Copley Scientific introduces BEP2
UK group Copley Scientific hopes that its new BEP2 flowability tester will enable pharmaceutical manufacturers to improve the handling of powder-based drug products.
BEP2 has been specifically developed to test pharmaceutical powders that are produced using the methods described in the US and European Pharmacopoeias. The system features interchangeable cylinder, funnel, angle-of-repose and shear cell attachments.
"Now that the USP and Ph.Eur chapters on powder flow are harmonised the industry has four well-defined methods for powder testing," said Mark Copley, sales manager for Copley Scientific. "The BEP2 offers three of these four methods - flow through an orifice, angle of repose and shear cell - in a single, cost effective unit."
In addition to providing the test methods detailed in the harmonised pharmacopoeia, it is also suitable for flowability testing, as described in European Pharmacopoeias.
Malvern's Morphologi G3
A new data analysis tool for the Morphologi G3 high sensitivity particle characterization system from Malvern Instruments is designed to aid the investigation of batch-to-batch variation in a powder feed or product during manufacturing.
From the database of size and shape measurements generated by the Morphologi G3, the data comparison tool rapidly identifies the parameters responsible for batch-to-batch variation. The results, in combination with process or product performance data, are used to identify those parameters that are 'critical to quality' and set appropriate criteria for QC.
The Morphologi G3 is designed to measure size and shape parameters for tens of thousands of particles in a sample in just a few minutes, generating significant quantities of information. The new comparison tool allows selected sets of data to be compared on the basis of any recorded variable.
The results are produced in a parameter variability bar chart that shows which properties vary most across the selected records, clustering those that are similar in terms of any chosen parameter.
If batches are known to perform well then they can be manually clustered, as an input, prior to analysis. The software will identify the linking parameter that is similar for all successful batches, and the value of this variable that defines success.
Oriel Therapeutics receives 4th US patent
Respiratory care specialist Oriel Therapeutics has received a US patent for its dry powder dose filling system and methods. The invention addresses the field of dry powder inhalers (DPI), and more specifically the technologies in the used in the containment and delivery of dry powder drugs.
Materials, geometries, and methods which facilitate the efficient and consistent delivery are described in the patent documentation. Among these are protocols designed to ensure that a sufficient level of drug containment system rigidity is achieved. The method also allows for the use of integral vibratory elements for active dispersion of powders.
Oriel's president and chief operating officer, Paul J. Atkins, said "Oriel has continued to deliver innovative technical solutions to problems associated with the commercialization of dry powder inhalers." He added that the "patent is part of an expanding portfolio that provides a strong intellectual property position for our range of delivery devices and their corresponding drug products."