As the market for inhalers builds rapidly, companies involved in their development are looking to automate their testing and validation. RTS Life Sciences has worked with 3M Health Care on new automated test systems
A niche part of RTS Life Science's business has long been the automated, robotic testing of inhalers used to treat respiratory illnesses such as asthma. 3M Health Care Ltd, a provider customised inhalation and transdermal drug delivery solutions to pharmaceutical companies, approached RTS to develop two radically different proof of concept systems that could form the basis of a different automated system for the testing of pressurised metered dose inhalers (pMDIs).
Now that the first of these robust technologies has been validated by 3M Health Care (3MHC), and the second is in the process of validation, both companies are moving towards their ultimate aim of developing a high throughput, flexible, fully automated system.
Richard Toon, senior scientist at 3MHC based in Loughborough, said: "Our brief has been to find an automated testing system that can run for nearly 24 hours a day, 7 days a week and which also attempts to shake the inhaler in a similar way to how the patient would. In addition, it must comply with the regulations laid down by the Pharmacopeias. We have worked closely with RTS, to define the required specifications and the subsequent designs to meet these specifications. Our overriding aim is robustness, in the method of shaking the devices and recovering the collected doses."
The first proof of concept system employed a robotic arm to shake the inhaler in a similar manner to that of a patient. 3MHC has rigorously tested the results of the RTS proof of concept system against manual testing carried out by a number of analysts. Several tests have been performed, benchmarking the automated methodology against manual testing and 3MHC is satisfied that the RTS methodology can deliver less variability in the results than a human tester.
Other advantages that accrue from an automated system include the removal of the risk of analysts developing work-related upper limb disorder, round the clock testing capabilities and less physical space taken up in the laboratory.
The second proof of concept system concentrates on the other end of the automated process and is a novel proprietary method that attempts to ensure that the collected dose is fully recovered in an automated wash down procedure.
Mark Fish, business manager for drug delivery automation at RTS Life Science said: "When these technologies are put together, we will have a high throughput, automated inhaler testing system that conforms to the methods and apparatus laid down by the pharmacopoeias. At the same time, it will have wide applicability, as it has been designed to cope with the different characteristics of the devices and drugs developed. These drug delivery devices can be very complex physico-chemical systems and our automation design has had to be both flexible and robust to ensure that the full range of products can be catered for.
"As 3MHC has found in its tests on our proof of concept systems, automated testing can give a greater level of reproducibility. However, there are other benefits too. Our second proof of concept system that is currently under evaluation is unique, using low volumes of solvent and volumetric analysis rather than the more traditional gravimetric methods. If this is successful, then it will have a significant cost advantage."
As laboratories increasingly look to eliminate sources of analytical variability in testing procedures, automation systems with effective in process metrology can help both in identifying and controlling environmental and analyst factors that might affect analytical data. However, the development and adoption of automation solutions for pharmaceutical development and quality control has been very limited, especially if one makes a comparison between other areas of life science, such as high throughput screening and drug discovery.
Mark Fish commented: "RTS has recognised that the complexity and costs of fully automating sample preparation processes can create barriers to the adoption of automation in the lab. It's for this reason that the company has plans to introduce scalable, modular solutions and semi-automation that can deliver many of the same benefits of its current range of fully automated instruments.
"For laboratories to maintain the quality and integrity of their analyses, while sustaining levels of throughput and capacity, automation solutions have to be evaluated to deal with increasingly complex drug delivery systems and testing methodologies."
RTS has recently established a business unit that is focused on developing new solutions to help pharmaceutical laboratories deal with the challenges of product development and quality control testing. As a result, the company plans to broaden its portfolio of inhaler automation solutions to not only include modular, scalable solutions but also to respond to other automation challenges in pharmaceutical laboratories, such as tablet testing and solid dose form processing.
The company's recent work with 3M clearly demonstrates RTS's approach in developing novel solutions to meet the challenges of sample preparation.