Pulmonary & nasal

Pulmonary & nasal: Drug formulations and inhalation devices

We deliver industry-leading phase appropriate analytical methods, hardware design, and inhalation formulation in both small and macromolecules for pulmonary & nasal products. From early-stage device selection and formulation design through all stages of product testing and process development, cGMP scale-up, and commercialization, combine forces with Kindeva to optimize your first-in-human timeline and maximize your drug-device product success.

Our pulmonary & nasal platform technologies

Choosing the best inhalation device for your drug is vital for creating an effective therapy, which is why we follow a detailed process to help determine the optimal option.

pMDI icon

The lungs offer a large surface area (~100m2) for drug delivery, while the nasal cavity provides a more modest surface area that also has an excellent blood supply for local, systemic, and nose-to-brain drug delivery. So we develop pressurized metered-dose inhalers (pMDIs) for both pulmonary & nasal use to suit the therapeutic need. As the original metered-dose inhaler manufacturers and inventors, we also continue to lead the charge as innovators in this space with extensive development and manufacturing experience.

Overarching platform benefits: A pMDI is considered the best delivery platform for bronchodilation rescue medication options. These inherently multidose devices are excellent for chronic therapies with target doses up to 2mg.

  • Delivery is relatively insensitive to patient inhalation effort, and with use of a spacer, this is greatly enhanced 
  • Patient familiarity/consistency of handling 
  • Significantly lower cost than other options 

Pulmonary pMDIs

Local delivery benefits:

  • Drug delivered directly to affected area 
  • Local delivery, therefore fewer side effects
  • Optional spacer enables great reduction in swallowed and throat-absorbed systemic action 
  • Rapid onset of action 

Systemic delivery benefits:

  • Large permeable surface area 
  • Noninvasive 
  • Avoid first-pass metabolism in the liver 
  • Potential for improved bioavailability may reduce required dose

Specifications:

  • 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: Typically up to 2mg  
  • Inspiratory effort: Low  
  • Device type:  
    • Multidose: Press and breathe or breath actuated, option for a built-in dose counter or indicator 
  • Number of available doses: Multidose, up to 200 

Nasal pMDIs

Local delivery benefits:

  • Drug delivered directly to affected area 
  • Reduced doses 
  • Fewer systemic side effects from reduced targeted dosing 

Systemic delivery benefits:

  • 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 

Specifications:

  • 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 

Kindeva is the industry-leading CDMO in bringing green propellants to commercial combination product manufacturing. We have installed pilot scale lines as well as two new manufacturing lines capable of filling inhalers with HFA-152a and/or HFO-1234ze propellants that have 90% and 99.9% lower Global Warming Potential (GWP) than P134a, the greenest pMDI propellant currently used.  

What do proposed regulations promoting green propellants mean for the pressurized metered-dose inhaler (pMDI) industry?

Find out their impact and the deeper considerations the industry must undertake with Nick Smalley, Vice President of Regulatory Affairs at Kindeva Drug Delivery.

Clinical supply is already available and commercial scale will be ready this year. We plan to introduce some of the first-ever products using these alternative propellants to the market, subject to regulatory approvals. These new, more eco-friendly inhalers will cut GWP by over 90%. 

Discover more about how Kindeva prioritizes sustainability. 

DPI icon

We continually strive to set new benchmarks for dry powder inhaler (DPI) performance in the pulmonary biologics combination product space. Our spray drying expertise enables development of stable, dispersible, and flowable powders capable of efficient dose delivery, even for drugs requiring very high doses. Kindeva is a leading DPI manufacturer with the know-how to form stable powders for biologics, including large molecules and particles.

Benefits:

  • High payload 
  • Room temperature (RT) stable
  • Inhalation flow rate independent
  • High delivery efficiency to the lungs

Specifications:

  • Devices: 
    • High payload delivery system for engineered particles and Lactose Blend
    • Nasal or pulmonary single-use: Off-the-shelf devices with prepackaged room temperature (RT) stable engineered powders inside 
    • Pulmonary multi-use: Off-the-shelf, simple, low-cost devices  
    • Pulmonary multidose: Off-the-shelf, dry-powder inhalers containing 14-30 doses per device 
  • 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 to multiple inspiratory effort 
  • Number of available doses: Single-use, unit dose, reusable, or multidose reusable 

Soft-mist inhalers (SMIs) provide an inhalation option that propels the medicinal mist at a slower rate, making it easy for patients to breathe in regardless of lung capacity or grip strength.

Benefits:

  • Multidose container with no cleaning required  
  • Aqueous formulation of small and large molecule drugs, including difficult-to-formulate biologics 
  • Expert characterization of stability and dose delivery 
  • Early-phase cGMP testing and manufacturing

Specifications:

  • Formulation type: Aqueous-based solution with excipients 
  • API requirements: Appropriate drug solubility in aqueous/co-solvent media 
  • Dosing capability: Up to 500 mcg 
  • Inspiratory effort: Low  
  • Device type: SMI provided by partner or third party 
  • Number of available doses: Multidose, typically up to 60
Nebulizer icon

We work with partners to rapidly develop aqueous formulations that can be delivered using off-the-shelf nebulizers.

