What does this research mean for the field?

Needle-free injectable devices are comparable to conventional needle-based injections in delivering biopharmaceuticals like insulin and ovalbumin without compromising pharmacological efficacy or tissue integrity. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

This research aims to evaluate the effectiveness of needle-free injectables compared to standard injections for administering biopharmaceuticals.

March 8, 2026Open Access

Evidence of the Utility of Needle-Free Injectable Devices for Subcutaneous Administration of Biopharmaceuticals: Comparable Study of in vivo Pharmacological and Vaccination Ability to Normal Injection

Key Points

This research aims to evaluate the effectiveness of needle-free injectables compared to standard injections for administering biopharmaceuticals.
Compared a novel NFI device (SAIJECT ® ) with standard SC injection.
Evaluated pharmacological effects of insulin by measuring blood glucose levels.
Assessed antibody production levels after vaccination with Ovalbumin (OVA).
Visualized drug delivery mechanism using Evans blue dye to study tissue distribution.
No significant differences in pharmacological activities of insulin and OVA between NFI and standard injections.
Evans blue dye showed broad distribution in dermis and subcutaneous tissue without skin damage or leakage.
The NFI device demonstrated negligible drug adsorption, indicating good compatibility.

Abstract

Background: Needle-free injectable (NFI) technology has attracted increasing attention as a promising alternative to conventional needle-based injections. NFI devices offer several advantages, including reduced pain, minimized medical waste, and the elimination of needlestick injury risks. However, quantitative evidence comparing their pharmacological performance with that of standard subcutaneous (SC) injections remains limited, particularly for different biopharmaceuticals. Methods: We compared a novel NFI device (SAIJECT ® ) with conventional needle-based SC injection for the administration of model biopharmaceuticals. The pharmacological activities of insulin were evaluated based on blood glucose levels, including time-dependent hypoglycemic response. The antigen-specific antibody production levels after the injection of Ovalbumin (OVA, a model antigen for vaccination) were also evaluated. Furthermore, the physical mechanism of drug delivery by the NFI device was visualized by studying the penetration of Evans blue dye after injection. Results: There was no significant difference in the pharmacological activities of insulin and OVA delivered via the NFI-device and those via standard SC injection, suggesting that the NFI device was comparable to normal injection. Evans blue dye injected by the NFI device was broadly distributed throughout the dermis and subcutaneous tissue without skin perforation, leakage, or localized accumulation. These results indicate that NFI device can deliver drugs efficiently into the subcutaneous tissue while maintaining tissue integrity. Moreover, this NFI device exhibited negligible drug adsorption, indicating favorable physicochemical compatibility. Conclusion: These findings provide direct evidence supporting the applicability of NFI technology for the SC delivery of biopharmaceuticals and highlight the potential of the NFI devices as a practical and effective alternative to conventional needle-based injection methods. In addition, this comprehensive evaluation of NFI devices provides fundamental insights for the translational application of NFI devices as a practical alternative to needle-based injections. Keywords: needle-free injectable device, insulin, ovalbumin

Bookmark

View Full Paper

Cite This Study

Taharabaru et al. (Sun,) studied this question.

synapsesocial.com/papers/69ada935bc08abd80d5bc7aa https://doi.org/https://doi.org/10.2147/mder.s582443

Bookmark

View Full Paper