Injection Devices
Aerami Therapeutics Announces Orphan Drug Designation for Imatinib for the Treatment of Pulmonary Arterial Hypertension
Aerami Therapeutics, Inc. recently announced the US FDA has granted the company orphan drug designation for imatinib for treatment of patients with pulmonary arterial hypertension…
SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
DELIVERY DEVICE - Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways
Degenhard Marx, PhD, Fotos Stylianou, PhD, and Stavros Kassinos, PhD, explain how PureHale provides a modern device option for the delivery of a fine mist for a variety of solutions to only the upper respiratory tract without significant deposition in the lungs and lower airways.
NASAL SPRAY BIOEQUIVALENCE - Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
ADVANCED STOPPER SOLUTION - PremiumCoat®: Proven Compatibility With Current Vial Standards
Sebastien Cordier, Bruno Morchain, and Estelle Verger review how PremiumCoat combines state-of-the art elastomer formulation with market-proven film-coating technology to create a highly advanced stopper solution.
Aptar Pharma Granted Exclusive License Option by Pharmaxis to Develop & Promote High Payload Dry Powder Inhaler
Aptar Pharma recently announced it has entered into an agreement with Pharmaxis under which Aptar Pharma has the option to acquire the worldwide rights to….
Sensirion Expands its Flow Sensor Portfolio for Ventilators
Sensirion, the sensor expert for medical ventilation and the world’s leading manufacturer of flow sensors, is expanding its product portfolio for the MD&M West 2021…
Evonik Acquires JeNaCell to Expand Biomaterials Portfolio for New Medical Device Markets
Evonik has acquired German biotech company JeNaCell. The acquisition expands Evonik’s biomaterials portfolio to provide biotechnologically derived cellulose. The nature-identical material developed by….
Pharmaceutics International, Inc. to Platform West Pharmaceutical Services, Inc.’s Daikyo Crystal Zenith Container-Closure Components for Aseptic Fill-Finish
Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO) will include Daikyo Crystal Zenith (CZ) container-closure components, offered by West Pharmaceutical Services, Inc…..
Pace Life Sciences Acquires Drug Delivery Experts, Expanding Capacity & Injectable Drug Product Services
Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), recently announced it has acquired Drug Delivery Experts, LLC (DDE)…..
Nemera & BIOMM Sign Partnership Agreement to Commercialize Reusable Insulin Pen in Brazil
A pioneer in biotechnological medicines in Brazil, BIOMM is launching Nemera’s Advapen under the trade name Lifepen® for the administration of….
Adocia Initiates BC LisPram Phase 1 Clinical Trial in Pump for People with Type 1 Diabetes
Adocia recently announced the launch of a Phase 1 clinical study in collaboration with Dr. Ahmad Haidar, McGill University, Canada, to assess pharmacokinetic, glycemic control…
2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
Idorsia Ltd Announces the Initiation of Phase 3 Registration Study of Antithrombotic Treatment for Use at the Onset of AMI Symptoms
Idorsia Ltd recently announced the initiation of the Phase 3 registration study “SOS-AMI” to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12…
Schreiner MediPharm & Plas-Tech Engineering Collaborate to Offer Full-Service First-Opening Indication for Prefilled Syringes
Schreiner MediPharm and Plas-Tech Engineering have entered into a collaborative partnership for Cap-Lock – an innovative first-opening indication for prefilled syringes. Schreiner MediPharm initially launched…
Nemera Breaks Ground in Brazil Through Milfra Acquisition
Nemera recently announced it has entered into an agreement to acquire Milfra. Milfra, based in Jaguariuna, state of São Paulo, Brazil, specializes in the development…
Noble Further Expands Capabilities of Its New Human Factors + Program
In direct response to the rapid growth of the recently launched Human Factors + (HF+) program, Noble, an Aptar Pharma company, recently announced the….
Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc. recently announced the US FDA has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of…
WEARABLE PLATFORM - Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
PRECLINICAL TESTING - Expanding Opportunities in Implantable Medical Devices With Optimized Preclinical Studies
Jaleel Shujath outlines the growing importance of implantable devices in clinical settings and our daily lives, highlighting the current state of preclinical testing and the regulatory barriers faced by device developers.
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.