Handheld Devices for Injecting Viscous Drugs Becoming a Defined Market

(Amherst, NH) – The high value, proliferation and properties of biological drugs are creating opportunities and challenges for device developers. In particular, sector participants are attempting to address the issue of high viscosity, and in the process are extending the design envelope for needle-based injectors. These companies are attempting to accommodate a range of viscous drugs that extend from 20 to over 1000 cP.
The five categories of handheld injection devices that can reliably administer high viscosity drugs includes legacy devices, modified designs, non-glass injectors, NFI and novel devices based upon pressurized gas and mechanical assist designs. As a group the current crop of devices is capable of meeting the viscosity challenge in a wide range of use cases.
Injection devices designed to deliver high viscosity drugs employ a number of methods for moving the drug from the primary container, through the cannula or needle, and into the patient. Most of the devices utilize a piston or piston-type method to deliver the drug, although liquified, pressurized gas and mechanically assisted devices have been introduced.
As currently formulated, biological drugs require dosage volumes well in excess of the upper range for subcutaneous delivery. Because the current class of biologicals has been developed for long-term self-administration, they represent the first group of injectables that have been designed with the end user in mind. These drugs are the first beyond insulin and vaccines to limit packaging in vials in favor of prefilled syringes and specialty injection devices. The price points for recombinant protein drugs allow developers to view the higher cost of customized branded delivery devices as an investment in patient compliance and satisfaction.
Highly concentrated systems present major concerns with respect to syringeability and injectability, especially as these products are typically stored refrigerated and temperature causes viscosity to increase significantly. Devices designed for use in injecting drugs with higher viscosities require features that reduce the amount of resistance of the drug to flow through the injection needle. These methods can be formulaic, resulting in a reduction of the shear force produced in Newtonian fluids, or they may be the result of materials selection and refinement. Some of the work in this area revolves are such injection specific parameters as plunger-stopper breakloose force, maximum force, and dynamic glide force.
As the trend toward self-administration continues, the need for careful consideration of primary container design and interaction with biologics, devices, and the patient becomes more critical. Regulatory scrutiny in this space is likely to continue to increase, requiring a more proactive approach on the part of pharmaceutical/biologic companies to address these questions.
Because a significant number of injectable drugs are being formulated or re-formulated for self-administration, it has become essential for drug developers and the injection device design partners to understand user preferences and to define usability features as they pertain to specific treatment groups. The critical nature of this requirement is further underscored by the design trend in specialty prefilled devices to incorporate a unique look-and-feel to devices in order to achieve product differentiation in the direct-to-consumer marketplace.
The biological drug sector and the challenge of administering biologicals are detailed in a new and comprehensive report researched and written by Greystone Research Associates. Handheld Devices for Injecting High Viscosity Drugs analyzes injectable devices capable of administering viscous drugs. The report includes analysis of competitive factors, therapeutic class product positioning, supply chain factors, supplier segment coverage strategies, and the product activities of sector participants.

More information is available at http://www.greystoneassociates.org



Source: Greystone Research Associates

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

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