The Phenom Provides Rapid Inspection and Qualitative Characterization of Pharmaceutical Particles - Application Note by Phenom-World

Topics Covered

Introduction
Particles
Performing Pharmaceutical Inspection with the Phenom

Introduction

FEI's Phenom is a revolutionary tabletop SEM with magnifications up to 20,000x.

The Phenom's intuitive touch-screen controls and never-lost sample navigation features remove the difficulties associated with operating a traditional SEM. Pharmaceutical scientists no longer have to outsource SEM work. High resolution images of pharmaceutical particles can be obtained at the lab bench within seconds. The Phenom can help shorten drug development and validation cycles, enabling faster time-to-market for new drug products.

Figure 1. Phenom Desktop SEM

Particles

Production of a solid drug dosage form typically begins with the formation of an active pharmaceutical ingredient (API) into particles, generally within the range of 0.1 to 10 micrometers. Once the API is in particulate form it is blended with an excipient to form a larger particle called a granule in order to improve the flow and physiochemical properties with respect to the API.

The size, shape, and morphology of API and granule particles are important characteristics that can influence dissolution behavior and drug bioavailability. Smaller particles with minimal size and shape variance provide faster and more predictable dissolution and absorption rates. Additionally, particle size and shape influence pharmaceutical production properties such as flow, compaction and dissolution.

The Phenom can be used as an imaging tool at the development, formulation, and manufacturing stages of pharmaceutical product development.

Performing Pharmaceutical Inspection with the Phenom

The structure and surface morphology of two classes of Kollidon provide their unique properties. For example, Figure 2 illustrates the smooth surface and spherical shape that provides Kollidon 25 with good film-forming and dispersing action properties. Figure 3 provides excellent views of the sponge-like structure of Kollidon Cl which allows the particles to act as a disintegrant by absorbing water and swelling.

Figure 2. Kollidon 25

Figure 3. Kollidon Cl

Phenom allows visualization of broken particles, agglomerates, fines, and foreign particles. The powder samples shown in Figures 4 and 5 were affixed to carbon tape on a standard SEM stub before loading into the Phenom.

Figure 4. Powder sample

Figure 5. Powder sample

Source: "Phenom use for Pharmaceutical Inspection" Application Note by Phenom-World

For more information on this source please visit Phenom-World

Date Added: Aug 19, 2008 | Updated: Jun 11, 2013
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