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RDD Europe 2009 Interactive Workshops
RDD Europe will feature half day Interactive Workshop Sessions during which the following companies will each sponsor 45 minute presentations (including demonstrations and questions) on new technologies and services related to nasal and pulmonary drug delivery. Focused presentations will be followed by a brief question and answer session. Meeting participants may select and attend up to FOUR of these sessions (on the Registration Form) which will be presented on Wednesday, May 20, 2009 from 2:00 to 6:00 PM at the conference hotel.
Please direct any questions or special requests about this event to Claire Jahan
3M Drug Delivery Systems (FULLY BOOKED)
An Introduction to Differentiating Characteristics Achieved Through the Use of Active Compared to Passive DPI Drug Delivery Technology
This workshop will highlight the differentiating characteristics of active dry powder inhaler (DPI) devices versus traditional passive DPI devices. It will include discussion on the various device design elements of devices as well as the importance of the patient’s perspective. The various design elements will be discussed by comparing and contrasting different design approaches as well as through visual methods (e.g. high speed video/research video). In addition, a new DPI device design will be discussed that incorporates several design characteristics we believe have been optimized.
Catalent
Formulation and Leachables Considerations in Component Selection for Inhalation Drug Products
Although the range of inhalation delivery devices and components has increased, the rate of new product approvals has not. One explanation is the need to thoroughly explore hardware and formulation compatibility and performance during product development. Additionally, global regulatory expectations have been raised since the publication and dissemination of the Product Quality Research Institute’s Safety Thresholds and Best Practices for Extractables and Leachables in Orally Inhaled and Nasal Drug Products. This workshop outlines an optimized approach for formulation-device combination screening and selection, and discusses the impact of leachables and materials characterization methods selection on the testing timeline.
Chemic Laboratories
Challenges of Providing Extractable/Leachable Testing Services in a Contract Chemistry Organization (CCO)
This presentation will focus on the unique contributions of various scientific disciplines to the provision of extractable/leachable testing services to clients ranging from start-ups to large pharma companies. The importance of vendor, client, and laboratory relationships will be discussed with emphasis on program timelines. We will outline “Best Practice” analytical study designs for final finished product containers and single use componentry. We will exemplify (1) The criticality of understanding the study sponsor’s program and timelines. (2) The importance of sharing of vendor, study sponsor and laboratory information and expertise, and (3) Regulatory guidelines associated with each study program type.
Cirrus Pharmaceuticals (FULLY BOOKED)
From Pediatrics to Compromised Populations: Special Challenges in MDI Development
It is often desirable to understand the in-vitro performance of a respiratory drug product under conditions of use for specific patient populations, such as children or those with a specific disease state (e.g. COPD or asthma). For example, to support a pediatric application of a metered dose inhaler, performance with valved holding chambers and face masks may be evaluated. This workshop will address aspects of in-vitro testing under simulated conditions of use, such as the application of model patient interfaces, breathing simulation, and low-flow cascade impaction.
DMV-Fonterra Excipients (FULLY BOOKED)
A Comprehensive Analysis of Particle Characterization for Dry Powder Inhaler Formulations
No predictive model has convincingly related the aerosol performance of dry powder inhalation formulations to the physical and bulk properties of drug and excipient powders or their blends. However, individual studies, including some with lactose, have resulted in interesting and helpful correlations between properties and performance. During our workshop the state-of-the-art will be reviewed and some general principles of assessment of pharmaceutical powders for inhalation proposed.
Harro Höfliger Verpackungsmaschinen
Dosing Powders for Inhalation With On-line Determination of ”Fill Weight”
Due to their small particle size and cohesivity most powders for inhalation are difficult to handle. In particular filling capsules or blister cavities at very low fill weights (1 to 10 mg) risks sporadic underfilling, which may not be detected by statistical in-process control methods. Therefore it is prudent to integrate a 100% check of the filled mass of powder into the filling line. We will present different approaches to 100% on-line control of the "fill weight", which can be applied to targets including capsules, cartridges or blisters. Gravimetric methods (tare - gross - checkweighing) and use of special mass-specific sensors will be presented.
INEOS Fluor Ltd
Medical HFAs – Keeping the Quality Through Appropriate Propellant Handling
Modern HFA medical propellants are very different to CFCs. Regulatory authorities take the view that as these complex chemicals make up most of the inhaled formulation they should be subject to stringent control. The high levels of purity that are now routinely achieved both demand sophisticated analytical methods, and great care in handling as any post manufacture contamination is now very obvious. During the workshop we will discuss good propellant handling practice from the manufacturer, into the MDI, to the patient. We will review the analytical methods used, and provide guidance to which should, and should not be attempted by end users.
InnovaSystems
How Automated Testing Can Enhance Your Design Space Justification
Quality by Design created a need to understand the limits in which OINDPs perform adequately. Hand actuation monitors combined with MDI and NSP automated actuation stations are a powerful tool to explore the design space of products, and subsequently justify tolerances applied during release testing or when proposing post-approval changes. Our workshop explores how your company can obtain data to justify selection of parameters to operate force and velocity controlled actuation stations, elucidate the impact of agitation and angle of product use on spray weight, and show how MDI actuation parameters influence moisture analysis and plume length.
Malvern Instruments & Next Breath
Understanding the Device Requirements for Reproducible Nasal Drug Delivery
Reproducible nasal drug delivery requires the selection of a nasal spray device which is able to fully atomize a defined volume of the chosen formulation. With the widespread use of rheology modifiers to improve product stability and increase retention times within the nasal passages, it can be complex for developers to define the optimum nasal pump configuration. Using the technique of laser diffraction, this workshop will explore how changing the actuator and pump design may produce the desired spray characteristics. Droplet formation and its potential for delivery to the nasal cavity will be illustrated using time-resolved laser diffraction data.
Micron Technologies (FULLY BOOKED)
Optimizing the Micronization Process and the Particle Size Analytical Method for Inhaled Powders
Due to the tightly specified particle size distribution associated with powders for inhalation, not only the micronization process, or the choice of the right technology but also the analytical technique has to be carefully selected and developed. This can be challenging for powders exhibiting particular behaviours during micronization or analytical testing, or for high potency drugs processed under full containment. This workshop will examine solutions to these challenges
Oxford Lasers
Analysis and Measurement of Drug Delivery Devices Using Alternative Imaging Techniques
Application of the Oxford Lasers EnVision® system in the analysis and evaluation of drug delivery devices will be presented. This workshop will describe various modes of illumination used in high speed imaging application, the basic principles of flow field vector analysis, plume geometry and spray pattern characterization. We will demonstrate how the flexible configuration of the EnVision R&D system can be used to collect images and provide high-quality reproducible data for various analytical techniques. A range of devices will be used to show how advanced imaging techniques can provide detailed information to evaluate and compare devices.
rap.ID Particle Systems
Ultra-High Throughput Chemical Identification of 2-10µm Foreign Particles (FPs) to Efficiently Define their Control Space
You will learn how easy it can be to implement Quality by Design (QbD) principles using a dedicated, ultra-fast, highly automated particle identification technology. We will prepare and measure one DPI sample during a live demonstration of the new Single Particle Explorer CSS Inhaler, and witness how fast you can obtain the number, size, shape, and chemical composition of thousands of 2-10 µm FPs. Attendees will learn how to develop an FP control specification based on both the number of FPs and their potential risk based on identification of their chemical composition (root cause) that can be instantly obtained from the instrument. |
