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Pressurized Metered-Dose Inhalers (pMDIs)

Nanopharm is dedicated to developing OINDPs. This includes its unique and proprietary development capabilities that can deliver fully optimized pressurized metered-dose inhaler (pMDI) products in combination with its high-quality metering valves from parent company Aptar Pharma. We provide an integrated pMDI development process to advance both traditional product development as well as supporting sustainability by partnering with our customers to introduce pMDIs using next generation lower Global Warming Potential (GWP) propellants.

Nanopharm Pressurized Metered-Dose Inhaler Expertise

Pressurized metered-dose inhalers (pMDIs) are one the most proven and trusted respiratory drug delivery platforms in the world and are ideal for delivering low doses of respiratory drugs to the lungs. They bring with them a convenient, portable, and reliable route to administer treatments for everything from disease management to rescue medications. Nanopharm is ideally suited to provide the specialized development services that can reduce costs and accelerate an inhaled drug product to market.  There is an ongoing drive to enhance the sustainability of pMDIs through the implementation of lower Global Warming Potential (GWP) propellants. With our specially designed manual and ATEX-rated pilot scale pMDI filling lines for handling these new propellants, Nanopharm can help keep you upgrade your pMDIs to satisfy the pending sustainability legislation.

pMDIs provide numerous advantages for delivering low doses of drugs to the lungs for rapid onset of action and are the most recognized and accepted inhalation device on the market.

Nanopharm offers comprehensive pMDI development and analytical capabilities that take an integrated approach to optimizing the formulation and drug delivery systems, even when using new lower GWP propellants.

Nanopharm’s parent company, Aptar Pharma, provides access to its industry leading pressurized metering valves, including for low GWP applications.

pMDI Advantages

The hallmark of pressurized metered-dose inhalers (pMDIs) is their trusted ability to reliably deliver drug product to the lungs in a portable and convenient package. pMDIs have a proven track record of successfully delivering low doses of required medications to the patient virtually anywhere. pMDIs allow targeted delivery of the drug to the lungs for rapid onset of local action as well as efficient absorption for systemic applications.  Whether it’s for reformulation, lifecycle management or product differentiation, Nanopharm is a strong provider of pMDI development services.

 

 

 

pMDI Development Services

Pressurized metered-dose inhaler (pMDI) product development requires specialized expertise and scientific capabilities that can meet today’s regulatory and performance requirements. Nanopharm has built the capabilities that can advance your pMDI development program with confidence. From the very start, we assess critical material attributes (CMAs) of the formulation, drug delivery system, and propellant to ensure the final product produces the desired overall product performance. Nanopharm also performs screening studies and deformulation studies for applicable reference products when developing generics.  Our use of proprietary breathing profile technology accounts for the variations of individual patient breathing parameters as well as by specific disease populations without the need to complete clinical studies. Nanopharm can determine critical parameters through aerosol testing, physicochemical characterization, API, and propellant compatibility studies as well as metered dosing valve selection and optimization to arrive at the right product formulation in the right drug delivery technology. We also offer in-silico modeling of regional lung deposition and physiologically-based pharmacokinetic (PBPK) modeling that can help produce optimized pMDI products and enable an alternative non-clinical pathway to comparative bioequivalence for generic pMDIs.

Advanced Pressurized Metering Valves

Aptar is one of the world’s largest and most trusted suppliers of metering valves. Aptar Pharma’s DF30 metering valve is the proven standard for many of today’s asthma and COPD treatments. Nanopharm’s understanding of metering valve technology is integral to developing pMDI products that can meet required specifications and performance. We have a long history of optimizing metering valves using traditional hydrofluoralkane (HFA) propellants but is also partnering with customers to use newer lower Global Warming Potential (GWP) propellants (HFA152a and HFO1234ze) for more sustainable pMDIs. Using a new propellant can require optimization of the formulation and metering valve in order to maintain acceptable product drug delivery performance and Nanopharm is ideally positioned to provide the integrated services needed to achieve this worthy goal. Aptar also offers digital health pMDI features including digital counters and other connectivity features designed to enhance patient compliance.