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Merck Serono commissioned PDD to find ways of simplifying the administration and management of its Growth Hormone therapy product Saizen®. De très nombreux exemples de phrases traduites contenant "auto-injector device" – Dictionnaire français-anglais et moteur de recherche de traductions françaises. 2020 Sep;7(3):537-552. doi: 10.1007/s40744-020-00216-5. The resulting forces are centralised to weaker locations, such as the syringe flange or shoulders, increasing the chance of a breakage. This allows the module to be easily removed from a used auto-injector and attached to a new one, for demonstration purposes, without affecting performance. One benefit of an MAF filing is that any device-related questions from the US FDA can be directed to the device partner, who will be able to provide answers to the device questions based on their prior experience of dealing with the FDA. In addition to higher concentrations, new drug formulations are also trending towards higher volumes (greater than 3 mL). Needle Activation Force. Auto-injection devices can be classified according to the type of delivery system used (prefilled syringe-based systems vs. cartridge-based systems) (Frew, 2011). Using a device to appropriately deliver the product demands a complex and balanced combination of power to apply the necessary force, while managing the forces applied to fragile components, such as the syringe. Designers work with an array of drug formulation properties, such as flow, viscosity and volume, and functionality requirements, including end user needs and scalability, to drive the design input requirements. As the sector continues to evolve, further advances will be forthcoming. The disposable pen injector device is designed to deliver drugs by injection through needles from multi-dose cartridges. Novel autoinjectors are emerging to address these needs, delivering substantial benefits for both patients and drug developers. ADAPTING TO CHANGING REQUIREMENTS: ADDRESSING THE NEED FOR FLEXIBLE PLATFORMS. : a device for injecting oneself with a single, preloaded dose of a drug that typically consists of a spring-loaded syringe activated when the device is pushed firmly against the body First Known Use of auto-injector 1905, in the meaning defined above More Definitions for auto-injector Our first introduction was in 1986 with Auto-injector and since then we have worked with some of the top pharmaceutical and biotech companies producing bespoke devices for use with their key drugs. Auto-injectors based on prefilled syringes are designed for the single-use administration of fixed doses only. 1 … Single-Dose disposable Autoinjector autoinjector is an automated disposable injection device for 2.25ml long pre-filled glass or polymer syringes suitable for all patient groups. One of the main advantages is that it provides a near constant force over the duration of the injection. VAT# : GB 153 0432 49, © 2020 Frederick Furness Publishing. With improved capabilities of platforms and better understanding of regulatory processes, we are going to see more and more therapies delivered via autoinjectors, which is a positive step for patients living with chronic diseases. Naloxone Auto-Injector must be administered according to the printed instructions on the device label or the electronic voice instructions (Naloxone Auto-Injector contains a speaker that provides voice instructions to guide the user When working with a platform, development has undergone the iterative process of prototyping, analysis and design modification to produce a reliable product. ONdrugDelivery, Issue 113 (Oct 2020), pp 86–88. auto-injector, self-assistive device A case of rheumatoid arthritis who became able to use ready-made prefilled auto-injectors because of the development of self-assistive devices Yoshihito Shima1), Tamaki Akimoto2)3)3)4) You can set your browser to block or alert you about these cookies, but then some parts of the site will not work. The autoinjector market has been growing, providing an easier alternative for patients to self-administer treatments that would otherwise be given by a healthcare professional. The complexity of a combination product filing and the level of detail regulatory agencies need is important to consider up front. The process parameters will be defined from the learnings during the development as products transition from prototype to small scale. 2020-09-27 08:18:27. This has 2 features that make it more useful for Trimix injections than the other Autoinjectors. Reenal Gandhi discusses the advantages offered by liquefied gas as a power source for autoinjectors compared with conventional spring-based systems, as well as covering the benefits of using a platform model for drug delivery device development. Our multi-use, disposable pen injector complements our portfolio of single-use pressure assisted auto injector devices. During pharmaceutical development, once a device requirement has been integrated, it can then be streamlined by analysing filled syringes and then assembling them into an autoinjector to study performance and identify potential areas for product-specific adjustments. Device vendors are now also addressing the market needs for high-volume injection devices. Autoinjectors rely on a needle shield that sheaths the needle until the device is pressed against the target injection site. EpiPen or Epinephrine Auto-Injector is a combination product containing drug and device components. auto-injector device IPT 23 2007 30/8/07 09:46 Page 57 and many ensure that the full dose is delivered every time. Most autoinjectors are spring-loaded syringes. For example, with technologies such as Bespak’s VapourSoft, the forces are contained within the can until the device is used, which virtually removes any