Particle Characterization of Excipients

As one of the important part of studies of physical properties of materials, particle analysis has become an increasingly non-negligible parameter in the excipient characterization. Extensive experiments have shown that particle size, distribution and shape affect the quality and properties of the final product. Furthermore, proper matching of active ingredient and excipient particles is very crucial for the manufacture and use of formulations. The final efficacy of the product may be affected by changes in the size and structure of the particles. From drug development to manufacturing, maintaining continuous monitoring and testing of excipient particle characteristics can facilitate safe and robust product development. Therefore, particle characterization is an irreplaceable part of the design of various pharmaceutical dosage forms. For powders, granules, creams, emulsions, liquids, the particle characteristics of excipients have a significant impact on their chemical and physical behavior, including:

• Bioavailability
• Flowability
• Adhesive strength
• Drying properties
• Solubility
• Filterability
• Thermal conductivity

BOC Sciences has strong scientific expertise and experience in particle characterization and is committed to providing a broad portfolio of validated new technologies for the orthogonal analysis of your excipient particles. Depending on different excipients in the formulation, we provide all the necessary analytical tools and technical support to assist in the investigation of your particle system.

Figure 1. API particles are deaggregted and get attracted to the surface of the excipient particles. (Alyami, H.; et al. 2017)

Significance of Particle Characterization

An in-depth study of the particle properties of excipients can help to produce products that are easy to develop, safe, stable and highly effective.

• Prediction of the product performance
• Pharmacological behaviour research
• Optimization of manufacturing process such as tableting and granulation

Typical Workflow for Method Development

• Sample Preparation
• Particle Imaging and Morphology Analysis
• Chemical Identification
• Particle Classification

Particle Characteristics Analysis Technologies

For a wide range of powders and granulates, BOC Sciences is able to provide comprehensive particle characterization to offer useful information. The measurement process has been automated for repeatable and interpretable results. In additionm, we provide reports that can be used for regulatory purposes.

• Laser Diffraction

In our laboratory, we use this instrument for the characterization of biodegradable polymeric excipients, and our well-established method is rapid, simple, flexible and reproducible.

Figure 2. A example of cumulative particle size distribution derived from a laser diffraction measurement. (Zhigang S.; et al. 2010)

• Static Image Analysis

We have developed this method to offer valuable information to help you select the optimal excipients.

• Dynamic Light Scattering

At BOC Sciences, this unique technique is especially developed for the sub-micron particle size analysis.

• Raman Mapping
• Scanning Electron Microscopy (SEM)

SEM allows for collecting information regarding particle size and shape. Our experts use SEM to study the size, morphology and chemical composition of excipient particles. In addition, single particles can be isolated and evaluated regarding to shape. BOC Sciences supports different types of detectors for generating SEM images.

• Dynamic Image Analysis (DIA)

Our DIA technology has shown a variety of application including: detection of agglomerates during pellet production, measurement of thickness of polymer membrane layers, prediction of mixture suitability of a mixture for tabletting., size and shape analysis of starch.

Figure 3. Variations of pellet size distributions during multi-layer coating processes. (Zhigang S.; et al. 2010)