Category Archives: Subcutaneous Administration

Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration

Enable Injections enFuse 25-mL on-body infusor

Enable Injections enFuse 25-mL on-body infusor

The Drug Development & Delivery annual special issue, Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration, featured the Enable Injections enFuse® Wearable Infusor as a Platform for Larger Volume Drug Delivery. Read an excerpt of the article, below:

SPECIAL FEATURE – Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration

The global self-injection devices market is expanding at a rapid pace due to high prevalence and incidence rate of chronic diseases, technological advancements, new product development and commercialization, and product differentiation strategies adopted by leading pharmaceutical companies worldwide. In terms of revenue, the global market was valued at $3.7 billion in 2017 and is projected to reach $11.3 billion by 2026.1

“The high numbers of new injectable drugs projected to reach the market in the coming years, as well as the trend to move therapies from clinics into home settings to save costs and provide more convenience for patients means increasing demands for injection devices,” says Hans Jensen, Global Business Development Director, Consort Medical, Bespak Drug Delivery Devices.

The global self-injection devices market is also driven by a significant rise in demand for home health care, owing to low cost of treatment and improvements in overall patient experience. The ability of self-administration is a key factor fueling demand for pen injectors. The pen injectors segment held a significant share of 67.6% of the market in 2017 and research indicates that it is likely to be the leading product segment, owing to the applications in diabetes, easy availability, and low cost, according to a report from Transparency Market Research.

Technological advancements in self-injection devices, especially in autoinjectors and wearable injectors, for the administration of high-viscosity and large-volume drugs represents a potential business development opportunity for leading players. Reports suggest that the wearable injectors segment is projected to expand at a CAGR of 20% between 2018 and 2026.1

“Traditional spring-based autoinjectors have previously been sufficient to deliver the drugs being developed, however many biologics by nature need higher doses to have an effect, which leads to higher viscosities and/or higher volumes to be delivered,” says Mr. Jensen. “Furthermore, others are working on viscous long-acting formulations to decrease frequency of injections, thereby increasing patient convenience. Finally, a number of drugs initially developed for IV administration in clinics are being re-formulated to allow home administration, but that also can result in high viscosity and/or higher doses that may not be appropriate for traditional autoinjector devices.”

This exclusive Drug Development & Delivery report highlights the innovation in injection devices – from wearables to connectivity to varied dose administration – that have occurred in the past year.

To read more from the article and Drug Development & Delivery‘s report on innovation in 2019, click here.

The Need for Advanced Delivery Reconstitution Systems

Seven of the ten top-selling prescription medicines in 2018 are classified as biologic therapeutics1. Since the first biologic drug product was commercialized in 1986, the development of biologic therapeutics has grown due to the increasing availability of genetic information, disease processes, and manufacturing processes.

Biologic therapeutics can be made up of sugars, proteins, nucleic acids, or combinations of the three, as well as living cells and tissues. These types of therapeutics are large, complex molecules, which may be difficult to transport and store without jeopardizing the effectiveness of the therapeutic for the end-user. To improve stability, shelf-life, and speed-to-market, many biologics will be lyophilized (freeze-dried). Lyophilized medications require reconstitution at the time of use, adding additional preparation steps for the user.

Why Reconstitution?

Reconstitution is the process of mixing a dried therapeutic with a sterile diluent to reformulate it into liquid form before it is administered. Reconstitution methods require several steps and typically include systems ranging from a vial adaptor to vial-to-vial systems to advanced dual chamber reconstitution systems.

This process typically involves manual extraction of diluent using a syringe and transfer needle from one vial and transfer of this diluent to the vial containing the lyophilized product. Once transferred, the contents are mixed until the mixture is fully reconstituted. In some cases, this process can take up to a half hour and require a significant amount of attention by the user. The reconstitution process is typically performed by a trained healthcare provider, but may be performed by patients and caregivers.

With the general movement of therapy from the clinic to the home, there is a need for a simple and effective way of reconstituting and administering lyophilized products by a user in a home environment.

Prevalence of Lyophilized Therapeutics

Currently, 16 percent of the top 100 pharmaceutical drugs are lyophilized2 and 25 percent of the biologics market is expected to be lyophilized in the coming years3.

