Spray Pattern and Plume Geometry are core in vitro characterization parameters for orally and nasally inhaled drug products (OINDP), directly related to device development, generic consistency evaluation, and regulatory submission. Based on the SprayVIEW platform with its high-resolution camera and non-contact laser illumination technology, it can capture spray dynamic morphology, pattern, and velocity at millimeter-level precision. It has been adopted by FDA and incorporated into multiple PSGs, serving as the industry gold standard.
01 Applications & Scenarios
Covering three major domains: nasal sprays, inhalation products, and topical/oral sprays.
I. Nasal Spray Products:
- Multi-dose nasal sprays: allergic rhinitis, nasal corticosteroids, etc.
- Single/dual-dose nasal sprays: vaccines, emergency medications, etc.
- Nasal MDI: pressurized metered-dose nasal delivery.
For all of the above dosage forms, characterization of the spray pattern (Dmax/Dmin/ellipticity/area) and plume geometry (angle/width/plume front velocity) must be conducted in accordance with FDA's Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (finalized in 2023).
II. Inhalation Products:
- pMDI: Standardized actuation with Vereo® automated actuator
- SMI, DPI: Capturing slow mist morphology and powder release consistency
III. Topical & Oral Sprays:
Evaluation of spray uniformity and dosing precision for topical, oral mucosal/sublingual, and ophthalmic spray products.
02 Milestone Spray Characterization Service
Milestone Pharma has established spray characterization capabilities for inhaled and nasal products, centered on the SprayVIEW in vitro characterization platform, and has passed CNAS scope expansion review.
03 PBE Population Bioequivalence Calculation
In Vitro BE studies require PBE statistical analysis of spray pattern and plume geometry data. The calculation process is as follows:
Note: For each parameter, at least 3 batches of test devices and 3 batches of reference devices are required, with 10 devices per batch, and data must be collected for each device during Phase B (the initial phase).
04 Milestone Pharma: CNAS Accreditation – PBE Analysis – One-Stop Regulatory Filing Support
Milestone Pharma is China’s first third-party testing organization to have obtained CNAS accreditation for both spray patterns and plume geometry. The company provides an end-to-end, closed-loop process—from data collection for spray patterns and plume geometry. to PBE statistical analysis—with data packages and report formats aligned with FDA, EMA, and NMPA requirements, covering the entire ANDA submission process.
