European CRO Offer FDA Approved Service
News Aug 27, 2012
Melbourn Scientific is the first European contract research organizations (CRO) to offer cGMP spray pattern and plume geometry measurement - a regulatory requirement for nasal sprays, oral sprays and metered dose inhalers destined for the US - following investment in the Proveris SprayVIEW® and Vereo® actuator.
Mark Hammond, CEO at Melbourn Scientific says: “Instrumental spray pattern and plume geometry analysis is already a regulatory requirement for products aimed at the US market and it provides another level of information above particle and droplet size characterization.
“We were the first CRO based in Europe to invest in the Malvern Spraytec for laser diffraction and the product and device development companies we support have found this service highly beneficial. It was following interest from these clients that we decided to extend our portfolio to include spray pattern and plume geometry measurement, using Proveris’s SprayVIEW.”
“When combined with droplet size, the shape of the plume is highly influential in the bioavailability of the product, particularly in a nasal spray, which has such a specific target area and enables better understanding of device performance.”
The 2002 FDA guidance on “Nasal Spray and Inhalation Solution, Suspension and Spray Drug Products - Chemistry, Manufacturing and Controls” lists several tests for characterizing nasal spray and inhalation drug products, including instrumental characterization of the plumes for spray pattern and for plume geometry.
Melbourn Scientific has significant experience in analytical and formulation support for the development of Orally Inhaled and Nasal Drug Products (OINDPs).
It selected the Proveris SprayVIEW® instrumentation as it helped establish the standards now recommended by the FDA.
Hammond says: “We are delighted to be working with Proveris to help accelerate the success of nasal and aerosol drug development and give our clients confidence that these test platforms are collecting valuable data with the accuracy, security, and traceability required for regulatory approval.
Zach Pitluk, Chief Commercial Officer at Proveris Scientific Corporation commented: “It is with pleasure that I announce that Melbourn Scientific is to be the first European CRO to offer a FDA accepted spray pattern and plume geometry analysis service based on Proveris’s SprayVIEW instrumentation.”
The Vereo actuator reliably replicates hand use of nasal and oral spray pumps and metered dose inhalers. It can also be used with Spraytec when using laser diffraction to measure droplet size distribution, or with cascade impactors to perform particle size distribution tests of nasal sprays and metered dose inhalers.
Additionally, Vereo actuators are also at the heart of all SprayVIEW® spray pattern and plume geometry measurement instrumentation.