Injection Devices
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery & Formulation Product Approvals of 2019
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
DEVELOPMENT TIMELINES – Drug Development Times, What it Takes – Part 2
Josef Bossart, PhD, reviews the Development and Review Times associated with new molecular entity (NME) approvals throughout the 2010 to 2018 period.
CONTAINER CLOSURE INTEGRITY – Mitigating Risk in Pharmaceutical Manufacturing With Visually Inspected Components
Olga Laskina, PhD, discusses visible particles and manufacturing defects of the packaging components as well as the impact these defects can have on container closure integrity and functional characteristics.
AUTOINJECTOR PLATFORM – Identifying New, Enhanced Device Delivery Solutions for Chronic Diseases
Karima Yadi, MSc, and Lionel Maritan, MSc, believe identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.
DEVELOPMENT TIMELINES – Drug Development Times, What it Takes – Part 1
Josef Bossart, PhD, explains how accurately estimating a product’s clinical development timelines is more than simply adding up the individual timelines, almost always optimistic. You need to “know” the numbers, not just calculate them.
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
PREFILLED SYRINGES – Selecting the Right Primary Container for Injectables in Acute Care
Alfred Harvey, MBA, MS, discusses how differences in primary container options for injectable drugs can add value by offering hospitals and care centers configurations that address universal pain points.
COMBINATION PRODUCT DEVELOPMENT – New Horizons in Development to Meet Emerging Demands
Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.
ON-BODY DELIVERY SYSTEMS – Analysis & Simulation of Injection Volume Accuracy
Christian Riva, MS, presents a case study proving it is possible to have a realistic prediction of the injection volume accuracy of a drug delivery system, even in an early stage of product development, when only a high-level product architecture is available.
PACKAGING SOLUTIONS – Dura Coat Combiseals – An Optimal Solution for Cartridge Applications
Carina Van Eester, MSCE, believes with state-of-the-art medicines, it is essential that drug manufacturers can rely on appropriate sealing solutions that provide the best possible protection for their products.
EXCLUSIVE ONLINE CONTENT
Sequel’s twiist Automated Insulin Delivery System Receives FDA 510(k) Clearance
Device bundles latest technology to deliver significant advancements for insulin management for people with type 1 diabetes….
Simtra BioPharma Solutions Announces $250+ Million Investment to Expand Sterile Fill/Finish Manufacturing Site
Simtra BioPharma Solutions recently announced a $250+ million expansion of its sterile fill/finish manufacturing campus in Bloomington, IN….
Novo Holdings to Acquire Catalent
Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, recently announced they….
Cristalia Products With Nemera’s Reusable Pen Injector Commercialized in Brazil
Cristalia’s human growth hormone will be administered with CRISPEN. Approved by ANVISA1, CRISPEN is part of Nemera’s state-of-the-art pen injector platform PENDURA AD……..
Kindeva Drug Delivery Acquires Summit Biosciences, a Specialized Nasal Drug Development & Manufacturing Organization
Kindeva Drug Delivery recently announced it has acquired Summit Biosciences Inc., an intranasal drug delivery contract development and manufacturing organization, from its founding….
WEBINARS
ON-DEMAND WEBINAR – Solve Common Design Challenges in Inhalation Devices With Porous Polymers
The effectiveness of inhalation devices relies on their ability to deliver the pharmaceutical directly to the targeted part of the body with precision and calculated dosing. Since these devices….
WEBINAR – Understanding Patch Composition for Effective Transdermal Delivery
As the advantages of transdermal drug delivery grow, the global market for transdermal patches also is growing. Join DuPont™ Liveo™ Healthcare Solutions and Gattefossé Pharmaceuticals for a complimentary one-hour webinar to explore the current….
On Demand Webinar – Emergent CDMO: High-Speed Manufacturing Solutions for Your Viral Vaccine or Therapeutic
Emergent and groniger partner to present the benefits and features of the INTEGRA® high-speed aseptic fill line with isolator technology for viral vaccines and therapeutics.