long-term loads on the device components compared with a conventional spring-based autoinjector. It is most often used for the treatment of anaphylaxis. Whereas known auto-injector systems require pre-filled syringes, the capability of transferring fluid into a chamber within the needle device permits greater scope for reusability. Auto-injectors are considered single-entity combination products (drug/device and biologic/device) and should retain their regulatory status before and after they are combined Manufacturers should understand regulations and should be technologically advanced with device design innovation to … This information might be about you, your preferences, or your device and is mostly used to make the site work as you expect it to. Figure 1 shows how an HFA-powered device provides a constant force and stopper velocity. A POLYMER-BASED PREFILLABLE SYRINGE SYSTEM TO MINIMISE RISK OF PROTEIN OXIDATION. Traducteur Traduisez des textes avec la meilleure technologie de This field is for validation purposes and should be left unchanged. The Aerio Auto-Injector uses proprietary gas-powered technology that enables delivery of larger volume and higher viscosity formulations and controls injection flow rates. The Aerio Auto-Injector is available in three different versions: single container, dual container, and dual chamber. Enhancement of an Auto-Injector Device for Self-Administration of Etanercept in Patients With Rheumatoid Arthritis Confers Emotional and Functional Benefits Rheumatol Ther . allsun EM276 Auto Injector Tester 4 Pluse Modes & Vehicle Fuel Injector Flush Cleaner Adapter DIY Kit Car Cleaning Tool 2 Nozzles 4.4 out of 5 stars 31 $38.00 $ 38. Progress at every stage of production must be evaluated via a gated review by the programme team and key stakeholders to decide if the criteria to progress to the next stage have been fulfilled. Figure 2 demonstrates the steady pressure afforded by HFA-powered autoinjectors for a more constant rate of injection. By leveraging a platform development, these “off-the-shelf” options can now offer drug developers multiple configurations that allow for fast changes to a device according to the needs of a specific therapy. This judgement should be made based on several factors, including the level of device experience within the pharma company and the regulatory strategy. By performing design reviews, adjustments can be identified to help define the specification and build the process parameters. Remove cap which removes the needle shield and primes device. This opportunity to work at a low-volume scale means that adjustments can be made to study performance, building confidence in the product capabilities. Because we respect your right to privacy, you can choose not to allow some types of cookies. ±æ³¨å°„の方法に関して説明を受けた後、患者 さんご自身あるいはご家族の方が、「ケブザラ®çš®ä¸‹æ³¨150mg・200mgオート インジェクター」を正しく安全に使用していただく方法を紹介したものです。 This applies lower stresses on the syringe and results in lower variation of force during drug delivery. NOVEL ADVANCEMENTS IN AUTOINJECTOR DESIGN. Rigorous in-process testing should also underpin all operations to provide the highest levels of style guide says no need to define – so just cGMP control, regulatory compliance and quality. These cookies do not store any personally identifiable information. The volume of the chamber into which the fluid is transferred is defined by the space between the distal end of the transfer assembly and the exit aperture. View our. If it stops, the rod can be manually forced in to complete the injection. Figure 1: Change in force applied to a syringe in an autoinjector with a standard spring (red) and a liquified gas-powered system such as Bespak’s VapourSoft (blue). Today, the use of liquefied gas, such as liquefied hydrofluoroalkane (HFA), as a power source for autoinjectors has presented several benefits over traditional spring-driven devices. The autoinjector market has established itself as a promising sector within the pharmaceutical industry. Audible and visual indication signifies end-of-dose; needle shroud prevents injury. Drug developers will want to work with partners that are able to support them during the filing phase and have proven experience of dealing with regulatory aspects. The industry is increasingly realising that the success of products no longer relies solely on the therapeutic success of the drug itself, but on maintaining patient satisfaction and adherence. In an effort to increase patient care and remain competitive in the growing biologics market, more products are moving towards reducing injection frequency, which often leads to increased concentration and higher viscosities. The initial force peak can be much lower compared with a spring. The device is triggered by push... Read More. The Aerio Auto-Injector uses proprietary gas-powered technology that enables delivery of larger volume and higher viscosity formulations and controls injection flow rates. The injectors were initially designed to overcome the hesitation associated with self-administration of the needle-based drug delivery device. E: [email protected], Company #: 8348388 The information does not usually directly identify you, but it can give you a more personalized web experience. (Registered in England) An autoinjector (or auto-injector) is a medical device designed to deliver a single dose of a particular (typically life-saving) drug. For example, a liquefied gas-powered autoinjector has the advantage that different force profiles can be obtained by simply changing the HFA gas, making it easy to adapt the platform to different drug products and different fill volumes without requiring complicated and lengthy device customisations. Click on the different category headings to find out more and change our default settings. An epinephrine autoinjector (or adrenaline