Driving Results in Inhaler Testing
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Driving Results in Inhaler Testing - 1

Driving Results in Inhaler Testing METERED-DOSE INHALERS • DRY POWDER INHALERS NEBULISERS • AQUEOUS DROPLET INHALERS • NASAL PRODUCTS 2021 EDIT

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Inhaler Testing About Us Copley: Driving Results for Over 75 Years Founded in 1946 in Nottingham, UK, Copley remains family owned and managed. We are recognised as the world’s leading manufacturer of inhaler test equipment, in addition to being a trusted provider of test instrumentation for other pharmaceutical dosage forms. We continue to work closely with industry groups and leading experts to bring relevant new products to market, with all equipment backed by expert training and lifetime support. These commitments are exemplified by our investment in the ISO 9001:2015 Quality Management...

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Contents Contents Inhaler Testing Delivered Dose Uniformity Breathing Simulators DDU Over the Entire Contents Breathing Simulator Model BRS 100i ISO 9001: 2015 Quality Management System Collection Devices for DDU Testing Dose Uniformity Sampling Apparatus (DUSA) Orally Inhaled Drug Products Metered-Dose Inhalers (MDIs) Dry Powder Inhalers (DPIs) Aqueous Droplet Inhalers (ADIs) Nasal Drug Products Organisations and Their Roles Regulatory Bodies in the European Union, China, Japan and USA International Regulation and Harmonisation DUSA for MDIs, BAIs, ADIs and Nasal Aerosols Waste Shot...

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Orally Inhaled & Nasal Drug Products Inhaler Testing Orally Inhaled Drug Products Metered-Dose Inhalers (MDIs) MDIs use a propellant to deliver a fixed volume of liquid solution or suspension to the patient in the form of an aerosol. They are small, inexpensive, convenient for the user and suitable for a wide range of drugs. However, the use of MDIs requires good coordination and technique to actuate the device. The actuation force needed means they are not always suitable for elderly or paediatric users. The use of breath-actuated MDIs or add-on devices such as spacers or valved holding...

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Orally Inhaled & Nasal Drug Products Inhaler Testing Dry Powder Inhalers (DPIs) As the name suggests, with a DPI the medication comes in the form of a dry powder, rather than a liquid. Nebulisers convert a liquid into aerosol droplets to produce a respirable cloud suitable for inhalation. They are widely used at home and in hospital and require little or no coordination for effective use. Nebulisers are normally loaded with the drug before each treatment and usually operate continuously once loaded. Typically, the active pharmaceutical ingredient(s) is mixed with a coarser excipient, such...

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Orally Inhaled & Nasal Drug Products Inhaler Testing Aqueous Droplet Inhalers (ADIs) Both MDIs and DPIs suffer from the same two inherent problems: low lung deposition (typically 5-20%) and dose variability (often due to patient difficulties in coordination or inspiration). ADIs (often known as “Inhalation Metered Sprays’’ or “Soft Mist®” Inhalers) actively aerosolise the liquid, forming a ‘soft mist’ to overcome these problems. These inhalers generally deliver a higher fine particle fraction than MDIs or DPIs. However, as with any multi-dose liquid system, microbial contamination can be a...

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Inhaler Testing Organisations and their Roles Organisations and their Roles The ultimate responsibility for the safety, quality and efficacy of medicines and medical devices lies with the various national regulatory bodies designated to safeguard public health. Regulatory Bodies in the European Union, China, Japan and USA. At present, there are no worldwide standards that are specifically applicable to OINDPs. In Europe, the responsibility for the regulation of medicines and medical devices lies with the European Medicines Agency (EMA) in the form of the Committee for Medicinal Products for...

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Inhaler Testing Organisations and their Roles International Regulation and Harmonisation The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique organisation consisting of representatives from the EMA, MHLW and the FDA, and experts from the pharmaceutical industry in the associated regions, in a single forum. The purpose of the ICH is to promote greater harmonisation in the way in which the individual regulatory bodies regulate new drugs such that the medicine reaches the patient economically and with the...

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Inhaler Testing Organisations and their Roles Expert Groups The ChP has four chapters contained within its Volume IV applicable to OINDPs, <0111>, <0112>, <0113> and <0951>, plus five drug specific monographs. In addition to the above, there are a number of industry and quasi-industry expert groups whose role is to assist the regulatory bodies in establishing best practice in their thinking and guidance. Chapter <0111> relates to general requirements applicable to MDIs, DPIs and nebulisers (incl. DDU) whilst <0951> describes those methods relating to APSD measurement for OINDPs. d) Japanese...

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Inhaler Testing Delivered Dose Uniformity Delivered Dose Uniformity (DDU) One of the four Critical Quality Attributes (CQAs) that determine the safety, quality and efficacy of orally inhaled and nasal drug products (OINDPs) as discussed in the previous chapter, delivered dose is the total amount of drug emitted from the drug device that is available to the user, when the device is actuated correctly. The delivered dose is measured by firing the drug device into a sampling apparatus containing a filter. The dose is captured, dissolved in solvent and an aliquot is then analysed, normally...

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Inhaler Testing Delivered Dose Uniformity Collection Devices for DDU Testing DUSA for MDIs, BAIs, ADIs and Nasal Aerosols Depending on the type of inhaler device under test, different apparatus set-ups are required. The key collection devices are highlighted below. For further information about device-specific testing, please proceed to the relevant sections within this chapter. The DUSA for MDIs consists of a sample collection tube, a filter to capture the delivered dose and a connector to connect the DUSA with the wider test set-up. It has been designed to enhance productivity and ensure...

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