regulatory Agency, and is now licensed to develop, manufacture, and pack non-potent and potent solid oral drug products at its site in Loughborough, England.

Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.