autoinjector) is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. Epinephrine Injection (Auto-Injector) is a prescription medicine in a disposable, prefilled automatic injection device (auto-injector) used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. Complementary interfaces The patient-facing iOS app we built ensures an accurate record of doses taken, providing a clear visual state change when an injection is due. In most programmes, a stepwise approach will allow for smart process design and predictable results. An auto-injector is a medical device designed to deliver a premeasured dose of medication. Over the past 20 years, drug delivery via an autoinjector has helped improve the patient experience and increase treatment adherence, with this trend continuing today. Participants scored the importance of specific attributes of an auto-injector device using a Likert scale from 1 to 7, where 1 indicated that the attribute was “not at all important” and 7 indicated thatn Frederick Furness Publishing Ltd Lewes, BN7 2NZ Easy-to-use, convenient, and portable to suit any lifestyle, Leverages Human Factors Engineering for manufacturing excellence, Combines ability to inject higher viscosity drugs and higher drug volumes, Leader in gas-powered auto injectors with over 5 million manufactured, Single syringe, cartridge, dual syringe, and dual chamber to suit various applications, We use cookies to ensure that you have the best experience on our site. ONdrugDelivery, This website uses functional cookies (but not advertising cookies). Our range of advanced auto injector devices support patient self-injection, designed to make the injection experience simple, convenient and more manageable. Many biologic therapies are monoclonal antibodies that require high doses, resulting in high-viscosity liquids which are challenging to inject with a syringe or typical spring-based autoinjector. There are 2 versions of the Owen Mumford Autoject® Injection Aid Device - white or blue. An autoinjector is often used to reduce dosage errors associated with self-administration, to alleviate patient concerns relating to needle phobia and to combat dexterity challenges. The ExtaviPro 30G auto-injector has been launched in Europe – initially in Germany. This rapid growth is driven by many factors. auto injector, for injecting e.g. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. The device is triggered by push-on-skin activation which is convenient, ergonomic and preferred by patients. Taltz has 2 device options, offering you the flexibility to choose the one that best suits your patients 1,6 Devices designed with patients in mind At first use, over 94% of adult patients with moderate to severe plaque psoriasis agreed the Taltz autoinjector was “easy to … Many variants exist; their relative ease of use by patients or other untrained persons make the auto-injector an ideal tool to quickly administer life-saving drugs. The injectable drug delivery market is expected to grow from US$362.4 billion (£280.6 billion) in 2016 to $624.5 billion (£483.6 billion) by 2021.1 This growth is, in turn, helping to drive the global autoinjector market size, which is expected to be worth in the region of $3.2 billion (£2.5 billion) by 2026, growing at a compound annual growth rate of 19.6% between 2019 and 2026.2, “Today, the use of liquefied gas, such as liquefied HFA, as a power source for autoinjectors has presented several benefits over traditional spring-driven devices.”. Prototyping and technical guidance is a crucial element of the development process to ensure all components can be robustly scaled up for high-volume production. Citation: Gandhi R, “The Changing Face of Autoinjector Technology”. This helps ensure a smooth transition from early-stage design to commercial manufacture. This is a major advantage compared with a spring-based autoinjector’s kick start, where the spring can apply a high impact to the syringe. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in, or filling in forms. We also share information about your use of our site with analytics partners. For example, in the US, vendors should be able to supply a medical device master file (MAF) filing which will contain all the detailed device information. This will make it possible to monitor injection data through data analytics and visualisation portals to help improve medication regimes. There are also significant cost benefits to be achieved by healthcare providers in moving the administration of some medicines out of the clinic and into patients’ homes. More than 500 MS patients and healthcare professionals in the US, the UK and mainland Europe were involved in the development process to ensure the device was underpinned by a deep understanding of the users. Push-on-skin release for most simple and ergonomic handling Clear confirmation “clicks” and large viewing window for optimum patient confidence and control If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. As the gas continues to expand, the stopper velocity remains near constant, providing a steady force as the complete dose is injected. Citation: Gandhi R, “The Changing Face of Autoinjector Technology”. Each device contains a single dose of epinephrine. Importance of device attributes. Séverine Duband provides a rundown of the features of Nemera’s injectable device offering, the Safe’n’Sound. Requirements to be met include 21CRF820.30 and ISO 13487 for design control parts and ISO 10933 materials compliance, as well as the ISO 11608 series of standards specifically for autoinjector products, amongst several other more specific standards and industry guidance. The Candlemakers Citation: Gandhi R, “The Changing Face of Autoinjector Technology”. The development of an autoinjector traditionally proceeds through several stages: “With technologies such as Bespak’s VapourSoft, the forces are contained within the can until the device is used, which virtually removes any long-term loads on the device components compared with a conventional spring-based autoinjector.”