Nasal Drug Delivery

Nasal Drug Delivery

We offer full-service support for nasal drug delivery, with horizontal and vertical integration to streamline your timeline and maximize efficiency. With a legacy of product approvals in the U.S. and European markets, we understand what it takes to bring your therapy to the world.

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Nasal delivery technology

Our deep expertise in nasal drug delivery allows us to customize our platform technology to your needs.

Nasal pMDIs

The nasal cavity boasts an excellent blood supply that makes it ideal for local, systemic, and nose-to-brain drug delivery. Our nasal pressurized metered-dose inhalers (pMDIs) optimize therapeutic outcomes through this versatile route of administration.

  • Drug delivered directly to affected area  
  • Reduced doses  
  • Fewer systemic side effects from reduced targeted dosing  
  • Noninvasive  
  • Avoid first-pass metabolism in the liver  
  • Bypass the blood-brain barrier (for nose-to-brain delivery)  
  • Potential for improved bioavailability may reduce required dose  
  • Formulation: Propellant-based suspension or solution with/without co-solvent/excipients  
  • API requirements: Suspensions: insoluble drug particles ideally 1-5 microns/ Solutions: appropriate drug solubility in propellant/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 

We also offer capabilities for pulmonary pMDIs.

1500 Assembly Tray Unloading Robot Arm

DPIs 

Our team is dedicated to innovating dry powder inhalers (DPIs). By leveraging our advanced spray drying techniques, we create powders that are not only stable and easily dispersible but also exhibit excellent flow characteristics. We are also able to formulate stable powder compositions for biological agents, including complex macromolecules and particulate matter. 

  • High payload  
  • Room temperature (RT) stable   
  • Inhalation flow rate independent   
  • High-delivery efficiency to the lungs  
  • Devices:  
    • High payload delivery system for engineered particles and lactose blend (LB)  
    • Single use: Off-the-shelf devices with prepackaged room-temperature (RT) stable engineered powders inside
  • Formulation type:   
    • Engineered particles via spray drying for solution and suspension-based formulations  
    • API/lactose crystals/excipient, dry powder blend  
  • Drug product formulation: Solid drug particles with aerodynamic particle diameters ideally 1-5 microns with/without carrier/excipients   
  • 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 
1500 Assembly Tray Unloading

 Nasal sprays 

We develop, manufacture, and commercialize nasal spray products, using a protocol-driven process and spray-specific approaches to manage the unique challenges of sprayable drug product development. 

  • Noninvasive  
  • Direct absorption into the bloodstream  
  • Direct access to CNS  
  • Rapid treatment  
  • Stability testing  
  • Formulation type: 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

Lexington, Kentucky, nasal spray facility

  • Established 10,000 ft² (930 m²) manufacturing facility (1,513 Facility)​ 
  • Adjacent 45,000 ft² (4,200 m²) of space for GMP manufacturing, packaging, warehousing, laboratories, and office (1,500 Facility)​ 
  • Employing 140 FTEs​ 
  • FDA/EMA-approved nasal spray production facility​ 
  • Implemented finished product serialization in compliance with the DSCSA and EU requirements​ 
  • DEA-registered to manufacture and test controlled substances 
Explore our facilities
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Analytical services

We offer an unrivaled breadth of analytical services to support your nasal product’s path to market. As one of only a few CDMOs with holistic analytical support from early development through life cycle management, we integrate every stage of the process to realize better outcomes.

Discover Our Analytical Expertise

Leverage expert support for intranasal drug delivery

Kindeva is ready to guide your journey to market with unrivaled expertise, unmatched capacity, and full-service CDMO capabilities.

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