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Nasal drug delivery
We offer comprehensive nasal drug delivery solutions, providing full-service support and streamlined development timelines through horizontal and vertical integration. Our deep expertise and proven track record of product approvals in the U.S., European and U.K. markets help ensure your nasal products progress with purpose.
Exceptional nasal drug delivery
The nasal cavity’s rich blood supply makes it ideal for local, systemic and nose-to-brain drug delivery. From pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) to nasal sprays, we leverage this versatile administration route to help you develop, manufacture and commercialize unique nasal delivery products.
Advantages
Local delivery
- Drug delivered directly to affected area
- Reduced doses
- Fewer systemic side effects from reduced targeted dosing
Systemic delivery
- Noninvasive
- Avoids first-pass metabolism in the liver
- Nose-to-brain delivery bypasses the blood-brain barrier
- Potential for improved bioavailability may reduce required dose
Specifications
- Formulation: Propellant-based suspension or solution with or without co-solvents or excipients
- Suspension API requirements: Insoluble drug particles ideally 1-5 microns
- Solution API requirements: Appropriate drug solubility in propellant or co-solvent
- Dosing capability: Up to 2mg
- Inspiratory effort: Nasal inhalation not always required
- Device type: Press and breathe
Number of available doses: Multidose, up to 200
Advantages
- High payload delivery for engineered particles and lactose blend
- Single-use off-the-shelf devices
- Room temperature stable
- Inhalation flow rate independent
- High-delivery efficiency to the lungs
Specifications
- Formulation: Engineered particles via spray drying for solution and suspension-based formulations. API/lactose crystals/excipient, dry powder blend
- Dosing capability: 50mg or more per actuation
- Inspiratory effort: Low to high
- Device type: Breath actuated for single inspiratory effort
- Number of available doses: Single-use
Advantages
- Noninvasive
- Direct absorption into the bloodstream
- Direct access to the central nervous system
- Rapid treatment
- Stability testing
Specifications
- Formulation: Aqueous solutions and suspensions
- Inspiratory effort: Low
- Device type: Nasal drug delivery system, customized for your therapy
- Number of available doses: Unit-dose, bi-dose, multidose
Our nasal spray facility
- Lexington, Kentucky
- 10,000 sq. ft. (930 m²) manufacturing facility
- Adjacent 45,000 sq. ft. (4,200 m²) space for GMP manufacturing, packaging, warehousing, laboratories and offices
- Employing 140 full-time employees
- FDA/EMA-approved nasal spray production facility
- Implemented finished product serialization in compliance with DSCSA and EU requirements
- DEA-registered to manufacture and test controlled substances
Value beyond manufacturing: Analytical services
We provide exceptional analytical support throughout your nasal product’s lifecycle, from early development to commercialization. As one of the few CDMOs offering holistic analytical services, we integrate expertise at every stage to help ensure optimal outcomes and accelerate your path to market.
Meet your nasal delivery experts
Partner with us and benefit from a team with technical expertise and a passion for purpose. As a true partner, strategically minded and dedicated to your lasting legacy, we provide customized solutions tailored to your precise requirements.
Nasal delivery resources and insights
Explore our library of resources to learn more about our nasal drug delivery capabilities and expertise.
Acoustic methodology for measuring discharge rate, and predicting spray velocity effects on potential lung deposition
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Pulmonary & nasal delivery capabilities
Get an overview of our pulmonary & nasal delivery capabilities, including: Customized approach to determining the right device for your drug Pulmonary & nasal platform technologies: pressurized metered-dose inhaler (pMDI), dry power inhaler (DPI), soft-mist inhaler (SMI), nebulizer, and nasal spray Green propellant innovations Experience bringing complex generics to market Expansive capabilities across state-of-the-art facilities […]
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Development of a theoretical model to predict pMDI spray force, using alternative propellant systems
Learn MoreLet’s transform tomorrow together
Every patient deserves a brighter tomorrow. As your strategic partner, we are dedicated to building your lasting legacy and helping you fast-track healthier tomorrows. You dream it, we deliver it.