Pharmaceutical Technology-08-02-2018

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.

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.

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.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

The PrepEngine Mini Sample Prep Station from Distek is suited for assay, impurity, and content uniformity applications.

The Flexmag 4050C Electromagnetic Flow Meter from Krohne is suited for biopharmaceutical applications including filtration processes, chromatography, or buffer and media preparation.

Ross, Charles & Son’s Laboratory Paddle Blender offers advanced features for automated powder blending and liquid spraying operation with recipe management.

The C-Series air-operated double-diaphragm (AODD) pump from Almatec, part of PSG, a Dover company, is an alternative to similar plastic pumps and is suited for almost any pumping application that uses an oscillating pump.

Increasing dwell time can improve tablet production.

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.

Industry experts discuss the challenges of performing glycan analysis and how companies can gain specific expertise from outsourcing partners.

Air transport continues to be the most secure way to ship valuable therapies, but it is also the riskiest. Standards are helping to improve service quality.

A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions.

Modular manufacturing systems offer a less costly way to increase capacity while reducing time-to-market.

Development costs and time to market continue to put pressure on the biopharma industry, driving the need for innovation in methods and technologies.

Click the title above to open the Pharmaceutical Technology August 2018 issue in an interactive PDF format.

The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.