Drug Particle Analysis Using the iEM Platform

As part of the drug validation process, particle characterization has significance in the pharmaceutical industry. Understanding the physical and chemical characteristics of drug particles is an essential aspect of drug product development. Creative Biostructure offers a perfect and reliable platform for drug quality control, involving the uniformity, particle size, surface morphology, and chemical composition of the drugs.

Drug Particle Analysis

Pharmaceutical preparations are drugs intended for human or veterinary use in the form of a finished dosage form. In general, there are two major materials in pharmaceutical preparation, including drug substances (active drug substance, API) and pharmaceutical excipients (formulation of the finished dosage form). Besides the importance of API, specific pharmaceutical formulation challenges refer to the dissolution process, particle size, drug and excipient phase behaviour, related to the effects of polymorphism, solubility and oxidation among others.The effective combination of the two is the key to determining the drug absorption effect. Scanning electron microscope (SEM) uses electron beam as signal source, which can provide nanometer resolution. Increasingly, SEM has been employed to investigate and reflect the microscopic structure and composition distribution information of drug preparation.

Our Capability

The iEM Platform is a unique integrated platform for electron microscopy with several features that make it a powerful tool for the investigation of pharmaceutical particles. The iEM Platform allows researchers to directly analyze the particles in the sample statistics, output complete particle size distribution, and morphology, composition information in a time efficient manner.

• The polymorphism and co-crystal formation in APIs.
• The changes in formulations under varying conditions.
• Chemical identification of precipitates and impurities in pharmaceutical formulations.
• Characterization of both large and small molecule formulations.

The appropriate dosage forms are important for effective treatment, involving product solubility and long-term stability. Our iEM Platform can be used for multiple dosage form imaging and analysis, including

Benefits of CDB-iEM in Drug Particle Analysis

• Combined with automatic image acquisition, the iEM Platform can achieve extremely high data throughput.
• Equipped with field emission scanning electron microscopy (FESEM), the iEM Platform can produce the highest resolution imaging.
• SEMs integrated energy disperse spectroscopy (EDS) enable quick determination of particle composition.

Drug synthesis and process selection is key process of drug development. Qualified drugs need a series of characterization at the initial screening stage. Creative Biostructure is a reliable and professional partner in the drug discovery industry. We are dedicated to providing high-resolution images of a wide array of samples, enabling medical researchers and professionals to obtain higher productivity and better conclusions.

If you are interested in our solutions, please contact us for more details.