. In addition, a greater market acceptance and transition to autoinjectors has been fuelled by increased convenience and ease of use. William Dierick and Koji Nakamura explore oxygen and free-radical mediated mechanisms of protein drug degradation within prefilled syringes. Click "Cookie Settings" to update your personal cookie preferences or review our. A disposable auto-injector developed for high viscosity formulations. As products progress to higher volumes, process scalability needs to be proven. Usability Study of the Commercial Auto-injector Device and the New Auto-injector Device (SYDNEY) in Patients With High or Very High CV Risk With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy - Full Text View. These cookies are necessary for the website to function and cannot be switched off in our systems. The company wanted to create an automatic device that made injections easier, improved patients’ quality of life and increased adherence to the treatment regime. All information these cookies collect is aggregated and therefore anonymous. Typically, self-injections with autoinjectors are recommended to take less than 10–15 seconds to complete but with high viscosity products this can pose a challenge. Place device on injection site, press button to inject. United Kingdom, T: +44 (0) 1273 47 28 28 By design, autoinjectors are easy to use and are intended for self-administration by patients, or administration by untrained personnel. The MAF can be used in the submission approach or, alternatively, the device information can be included within the drug product filing itself. For kaléo, the needs of the patient will always come first. insulin to patient, has piston rod and drive spring distally displaced, and holding device distally driven by rod and spring by distal movement of release button GB201407682D0 Bespak by Recipharm supplies pulmonary and nasal delivery devices, valves and actuators, injectable devices and medical check valves into major markets. To achieve full injection, HFA-powered autoinjectors require lower peak forces compared with a typical spring autoinjector because the force does not decay. Regulatory requirements should be incorporated from the initial stages of product development, as doing so will help to ensure that submission processes are as straightforward as possible further down the line. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. By using the platform approach to design, the validation requirements of the final device are then based on a risk assessment of the gap between the basic device and the drug-specific variation. There has been an increase in the number of treatment options for chronic diseases involving biologics. Now, the same innovation and design found in kaléo’s patented technology is available through the Aerio™ Auto-Injector Platform. This type of approach can ensure that specifications are designed appropriately to ensure a drug product and device work together in the best possible way, while reducing the necessary time and resources for development. SHL Group explores the growth of the Molly® family of drug delivery devices as an example of how the auto injector market has changed over the last five years, and looks to the future. As the liquefied HFA converts to gas, the expansion leads to a soft start of injection. For pen injectors, it is necessary to measure the force required to depress the button and initiate the expulsion of the medicine. The first epinephrine autoinjector was brought to market in 1983. They help us to know which pages are the most and least popular and see how visitors move around the site. All rights reserved. Longer lifespans and greater numbers of patients being diagnosed with chronic conditions are calling for greater significance to be placed on the self-administration of medications. Injector for convenience and safety Tested and verified as a high functional Injection system under ISO classification 04.19.12 Relevant parts are tested according to EN 12182 and ISO 11608-1 This gas powered auto-injector is a compact, portable device that is easy-to-use. West Street Figure 2: Pressure in a liquefied gas-powered autoinjector during injection. Working with a device partner that has the experience and capabilities to take the device design platform through to full scale and commercial manufacturing provides experience and development that can be flexible enough to meet unique product needs. When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Automatic delivery of single dose, up to 10 mL, Automatic delivery of two independent doses, up to 10 mL each, Automatic delivery of lyophilized product or two different liquids, Seamless automatic mixing and administration using off-the-shelf bypass cartridge. An autoinjector (or auto-injector) is a medical device designed to deliver a dose of a particular drug. As a high-volume manufacturer, each year it moulds around 2.6 billion components which are assembled into approximately 550 million devices. Injection device i.e. In line with this, more drug developers are looking to improve therapies to reduce dose frequency, achieve better convenience and ensure comfortable delivery for patients. There is a great opportunity for connectivity to be incorporated into devices, with steps towards these capabilities already being made by many device developers. The Aerio Auto-Injector is available in three different versions: single container, dual container, and dual chamber. There is a rod that sticks out the back to display the progress of the injections.

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