More than 30 percent of the FDA-approved parenteral therapies are lyophilized3. The market is growing for biologics and the storage demands are increasing. Roots Analysis values the market for novel drug reconstitution systems to be $1.5 billion USD by 20254, not counting the cost of the drug in the valuation, driven by more complex drug formulations emerging on the market.

Reconstitution Benefits to Pharma

An advanced reconstitution system would provide benefits to pharmaceutical and biopharmaceutical companies seeking to ship and store therapeutics in the existing lyophilized container closure. Other potential benefits may include:

  • Increased shelf-life and decreased time-to-market
  • Increased adherence: Advanced reconstitution systems simplify the number of steps needed for reconstitution of the therapeutic and could encourage patients and users to better adhere to their prescribed regimen.
  • Reduce medication errors: advanced reconstitution systems provide the correct dilution of lyophilized therapeutic with diluent, reducing potential medication errors during dose preparation.

Reconstitution Benefits to Patients

Enable Injections continues to develop the innovative enFuseTM technology platform with the patient in mind. Paired with an advanced reconstitution transfer system, the enFuse will allow the patient to automatically transfer their therapeutic from the existing lyophilized vial container closure into the enFuse device for self-administration. Additional potential benefits of the advanced reconstitution transfer system may include:

  • Ease-of-Use – Classic reconstitution of lyophilized drugs is labor-intensive and time-consuming, requiring the user to perform several steps. An advanced reconstitution system designed within the enFuse vial transfer system’s automatic transfer technology, including a diluent, to streamline drug preparation.
  • Improve User Interface: An advanced reconstitution system without the need for additional transfer devices (syringes, needles, adaptors, vials) may potentially reduce the chance of needlesticks and reduce the risk of use errors by intended users, improving the user experience.

The enFuseTM Reconstitution Transfer System

The Automatic Reconstitution Transfer System is being developed as a fully automated mixing/reconstituting and filling system that is capable of mixing liquid and powder. The user simply inserts the two vials into the receptacles, initiating fully-automated mixing and transfer of the drug.

Design Features:

  • Fully-automatic mixing or reconstitution
  • No user input with manual mixing
  • Uniform mixing process
  • Reconstitution vial(s)
  • Liquid – liquid mixing vial(s)

To learn more about subcutaneous administration via the innovative enFuse on-body infusor, visit EnableInjections.comand contact us.

 

Authors:

Matt Huddleston, Executive Vice President and Chief Technology Officer, Enable Injections

Jennifer King, Marketing Manager, Enable Injections

 

Resources

1. Pharmaceutical Technology, “The Top Selling Prescription Drugs by Revenue,” 21 MAY 2019, https://www.pharmaceutical-technology.com/features/top-selling-prescription-drugs/ accessed 22 JUL 2019.
2. R&D Magazine, “Lyophilization Basics,” 07 MAR 2017, https://www.rdmag.com/article/2017/03/lyophilization-basicsaccessed 22 JUL 2019.
3. Contract Pharma, “Rising Demand for Lyophilized Products,” 25 JAN 2019, https://www.contractpharma.com/issues/2019-01-01/view_features/rising-demand-for-lyophilized-products/53359, accessed 22 JUL 2019.
4. Roots Analysis, “Subcutaneous Biologics, Technologies and Drug Delivery Systems (2nd Edition), 2018 – 2030,” December 2018, page 315.

Advantages of Subcutaneous Drug Delivery

Innovation in medicine has led to the development of novel small molecule and biologic formulations that require parenteral administration via intravenous (IV), subcutaneous (SC), intramuscular (IM), or other administration routes via injection. Concurrently, innovative drug delivery systems (e.g., infusion pumps, autoinjectors, wearable infusors, etc.) have also been developed to facilitate patient access to parenteral therapies. Accordingly, the number of novel small molecule and biologic drug products approved for parenteral administration have risen in recent years (Figure 1), including drug products for subcutaneous administration. There were 95 biologic therapies for subcutaneous administration approved by the FDA in 2017 alone and an approximate 240 biologics for subcutaneous administration are in development or in process for approval by the FDA1.

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