Nebulizer Testing & Formulation Screening Services
Accelerate your liquid inhalation product with early-stage formulation screening, ISO 27427 testing, and deep aerosol science.
Developing liquid formulations for inhalation, whether small molecules, suspensions, liposomes, or biologics—presents complex physical challenges. Nebulization efficiency depends heavily on formulation properties such as viscosity, surface tension, and shear sensitivity. Furthermore, during laboratory testing, droplets are highly susceptible to evaporation, which can distort particle size distributions and compromise regulatory filings.
At Emmace Consulting, we combine state-of-the-art laboratory instrumentation with decades of specialized aerosol physics experience. As a boutique Nordic CRO based in Medicon Valley, we provide comprehensive, analytical testing and early-stage screening across all nebulizer platforms—giving you the data-driven clarity needed for formulation selection, generic bioequivalence (ANDA), and regulatory submissions (FDA, EMA, MHRA).
Comprehensive Nebulizer Analytical & Screening Services
We tailor our testing protocols to evaluate all liquid delivery technologies—including jet (compressor), vibrating mesh, and ultrasonic nebulizers—across all stages of development:
- Early-Stage Formulation Screening & Device Selection – Unsure which nebulizer technology fits your drug candidate? We screen your formulation using our comprehensive in-house library of commercial jet and vibrating mesh nebulizers. By assessing output rate, aerosolization efficiency, viscosity impact, mesh clogging propensity, and shear degradation, we provide a data-driven recommendation on the optimal nebulizer type for your development pathway.
- Aerodynamic Particle Size Distribution (APSD) – High-precision measurement using Next Generation Impactors (NGI). We utilize cooled impactors to suppress droplet evaporation during aerosol transport, ensuring accurate Fine Particle Fraction (FPF) profiles.
- Clinically Relevant Delivered Dose (ISO 27427) – Characterization of delivered dose and delivery rate using advanced breathing simulators that generate realistic tidal breathing profiles (infant, pediatric, and adult patterns).
- Real-Time Droplet Sizing (ISO 13320 / Laser Diffraction) – High-speed optical measurement using Malvern Spraytec instrumentation to monitor dynamic droplet size distribution throughout the nebulization cycle.
Supporting Complex Formulations & Bioequivalence (BE)
Characterizing nebulized aerosols requires strict adherence to international standard guidelines while maintaining the flexibility to evaluate complex therapeutic modalities.
At Emmace, we support your CMC dossier with testing performed in strict alignment with:
- Pharmacopeial Compliance: Procedures aligned with European Pharmacopeia ( Eur. 2.9.44) and US Pharmacopeia (USP <1601>) for liquid preparations for inhalation.
- ISO 27427 Standard Testing: Standardized evaluation of aerosol performance and safety requirements for general-purpose nebulizing systems.
- In Vitro Bioequivalence (BE): Comparative delivered dose and APSD studies supporting generic ANDA filings for generic inhalation solutions and suspensions.
- Advanced Biologics & Complex Therapeutics: Assessing shear stress degradation, protein aggregation, foaming and similar phenomena.
Senior Advising & Realistic APSD (rAPSD) Modeling
Raw laboratory data is only valuable when paired with scientific insight. When droplet distributions shift or delivered dose varies between breath profiles, you need senior scientists who understand the root aerosol physics.
Supported by experts with hundreds of years of combined experience from Big Pharma, academia, and CRO leadership, Emmace provides strategic advising:
- Evaluating formulation-device compatibility to prevent costly late-stage failures.
- Applying innovative realistic Aerodynamic Particle Size Distribution (rAPSD) methods paired with anatomical throat models for in-vivo relevance.
- Predicting lung dose deposition and in vivo exposure using our proprietary Mimetikos Preludium™
Nordic Quality Framework & Facility Identity
Emmace operates a specialized CRO laboratory located in Lund, Sweden, within Medicon Valley. While our nebulizer testing and screening services fall outside our ISO 17025 accreditation scope (which covers ISO 18562 medical device testing), all testing is executed within our Quality Management System aligned with pharmacopeial standards.