Issue link: https://www.e-digitaleditions.com/i/1420709
Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 39 interest in biologic therapy drives an increased inter- est in nebulization, particularly via more sophisticated smart nebulization technologies. In the DPI space, simple, capsule-based inhalers continue to be popular. The design is not especially sophisticated, but these non-proprietary, off-the-shelf device types are cost effective, flexible, and perform well. They can either be used through development, or they can be used early on in development and then switched to a more sophisticated device for final commercial presentation. Another key trend is the emergence of intranasal products as a delivery sys- tem. [There has been an] explosion of interest in the use of intranasal delivery in nose-to-brain delivery for a broad range of [central nervous sytem] indications and vaccine delivery, removing the requirement for delivery via injection. COVID-19 has also generated many intranasal therapy ideas. Another area that is beginning to gain traction is connected device technologies for all delivery plat- forms. The thought [is] that this technology can offer huge advantages in the battle against major diseases such as asthma and COPD, where there are many good medicines but where the issue is often around the patient remembering to take their medicine regu- larly. In the earlier stages of development, the advan- tage to this type of technology is in the clinical trial setting, where it could potentially be used to validate clinical trial outcomes for individual patients. Selecting a device PharmTech: What are the considerations for choos- ing DPI vs MDI? Munro (Vectura): The tendency is for pMDIs to be used for very established potent small molecules or combinations of the same, typically for the treat- ment of asthma and COPD, whereas DPIs, which are also used in these indications (often to deliver the same molecules as for the pMDI), can also be used much more broadly than pMDIs because they are able to deliver much higher doses. So in an en- vironment where the trend is towards higher doses and where biologic therapies are becoming much more common, typically requiring higher doses, the DPI platform along with nebulization is much more likely to be used. Additionally, pMDIs are very easy delivery devices to use but can be quite difficult to use well. This is fine where the pMDI delivery platform is being used to deliver low-cost potent small molecules with a broad therapeutic window but will be less acceptable in an environ- ment where there needs to be more assurance that the patient has received the correct dose. The other major difference is that pMDIs are reservoir devices so typically need to be overfilled by as much as 40% to ensure that they reliably deliver each dose up to the end of the stated use period so the overfill be- comes waste assuming that the patient discards the device after the stated number of uses. This waste can be expensive for more valuable drugs. As part of the trend towards biologics, less regular dosing "Another area that is beginning to gain traction is connected device technologies for all delivery platforms ... where the issue is often around the patient remembering to take their medicine regularly." —Sandy Munro, Vectura