Analytical Technologies Singapore

inhaler

New literature from Copley provides guidance for better inhaler testing.

New literature from Copley Scientific, the world’s leading manufacturer and supplier of inhaled product testing equipment, highlights the importance of controlling temperature, relative humidity (RH) and electrostatics in the test environment to maximise the integrity and value of inhaler test data. In an application note and white paper, company experts provide insight into the issues and practical guidance for improvement including experimental data demonstrating the performance of EnviroMate™, a benchtop environmental control chamber for inhaler testing. An interesting and informative read for anyone looking to minimise variability in inhaler testing, the new literature is freely available for download.

“Variability in the test environment is a frequently overlooked contributor to poor quality data and out-of-specification results,” said Clair Brooks, Applications Specialist, Copley. “This white paper explains the links between test environment, orally inhaled product (OIP) performance and measured metrics, while the app note provides experimental evidence showing how EnviroMate can help. Both make good reading for those with a problem with temperature, RH or electrostatics control within the lab.”

Establishing a robust environment for inhaler testing’, the recently released white paper, addresses questions such as:

  • Why is OIP testing prone to variability?
  • What is the economic impact?
  • How do changes in temperature, RH and electrostatic charge affect the performance of different classes of OIP – nebuliser, metered dose inhaler and dry powder inhaler?
  • How can environmental conditions influence cascade impactor measurements?
  • What strategies and solutions are available to improve environmental control?

Reducing variability in the inhaler testing environment’ is a complementary application note detailing an experimental study of the performance of an EnviroMate. The resulting data show how the unit delivers constant temperature and RH in the face of variability in an air-conditioned lab typical of those used for inhaler testing.

“During training, customers routinely ask how to tackle sources of variability and improve data integrity, so we’re delighted to add these valuable pieces to our literature library,” concludes Brooks.

Read the white paper here, the app note here, or find out more about the EnviroMate here

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New, automated shake and fire platforms from Copley cut the burden of MDI and nasal drug product testing

 The latest generation of Vertus® automated shake and fire platforms from Copley Scientific make it easy and intuitive to integrate automation into a wide range of drug product testing workflows to boost productivity, drive down test variability, and simplify training. The Vertus® III+ is the company’s new flagship, fully automated benchtop system for pressurised metered dose inhaler (MDI), nasal spray and nasal aerosol testing. Comprehensively updated to meet testing requirements for an even wider range of device types, it incorporates a greater array of interchangeable test plates and, integrated shot weight measurement. The DecaVertus® III is a complementary, high throughput solution for firing-to-waste, with the capacity to simultaneously discharge 10 devices under identical conditions to those applied by the Vertus III+. Both feature a new exhaust system that eases the handling of highly flammable propellants. Together they present a compelling, highly effective solution for product testing.

The current regulatory and clinical landscape has resulted in a surge of activity in MDI reformulation and nasal drug product development; the Vertus platform can help significantly reduce the associated burden of routine analysis. Automated shake and fire systems eliminate any requirement for manual device actuation, simulating device handling by the patient via parameters such as shaking action, time between doses, and actuation force profile. Through life testing for MDIs, which requires the firing of hundreds of doses to waste, and regulatory guidance that recommends a ‘mechanical means of actuating the pump assembly be employed’ for spraysi are notable drivers for adoption.

The new Vertus systems are compliant with both pharmacopoeial specifications and 21 CFR Part 11.  Vertus and DecaVertus share an arc-like shaking motion consistent with typical analyst technique, enabling device actuation methods developed on the Vertus to be transferred directly to, and rigorously replicated on, the DecaVertus for firing-to-waste. Both shaking angle and firing force ranges have been increased relative to previous models for greater flexibility with respect to test configuration.

Other key features of the new Vertus III+ include:

  • Integrated shot weight measurement for rapid and efficient Uniformity of Delivered Mass testing for nasal solution products, in line with compendial specifications.
  • A re-engineered exhaust port for simple connection to airflow extraction, making it easier to handle highly potent drugs and more flammable propellants such as HFA152a, a low global warming candidate for MDI reformulation.
  • A large, adjustable screen and intuitive user interface allowing easy interaction with minimal training.
  • A new integrated priming and waste module for streamlined, automated testing, notably across the entire contents, with minimal manual input.
  • An extensive range of interchangeable interface plates for test apparatus such as a Spray Force Tester, Thin Layer Chromatography plates (for spray pattern), Alberta Idealised Throat and Alberta Idealised Nasal Inlet, for the comprehensive testing of both innovator and generic products.

