Expert Solutions for Inhaler Testing Helping Scientists Improve People’s Lives METERED-DOSE INHALERS • DRY POWDER INHALERS • NEBULISERS SOFT MIST INHALERS • NASAL PRO

Inhaler Testing About Us Helping Scientists Improve People’s Lives for Over 80 Years Founded in 1946 and headquartered in Nottingham, UK, Copley Scientific remains a family-owned and managed company. For over 80 years, the company has helped scientists worldwide generate reliable data that supports the development and quality of inhaled medicines. Recognised as the global leader in inhaler testing, Copley delivers more than precision instruments. The company provides a connected ecosystem designed to support modern laboratory workflows, combining advanced hardware with software-enabled data management...

Inhaler Testing Contents Introduction 2 Delivered Dose Uniformity ISO 9001: 2015 Quality Management System 2 Orally Inhaled & Nasal Drug Products (OINDPs) Orally Inhaled Drug Products 7 Metered-Dose Inhalers (MDIs) 7 Dry Powder Inhalers (DPIs) 8 Soft Mist Inhalers (SMIs) 10 Nasal Drug Products 10 Organisations and their Roles Regulatory Bodies in the UK, European Union, China, Japan and USA 12 International Regulation and Harmonisation 14 Drug Safety, Quality and Efficacy -The Pharmacopoeias 15 United States Pharmacopeia (USP) 15 Device Safety, Quality and Efficacy - International Standards Organisation...

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 chambers...

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 as...

Orally Inhaled & Nasal Drug Products Inhaler Testing Soft Mist Inhalers (SMIs) 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). SMIs (often known as “Inhalation Metered Sprays’’ or “Aqueous Droplet 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 problem....

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 UK, European Union, China, Japan and USA Biotechnological Products Q13 - Continuous Manufacturing of Drug Substances and Drug Products At present, there are no worldwide standards that are specifically applicable to OINDPs. In the European Union, the responsibility for the regulation of medicines lies with the European Medicines...

Inhaler Testing Organisations and their Roles International Regulation and Harmonisation The International Council for 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 minimum...

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 it 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. Organisational...

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 using...

Inhaler Testing Delivered Dose Uniformity Collection Devices for DDU Testing 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. Also suitable for DDU testing of Nasal Sprays & Nasal Aerosols (see page 26) 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...