Part of our Three Reasons Why You Should Use a Desktop SEM for Drug Development blog series.
Anyone who suffers from a respiratory disease such as asthma, bronchitis or emphysema knows the importance of dry powder inhalers. These handheld devices enable people to absorb dry powder medicine deep into their lungs, relieving uncomfortable symptoms.
The manufacturing process of dry powder inhalers has various steps to ensure the medicine absorbs properly. Drug formulations make use of a drug carrier, or excipient, which is responsible for ensuring the appropriate bioavailability of the drug. If a drug’s active dose is in the microgram range, for example, it would be impractical to produce tablets that only contain a few micrograms of active pharmaceutical ingredient (API). In such cases, excipients are added to the formulation so tablets can be given to a patient that are reasonably sized.
Dry powder inhaler medication also contains excipients. However, all excipients are not created equal and pharmaceutical companies needs to ensure that the API is adsorbed properly onto the excipient for the medication to work effectively. If the API doesn’t adsorb onto the excipient during production, the formulation might end up having an API concentration that’s too low.
Using an SEM, pharmaceutical companies can characterize the morphology of both the API and the excipient. If the API contains chemical elements that are not present in the excipient, it is possible to study the distribution of the API on the excipient using energy dispersive X-ray spectroscopy (EDX). Furthermore, researchers can examine the desorption of API particles upon exposure to airflow, which is particularly helpful during the manufacturing process of dry powder inhalers.
SEM image (left) and elemental map (right) showing the distribution of the API (orange) and excipient (yellow), using a Phenom ProX G6 Desktop SEM. With a desktop SEM, pharmaceutical companies can improve R&D and QA turnaround times by testing the drug absorption process in-house.
While an SEM makes it possible to study the API and excipient, it often requires a large, dedicated laboratory space, which can be cost-prohibitive for smaller pharmaceutical companies. To perform their SEM analyses, many pharmaceutical companies rely on external contract laboratories, which typically results in slower turnaround times as they wait for analyses.
A desktop SEM addresses this issue by making it possible to bring SEM analyses in-house. A desktop SEM such as the Phenom ProX G6 Desktop SEM requires little space, eliminating the need for specialized infrastructure or expert oversight. It also allows researchers to place the microscope exactly where it’s needed, whether that’s in the lab or on the production line for real-time analyses.
With the Phenom ProX G6 Desktop SEM, SEM analyses can be completed within the same day rather than the multiple days typically required with an external contract lab. Moreover, the Phenom ProX G6 Desktop SEM is fast and easy to use, even for novice users. It integrates EDX for quick and robust elemental analysis.
For the pharmaceutical industry where fast turnaround is important, a desktop SEM such as the Phenom ProX G6 Desktop SEM makes it possible for companies to study active ingredients and excipients within their own labs. Whether they’re studying dry powder inhaler technology or a different type of drug formulation, researchers can quickly get the high-quality results they need and ensure the effective delivery of the medications they develop.
For more reasons why you should use a desktop SEM for drug development, see our previous blog post about optimizing pharmaceutical formulations using a desktop SEM. Also, please visit our Phenom ProX G6 Desktop SEM webpage.
Willem van Zyl is an application engineer at Thermo Fisher Scientific.