Driving Results in Inhaler Testing METERED-DOSE INHALERS • DRY POWDER INHALERS NEBULISERS • SOFT MIST INHALERS • NASAL PRODUCTS

Inhaler Testing About Us Driving Results for Over 75 Years Copley Scientific, founded in 1946 and headquartered in Nottingham, UK, remains a family-owned and managed company. With a rich history spanning nearly eight decades, we have solidified our position as the leading global manufacturer of inhaler test equipment. Additionally, we are well-recognised as a reliable provider of high quality test instrumentation for other pharmaceutical dosage forms, including tablets, capsules, creams, ointments and powders. We continue to work closely with industry groups and leading experts to bring relevant...

The Copley Promise Innovative Novel solutions that maximise understanding and productivity Compliant Certified to the standards defined by global regulators and pharmacopoeias Trusted Quality products with accuracy, robustness and reliability built-in

Inhaler Testing 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 12 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 (ISO) 16 European Pharmaceutical Aerosol...

Morphology Cold Freon® Effect Spray Force Tester SFT 1000 256 Plume Temperature Tester PTT 1000 258 Special Applications Abbreviated Impactor Measurement (AIM) 261 Fast Screen Andersen (FSA) 263 Fast Screening Impactor (FSI) 266 Volume and Resistance Compensator VRC 268 Generic Drug Development 270 Fluticasone Propionate/Salmeterol Aerosols & Powders 271 Albuterol Inhalation Aerosols 274 Device Robustness/Inhaler Misuse 276 Patient Exhalation Simulator PES 276 Stage and Components Mensuration 312 Data Interpretation 313 Impactor Performance Restoration 314 In-House and On-Site Equipment Servicing...

Inhaler Testing Orally Inhaled & Nasal Drug Products (OINDPs) The range of OINDPs available is broad, encompassing inhalers (metered-dose, dry powder and soft mist), nebulisers (jet, ultrasonic and vibrating mesh) and nasal sprays, aerosols and powders (aqueous-based, propellant-based and dry powder). Metered-Dose Soft Mist Nasal Spray Nasal Powder

Orally Inhaled & Nasal Drug Products 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 (VHCs) can...

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. Typically, the active pharmaceutical ingredient(s) is mixed with a coarser excipient, such as lactose, to which it attaches. During aerosolisation the active is stripped from the carrier and inhaled whilst the carrier particles impact on the mouth and throat and are ingested. However, their relatively high cost and reliance on inhalation strength and duration are potential drawbacks. Passive The majority of DPIs are passive devices, that is to say...

Orally Inhaled & Nasal Drug Products Nebulisers 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. The main advantage of nebulisers is that their use requires little or no coordination on the part of the patient. However, they tend to be cumbersome and require either compressed air or an electrical supply. Expense, inefficiency...

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. SMIs do not use a propellant to...

Orally Inhaled & Nasal Drug Products Applications of OINDPs Pulmonary and nasal delivery offers a number of advantages compared to traditional oral and parenteral (subcutaneous injection) routes: Directly targets the site of action Rapid onset of drug action Drugs effective in relatively low doses Fewer side effects Avoids first pass metabolism Non-invasive administration Such drugs include treatments for diverse applications such as diabetes, erectile dysfunction, migraine, osteoporosis and for vaccine delivery. Orally Inhaled Drug Product Applications Orally inhaled drugs are becoming increasingly...

Inhaler Testing 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. At present, there are no worldwide standards that are specifically applicable to OINDPs. In the European Union, 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 Human Use (CHMP). The EMA was set up in 1995 to harmonise the work of existing national regulatory bodies in Europe....