Benefits:

Kindeva is a leading innovator in the nebulizer platform space, creating devices with the following improvements over older technology:

  • Low cost 
  • Quick to the clinic 
  • Silent, allowing for more discreet usage and more positive user experience 
  • Easy-to-use controls — connectivity available 
  • Dose proportionality available with certain devices 
  • High payload and increased lung deposition 
  • Small, discreet devices available 

Specifications:

  • Formulation type: Aqueous solutions, suspensions, high viscosity 
  • API requirements: Appropriate drug solubility in aqueous/co-solvent media 
  • Dosing capability: Water solubility or nano emulsion concentration dependent: potent drug with good solubility offers dosing in a few breaths; drugs that are not potent can take many minutes 
  • Inspiratory effort: Normal tidal breathing  
  • Device type: Air-jet or vibrating mesh with continuous or breath-actuated mode 
  • Number of doses available: Unit dose, reusable 
Nasal Spray icon

We develop, manufacture, and commercialize nasal spray products, formulated for distribution, bioavailability, and improved retention within the nasal cavity.

Benefits:

  • No inhalation effort, treatment of incapacitated patients
  • Direct delivery to CNS
  • Delivery route minimizes first-pass metabolism
  • Aqueous and non-aqueous formulations

Specifications:

  • Formulation type: Suspensions and aqueous and non-aqueous solutions
  • API requirements: Appropriate drug solubility in aqueous/co-solvent/non-aqueous media
  • Dosing capability: Up to approximately 30 mg
  • Inspiratory effort: None
  • Device type: Provided by partner or third party
  • Number of available doses: Single-use, multidose
1500 Assembly Tray Unloading Robot Arm

From dry powder inhalers to green propellants: Create exceptional products

Our expertise in pulmonary & nasal products offers an array of technical and operational benefits: 

  • Lab-scale and commercial experience formulating stable products 
  • Formulations ranging from small molecules to macromolecules 
  • Particle engineering & raw material screening 
  • Phase appropriate method development & GMP validation 
  • Globally minded regulatory and leadership 
  • Expert data analysis and interpretation  
  • Expert analytical method development  
  • Automated filling and packaging lines 
  • Pressure and cold pMDI filling capabilities 
  • Micronization and powder handling technologies 
  • Small-to-large order packaging flexibility 

Pulmonary biologics 

As industry-leading experts in the pulmonary biologics space, our renowned team does an evaluation of your product needs and timeline, then offers a flexible, fast, cost-effective strategy for fulfillment. Our extensive experience and advanced capabilities provide speed and quality for early feasibility studies, and we serve multiple molecule classes with a primary container agnostic approach to accelerate first-in-human trials. Kindeva gets your pulmonary biologics combination product right — the first time.

man operating equipment

Generic products

We have a rich and proven heritage in the generic medicine space, characterizing and developing equivalent options for complex therapies and extending access to more patients. Kindeva Drug Delivery launched first FDA-approved generic version of Symbicort® within the U.S. (Breyna™) as well as a generic alternative to Seretide ® in the U.K. (Sirdupla™). 

Why Kindeva for your pulmonary & nasal needs? 

Our team members live and breathe this work, guided by more than a half century of industry experience. We’re passionate about the science, are regularly published, and conduct ongoing academic research.

Our world-class diversity of development and delivery capabilities, range of products, and scope of therapeutic compound experience are second to none.

We have been there, we have done it, and we know what it takes. Meticulous planning, a holistic view of the entire product development cycle, and our proven technical excellence allow us to react to any situation, resulting in high-quality, realistic, successful outcomes.

At Kindeva, your success means our success. We work in a collaborative manner, dialoging with you about various learnings, tried-and-tested approaches, and outcomes as we go. 

When you need to move quickly and maximize ROI, we have options on the shelf and ready, and we can customize your packaging to align with your branding.

We know how to get your submissions to the finish line because we keep pace with the latest regulatory guidelines from all over the globe. Through our membership in key oversight groups (IPAC, IPAC-RS, EPAG, PQRI, etc.), we also regularly review and comment on draft guidance to ensure it’s fit for purpose.

Our analytical specialty service capabilities have been used for 60+ years to support successful commercial pulmonary & nasal products and include phase appropriate methodology, methodology validation, complex methodology development, extractables, leachables, and clinically relevant testing. In our industry, this scope of support is difficult to find all in one place.

Leverage Our Analytical Expertise

Through organizations such as IPAC, IPAC-RS, EPAG, PBOA, Medical Alley, DDL, and DCAT, we maintain a robust industry presence.

Your pulmonary & nasal product benefits from the extensive capacity of our state-of-the-art R&D and manufacturing facilities, with most offering targeted capabilities for pulmonary & nasal delivery, including our Loughborough, Union City, Woodbury, and Lexington facilities.

Kindeva Products

Ready to get started?

Whether you are determining ideal delivery and dosage or looking to scale sterile manufacturing and fill-finish operations, combine forces with Kindeva throughout your process to minimize risk with proactive, informed solutions that accelerate every stage of your product’s pathway.

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