Pharmaceutical Technology-08-02-2018

Pharmaceutical Technology

Pharmaceuticals in the Environment

August 02, 2018

Regulatory Watch

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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.

Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets

August 02, 2018

Peer-Reviewed Research

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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.

Key Considerations in Multilayer Tableting

August 02, 2018

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

FDA is Not Playing Games with Biosimilars

August 02, 2018

From the Editor

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

Single-Use Electromagnetic Flow Meter

August 02, 2018

Product Spotlight

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

AODD Pump Alternative to Plastic Pumps

August 02, 2018

Product Spotlight

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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.

Submitting Extractables and Leachables Data to Regulators

August 02, 2018

Ask the Expert

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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, August 2018 Issue (PDF)

August 02, 2018

Issue PDF

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

FDA Seeks to Revive Quality Metrics Initiative

July 02, 2018

Regulatory Watch

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