Pharmaceutical Technology-08-02-2018

Regulatory Watch
Pharmaceutical Technology

August 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.

Pharmaceutical Technology

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

Pharmaceutical Technology

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology

August 02, 2018

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

From the Editor
Pharmaceutical Technology

August 02, 2018

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

Pharmaceutical Technology
API Synthesis and Manufacturing

August 02, 2018

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

Pharmaceutical Technology
Product Spotlight

August 02, 2018

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

Pharmaceutical Technology
Product Spotlight

August 02, 2018

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

Pharmaceutical Technology
Product Spotlight

August 02, 2018

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

Pharmaceutical Technology
Product Spotlight

August 02, 2018

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.

Pharmaceutical Technology

Increasing dwell time can improve tablet production.

Ask the Expert
Pharmaceutical Technology

August 02, 2018

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.

Pharmaceutical Technology
Features

August 02, 2018

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

Pharmaceutical Technology

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.

Pharmaceutical Technology

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

Pharmaceutical Technology

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

Issue PDF
Pharmaceutical Technology

August 02, 2018

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

Regulatory Watch
Pharmaceutical Technology

July 02, 2018

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