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Formulation

Discovery & Development Formulation

Blistering Headspace

| Craig Voellmicke

Packaging solutions should target headspace to overcome stability issues.

Discovery & Development Formulation

Quality From the Ground Up

| Sponsored by Capsugel

Six Sigma has the potential to deliver real cost savings by improving productivity and reducing defects, but making the change is challenging.

Discovery & Development Drug Delivery

Why Encapsulation Is (or Should Be) King

| Stephen Brown

For modern medicines, I believe that liquid-filled encapsulation has the edge.

Manufacture Business Practice

Direct visualization, sizing and concentration measurements of drug delivery nanoparticles

In this application note, we discuss how Nanoparticle Tracking Analysis (NTA) is used to measure the size and concentration of nanoparticles used for drug delivery, such as liposomes, in order to determine efficacy and rate of uptake, degradation and clearance from the body.

Discovery & Development Business Practice

In-vitro bioequivalence studies

The Morphologi G3-ID can be used to compare the Active Pharmaceutical Ingredients (API) within oral solid dose formualtions. Here we apply it to comparing innovator and generic versions of a product containing two APIs.

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 Formulation

The Formulation Complex

| Thomas R. Tice, Firouz Asgarzadeh, Norbert Maurer, and Anthony J. Hickey

Experts discuss the trends and challenges in the development of complex dosage forms.

Discovery & Development Dosage Forms

Swallowability by Design

| Thomas Hein

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

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