Pharmaceutical Technology’s Pharma Knowledge Resources Newsletter:
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PharmTech
June 2019
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In This Issue

Build your pharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from bio/pharma industry suppliers.

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FEATURED WHITEPAPER

Monitoring of Transdermal Drug Delivery in Skin Using the Renishaw Biological Analyser

Renishaw, Inc.

Detecting the presence and depth of penetration of drug compounds in skin can prove challenging. Current technologies fail to achieve adequate penetration through layers of dermal tissue. In this study, Raman spectroscopy using the Renishaw RA816 Biological Analyser confirmed the presence of a topical compound in the epidermis and reticular dermis with high specificity and sensitivity.

SOLID DOSAGE

Size Doesn't Matter … Under Pressure

Gary Bubb; Specialty Measurements Inc.

This whitepaper will evaluate the properties of different tablet sizes through normalization. This will be accomplished by using compression pressure rather than compression force and tensile strength versus breaking force (hardness).

Evaluation of High Productivity Film Coating System

Kapish Karan, Thomas Dürig, Stuart Porter; Ashland Specialty Ingredients

This paper provides quantitative and qualitative overview of a new high productivity aqueous film coating that can be coated in one-third the time of traditional coatings while maintaining excellent product aesthetics.

API

Six API Challenges That Could be Slowing Your Development and How to Avoid Them

Andreas Stolle, vice-president, process development services, API; Peter Poechlauer, PhD, innovation manager, API; Bernt-Dietmar Schober, senior business manager, CBP; Thermo Fisher Scientific (Patheon)

One of the best ways to stay on schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline.

QUALITY

Advantages and Benefits of Presaturated Wipes

Dave Nobile; Contec, Inc.

Cleaning surfaces has historically been accomplished through a variety of methods. The challenge has been maintaining consistency to ensure product quality. This paper discusses how presaturated wipes ensure a more consistent outcome.

Corning Valor® Vials Demonstrate Superior Performance by Resisting Breakage During Low-Temperature Processing

Christy Chapman, senior product development engineer; Carol Rea Flynn, glass standards and technical services manager; Kyle Ho, applications engineering manager; Corning Pharmaceutical Technologies

Cleaning surfaces has historically been accomplished through a variety of methods. The challenge has been maintaining consistency to ensure product quality. This paper discusses how presaturated wipes ensure a more consistent outcome.

Applications in Pharmaceutical Manufacturing

Alconox, Inc.

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation.

MANUFACTURING

Analysis Using Counter-Rotating Twin Screw Extruder

Charlie Martin, Brian Haight, Augie Machado, Abbe Haser, Feng Zhang; Leistritz Extrusion

Various extrusion operating conditions and formulations were used to enhance the solubility and recovery of meloxicam (MLX) in copovidone to near 100% on a counter-rotating twin screw extruder (TSE).

BIOLOGICS

Is Your In-House Strategy Ready for the Uncertainties of Biologic Drug Development?

John Ward, vice-president, engineering; Thermo Fisher Scientific (Patheon)

The pharmaceutical industry's past reliance on blockbuster drugs has evolved to include developing drugs that treat the needs of smaller patient populations. These drugs most often come in the form of biologics, which are an increasingly larger share of new drug approvals in the past decade–from 10% to 27%.

Regulatory

JPEO-CBRND Supports International Partners in Congo Ebola Outbreak

Hannah Feldman, JPEO-CBRND; Rachel Overman, JPEO-CBRND, joint project manager; Medical Countermeasure Systems

Teams from the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) provide continuing support to the Ebola virus outbreak response in the Democratic Republic of the Congo (DRC) and neighboring countries.

ANALYTICAL

Positioning Your Pharmaceutical Lab for Success

LabVantage Solutions

A purpose-built lab information management system (LIMS), with the option to embed an electronic lab notebook (ELN), lab execution system (LES), and other modules, leapfrogs the lengthy customization process. Because your industry's best-established workflows and operating procedures determine its functionality, your platform is configured to meet your needs before you've even begun. The advantages of this accelerated start are numerous and notable.

Rapid & Precise Moisture Analysis for Healthcare Products

Ian Olmsted, PhD; CEM

One of the critical parameters in pharmaceutical manufacturing is moisture content. The SMART Q uses patented and proprietary technology to bring moisture test times down significantly without compromising accuracy or precision.

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