44 New Results Point the Way to Faster Inhaled Product Testing
Current interest in the use of Abbreviated Impactor Measurement (AIM) was clear at the recent EPAG (European Pharmaceutical Aerosol Group) sponsored workshop at Drug Delivery to the Lungs 21, where presenters from a number of leading pharmaceutical companies shared experimental data comparing AIM results. New instrumentation, such as the Fast Screening Impactor (FSI) and Fast Screening Andersen (FSA), from Copley Scientific, were shown to deliver data comparable to conventional cascade impaction in less time.
Aerodynamic particle size distribution is a routine measurement for all inhaled products using full resolution cascade impaction. AIM reduces measurement times by focusing on the fine particle fraction - typically the sub-5 micron portion of the dose that is considered to deposit deep in the lung - and has the potential to accelerate information gathering, especially for rapid screening in R&D and routine QC.
Pharmaceutical industry presenters shared data comparing AIM results with those obtained using full resolution impaction. There was broad consensus that good agreement is achievable with both the FSI and FSA, two of the commercially available systems discussed, for nebulisers and metered dose inhalers. Data on dry powder inhalers (DPI) suggest further research is needed in this area. Every company reported significant savings in analytical time with AIM, some also reporting reduced solvent consumption.
The workshop concluded with a wide ranging discussion of the results and the way forward, covering: the need to better understand the kinetics of DPI testing; the likely attitude of the regulators and the criticality of this in AIM uptake; and the requirement for further studies to support the validity of the technique, including information on the performance of the Twin Impinger (an AIM-type instrument already approved for use by the European Pharmacopoeia).
Circle no. 169
LABORATORY PRODUCTS
New Additions To Range
Of Novel Building Blocks Endeavour Speciality Chemicals (Endeavour) announced the launch of new additions to its range of novel building blocks and reactive intermediates, including new compounds targeted at Oncology research, a focused selection for researchers studying Nanomaterials and an expansion of its offering of novel Thioamides.
Thioamides in particular are of great interest to researchers working in the pharmaceutical industry, as they are a well-established route to forming Thiazoles - a group of compounds with applications for research into many debilitating diseases. These include auto-immune disorders, cardiovascular disease and cancer. One of the major factors behind this interest is the recent discovery that it is likely to be the presence of the Thiazole ring itself which inhibits tumour growth in certain types of cancer and this revelation will further heighten the significance of this particular branch of chemistry.
With the introduction of the new products, Endeavour will have added over 100 original compounds to its catalogue of over 950 products since the 2010 Informex USA event in San Francisco. Designed for the synthesis of complex molecules, the majority of Endeavours’ products are based on its core technologies of sulphur and heterocyclic chemistry and are often unavailable from other manufacturers. The new, non-exclusive products will be available from stock in small packs (1g - 100g) for early stage R&D or larger quantities (100g - 100kg) for projects moving through the development stage.
Endeavour’s products have applications across industry sectors, including pharmaceuticals, agrochemicals and materials sciences. Together with parent company, Robinson Brothers, Endeavour can support projects from initial development through to full-scale commercial production.
Circle no. 170
Enabling Equipment Qualification and
Gmp Compliance Across The Range GE Healthcare launches Installation Qualification (IQ) and Operational Qualification (OQ) protocols for ImageQuant™ LAS 4000 mini, 4000 and 4010 biomolecular imagers. Required for controlled environments, the protocols enable ImageQuant systems to comply with regulatory and Good Manufacturing Processing standards (GMP). The protocols have been developed in accordance with recent guidelines, including GAMP5 and ASTME2500, and highlight data integrity and product quality. The IQ protocol is carried out during installation of the ImageQuant system and demonstrates that the device has been set up correctly and adheres to regulatory guidelines. The subsequent OQ protocol is performed to ensure that the instrument functions as intended.
Both qualification protocols must be performed by a certified GE Healthcare Service Specialist. The resulting validation documents are uniform, simplifying document handling for all stakeholders. As required by current regulatory guidelines, the protocols have been reviewed by Subject Matter Experts to ensure compliance. The ImageQuant IQ/OQ document package includes: protocols describing the objective and acceptance criteria of the different tests included in the IQ/OQ; record sheets for each test module with descriptions of the qualification criteria; and reports summarising the IQ/OQ results.
Circle no. 171
Space Saving Evaporator
The TurboVap II from Biotage AB is ideal for evaporation of large sample volumes of 50ml to 200ml. The instrument has 6 sample positions and uses special glass tubes with either a 1mL or 0.5mL end point.
The glassware and optical sensors automatically stop gas flow when evaporation has reached its end-point and allows for concentration of samples without the risk of drying, preventing the loss of volatile compounds.
The TurboVap II takes up only a fraction of the bench space used by conventional rotary evaporators and can be used outside a fume cupboard by using the integral vent tube. The main application areas for the TurboVap II are food, water and environmental.
Circle no. 173
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Circle no. 172 INTERNATIONAL LABMATE - MARCH 2011 - LABORATORY PRODUCTS
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