Broughton Chief Regulatory Officer, Dr. Nveed Chaudhary shares his thoughts on the latest Food and Drug Administration (FDA) updates including Marketing Denial Orders (MDOs) for flavored e-liquids...
Learning from nicotine: using the advances in nicotine delivery to revolutionize inhalation therapy
Pharmaceuticals
Nov 11, 2022 | Published by Dr. Nveed Chaudhary
Pharmaceuticals
Smoking is one of the most efficient and effective methods of delivering a drug to the lungs; which is one of the reasons smoking provides such efficient and quick drug delivery is the way that the nicotine coalesces with water molecules. This is potentially ground-breaking research and will be opening new avenues for drug delivery systems.
Based on recent research, pharmaceutical giants are on the cusp of the biggest revolution in inhalation therapy since the breakthrough of Boehringer Ingelheim’s soft-mist inhaler (Respimat®), and bronchodilator tiotropium bromide (Spiriva®). The combination has been a proven success in the treatment of asthma and COPD (chronic obstructive pulmonary disease) and kickstarted a revolution in inhalation therapy. This was the first time an addictive substance was delivered through inhaled water droplets, and pharmaceutical pioneers are now working on how this method can be emulated with other drugs.
We’ve already established that cigarettes are a hugely effective drug delivery mechanism in the case of nicotine. Interestingly, e-cigarettes are not far behind. This has given the pharmaceutical industry food for thought, and Broughton has proffered the question: “instead of nicotine being delivered through e-cigarettes, could we administer other active molecules this way?”
Utilizing e-cigarette technology in a pharmaceutical environment would not only be exceptionally cost-effective, but fantastically efficient in terms of delivering active substances to the lungs. Furthermore, the e-cig delivery method is more accessible and user-friendly for patients - inhaler use depends on very close coordination between the trigger and inhalation whereas using e-cig technology would greatly increase the success rate of patients self-administering.
As with any medicine, it is imperative that patients take only the medically prescribed dose. With inhalation therapy, ensuring this is twofold ─ firstly, the device must deliver a consistent amount of active substance and, secondly, the patient must self-administer correctly. Any e-cigarette (or inhaler) used in a pharmaceutical setting must demonstrate delivered dose uniformity (DDU), both within and between devices.
It is of course important to note that e-cigarettes are a fundamentally different technology to inhalers, and it is not possible for them to behave identically. Inhalers use a pressurized canister, which is calibrated to deliver an exact dosage per puff, whereas an e-cigarette is traditionally based on coil and wick technology. This means that patients can self-titrate and may take larger or smaller puffs depending on their symptoms. The coil and wick technology can be inconsistent, a challenge which is prescient throughout the industry: if we are to use e-cigarettes to deliver medicine, it remains vitally important to understand exactly how much active substance is administered per inhalation to ensure the patient can take the drug as prescribed.
Of course, the e-cigarette industry is working on methods to overcome this - many cutting-edge industry leaders are moving towards ceramic heating elements. This approach has two clear-cut advantages: Firstly, the tightly controlled dimensions of the heating element ensure accurate and consistent power delivery (the amount of power delivered to the heating element responsible for vaporizing the liquid will impact the amount and size of particles inhaled). Secondly, the porous ceramic wick can accurately control the wicking rate and, therefore, the amount of aerosol produced.
This new approach to inhalation therapy is potentially groundbreaking, though there is still research to be done on drug formulation and suspension. Previous pharmaceutical breakthroughs have been inspired by research performed in the nicotine industry, and what we need now is a major pharmaceutical player to commit to bringing this technology to market. The hardware and software already exist, potentially providing millions of patients and carers with more effective, accessible treatment.