Inhalation Drug Delivery
Supported by an expansive portfolio of device IP, we’ve led the field. Bolstered by predictive engineering and rapid prototyping capabilities, we strive to be on the cutting edge of novel inhalation device development. Our to-date developments include: metered-dose inhalers (MDIs), nasal MDIs, dry-powder inhalers (DPIs), soft-mist inhalers (SMIs), digital/connected devices, nebulizers, components (canisters, valves, dose counters), and application of novel coatings. We also have experience with tech transfers. Whatever your need, Kindeva has you covered.
Inhalation Formulation Decision Making & Respiratory Delivery Device Comparison Charts
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Pressurized Metered-Dose Inhaler - pMDI (pulmonary)
The lungs provide a large surface area (~100m2) for local and systemic drug delivery, using portable, hand-held delivery devices (different devices are available to meet the needs of the product and the patient).
Formulation Type • propellant based suspension or solution with/without co-colvent/excipients
API Requirements • suspensions: solid drug particles ideally 1-5 microns / solutions: appropriate drug solubility in propellant/co-solvent
Dosing Capability • up to 2mg
Inspiratory Effort • low *
Device Type • press and breathe or breath actuated
Number of Doses Available • multi dose, up to 200
Benefits of local delivery:
- drug delivered directly to the affected area
- reduced doses
- rapid onset of action
- fewer systemic side effects
Benefits of systemic delivery:
- large permeable surface area
- non-invasive
- avoid first-pass metabolism in the liver
- potential for improved bioavailability which may reduce the dose required
* Required to obtain therapeutic dose.
Low = easy to inhale from for all patients
High = may be difficult to inhale from by children/elderly
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Pressurized Metered-Dose Inhaler - pMDI (nasal)
The nasal cavity provides a relatively large surface area with an excellent blood supply for local, systemic, and nose-to-brain drug delivery, using portable, hand-held delivery devices.
Formulation Type • propellant based suspension or solution with/without co-colvent/excipients
API Requirements • suspensions: solid 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 Doses Available • multi dose, up to 200
Benefits of local delivery:
- drug delivered directly to the affected area
- reduced doses
- rapid onset of action
- fewer systemic side effects
Benefits of systemic delivery:
- non-invasive
- avoid first-pass metabolism in the liver
- bypass the Blood-Brain-Barrier (for nose-to-brain delivery)
- potential for improved bioavailability which may reduce the dose required
- relatively large permeable surface area (almost 2m2)
* Required to obtain therapeutic dose.
Low = easy to inhale from for all patients
High = may be difficult to inhale from by children/elderly
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Dry-Powder Inhaler - DPI
Formulation Type • API/Lactose/Excipient, dry powder blend
API Requirements • solid drug particles ideally 1-5 microns with/without carrier/excipients
Dosing Capability • up to 50mg+
Inspiratory Effort • low to high *
Device Type • breath actuated
Number of Doses Available • unit dose, reusable
Promising Early Results for New High-Performance DPI
by Kindeva Drug Delivery and Cambridge Healthcare Innovations
* Required to obtain therapeutic dose.
Low = easy to inhale from for all patients
High = may be difficult to inhale from by children/elderly
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Soft-Mist Inhaler - SMI
Formulation Type • aqueous based solution with excipients
API Requirements • appropriate drug solubility in aqueous/co-solvent media
Dosing Capability • up to 3mg
Inspiratory Effort • low *
Device Type • breath actuated
Number of Doses Available • multi dose, typically up to 60
* Required to obtain therapeutic dose.
Low = easy to inhale from for all patients
High = may be difficult to inhale from by children/elderly
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Nebulizer
Formulation Type • aqueous solutions, suspensions, high viscosity
API Requirements • appropriate drug solubility in aqueous/co-solvent media
Dosing Capability • up to 5mg
Inspiratory Effort • continuous flow *
Device Type • continuous or breath actuated
Number of Doses Available • unit dose, reusable
* Required to obtain therapeutic dose.
Low = easy to inhale from for all patients
High = may be difficult to inhale from by children/elderly
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Technical Leadership
More than 60 years of industry-leading expertise in inhalation science and product development drives our success. We have the R&D expertise to go from molecule to patent. We have successfully developed and commercialized both mono and combination therapies and both generic and branded products.
- Lab-scale and commercial experience formulating stable products
- Formulations ranging from small molecules to macromolecules
- Particle engineering & raw material screening
- Phase appropriate method development & validation
- Globally minded regulatory and clinical leadership
- Expert data analysis and interpretation to support regulatory submissions
- Expert analytical method development capabilities
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Operational Excellence
Our cGMP manufacturing sites are positioned to supply to global markets. Operating under strict quality standards, we are always audit-ready.
- Automated filling and packaging lines
- Cold-fill and pressure-fill capabilities
- Micronization and powder handling technologies
- Small-to-large order packaging flexibility