Study question
Early clinical programs for dry-powder nasal sprays often need to answer a practical question before they move forward: can the device and formulation deliver a consistent dose, produce a defined spray, and keep most recovered material in the intended upper-airway size range? The sponsor had two anonymized dose variants and needed an in-vitro characterization package before the program advanced.1,2
ARE Labs framed the work as product characterization, not a clinical efficacy claim. The sponsor needed data that could support an FDA request for initial Phase 1 product characterization without exposing proprietary product details. That meant the report had to connect method, measured performance, and interpretation while staying inside the limits of the in-vitro data.1,2,3
The core questions were straightforward but technically important. Could each variant be actuated with consistent force? Did the emitted powder produce a controlled spray pattern and plume? Was the delivered mass consistent? Did the aerodynamic particle size distribution suggest that most recovered material remained in the larger-particle nasal or upper-airway region rather than shifting into smaller respirable fractions?1
Test package
The study combined mechanical actuation, NGI cascade impaction, HPLC recovery, spray pattern imaging, plume geometry capture, delivered dose assessment, and regional deposition classification. USP <601> and FDA nasal product guidance provide public context for why these product-quality measurements are commonly discussed for inhalation and nasal drug products.1,2,3
Both variants were evaluated under controlled actuation to reduce operator-related variability. That was important because manual actuation can add noise to the results, especially when a program is comparing dose variants or trying to establish a baseline for later development work. The final data package connected method, measured performance, and interpretation under a GLP-aligned documentation framework.1,4
| Metric | Dose Variant A | Dose Variant B |
|---|---|---|
| Average actuation force | 5.68 +/- 0.54 kg | 5.44 +/- 0.25 kg |
| Delivered dose / emitted mass | 9.6 +/- 2.5 mg | 19.6 +/- 0.6 mg |
| Ovality ratio | 1.23 +/- 0.10 | 1.20 +/- 0.09 |
| Spray angle | 33.33 +/- 0.78 deg | 29.97 +/- 0.97 deg |
| Nasal / upper-airway deposition | 97.9% | 98.6% |
| Tracheobronchial deposition | 1.2% | 0.8% |
| Alveolar deposition | 0.8% | 0.6% |
| Exhalable fraction | 0.1% | 0.1% |
What the data showed
Both dose variants showed similar mechanical and spray-performance behavior. Average actuation force was 5.68 kg for Dose Variant A and 5.44 kg for Dose Variant B, with comparable variability. Spray patterns were mostly circular to slightly elliptical, and the measured spray angles stayed in a narrow range.1
Delivered dose or emitted mass scaled with the dose configuration: 9.6 mg for Dose Variant A and 19.6 mg for Dose Variant B in the summarized report data. That difference was expected from the configuration comparison. The more important development question was whether the broader performance profile remained interpretable across variants.1
Regional deposition result
The most important technical result was the regional deposition profile. Dose Variant A showed 97.9 percent of recovered material in the nasal or upper-airway category, and Dose Variant B showed 98.6 percent in the same category.1
Source: anonymized ARE Labs client study report and addendum.
- Percentages are calculated from recovered material in the anonymized study data table.
- The chart is not a clinical deposition claim.
The smaller tracheobronchial, alveolar, and exhalable fractions were low for both configurations. That gave the sponsor a clear technical signal: the prototype behaved like a larger-particle nasal powder system rather than a primarily lung-directed aerosol under the tested conditions.1
Source: anonymized ARE Labs client study report and addendum.
- Excludes the nasal / upper-airway fraction (~98%) so the small fractions are legible.
- The chart is not a clinical deposition claim.
This was an in-vitro classification rather than a clinical deposition claim. In the source report, respirable MMAD and GSD were not calculated because most recovered material was above the relevant upper size range for respirable curve fitting. In this setting, that was part of the interpretation rather than simply a missing endpoint.1
Regulatory-facing use
According to the client-reported project outcome, the characterization report satisfied an FDA request for initial Phase 1 product characterization. That statement is not a claim of product approval, clearance, or agency endorsement.1,2
The practical value was the completeness of the early-stage package: defined test methods, controlled actuation, quantitative recovery, clear interpretation, and documented limitations. For teams preparing early clinical programs, this type of study can help answer regulator, investor, or internal program questions before a formulation or device design is locked.1,2,4
- Use this type of study when a program needs early performance characterization for an intranasal drug-device product.1
- Keep interpretation limited to the data package; in-vitro regional classification is not a clinical deposition result.1,2
- Document limitations clearly when public FDA or USP context is used to explain the measurement rationale.2,3
A similar design may be useful when a sponsor is preparing for first-in-human work, responding to an agency information request, comparing early device variants, evaluating a formulation change, or building a data package for internal program decisions. The key is to interpret the device as a system, because actuation, powder release, spray geometry, delivered dose, and aerodynamic sizing all influence the development picture.1,2
The study can also serve as a baseline for later comparability work. If the actuator, powder formulation, filling process, or dose configuration changes, the same endpoint family gives the sponsor a way to compare new data against the original characterization package without turning each later question into a new, unrelated method discussion.1
The confidentiality boundary also shaped the public article. The published version keeps dose variants, method categories, measured endpoint summaries, and regional deposition values, but removes the client name, product name, API, indication, client-specific codes, batch codes, personnel names, raw-data screenshots, and device-identifying details.1
Summary
In summary, the study gave the client a clearer early-performance baseline for two dry-powder nasal spray variants by connecting actuation, delivered dose, APSD, spray geometry, and regional deposition results. The work helped the client answer an initial characterization need without extending the article into approval or clinical-effectiveness claims. ARE Labs was useful here because the measurements, documentation, and interpretation stayed aligned with the study question.1