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Dosage Forms

Manufacture Biosimilars

The optimization and scale-up of high shear granulation

This article explains how an inline probe was used to monitor a granulation at three different scales to confirm that, in each case, the granules produced were the same size, and more importantly produced tablets of identical quality as quantified by hardness.

Manufacture Standards & Regulation

Regulating a 3D-Printed Future

| Akm Khairuzzaman

Sitting Down With… Akm Khairuzzaman, a 3D printing expert from the FDA.

Discovery & Development Biosimilars

Accelerating the development of generic pharmaceuticals

In this article, triple detection SEC and MDRS are considered within the context of characterizing complex drug formulations, with specific case studies and results illustrating their application.

Discovery & Development Business Practice

Gold therapy using dynamic light scattering

This article explains how dynamic light scattering (DLS) can be used to gather particle size distribution data for the successful use of nanosized colloidal gold in drug delivery applications.

Manufacture Facilities

Nominations for The Power List 2017

| Stephanie Vine

Nominations for the 2017 Power List are now open and will close on February 1, 2017.

Discovery & Development Business Practice

Combining spectroscopy: a new approach to meeting new pharmaceutical challenges

Automated image analysis has been combined with Raman spectroscopy to achieve component-specific size and shape analysis of active ingredients, supporting and accelerating the commercialization of both innovator and generic pharmaceutical products.

Discovery & Development Business Practice

Investigating the deagglomeration profiles of dry powder inhaler formulations

Which equipment can measure how the particle size delivered by a dry powder inhaler (DPI) changes as a function of applied air flow rate, providing a deagglomeration profile which can be used to compare the performance of different formulations in a device and improve drug delivery.

Discovery & Development Business Practice

Detecting agglomerates within pharmaceutical formulations

Particle agglomeration can compromise the clinical efficacy of pharmaceutical products and must therefore be closely controlled. This article provides practical guidance on using automated imaging for efficient agglomerate detection.

Manufacture Business Practice

Using GPC/SEC for excipient characterization

OMNISEC measures the Critical Quality Attributes of polymeric pharmaceutical excipients with unrivalled sensitivity supporting their efficient use to formulate safe and effective pharmaceutical products.

Discovery & Development Business Practice

Measurement and characterization of protein-LMW compound interactions

Measurement and characterization of binding interactions between proteins and low-molecular weight (LMW) ligands are a focus of academic research and drug discovery. Isothermal titration calorimetry directly measures heat released or absorbed in a binding event, providing means for studying protein-small molecule interactions in solution without the need for labeling or immobilization. Importantly, ITC is often utilized to characterize differences in entropic and enthalpic contributions to binding of novel ligands.

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