The International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC‑RS) is highlighting the recent publication of a new paper titled “Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC‑RS)” online in AAPS PharmSciTech. The paper covers regulatory requirements as well as methodologies for aerodynamic droplet/particle size distribution (APSD) testing of aqueous nasal sprays, including laser diffraction (LD), cascade impaction (CI), and morphologically-directed Raman spectroscopy (MDRS).
IPAC-RS Secretariat representative Lana Lyapustina commented, “This paper represents a significant addition to the toolbox of developers of nasal spray products based on aqueous formulations. Characterizing and controlling droplet/particle sizes of these products is important for ensuring appropriate product quality and in-vitro performance, and is also required by regulatory agencies. Now product developers have an authoritative source at their fingertips.”
Lyapustina noted, “This comprehensive review of current approaches and technologies was prepared by an IPAC-RS working group comprised of subject matter experts with decades of regulatory and industry experience.” The paper was authored by 6 members of the working group: consultants William Doub and Jolyon Mitchell; Aptar Pharma VP of Scientific Affairs Julie Suman; Merck Senior Principal Scientist Adrian Goodey; Lonza Sr. Product Development Scientist Sana Hosseini; and Copley Scientific CEO Mark Copley.
Copley said, “As we note in the paper, nasal and orally inhaled products are usually grouped together but the associated particle/droplet sizing challenge is distinctly different. For deposition in the nose we’re looking at a larger APSD, but with the risk of unintended deposition of fines in the lung. The need is for relevant, informative measurement across the whole APSD with CI and LD typically used in combination to cover the range of interest.”
Read the AAPS PharmSciTech paper.
Read the Copley Scientific press release.
