The Future of Nasal Spray Development: Insights From a CDMO Perspective
Why Nasal Spray Development Requires Scientific Precision
Nasal sprays are complex drug products. Achieving consistent performance requires tight control over parameters such as droplet size distribution, spray pattern, plume geometry and dose uniformity. These critical quality attributes directly influence therapeutic effect and patient safety.
Core considerations during development include solubility and stability of the API, suspension behavior when applicable, pump–formulation compatibility and device robustness. Whether developing a generic nasal spray or an innovative therapy, each element must be optimized to meet global regulatory expectations.
The Role of Analytical Excellence in Nasal Spray Development
Advanced analytical capabilities are essential for developing safe and effective nasal spray products. At Basic Pharma, our analytical team develops and validates non-pharmacopeial methods (e.g. assay and impurities) , ensuring precise assessment of assay, impurities, particle size and in vitro performance.
Stability studies are conducted in-house across the entire shelf life, supported by climate chambers configured for Climatic Zones II, IVa and IVb. This allows us to generate robust data aligned with EU and international regulatory requirements.
Learn more about our analytical expertise through the Laboratory Division.
Bridging Development and Manufacturing Through CDMO Integration
Moving from laboratory development to commercial supply requires an efficient and scientifically justified scale-up strategy. As a nasal spray CDMO, Basic Pharma provides seamless transition from formulation to full GMP production.
Our capabilities include:
- Pilot- and commercial-scale GMP nasal spray manufacturing
- Filling and packaging of non-sterile products
- Full technical transfer support
- Regulatory guidance throughout development and registration
These services ensure that nasal spray products maintain their critical quality attributes at every manufacturing stage.
Explore our integrated development and manufacturing services.
Proven Expertise Across Multiple Nasal Spray APIs
Basic Pharma supports a broad range of nasal spray products, from OTC decongestants to prescription corticosteroids and combination therapies. We have established experience with key APIs such as Xylometazoline, Mometasone Furoate, Fluticasone Propionate, Fluticasone Furoate and Azelastine combinations commonly used in seasonal allergic rhinitis.
Partnering For Successful Nasal Spray Development
With scientific expertise, modern infrastructure and an integrated CDMO model, Basic Pharma helps partners bring high-quality nasal spray products to market with confidence. Whether developing a generic or innovative therapy, we ensure a smooth path from concept to commercial production.
Contact our experts: CDMO@basicpharma.nl