DPI and pMDI
At Nemera, we are your holistic partner to develop and manufacture patient-centric inhalers
Discover MoreInhalation devices
A breath of expertise
From the concept idea to large scale manufacturing, we’re the utmost holistic partner to develop your inhalers. We help our customers succeed in the sprint to market with their formulations targeting the inhalation treatments.
We also are an active contributor to the scientific community and we strive to consider in our research evolving trends in inhalation and in patient needs, as well as increasing interest to digital and sustainability related factors.
Our integrated combination product services
ANALYTICAL SERVICES & DESIGN VERIFICATION
Our team of experts is dedicated to ensuring the safety, efficacy, and compliance of your combination product including:
• Comprehensive analytical services and design verification
• Advanced testing methods tailored to your formulation and active ingredients
• Testing method development, administration, and reporting
• Performance and integrity verification of your device and drug product
• Adherence to global standards throughout the process
HUMAN FACTORS & USER EXPERIENCE MANAGEMENT
We provide exceptional support for combination products across diverse regulatory pathways, device types, and patient populations for global markets including:
• Human Factors program strategy and risk management
• Formative/summative testing (design validation) administration
• Human Factors Enginering documentation for regulatory submissions
• Enhances safety, usability, and overall satisfaction of your combination product.
• Aligns with FDA Human Factors Engineering guidelines and ISO 62366 standards
• Extends beyond the device to include instructions for use, packaging, and training programs to optimize user adherence and engagement
REGULATORY STRATEGY & SUBMISSION AUTHORING
We provide tailored strategies and support for all stages of the regulatory process, including:
• Development of a comprehensive regulatory strategy including premarket to post-market support
• Guidance on FDA regulations and international standards (ISO 14971, ISO 10993)
• Expert support in regional regulatory guidelines
• Assistance in authoring and compiling regulatory submissions, including: Premarket Approval (PMA), 510(k) submissions, CE marking documentation, and Notified body opinion support
• Accelerated submission processes, drawing from, our experience in over 54 markets
FAQ
Nemera designs and develops 2 types of inhalers, Pressurized Metered Dose Inhalers and Dry Powder Inhalers, to treat the following diseases:
- Asthma is a chronic inflammatory disease is a chronic disease of the air passages of the lungs which causes recurring symptoms, such as reversible airflow obstruction, episodes of wheezing, coughing, chest tightness, and shortness of breath. It was estimated that more than 339 million people had Asthma globally in 2016. There is no cure for asthma, but symptoms can be prevented by using of inhaled corticosteroids.
- COPD (Chronic obstructive pulmonary disease) is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. The main symptoms include shortness of breath and cough with sputum production. Globally, it is estimated that 3.17 million deaths were caused by the disease in 2015 (that is, 5% of all deaths globally in that year). COPD treatments include smoking cessation, vaccinations, respiratory rehabilitation, and often inhaled bronchodilators and steroids.
Inhalers are drug delivery devices used to administer the drug into the lungs through patient’s breathing. This allows medicines for lung treatments to be delivered directly to the diseased lungs allowing a rapid effect as well as a reduction in the side effects of oral or injectable medications.
A Dry Powder Inhaler (DPI) is a type of inhaler commonly used to deliver powder formulations into the lungs.
A DPI can be preloaded with the medication(s) or loaded by a patient with capsules as the dose-holding system, prior to use. DPIs are breath-activated as the medication is released only when you take a deep, fast breath in through the inhaler. This is different than a metered dose inhaler that pushes medication into the lungs.
In DPIs, a patient’s breathing capacity is critical in generating the desired therapeutic outcome as the dispersed powder needs to be broken into particles of the right size and be deposited appropriately into the lungs.
A Pressurized Metered-Dose Inhaler (pMDI) is a device used to deliver medication into the lungs. It is composed of a pressurized canister of medication that fits into a mouthpiece.
In most instances, a dose of medication is released into the lungs by pushing the canister into the mouthpiece.
Breath-activated pMDIs release medication automatically when the patient inhales. Most pressurized metered-dose inhalers have counters that track how many doses remain in the canister.
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We design and manufacture devices that maximize treatment efficacy and partner with our customers in their device strategies, to ultimately bring high-quality and safe treatment solutions to patients.
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