IPEC e-newsletter - Excipients Insight October 2017 - 16-10-17


Inside this issue


Highlights of APV/IPEC Europe Excipient Conference 2017

The APV/IPEC Europe Excipient Conference 2017 was held on 19-20 September in Berlin, Germany, providing the usual high-quality insights into regulatory developments in the excipient field and their application.

The well-attended event got underway with three parallel workshops on issues that are of particular importance at present in the excipients arena.

Christa Farber of Staatl. Gewerbeaufsichstsamt Hannover and Eberhard Kwiatkowski of PharmAdvantageIT covered the topic of data integrity, examining how this concept can be applied to the excipient manufacture and supply chain. Astrid Stockrahm of DFE Pharma tackled quality agreements, showing how IPEC’s forthcoming QA guide and template can ease the relationship between excipient supplier and pharmaceutical manufacturer. Rounding out the trio was a workshop on stability testing of excipients by Tanja Natterer of Aug. Hedinger GmbH & Co, which showed how the IPEC Excipient Stability Guide can help in the design of an effective testing programme.

Thomas Storm of Novartis kicked off the conference proceedings on the second day, with a presentation on the challenges of multi-compendial compliance for excipients, reviewing the status of pharmacopoeial harmonisation as well as requirement beyond pharmacopoeial compliance. He said that compliance requires continuing efforts in development and routine quality assurance and unfortunately also redundant testing as the large majority of excipient monographs are not harmonised and there are incompatible standards or specifications between regions. The harmonisation effort is a successful process but slow, and industry “would like to see more of it, and faster,” he said, noting that functionality-related characteristics are becoming more of a focus.

The topic of extractables and leachables from excipient storage containers, and their potential as a source of impurities, was tackled by Steven Watt of A&M StabTest GmbH, who noted that while this has been considered in finished drug products there does not appear to be any direct guideline on this as it applies to excipients. He described leachable/extraction studies and workflows used in finished products and described how these concepts could be applied to excipients in storage containers

Jean-Claude Soule of Eli Lilly covered quality audits and how they can be used to ensure excipient supply chain security, reviewing supply chain vulnerabilities, regulatory expectations and guidelines for quality management system audits laid down in ISO 19011:2002. He described the various warning signals that can be looked for during an audit advised on ways to handle a refused audit, concluding that a combination of auditing, testing and pedigree is the best way to reduce risk. He noted that the quality agreement between an excipient supplier and user must describe all the companies involved from raw materials to finished excipient.

Speaking on behalf of the IPEC Federation, Frank Milek of Aug. Hedinger GmbH & Co examined the challenges posed by the complexity of the excipient supply chain, focusing on a string of events in which adulterated excipients have resulted in fatalities since the 1990s, the regulatory response to those tragedies, and showing how tools such as the recently-revised IPEC GDP guide can be deployed to ensure the safe supply of excipients. He also described how the IPEC Federation can facilitate that vision.  The organization’s position as the umbrella association for IPECs in the Americas, Europe, Japan, China and India put it in an important position to achieve this goal, he said, through measures such as the development and adoption of harmonised guidance and risk-based global regulatory standards, and serving as a reliable and credible source if information relating to excipients.

A regulatory perspective on the implementation of ICH Q3D on elemental impurities – which applies to marketed products including new mutual recognition applications of already approved products from December - was delivered by Bruno Spieldenner of the European Directorate on the Quality of Medicines and Healthcare (EDQM). He discussed the implementation of ICH Q3D in the context of the European Pharmacopoeia (Ph. Eur.) general text, chapters, methods and monographs, and reviewed approaches for specific elemental impurities tests, calling for additional expertise and support – especially from manufacturers – to revise and maintain those tests. He also took some time to review the implementation of the new requirements in the certification procedure, referring to a policy document adopted by EDQM in August.

Nikola Matic of Kline & Co broadened out the discussion with a presentation on the global excipients market, and particular those used in oral solid dosage forms which remains the most important sector for excipient suppliers in terms of size and while fragmented had an estimated value of $4bn in 2016, with a volume consumption of around 641,000 tonnes. The market is expected to grow at a healthy 5.6% rate to 2021, driven by an expanding overall pharma and particularly the generic drug market, the increasing complexity and low bioavailability of new active pharmaceutical ingredients (APIs) that need functional excipients, and the development of improved excipient grades for new applications.

Johann Philipp Hebestreit of BASF began the technical part of the conference programme with a presentation on preventing alcohol-induced dose dumping (ADD), the problem of unintended and excessive release of a pharmacologically-active ingredient as a result of alcohol consumption, which is known to be an issue with some sustained-release formulations. With the use of case studies, he showed how formulations can be at risk of ADD, and described how it can be avoided through the use of excipients such as BASF’s polymer-based Kollidon SR.

Laura de Miguel of Omya International took on another technical topic, looking at filler-binder excipients for direct compression and particularly co-processed excipients – new or novel combinations of established excipients – that in this setting can improve characteristics such as compactability, flowability and friability. With regulatory pathways to approval of novel excipients challenging, co-processed excipients help improve finished product characteristics, delivering a marketing advantage and potentially extending a product’s life cycle.

Excipients are also an important enabler of transdermal drug delivery systems (TDDS), and Sebastian Braun of Tesa Labtec GmbH broke down the various components of a TDDS, and showed how excipients fit into the structure of these products. He also looked at the documentation requirements involved if a drug master file (DMF) is available or not, and discussed the impact of the EU guideline on formalised excipient risk assessment in the context of TDDS development.

The technical programme also included a presentation by Kofi Asare-Addo from the University of Huddersfield School of Applied Sciences on advanced imaging in pharmaceutical materials, covering technologies such as infinite focus microscopy and how they can be applied to the design of robust formulations for drug delivery. Finally, Mats Hertel of Christian-Albrechts-Universitat Pharmazeutisches Institut looked at the use of excipients as drug carriers for pulmonary drug delivery, including the importance of matching the carrier to the device and optimal blending practices.

The next APV/IPEC Europe Excipient Conference is scheduled to take place on 18-19 September 2018.




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