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Professor Afzal R Mohammed is Professor of Pharmaceutics at Aston University and advisor to Max Bio+.
The pharmaceutical sector has been steadily shifting toward what are known as biologics – biological drugs. The previous generation of chemically synthesised drugs are pretty much one-size-fits-all. Drugs like paracetamol work for many people in safe doses, they come in stable pill form, and it is difficult to accidentally overdose. Overall, they are safe to self-administer, relatively effective and cheap to produce, transport and sell.
Professor Afzal R Mohammed
Biological drugs, on the other hand, are very different in terms of properties and formulations. They are much more complicated, specific, and targeted, meaning greater efficacy and fewer side effects, However, most biological drugs need to be stored in refrigerated units at exact temperature ranges to keep them stable. They also need to be administered in very specific doses tailored to the individual and usually injected intravenously. As such, they tend to be stored, handled, and administered in hospitals, health centres and GPs, complicating the delivery of these medications. Biological drugs are harder to transport and store, especially in countries without reliable refrigeration or power, making global adoption of these drugs much more difficult.
These key challenges are holding the pharmaceutical industry back. Biological drugs are often far more effective, have fewer unwanted side effects and can be used to manage or cure a wide range of otherwise life-threatening illnesses.
Thankfully, two particularly promising advancements currently being explored could revolutionise biological drug delivery: liquid-based delivery and inhalation.
Inhalation Delivery
Inhalers for conditions like asthma have been around for years. However, formulating drugs for inhalers typically requires a lot of energy and, therefore, heat as well as solvents. While this isn’t a problem for most synthetic drugs, biological drugs are much more sensitive to heat and solvents. As a result, traditional inhalation manufacturing methods don’t lend themselves to formulating biologics drugs.
Additionally, the majority of inhalation drugs are low-dose compounds, making it easier to reliably measure and deliver the correct dose into the lungs. For more potent or high-dose drugs, it can be a challenge to ensure that the right dose is delivered and, importantly, absorbed in the lungs. If the molecule is too light, it will simply be exhaled, if it’s too heavy it might not be absorbed.
An interesting approach being developed by Aston Particle Technologies uses isothermal dry particle coating technology to blend potent and high-dose biologics into inhalation formulas at ambient temperatures. No additional heat and no solvents are required, making it the ideal candidate for delivering biologics via inhalers.
The approach is also simpler than other methods of formulating high-dose drugs as it doesn’t require a complex multi-stage process, helping accelerate drug development and route to market timelines while reducing costs. The fact that it doesn’t use excessive energy or solvents means it is also more environmentally friendly as well.
Liquid-Based Delivery
One common way to deliver synthetic drugs is via the gut (the buccal system). Over the years, the pharmaceutical industry has developed reliable ways to transport drugs to the gut without being damaged by stomach acid. The main difficulty with biological drugs, however, is that they tend to be much larger compounds, which are harder to absorb in the gut.
One approach being developed by Max Bio+ is to use a unique combination of polymers and lipids to create a liquid-based delivery system for biological drugs. This composite system creates nanostructures that hold and disperse biologics in an aqueous solution, such as water. The result is the creation of nano-particulates that can permeate across multiple cell layers into the bloodstream via the buccal route (gut).
What’s more, this unique combination of polymers and lipids has been found to create a synergistic effect with biological drugs, increasing their potency.
The application of this approach could be incredibly broad, offering a stable oral liquid form of important drugs, such as insulin. So, rather than diabetics needing to inject insulin several times a day, they could simply drink a shot of insulin when required.
Other applications could also include drugs that are otherwise insoluble in water, such as CBD which binds to fats and is often found as oils. Instead of requiring often unpalatable emulsifiers to mix these compounds into other water-based liquids, they can be added at higher concentrations without sacrificing flavour. The result could be more potent CBD-based drinks and foods, including alcoholic beverages.
The Future
Six out of the past ten new FDA-approved drugs have been biologics, demonstrating how much things are changing. We are on the cusp of a transformative wave of biological drugs. It is exciting to think of how biologics will transform lives over the next decade and beyond.