A non-invasive alternative to needles; a fast track to better bioavailability; a vehicle for bypassing the blood brain barrier; there are many reasons why intranasal drug delivery continues to attract attention among developers of next generation drug products.
In order to unlock such significant benefits, appreciation must be given to the complexities associated with delivering drugs to the nose, from the earliest stages of formulation all the way through to device design and manufacture. Moreover, these factors must be considered in the context of the specific molecule, which can range from smaller APIs through to complex, fragile biologics.
For stakeholders working in this space, forums such as the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) provide a vital platform for maintaining momentum on the many key issues associated with inhaled and nasal drugs. A not for profit, collaborative organisation, IPAC-RS has supported the advancement of science, in particular regulatory science, in this part of the industry for more than 25 years.
Events are an important strand of the IPAC-RS offering, and the consortium’s Nasal Innovation Forum provides a valued opportunity for industry leaders, regulatory experts and scientific pioneers to come together, explore and advance discussions around intranasal drug delivery.
Nanopharm’s Lucas Silva was among the speakers at this year’s event, which was held in West Trenton, New Jersey in September and attracted support from Eli Lilly and Company, Satsuma Pharmaceuticals, Inc., and the U.S. Food & Drug Administration.
Lucas spoke about how the formulation of liquid nasal drugs can be optimised and accelerated through the lens of Target Product Profiles (TPPs). This approach involves aligning formulation attributes (such as as viscosity, pH, osmolarity, droplet size and delivery mechanism) with defined therapeutic objectives and in light of desired characteristics around patient outcomes, safety and usability.
This is an approach that is increasingly being employed within the development of nasally administered biologics… “To date, nasal drug delivery has mainly been focused on small molecule drugs, but we are now increasingly talking about biologics, which have their own formulation challenges,” explains Lucas. “At the IPAC-RS Nasal Innovation Forum, we were able to show how those challenges can be overcome efficiently using a TPP-based approach, supporting innovation and differentiation for liquid nasal drug products.”
Beyond formulation strategies, talks at the event tackled a wide range of key topics in the current intranasal drug delivery landscape, from regulatory developments to device manufacture. Full details of the programme are available at the dedicated event page on the IPAC-RS website.
https://www.ipacrs.org/ipac-rs-nasal-innovation-forum
Aptar Pharma, reinforcing its position at the forefront of drug delivery innovation, played a key role in co-ordinating the programme and also in the presentation and moderation of sessions. Speakers included Reenal Gandhi, Global Business Development Director, Systemic Nasal Drug Delivery (SNDD); Sana Hosseini, Principal Engineer, Aptar Pharma Services; Paul Shields, Site Director, Aptar Pharma Services; and Julie D. Suman, Vice President, Scientific Affairs.
Lucas concludes: “The IPAC-RS Nasal Innovation Forum is well-established and highly respected as a platform for exploring the scientific and regulatory issues that are crucial for unlocking the potential of nasal drug delivery. As Nanopharm, and as part of the wider Aptar Pharma family, it is rewarding to come together with colleagues across the sector to know that we are advancing and accelerating the progress of therapies that will be transformative for patients worldwide.”
