Thursday 9th February 2017Dissolution testing: current and future considerationsRoyal Society of Chemistry, London
Dissolution and disintegration are the only release tests for solid oral dosage forms that provide any insight into the rate of release of the drug into the body. Historically, dissolution was viewed primarily as a quality control tool affirming that the rate of release after manufacture and at the end of the product’s shelf-life, were aligned with global regulatory expectations and commitments. Over the last two-decades this view has started to change and now there is clear expectation that dissolution must have clinical relevance and be predictive of any changes that may have an impact on bioavailability of the product. However, the challenge remains: how can a single test be sensitive enough to predict changes that may be of clinical relevance, whilst being robust enough to satisfy the needs of a quality control environment?
During the morning session, this symposium will explore the current state of these techniques from a regulatory, pharmacopoeia, academic and industry perspective. In the afternoon session, the OrBiTo consortium will explore how emerging biorelevant dissolution tools can improve our prediction of oral drug behaviour.
This symposium should be attractive to scientists working in research and development, quality control, regulatory, pharmacopoeias and academia. In addition senior managers will benefit from attending.
Registrations starts at 09.30 and the symposium starts at 10.00This symposium is organised in association with IMI OrBiTo consortium.
IMI OrBiTo is an EU funded 5 year industry/academic collaboration.
Vision: Transform our ability to predict the in vivo performance of oral drug products across all stages of drug development
Mission: Through partnership, collaboration and data sharing, we will develop our fundamental knowledge of the gastrointestinal environment to deliver innovative biopharmaceutics tools which will accurately predict product performance over a range of clinically relevant conditions. The integration of in vitro and in silico approaches will provide a biopharmaceutics toolkit, validated using clinical data, to accelerate drug development.
Novel, in-vivo relevant dissolution tools are a critical component to the toolkit being developed.EVENT EXHIBITORS
JPAG gratefully acknowledges the Gold support of Sotax,
the Silver support of PHAST, RSSL and Agilent Technologies
and the Bronze support of Sirius Analytical, for this symposium
SOTAX is a global leader in providing high-quality dissolution testing systems, automated sample preparation workstations for content uniformity, assay and blend uniformity testing, as well as physical tablet testing instruments for the pharmaceutical, dietary supplement, medical device and biopharmaceutical industries.
Since its foundation in 1973, SOTAX has grown considerably from a small engineering company to its current position as a global leader in tablet testing technologies. SOTAX still remains a privately owned independent company. Globally, the SOTAX Group is represented by local SOTAX subsidiaries (USA, Canada, Switzerland, Germany, France, Great Britain, Czech Republic, India and China) and distributors dealing with sales, service and validation of instrumentation. SOTAX also offers technical and analytical services. Continued growth has been cemented by the acquisition in 2008 and 2013 of the Zymark (Fully Automated Dissolution & Sample Preparation Workstations) and Dr. Schleuniger® Pharmatron (Physical Tablet Testing Technologies) brands respectively. The success of SOTAX can be attributed to the strong commitment for continual product improvement. SOTAX design concepts allow for customization of the pharmaceutical testing systems for specific needs. For example the new Xtend™ Dissolution Line for tablet testing: For customers, the ability to flexibly respond to permanent change in today’s fast-paced pharmaceutical environment can make the difference between success and failure. Fast time-to-market requirements, outsourcing, relocations, shift of manufacturing capacities and short return on investment considerations ask for equally flexible testing solutions in R&D and quality control laboratories. The new and fully modular and scalable Xtend™ concept is 100% based on this basic premise and allows lab scientists to tailor tablet dissolution testing to both their current and future needs – making their investment future-proof. This new concept consists of new individual and standardized Xtend™ modules, which can be flexibly combined for different customer requirements.
For more information, visit www.sotax.com.
PHAST is one of the world’s leading service providers in the field of the pharmaceutical product quality for the international research-based pharmaceutical industry. In addition PHAST provides pharmaceutical and scientific services, modern drug development and the management of the supply chain of investigational medicine products (Clinical Trial Supply). PHAST has analytical labs in Homburg and Konstanz with more than 6000 sqm of laboratory area, and sales offices in Sulz (CH) and Robion (F).
In the specially designed centers of excellence in Konstanz PHAST develops and validates biorelevant dissolution techniques and investigates the performance of aerosol dosage forms. Furthermore the development of particle characterization methods and specifications as well as the structural elucidation belong to the center of excellence. State of the art technology, e.g. scanning electron microscopes (SEM/REM) and nuclear magnetic resonance spectroscopes (NMR), is established.
The existing expertise and skills enables PHAST to achieve the highest quality and flexibility. All laboratories have been successfully GMP certified, nationally and internationally (FDA), for confirmation of the highest quality standards implemented.
RSSL is a global leader at the forefront of scientific analysis, research, consultancy and training. We provide services to the life sciences and food industry. Our multi-disciplinary teams provide rapid results, expert interpretation and sound advice to support clients. We are regularly inspected by the MHRA, FDA and UKAS which ensures that our analytical support is of the highest standard.
We provide a comprehensive range of services from early phase characterisation to finished product testing, including method development & validation, stability studies, contamination identification and training. Our elemental impurities capability utilizes the latest technology to ensure compliance to ICH Q3D and other regulatory guidance.
Agilent Technologies Inc. is a technology leader in life sciences and diagnostics. The company has about 12500 employees globally and had revenues of $4.2 billion in fiscal year 2016. Agilent offers a strong portfolio of pharmaceutical dissolution testing products. Agilent has built on the original VanKel/Varian dissolution business since acquiring the business in 2011. Agilent offers a complete dissolution portfolio of USP Apparatus 1,2,3,5,6 & 7. The portfolio also includes automated sampling as well as on line UV Vis solutions based on the Cary and Agilent spectrophotometers. Agilent also provides qualification tools to ensure your apparatus are in proper alignment. We also offer a number of software solutions to improve your workflow and ease your simplify your analytical analysis, data review and reporting.
Agilent sells and supports all their products through direct sales forces or selected representatives. We can not only provide you with high quality equipment, but assist with preventative maintenance as well as all your qualification needs (IQ, OQ, MQ and PQ).
For more information visit: www.agilent.com
The 708-DS Dissolution Apparatus is designed for reproducibility and ease of qualification; the 850-DS Dissolution Sampling Station offers the latest capabilities for centralizing laboratory workflow of sample transfer, filtration and collection.
Established in 1989, Sirius Analytical specialises in the provision of instruments, data and consultancy services with facilities in the US and UK. Sirius Analytical designs, manufactures and supplies unique analytical instrumentation for the pharmaceutical industry. Our instruments provide accurate and reliable values for pKa, log P, log D, solubility and dissolution, particle size and shape analysis. These critical physicochemical parameters are important in drug formulation, and also influence the ability of New Chemical Entities to cross biological membranes such as the gastro-intestinal tract, blood-brain barrier, skin and cell walls. Sirius also offers an analytical service for high quality PhysChem outsourcing, used by hundreds of clients worldwide.
Dr Karin Boon - MHRA
Dr Karl Box - Sirius Analytical
Dr James Butler - GlaxoSmithKline
Dr David Elder - JPAG/Consultant
Dr Edmund Kostewicz - Frankfurt University
Dr James Mann - AstraZeneca
Steve Young - MHRA