Find out more about the next generation of the Vertus family and how they could transform your testing practice.

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Copley introduces the new Flow Rate Sensor, a dedicated device for inhaler testing systems.

The new Flow Rate Sensor FRS is the latest addition to Copley Scientific’s orally inhaled and nasal drug product (OINDP) testing portfolio which sets the benchmark for innovative, efficient, and reliable inhaler testing solutions. The FRS is a robust, low resistance, bi-directional flow sensor that delivers rapid data output via a direct interface with a suitable flow controller, streamlining operation and maintaining a reduced test set-up footprint. A product of Copley’s engineering excellence, and designed specifically for inhaler testing, it offers exemplary flow rate measurement for compendial-compliant testing and allows users to accurately track complex inhalation profiles.    

Compendial methods for OINDPs specify the setting of representative flow rates for both delivered dose uniformity testing (DDU) and aerodynamic particle size distribution (APSD) by cascade impaction. Accurate control is especially important for APSD measurement since cascade impactor performance is calibrated as a function of air flow rate. Beyond compendial methods, assessing the impact of inhalation profile characteristics such as rise-time is increasingly common practice as developers work to enhance product performance for specific patient populations.  

The FRS is an easy-to-use device that integrates seamlessly into standard test set-ups to provide consistent and accurate flow measurement for all types of OINDPs including dry powder inhalers, metered dose inhalers, aqueous droplet inhalers, nebulisers, nasal sprays, and nasal powders. Key features include: 

  • Simple, robust design specified for integration, control, and display via the Breath Actuation Controller BAC 100i or Critical Flow Controller TPK 100i
  • Bi-directional flow functionality for flexible installation
  • Rapid data output for in-depth analysis
  • Low flow resistance for high flow testing with minimal impact 

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Copley launches EnviroMate™, an efficient, benchtop environmental chamber for inhaler testing

EnviroMate™ is a benchtop environmental control chamber from Copley, the world’s leading manufacturer and supplier of inhaler testing equipment, designed specifically to improve the repeatability and integrity of inhaler test data. The performance of orally inhaled and nasal drug products (OINDPs) can be directly influenced by ambient temperature, humidity and electrostatics found in the laboratory, as highlighted by the US and European Pharmacopoeias. EnviroMate is an accurate, efficient, low maintenance solution that addresses these issues with considerable value for scientists faced with:

  • Variable lab conditions or inadequate climate control
  • OINDPs with high sensitivity to temperature, humidity and/or electrostatics, such as powders and aqueous formulations where hygroscopicity and evaporation can be an issue
  • Poor inter- or intra-lab reproducibility and unexplained out-of-specification (OOS) results
  • Achieving better environmental control, in a cost-effective manner, without investing in a dedicated room for testing.

Delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement by cascade impaction are critical tasks for the inhalation community. Variability in the test environment can affect the dose emission and aerosol generation performance of OINDPs, and APSD measurement methods, compromising the integrity of these tests. By tackling this source of variability EnviroMate reduces the risk of erroneous data and costly testing delays.

EnviroMate is a compact, movable, benchtop unit with a spacious, clear-view chamber, large hinged front door, and slot-sealed rubber entry ports. It comfortably accommodates the Inhaler Testing Workstation™, all types of cascade impactor (including preseparator and mixing inlet as required) with dedicated side wall ports and quick-connectors for interfacing with externally located ancillaries. EnviroMate accurately controls and maintains uniform temperature (± 2°C) and humidity (± 5% RH) by circulating air through the entire chamber, whilst an integrated anti-static system helps to minimise electrostatic effects. The unit contains a self-regenerating desiccant dehumidifier and is refrigerant-free, easing maintenance and environmental impact.

“Controlling environmental conditions precisely during the testing of OINDPs is crucial, but is typically complex and expensive,” says Mark Copley, CEO, Copley Scientific. “The EnviroMate is a pragmatic, well-engineered, highly effective option tailored specifically to inhaler testing requirements. It’s a great addition to our range and we’re sure it will have a positive impact on the quality of test data, for those struggling to achieve stable conditions during DDU and APSD testing.”

