Nanotherapeutics – Development and Quality Control of Core-Shell Nanoparticle Formulations with AFM

By AZoNano.com Staff Writers

Topics Covered

Introduction
Particle Size, Aggregation, and Coating Characterization
Comparative Observation
AFM in Quality Control
Conclusion
About the P100 AFM
About Ardic Instruments

Introduction

A large number of new drugs are adopting nanoparticle constituents with the growth and maturity of nanomaterials. Such drugs can achieve reduced effects, targeted delivery, time-released design and reduced toxicity. As these drugs cause a higher degree of variability by including factors such as particle aggregation, size, coating distribution and coating thickness, the FDA has emphasized the process control of nanomaterial-based therapeutics.

Particle Size, Aggregation, and Coating Characterization

There are several drugs in the market with a core-shell type design. Drugs such as CosmoFer, Monofer and Venofer are used for treating iron deficiency anemia and adopting an iron core with a carbohydrate shell. The particle consistency plays a key role in maintaining the efficacy of the drug for such drugs.

Ardic instruments while working with a pharmaceutical company developing drugs with a similar concept made use of the P100 Atomic Force Microscope (AFM) to aid in comparing their drug with FDA-approved benchmarks.

Comparative Observation

The differences in sample quality are apparent especially while comparing an FDA approved sample in Figure 1 with a similar drug under development as shown in Figure 2. It is observed that particles in the FDA-approved sample have a consistent particle size and little signs of aggregation, however the drug in development has large clusters of aggregation and a wider range of particle sizes. When compared to the drug in development, the FDA-approved sample shows a better spherical consistency.

Figure 1. 1µm by 1µm AFM scan of FDA-approved sample

Figure 2. 1µm by 1µm AFM scan of drug in development

AFM in Quality Control

It is required by the FDA that manufacturers submit TEM scans to characterize the nanoparticles conventionally for core-shell drugs. However the AFM is suited for offering high spatial resolution data. Also with systems such as the Ardic Instruments P100, AFMs are simple and economical enough for routine quality control. Labs that do not have any prior experience in handling AFMs have adopted the P100 system because of its unique features such as the one-click scan software feature and the perpetually aligned optical system.

Conclusion

By integrating nanomaterial attributes, much can be gained in the life sciences industry. The AFM will become a crucial piece of equipment as pharmaceutical companies start developing and manufacturing more nanotherapeutic drugs. Systems such as the P100 can be favored by labs seeking a practical system requiring minimal calibration.

About the P100 AFM

With a sub-nanometer Z resolution, the P100 can be used for high resolution imaging and measurement. The integrated low-noise and open-loop scanner allows for quick and effective experiments up to 15μm by 15μm. Our unique astigmatic optical design produces a small 0.56um laser spot size, allowing users to experiment with smaller and faster AFM cantilevers.

About Ardic Instruments

Ardic Instruments is an analytical equipment manufacturer aiming to serve the global scientific community with the best customer experience possible. Through a transparent, accessible, and community-driven approach, Ardic Instruments fosters a direct channel of communication between the end-user and the manufacturer.

Ardic Instruments produces atomic force microscopes, MEMS analyzers, and label-free molecular diagnostic platforms for both academic and industrial applications.

This information has been sourced, reviewed and adapted from materials provided by Ardic Instruments.

For more information on this source, please visit Ardic Instruments.

 

Date Added: Sep 5, 2013 | Updated: Sep 5, 2013
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