Inhaler Testing Brochure
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Inhaler Testing Brochure - 1

COPLEY SCIENTIFIC metered-dose inhalers nasal sprays

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Who are Copley Scientific? Copley Scientific was founded in 1946 in Nottingham, UK by Frank Copley to supply laboratory equipment to the local pharmaceutical industry. Today, still 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. This focus on pharmaceutical test instrumentation began in 1957. Subsequent decades saw marked expansion and today we manufacture a range of innovative equipment for tablet dissolution, disintegration,...

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Our Philosophy Copley Scientific is a strong, stable company with a track record of success, but equally important we are agile and forward-looking, with a philosphy closely aligned to the needs of the market we serve. Continuous improvement is a core element of this approach and we strive to exceed the expectations of the industry, not only by enhancing equipment performance but also through unrivalled service. Accurate, precise, reproducible data drives pharmaceutical development and ensures product safety, but high productivity in testing is increasingly important. These commitments are...

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Equipment Selection Guide Equipment Selection Guide Inhaled Drug Products Inhaled Drug Products 7 Metered-Dose Inhalers (MDIs) 8 Valved Holding Chambers (VHC) 8 Dry Powder Inhalers (DPIs) 9 Aqueous Droplet Inhalers 9 Nasal Delivery Systems 11 Metered Spray Pump Powder based Nasal Devices 11 Propellant based Nasal Aerosols (MDIs) 11 Novel Nasal Devices 11 Organisations and their Roles European Medicines Agency Food and Drug Administration Global Harmonisation Task Force (GHTF) 15 Drug Safety, Quality and European Pharmacopoeia United States Pharmacopeia Device Safety, Quality and...

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Critical Flow Control 78 Critical (Sonic) Flow 79 Critical Flow Controller Critical Flow Controller Breath Actuation Controller Data Analysis Software Copley Inhaler Testing Data Analysis Software (CITDAS) 86 Waters Empower Spreadsheet 88 Flow Meter Model DFM3 Flow Meter Model DFM 2000 Low Capacity Pump Model High Capacity Pump Model Super Capacity Pump Model Device Resistance Measurement 96 Dissolution Testing (Generic Drug Development) 100 Spray Force Tester Plume Temperature Tester Labour Saving Tools - Delivered Dose Uniformity 106 Labour Saving Tools - Sample Sample Prep Unit SPU 2000...

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Equipment selection guide INHALER TESTING SYSTEMS - SUMMARY Metered-Dose Inhaler (MDI) Nasal Spray (Aqueous) Description of Drug Delivery Device Delivered Dose Uniformity Sampling Apparatus (Page 24) Waste Shot Collector (Page 31) Breath Actuation Controller (Page 84) - USP only Flow Meter (Page 90) Adapter for above (Page 91) Mouthpiece Adapter (Page 92) Pump (Page 93) DUSA Shaker (Page 106) Sampling Apparatus (Page 28) Waste Shot Collector (Page 31) Critical Flow Controller (Page 78) Flow Meter (Page 90) Adapter for above (Page 71) Mouthpiece Adapter (Page 92) Pump (Page 93) DUSA Shaker...

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Inhaled drug products Inhaled Drug Products Introduction The devices used for inhaled and nasal drug delivery are collectively referred to as orally inhaled and nasal drug products (OINDPs). The range of products available is broad, encompassing inhalers (metereddose, dry powder and aqueous droplet), nebulisers (jet, ultrasonic and vibrating mesh) and nasal (aqueous based, dry powder and propellant based). Pressurised metered-dose inhalers (pMDIs or simply 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...

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Inhaled drug products MDI incorporating Dose Counter Drug Delivery Devices APPLICATIONS (LOCAL/SYSTEMIC) DRUG DELIVERY DEVICES Inhaled drug products are becoming increasingly popular as a means of delivering local or systemic therapy via the lungs or nasal mucosa. Collectively described as orally inhaled and nasal drug products (OINDPs), these can be divided into the following categories: Inhalation therapy has been in use for a number of years: 1. Metered-Dose Inhalers (MDIs) locally (directly) to treat lung diseases such as asthma and chronic obstructive pulmonary disease (COPD), and to...

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Inhaled drug products Dry Powder Inhaler - Passive Type (device metered) Drug Delivery Devices Dry Powder Inhaler Passive Type (pre-metered) 2. Dry Powder Inhalers (DPIs) Historically, the DPI was limited to single dose capsule systems and the inhaler market was dominated by the chlorofluorocarbon (CFC) propelled MDI. When, in 1997, the Montreal Protocol effectively banned the ozone depleting CFCs, the pharmaceutical industry was faced with the option of: a) finding an alternative propellant (as in the HFA propelled MDI), or b) developing new ways of delivering drug to the lungs It is the...

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Inhaled drug products Drug Delivery Devices 4. Nebulisers A nebuliser may be defined as a device that can convert a liquid into aerosol droplets to produce a respirable cloud suitable for inhalation. Normally it must be loaded with the drug before each treatment. Once activated it operates on a continuous basis. It should not be confused with the Aqueous Droplet Inhaler described in the preceding section which delivers a pre-metered dose or bolus of medication. This difference is important since the regulatory bodies have traditionally classified nebulisers as medical equipment. This is...

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Inhaled drug products Drug Delivery Devices 5. Nasal Delivery Systems Traditionally, nasal preparations have been used for the local administration of anti-histamines, decongestants and steroids in order to alleviate cold or allergy symptoms and nasal congestion. Metered Nasal Spray Pump More recently attention has focused on two other areas: a) Metered Spray Pumps (Aqueous based) a) The potential rapid drug absorption into the systemic circulation provided by the turbinates and lymphoid tissues located at the back of the nasal cavity. This is already in use in a number of areas, e.g....

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