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Copley launches a new semi-automation tool for inhaled product testing

Copley Scientific, the global leader in inhaled product testing equipment, has launched the new Gentle Rocker 100i, a simple, cost-effective device that boosts the productivity and repeatability of aerodynamic particle size distribution (APSD) measurements with the Next Generation Impactor (NGI). APSD is a critical quality attribute for all orally inhaled and nasal drug products (OINDPs) and routinely measured with the NGI. The new Gentle Rocker 100i offers:

  • Method flexibility, enabling agitation at speeds across the range 10 to 60 rpm
  • Touchscreen operation with clearly displayed test parameters, time elapsed monitoring and audible alarm options
  • Convenient tilting functionality to facilitate effective solution sampling post drug recovery
  • Efficient reporting including data transfer to printer or PC
  • An optional evaporation cover (with seals) for volatile solvent handling.

The recovery of drug from each collection cup is a critical but time-consuming element of APSD measurement with the NGI. It involves dispensing a defined aliquot of solvent into each cup, followed by agitation to ensure complete drug dissolution. The Gentle Rocker 100i holds a full tray of collection cups and applies a consistent, defined agitation pattern to ensure well-controlled and complete drug dissolution. It enables the application of specific, reproducible methods and easy method transfer, delivering reliable results and a lighter analytical workload.

The Gentle Rocker 100i is just one of a range of semi-automation tools that Copley provides for inhaled product testing. Together these products support a stepwise approach to the automation of test methods that remain predominantly manual in many labs. This approach minimizes risk while maximizing return on investment and maintaining the flexibility to test multiple products.

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Introducing Inhalytix®: a new solution for analysing and managing inhaler test data from Copley

Inhalytix® is a completely new software solution from Copley, the global leader in inhaler testing equipment, that brings a standardised approach to cascade impactor data analysis, efficiently converting raw data into performance-defining metrics for all inhaled products. Cascade impactors determine aerodynamic particle size distribution (APSD), a critical quality attribute for inhaled drug delivery. Inhalytix® is flexible, user configurable and suitable for all cascade impactors in routine use, for both standard and bespoke test set-ups and methods. It handles the entry, analysis and reporting of APSD data to company and regulatory standards, in accordance with draft USP Chapter <1603>, Ph.Eur. Chapter 2.9.18 and relevant US FDA guidance. The software also serves as a database for laboratory cascade impactor inventory enhancing data traceability and integrity.

Cascade impaction involves quantitative recovery and chemical analysis (typically by HPLC) of the size fractionated aerosol from an inhaled product to generate a drug specific APSD. The technique generates substantial quantities of data. Inhalytix® is the successor to Copley’s highly regarded CITDAS™ software, built from the ground-up, drawing on the company’s established expertise in this area. It uses the same core calculation protocols but offers significantly enhanced functionality allowing customers to configure:

  • Reports – choosing which metrics to include to ensure the consistent and informative delivery of results, to meet regulatory requirements.
  • Equipment – selecting from a library of test equipment to handle standard and complex equipment configurations.
  • Methods – to combine detailed product information with reporting and equipment configurations, and to define metrics such as stage groupings and fine particle dose.

Interactive routine analysis, with a defined method, proceeds via a simple three-step process: Prepare, Execute and Analyse. Data can be entered manually or imported and comparison tools simplify assessment of the results, especially when comparing test and reference products in the case of generics. Using the equipment database users can link mensuration data, which quantifies changes in the critical dimensions of an in-use impactor, to specific, serialised impactors. This capability enhances data traceability and makes it possible to use actual rather than nominal dimensions to calculate APSDs, with greater accuracy.

Inhalytix® incorporates new metrics such as Impactor Sized Mass (ISM), Large Particle Mass (LPM), Small Particle Mass (SPM) and LPM/SPM ratio, amongst others and handles a broad array of impactors and components, including abbreviated impactors such as the Fast Screening Andersen (FSA). The software is 21 CFR Part 11 compliant with user access management and audit trails, and is also fully validated with a unique, built-in, auto-validation capability. Available in various expandable, multi-user licence configurations, Inhalytix® can be either server, cloud or individual computer-based, enabling access in and away from the lab.

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