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Dosage Forms

Discovery & Development Business Practice

Top five reasons to replace a viscometer with a rheometer

Is your viscometer approaching the end of its life? Are you starting to feel that your trial and error, ‘rheology-light’ approach to formulation is becoming dated? Or are there longstanding product performance issues that you’re failing to gain traction with, where you suspect rheology may hold the answer? 

Discovery & Development Business Practice

Dry Powder Inhaler Formulation Development

Dry powder inhalers are accepted as being complex drug products due to the interactions which occur between the active pharmaceutical ingredients (APIs) and excipients within the formulation and the way this then affects the efficiency of drug delivery by the inhaler device. Obtaining component specific particle size and particle shape distribution data can help with understanding the properties of the formulation as part of formulation or deformulation studies. This application note describes how the combination of automated image analysis with Raman spectroscopy in the Morphologi G3-ID allows the individual components present within a dry powder inhaler formulations to be independently characterized and compared.

Discovery & Development Business Practice

Use of microcalorimetry and its correlation with Size Exclusion Chromatography for rapid screening of the physical stability of large pharmaceutical proteins in solution

Learn how to use DSC to screen for physical stability of proteins in solution. The utility of microcalorimetry as a rapid screening tool for assessing the solution stability of high molecular weight pharmaceutical proteins was evaluated using model recombinant antibodies, Protein I and Protein II. Changes in the transition midpoint, Tm, were monitored as a function of pH and/or in the presence of excipients, and results were compared with traditional accelerated stability data from samples that were analyzed by size exclusion chromatography (SEC). The data from microcalorimetry were well correlated with those from SEC for predicting both optimal solution pH as well as excipient effects on solution stability. These results indicate that microcalorimetry can be an efficient screening tool useful in identifying optimal pH conditions and excipients to stabilize pharmaceutical proteins in solution formulations.

Discovery & Development Dosage Forms

Swallowability by Design

| Thomas Hein

Tablets are the most common dosage form, but have you considered all of your options?

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 Sutton

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.

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