Drug delivery technologies are growing in use across many segments of healthcare. They also bridge the gap between technology sectors—medical device to pharmaceuticals to biologics. These combination devices work due to a convergence of two of the aforementioned components, but a number of other technologies must be implemented to achieve a successful product.
One of the most critical parts within a drug delivery device is the filtration media. As a rarely seen component in a finished device, it is not always considered as early in the development process as it should. Design engineers developing a drug delivery product, however, would be remiss if they didn’t invite their supply partner into the discussion early so as to optimize this component’s inclusion.
With this in mind, Nadia Hajjar, category manager for life sciences at Porex, responded to a number of questions around the filtration media for drug delivery devices. She addresses the growth in this segment, what is accomplished by working with the supplier early, and the role filtration plays in the product.
Sean Fenske: Where are you seeing growth in the drug delivery device sector? What is fueling this?
Nadia Hajjar: One of the key areas where we are seeing growth in drug delivery devices is in the area of pharmaco-genomics—specifically in identifying biomarkers that can influence the development of drug treatments. Porous polymers play a key role in each of the main stages of this drug development process, including the research, extraction/purification, therapy development, processing, and final device design stage for drug delivery.
The initiation of open-sourced CRISPR technology has fueled an explosion of biological therapies that are able to treat diseases formerly untreatable with synthetic medications, including certain types of cancer, Alzheimer’s, and MS. The use of whole blood versus synthetic drugs is a byproduct of this space, with treatments derived from tissue and DNA. The advent of more treatment therapies using whole blood, opens up a need for innovative materials that can separate, filter, wick and diffuse.
A second key growth area within drug delivery is neurology. Traditionally we characterize medicine as a liquid going through our body, but by focusing on the brain, more innovative therapies have utilized frequency to target the nervous system and thereby treat conditions such as ADHD, migraines, and mental health disorders. These new treatment devices can require sensors, vents, and light filters to function.
The third and final growth area is the increase in point-of-care devices being used for at-home diagnosis and treatment. There has been a steep growth in at-home care post-Covid, and an increased need for materials that can act as a vehicle for whole blood cell separation, pre-whole blood filtration, refined dosing, and increased dose accuracy.
Fenske: When it comes to drug delivery devices, what role can filtration play?
Hajjar: One of the key benefits of custom-engineered porous polymer components is that the role of filtration can be modified and adapted to take on additional responsibilities within the drug delivery device. The porous filtration media can impact device sterility, flow of both air and drug, shelf life, clogging, and metered dosing; it can even build a barrier for oil and water in or around the device. One porous component can also act as a vent or diffuser within the device in addition to filtration.
Fenske: Are there an array of material options for porous filtration media in a drug delivery application or are they limited? What are they?
Hajjar: There is a broad array of materials and additive options available for porous filtration media in drug delivery devices, including sintered porous plastics, porous fibers, and several types of porous membranes. Depending on the need, clean materials are available that are medically safe and will pass all FDA/regulatory device requirements. Based on the specifications of the specific device, our material science experts will work with you to decide what materials make the most sense to leverage, and we will work together to test on your device.
Fenske: What are the most important factors designers need to consider in selecting the filtration material?
Hajjar: When we work with a customer on designing their filtration media, we typically ask questions about the following areas:
- Pore size—What size particle(s) are you trying to filter?
- Flow rate—What kind of liquid and air flow rate is desired?
- Sterility requirements
- Geometry of the device—How thin does the filter need to be? Is it a membrane or 3D component?
- Chemical components of the liquid
Fenske: What benefits can be realized from working with a filtration material supplier early in the drug delivery device design process?
Hajjar: Due to the custom nature of the porous filtration media, the earlier in the process a supplier can begin discussing the specific needs for the device, the better material science engineers will be able to identify the best design. In many cases, the porous filtration media provides a critical functionality and differentiator for the device, which then enables the device engineer to design around the component. At Porex, we pride ourselves on our unique collaborative innovation process, which was recognized by the PDMA (Product Design & Management Association) as the 2019 Outstanding Corporate Innovator.
Fenske: Can the filtration material help further enable capabilities of a “smart” drug delivery device?
Hajjar: Absolutely. Our custom porous filtration material is an excellent solution for smart drug delivery devices. One advantage our Porex components can provide is with our Certified Pure Porex program, offering 100% clean materials that can assist with streamlining regulatory processes and ensuring 100% quality control, free of leachables and extractables. The ability to adapt and customize to a variety of device designs also provides versatility and functionality within your device. As the smart device adapts to the patient’s needs, porous filtration materials enable better metered dosing that helps regulate the dose the patient receives.
In addition to filtration media, smart devices leverage sensor technology, which is another application that utilizes porous polymers for venting, absorption, and filtration.
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