Particle size characterization in the pharmaceutical industry


Material characterization is a technique used in material sciences that analyses the structure and composition of various materials. This technique has applications in a variety of industries, being the cornerstone in providing high quality construction materials, food medication and several other industries. Generally, it is used to improve the quality of the manufactured products. Particle size characterization is using a multitude of different techniques to determine the structure, measurement and characteristic of different materials. The pharmaceuticals industry seems to have some of the greatest benefits emerging from using this type of testing.

The pharmaceutical industry may be the one that is using on large-scale particle size characterization. In this industry, these methods impact the products in two significant ways. First, it impacts the drug’s performances, and secondly, it indicates potential contamination.

Particle size and drug performance

Particle size of drug and pharmaceutical components influence enormously their behaviour and effectiveness, as they impact their chemical and physical comportment. As a result, particle size analysis is highly relevant for manufacturing powders, creams, lotions, liquids, and so on. The size of the particles will determine in which way they interact with: flowability, adhesive strength, bioavailability, solubility, drying capabilities, thermal conductivity, and filterability. A material characterization service provider seems to be especially useful for pharmaceutical manufacturers that aim to deliver new types of medical products, based on nanoparticles and liposomes. Also, by acquiring an appropriate size of the particles, the manufacturer has the capability to provide more homogenous products, with better properties.

This type of analysis is especially important in stability testing, before releasing the drug on the market. In many cases, if the particle size is inappropriate for the product, there have been observed the following phenomenon:

• Smaller particle size means higher rates of absorption and higher weight;
• Prolonged storage caused crystal formations, and modifications of the active ingredients. This was easily observed under the microscope.
• Prolonged storage caused a decrease of the particle size in many products, which resulted in increased agglutination;
• Emulsions separate in two different phases due to wrong particle size;
• Modifications in particle size of eye drop solutions caused incompatibility.

As you can easily notice, particle size influences greatly the qualities of the products in the pharmaceutical industry.

Indicator of contamination
For injectable solutions, it is crucial to control the limits of contamination of contaminating particles. Particle contamination can have unpleasant results, as it follows:

• Adverse direct reactions;
• Adverse indirect reactions.

A good example of an adverse reaction in the particles is their distribution in the body via blood that may cause increased toxicity levels in the blood and organs. A good example of indirect adverse reactions is that the body may perceive the cells in injection solutions as foreign material and this may cause an immune reaction.

These are several reasons why particle size characterization is an important step, maybe the most important. Stabilizing medical solutions and drugs makes them usable by patients across the world, saving numerous lives.

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