Whitepapers - Pharmaceutical Technology

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PharmTech Europe

Whitepapers

Best Practices for Overcoming Softgel Coating Challenges

September 25, 2014

Soft elatin capsules (softgels) have become an increasingly popular method for the delivery of pharmaceuticals and dietary supplements due to to the ability to encapsulate sensitive compounds, accurately deliver potent molecules, and directly appeal to the consumer. However, applying a functional coating to softgels is a challenging endeavor requiring precise formulation and finely tuned processing parameters that only recently have been explored. In this executive summary, pharmaceutical scientists and formulators will learn about key aspects of successful softgel coating processes.

New Webcast: Understanding USP 36

September 24, 2014

Please enjoy this 30-minute webcast from Mary G. Foster, PharmD., Chair of the USP Expert Committee, with Vaisala's Senior Regulatory Compliance Expert Paul Daniel as they review changes to the latest revision of USP <1079> and forthcoming changes to GDP.

Techniques for Reducing the Effects of Sample Solvent on UHPLC Analyses

September 24, 2014

For HPLC, sample solvents that adequately dissolve target compounds are required; therefore, sample solvents that contain a high concentration of organic solvent are often used for reversed phase chromatography. However, these solvents sometimes cause peak broadening. This paper presents techniques to reduce the effects of sample solvents using recent widespread UHPLC analyses as examples.

Review of Application of HPMCAS in Hot Melt Extrusion Technology

August 27, 2014

HPMCAS (Hypromellose Acetate Sucinate) has been used for enteric coating and solubility enhancement for over 30 years. This white paper shows basic data of this polymer for solubility enhancement using melt-extrusion process.

Complying with Combustible Dust Standards

August 27, 2014

Dust collector explosions are a danger in many industries, but the pharmaceutical industry is particularly at risk. Does your dust collection system comply with combustible dust standards? This white paper reviews the OSHA National Emphasis Program for combustible dust, the NFPA standards that address explosion hazards, and the types of equipment used for explosion protection.

Differentiation of Drug Particle Agglomeration in OINDPs

August 27, 2014

This whitepaper presents the results of a collaborative study with the FDA that reviewed the effects that can occur in aqueous nasal spray suspensions during long-term shipping or storage conditions. Having the knowledge of the environmental conditions and their effects on OINDPs may benefit developers of formulations containing multiple APIs and/or excipients such as nasal suspensions, dry powder inhalers, and metered dose inhalers.

Strategies for Successful Scale- Up Using Quality by Design

July 30, 2014

This executive summary will outline best practices for ensuring successful scale-up for manufacturing finished drug products by offering a systematic approach and technical case studies for implementing QbD through development to scale-up to commercial manufacture.

Improving Product Quality with Risk Assessment Tools

June 25, 2014

With the product lifecycle moving so fast, many organizations may ask the question, "How can we effectively measure quality?" The answer is risk management. Learn the elements of risk management and how they help to identify, prevent, and mitigate risk throughout an organization.

NEW eBook: Using GAMP to Validate Monitoring System Software

May 27, 2014

Learn how to use the GAMP methodology to validate monitoring system software. This ebook describes a 10-step process to help ensure your environmental monitoring systems align with both your QMS and good practice as described by the ISPE. Also, learn about the category of system that best suits your qualification capabilities and how to manage costs and risks.

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Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
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