Delivered Dose, Emitted Dose & DUSA Testing for OINDPs
Ensure regulatory compliance, method robustness, and batch-to-batch consistency with pharmacopeia-aligned Delivered Dose Uniformity (DDU) testing across all oral inhalation and nasal drug products (OINDPs).
Demonstrating consistent Delivered Dose Uniformity (DDU) – or Emitted Dose – is a fundamental regulatory requirement for every inhaled and nasal drug product. Whether you are filing an ANDA for a generic DPI, validating a pMDI transition to low-GWP propellants, or developing a novel soft mist or nasal formulation, regulatory authorities require rigorous proof that the target dose is reproducibly delivered to the patient.
At Emmace, we deliver fast, reliable testing aligned with European Pharmacopeia (Ph. Eur. 2.9.18) and US Pharmacopeia (USP <601> / <1601>) standards – tailored specifically to your device platform and stage of development.
Comprehensive Emitted Dose Testing Across All Device Platforms
We adapt our testing protocols to match the exact physical and operational characteristics of your inhalation or nasal delivery system:
- Dry Powder Inhalers (DPIs): Precise control of airflow rates, pressure drops (e.g., 4 kPa), and total air volumes during dose collection to accurately mirror patient inspiratory profiles.
- Pressurized Metered Dose Inhalers (pMDIs): Life-cycle dose uniformity characterization (through canister life), automated firing setups, and compatibility evaluations for next-generation green propellants (HFA-152a, HFO-1234ze).
- Nasal Sprays & Soft Mist Inhalers (SMIs): High-precision sampling collection and automated actuation setups to measure delivered dose per spray with minimal droplet distortion.
- Nebulizers: Delivered dose determination utilizing breathing simulators to model tidal breathing patterns in accordance with ISO 27427 and pharmacopeial standards.
Pharmacopeial Alignment & Method Development
Delivered Dose Uniformity testing requires strict analytical discipline. Subtle variables – such as flow rate stability, actuation pressure, waste-shot firing protocols, and solvent extraction efficiency – can directly impact dose recovery and data integrity.
At Emmace, we offer:
- Pharmacopeial Alignment: Rigorous testing performed in alignment with regulatory practices, such as European Pharmacopeia (Ph. Eur. 2.9.18) and US Pharmacopeia (USP <601>) standards.
- Custom Method Development & Validation: Tailored, validated HPLC/UV assay procedures optimized for complex single-component or combination therapies.
- Stability & Lifetime Testing: Evaluation of delivered dose consistency across real-time and accelerated stability conditions.
- Bioequivalence (BE) Support: High-throughput testing protocols designed to support vitro bioequivalence studies and ANDA submissions for generic OINDPs.
- Early prototype testing: Test methods and instrument setups can be adapted for unique design, functionality and handling.
Senior Advising: Root-Cause Analysis Beyond the Raw Data
Generating dose uniformity data is only part of the solution. When out-of-specification (OOS) results or high variability occur, you need an experienced scientific partner who can uncover the underlying cause.
We can help evaluate whether dose variability stems from powder agglomeration, device resistance, actuation dynamics, or electrostatic charge – providing clear, actionable insights for your product development.
World-Class Nordic Precision & Quality Assurance
Emmace operates a specialized CRO laboratory located in Lund, Sweden, at the core of Medicon Valley. Our quality framework and specialized analytical procedures ensure data integrity and scientific reliability for your global regulatory submissions.
Ready to Optimize Your Delivered Dose Testing?
Connect directly with our OINDP analytical team to discuss your testing requirements, request a tailored proposal, or schedule an expert consultation.