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
WHITE PAPERS
TECH BRIEF – Expedite FDA Approvals With Certified Pure Materials
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly…
WHITEPAPER – How to Mitigate Risk for Biologics During Fill/Finish Manufacturing
Aseptic processing with the highest degree of sterility assurance, filling accuracy, and quality is critical for high-value, small-batch therapies. This white paper explores the specialized…
WHITEPAPER – Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
WHITE PAPER: Tackling a Changing Climate; Metered Dose Inhalers | Recipharm
Are you prepared for the HFA phasedown? With many industries switching to more environmentally friendly propellants, pMDI developers need to be ready. Recipharm explore alternative…
WHITE PAPER: Molly Modular Autoinjector Platform by SHL Medical
White Paper: A Systematic Review of Molly’s Integrated and Flexible Device Design and Development Model SHL Medical has redefined the conventional platform model by…
What are Injection Devices?
Drug delivery devices are the physical agents that are included in the drug delivery system. There are a multitude of devices that people interact with every day which fall under this category. In modern pharmaceuticals, novel drug delivery devices and combination products are being designed for a number of reasons, including giving patients the ability to self-administer some medications at home, which can help them adhere to recommended regimens.
Evolution of Injection Devices
With modern technology and medicine, the combination product market is evolving. Any combination device, especially drug device combination devices, must follow strict guidelines. Thanks to advancements in engineering, an increasing number of drug delivery devices are being developed as electromechanical devices linked to apps in order to provide patients with more supervision when administering medications at home. Some of these medical apps may receive feedback from the device to track how much drug is being administered and how often, provide patients with dosing reminders and connect clinicians with this information so they can monitor patient compliance. The drug delivery devices that so many patients depend on must adhere to regulatory standards. There are strict guidelines for all methods of drug delivery, such as needle-based, aerosol, and needle-free injectors.
Smart devices, interconnectivity, and related technology provide real-time data to healthcare providers for analysis, but these device additions should not increase risks, including patient understanding of treatment delivery, or jeopardize compliance. Data collection needs to be “passive” to the patient. In other words, invisible to the patient’s use of the device so that the collected data provides a true benefit to the end user. If these design considerations can be implemented without impacting the patient or how they administer and receive treatment, then smart devices can provide advantages to the patient and the industry.
Injection Device Global Market Trends
The global injectable drug delivery devices market is expected to show significant growth in the coming years as manufacturers introduce technological advancements and product innovation meant to improve convenience, compliance, and ease of administration of parenterals. Additionally, the increasing preference for at-home self-injection is driving the market as patients prefer to continue to avoid healthcare settings post-COVID. With all of this taken into account, one market study predicts the global market to reach almost $26 billion by 2025, up from $15 billion in 2020. However, another report values the global market at $42.76 billion in 2021 and expects it to reach $50.9 billion in 2025.
How the numbers will play out is yet to be determined, but the studies do highlight the focus on single-use and reusable systems. Disposable-use prefilled syringes (PFS) are increasingly used due to the prevalence of chronic diseases and the growing number of biologics best delivered by syringes. Single-use autoinjectors are also poised to experience increased demand, particularly with the growing pervasiveness of anaphylaxis disorders. Autoinjectors also provide a convenient alternative to manual syringe injections for subcutaneous administration.
Reusable Injection Devices
Pen injectors with prefilled cartridges have also proven to be a viable alternative to syringes. These injectors can perform hundreds of injections, with patients controlling the speed of delivery to minimize pain or discomfort during use.
Making injection devices partially reusable is a cost-saving strategy. Ideally, the device’s mechanism and/or electronics are the reusable parts of the system – as these are often the costliest – and the drug containers and needle are one-time use.
Another cost-saving strategy that several large pharmaceutical companies are deploying is to develop a device platform for multiple drug products in their portfolio. This allows them to spend resources on a single significant development program, for one optimal injection device, which then requires minimal customization for each sub-sequent product line.
Despite efforts to make better, safer, simpler injection devices, patient adherence is still a challenge associated with self-administration. This has resulted in the emergence of smart devices, such as wearable injectors, which share patient data with healthcare providers to ensure compliance. And while it is expected this sector will continue to grow, some industry insiders warn against making these devices too intrusive.