Injection Devices
Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Injection
Amphastar Pharmaceuticals, Inc. recently announced the US FDA has granted approval of its Abbreviated New Drug Application (ANDA) for Epinephrine Injection, USP 30 mg/30 mL…
Histogen Announces Investigational Device Exemption Application
Histogen Inc. recently announced it has submitted an Investigational Device Exemption (IDE) application with the US FDA for the initiation of a….
Hovione's Inhaler for High-Dose Delivery Earns Product Design Award
Hovione Technology recently announced its innovative 8Shot Dry Powder Inhaler (DPI) enabling high-dose drug delivery to the lungs has received the Red Dot 2020 Product…
Proveris to Present: The Effect of Ethanol Concentration on pMDI Evaporation Fraction
Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, recently announced that on April 26…
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.
Proveris Scientific Announces 25th Anniversary; Reviews Key Milestones
Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, recently announced its 25th Anniversary and…
Origin Files Patent Application to Protect its Proposed Treatment for Viral & Bacterial Respiratory Infections
Origin, Inc. recently announced it has filed a provisional US patent application to enhance the ability of its plasma-generated nitric oxide (NO) antimicrobial and antiviral…
Haselmeier Receives Medical Device Master File Number for Product Platform
Haselmeier officially announced it has received Master File Number MAF3202 from the US FDA for its D-Flex product platform, a new generation of injection pen…
Bormioloi Pharma Issues Binding Offer to Acquire GCL Pharma
Bormioli Pharma recently announced the issuing of a Binding Offer for the acquisition of 100% of GCL Pharma, an Italian subsidiary of the Guala Closures…
Itamar Medical & Clalit Research Institute Establish Research Collaboration
Itamar Medical Ltd. recently announced it has entered into a research collaboration agreement with Clalit Research Institute (CRI), a subsidiary of Clalit Health Services (CHS),…
CN Bio Innovations Raises $9 Million to Strengthen Commercial Development
CN Bio Innovations recently announced it has raised $9 million investment, led by CITIC Securities Investment Co., Ltd., and supported by existing investor CN Innovations…
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.
Perrigo & Catalent Announce FDA Approval
Perrigo Company plc and its partner Catalent Pharma Solutions recently announced the US FDA has approved Perrigo’s abbreviated new drug application for generic albuterol sulfate…
BD Completes Clinical Trial for Wearable Injector
BD (Becton, Dickinson and Company), a leading global medical technology company, recently announced the completion of a 50-subject human clinical trial with the BD Libertas…
Credence MedSystems Receives Award for Best Innovation in Drug Delivery Devices
Credence MedSystems, an innovator in injectable drug delivery technology for the biopharmaceutical industry, has received the Pharmapack Award for its….
Stevanato Group & Bormioli Pharma Sign Collaboration Agreement
Stevanato Group, through Ompi, its specialist in glass primary packaging for the pharmaceutical industry, and Bormioli Pharma recently announced a collaboration agreement that will enable…
Hovione Technology Announces Key Patent Grants for its Large-Dose DPI
Hovione Technology recently announced the notice of patent grants in key territories of the world for one of its Large-Dose dry powder inhaler (DPI) platforms,…
Theralase Granted US Patent for Multiwavelength Photodynamic Therapy
Theralase Technologies Inc. recently announced it has been granted a US Patent for Multiwavelength PhotoDynamic Therapy (PDT) technology. The US patent, titled Apparatus and Method…
Aptar Pharma’s Nasal Unidose Device Approved by US FDA
Aptar Pharma recently announced that its patented Unidose Liquid System is the device delivering a new nasal spray approved by the US FDA as a rescue treatment for….
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.