Injection Devices
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
Enesi Pharma & BARDA Drive Enter Public-Private Partnership to Develop Solid Dose Vaccine Delivery Technology
Enesi Pharma recently announced it has entered a public-private partnership with the US Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation,…
Hovione Technology Announces Acquisition of Global Rights to New Pulmonary Inhaler Device
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Industry Trends: Vigilance is Critical for Future Success
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
Moldworx Offers Unique Manufacturing Solutions to Medical Device Manufacturers
Designing solutions for medical device OEMs is the expertise of Moldworx LLC, a Gilbert, Arizona-based custom designer and builder of molds, automation solutions, and custom…
SMART DEVICES - Add-On Connectivity Facilitates New Generation of Smart Inhalers
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
Amphastar Pharmaceuticals Receives ANDA Approval for Multi Dose Vial Drug
Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV).
Aptar Pharma’s Nasal Device Approved by FDA for Breakthrough Treatment
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
Proper Fill & Finish in Clinical Development Requires a Comprehensive Approach
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
Nemera’s Preservative-Free Multidose Eye Dropper Approved for Santen’s Drug in 29 European Countries
Nemera recently announce its multidose eye dropper Novelia has been approved for the preservative-free formulation Cosopt iMulti (20 mg/ml dorzolamide + 5 mg/ml timolol eye drops, solution).
Active Biotech's Partner NeoTX Enters Clinical Collaboration With AstraZeneca
Active Biotech recently announced its partner NeoTX entered a clinical collaboration with AstraZeneca Group Plc global biologics research and development arm, MedImmune, to support Phase…
AIT Receives Milestone Payment From Commercialization Partner
AIT Therapeutics, Inc. recently announced it has received a milestone payment of $3.15 million from its commercialization partner Circassia Pharmaceuticals for the successful completion of…
West Annouces Significant Agreements With Swissfillon & scPharmaceuticals
West recently announced it has commenced discussions with two companies regarding the use of West’s proprietary SmartDose drug delivery platform for complex molecules.
Gerresheimer Expands to Include Irradiation of Plastic Dropper Bottles
Gerresheimer used this year's Pharmapack held in Paris, Porte de Versailles, as a platform to unveil its latest ophthalmology and rhinology services. The company has…
BioTime Enters Into Exclusive Agreement With Orbit Biomedical
BioTime, Inc. recently announced it has entered into a research and option agreement with Orbit Biomedical Limited. Orbit Biomedical, based in London, UK, and Ambler, PA,…
EXECUTIVE INTERVIEW - Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
DEVICE REGULATIONS - The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
Cartridge Filling: Combination of Features That Can Help Gain a Competitive Edge
By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.
EXECUTIVE INTERVIEW - BD Integrated Systems: From Innovation to Integration
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
Enable Injections Enters Strategic Partnerships With UCB & Apellis
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
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.