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PharmTech
May 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

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).

APIs

Strategies for API Solubility and Bioavailability Enhancement

Sanjay Konagurthu, PhD, and Tom Reynolds; Patheon

The landscape of today’s drug development industry looks far different than it did a decade ago. Improvements in synthetic chemistry and high-throughput screening have opened up the small-molecule chemical space, leading to novel compounds with the desirable potency. However, they also come with greater solubility challenges.

Drug Delivery

Comparative Human In-Vivo Study of an Immediate Release Tablet Over-Encapsulated by Gelatin and Hydroxypropyl Methyl Cellulose Capsules

Sven Stegemann, Sudershan Vishwanath, Ravi Kumar, Dominique Cade, Missy Lowery, Keith Hutchison, Michael Morgen, Aaron Goodwin, and Chang Lee; Capsugel® | Lonza Pharma & Biotech

Small differences in in-vitro dissolution are not expected to result in significant in-vivo performance differences. The slight in-vitro dissolution delay observed by over-encapsulation for double-blind clinical trials, as well as switching from gelatin to hydroxypropyl methyl cellulose capsules often raises concerns about the potential impact on in-vivo bioavailability.

Quality

Cleaning Validation for Pharmaceutical Manufacturing

Alconox, Inc.

This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.

Analytical

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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