Inhalation drug product testing is a crucial factor in ensuring that orally inhaled and nasal drug products (OINDP) are safe and effective for use. Characterising inhalation drug products ensures they meet stringent quality assurance standards and are free from contaminants.
From metered dose inhalers (MDIs) to dry powder inhalers (DPIs) and soft mist inhalers (SMIs), nebuliser solutions, suspensions and aerosols, HMR Labs has the expertise to quality test a wide range of inhalation drug products. With specialised equipment and pharmaceutical testing knowledge, our technical team are well-versed in performing the necessary tests and analyses to characterise inhaled product formulations, dose uniformity and particle fractions. Our state-of-the-art instrumentation also provides FDA, EMA and other regulatory body compliance.
Although testing applications vary depending on the type of inhaled medication, our inhalation test laboratories house the very best in innovative techniques and instrumentation to provide you with the safety and efficacy data you need.
Start your inhalation drug product testing journey:
Purpose built laboratories
housing a range of
qualified equipment
Extensive knowledge of a
variety of dosage forms
Inclusive of novel
drug compounds
Quality Inhalation Drug Product Testing and Analysis
HMR Labs offers a comprehensive range of inhalation drug product tests, which encompass techniques optimised and developed specifically for the inhaled product and its intended use.
We have dedicated resources for inhalation testing at our facilities, which allows pharmaceutical manufacturers to accelerate their product release to a timeframe that suits them. HMR Labs is passionate about working to customer requirements, which is why drug development companies choose us to support their inhaled product development.
Whether it’s routine inhaled drug product testing to specification or ICH stability testing to assure shelf life and impurity analysis, HMR Labs are committed to executing projects where the customer is in control.
A robust project management system gives our customers immediate access to Project Managers directly involved in the project.
Looking for inhaled product testing that’s cGMP and ICH compliant?
Our specific inhaled product characterisation testing includes;
Aerodynamic particle size distribution
Drug delivery rate and total drug substance delivered
Valve delivery (shot weight)
Leak rate
Moisture content analysis
Microbial limits
Emitted dose and content uniformity
Net content (fill weight)
Input material analysis to compendial specifications
Impurities and degradation products
Alcohol/antioxidants/preservatives content
Bespoke Method Development for Inhaled Drug Products
HMR Labs’ purpose-built inhalation laboratories house an expansive range of qualified equipment, including high resolution and high throughput Agilent and Waters HPLC and UHPLC chromatography systems. We also offer Next Generation Impactor (NGI) analysis, Anderson Cascade Impactor (ACI) analysis, as well as a variety of impingers, Dosage Unit Sampling Apparatus (DUSA) and Breathing Simulators. All are in accordance with compendial requirements.
With over 35 years of pharmaceutical testing expertise centred around regulatory compliant services, the HMR team understand the complexities and challenges involved in the development of inhaler technologies.
Our testing and validation services can be designed with your specific requirements in mind. Whether motivated by time restraints, cost effectiveness, scalable methodology or refined formulation requirements, our bespoke projects and expert method validation services can ensure inhaled product testing is in line with GMP and ICH protocols, while meeting your bespoke requirements.
Take advantage of HMR Labs’ practical knowledge of inhalation delivery systems and gain the data and assurance you need to demonstrate inhaled product safety.
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Contact us today to discuss your specific test requirements directly with our team of analytical scientists.
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