Home Medizin Neue, automatisierte Shake-and-Fire-Plattformen von Copley reduzieren die Belastung durch MDI- und nasale Arzneimitteltests.

Neue, automatisierte Shake-and-Fire-Plattformen von Copley reduzieren die Belastung durch MDI- und nasale Arzneimitteltests.

von NFI Redaktion

The latest generation of Vertus® Automated Shake and Fire Platforms from Copley Scientific allows for easy and intuitive integration of automation into a variety of pharmaceutical testing workflows, to increase productivity, reduce testing variability, and simplify training. The Vertus® III+ is the company’s new flagship, a fully automated benchtop system for testing pressurized metered-dose inhalers (MDIs), nasal sprays, and nasal aerosols. It has been extensively updated to meet the testing requirements for an even wider range of device types. It features a wider range of interchangeable test plates and an integrated shot weight measurement. The DecaVertus® III is a complementary high-throughput solution for waste firing, with the capacity to discharge 10 devices simultaneously under identical conditions to the Vertus III+. Both have a new exhaust system that facilitates handling of easily flammable fuels. Together, they present a compelling and highly effective solution for product testing.

The current regulatory and clinical landscape has led to an increase in activities related to reformulating MDIs and developing nasal drug products. The Vertus platform can help significantly reduce the effort associated with routine analyses. Automated shake and fire systems eliminate the need for manual device operation and simulate patient device handling through parameters such as shake action, time between doses, and actuation force profile. Lifetime testing for MDIs, which requires firing hundreds of doses until exhausted, and regulatory guidelines recommending the use of mechanical means to actuate the pump assembly for sprays, are notable drivers for its acceptance.

The new Vertus systems comply with both pharmacopeial specifications and 21 CFR Part 11. Vertus and DecaVertus share an arc shake movement that replicates the typical analyst technique, allowing device actuation methods developed on the Vertus to be transferred directly and reproduced accurately on the DecaVertus for waste firing. Both the shake angle and shot force ranges have been increased compared to previous models to provide greater flexibility in test configuration.

Other key features of the new Vertus III+ include:

  • Integrated shot weight measurement for rapid and efficient testing of delivered mass uniformity for nasal solution products in compliance with compendial specifications.
  • An overhauled outlet port for easy connection to air extraction facilitates the handling of highly potent drugs and easily flammable propellants, such as HFA152a, a low-global-warming MDI reformulation candidate.
  • A large, customizable screen and intuitive user interface for easy interaction with minimal training required.
  • A new integrated preparation and waste module for optimized, automated testing, especially for whole content, with minimal manual intervention.
  • An extensive range of interchangeable interface plates for test devices, such as spray force testers, thin-layer chromatography plates (for spray patterns), Alberta Idealized Throat, and Alberta Idealized Nasal Inlet for comprehensive testing of both innovative and generic products.

Learn more about the next generation of the Vertus family and how it could transform your testing practice.

Bildnachweis: Copley Scientific

Über Copley Scientific

Copley Scientific is widely recognized as a global leader in the manufacturing and supply of inhalation product testing equipment and is a major provider of testing systems for other pharmaceutical dosage forms. The company also supplies equipment for detergent testing.

Copley’s pharmaceutical product range includes testing equipment for all types of orally inhaled and nasal drug products – metered dose inhalers, dry powder inhalers, nebulizers, and nasal products – with a particular focus on solutions for dose uniformity and measurement of aerodynamic particle size distribution. It also encompasses testers for tablets (dissolution, disintegration, friability, and hardness), capsules, powders, suppositories, semi-solids, and transdermals.

This extensive equipment range is used from research and development to quality control and is supported by complete validation and customer service. Copley collaborates with distributors, providing local support worldwide. This network offers expert assistance and training to every customer, directly enhancing the application of all Copley products. www.copleyscientific.co

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