ArticleAAPS PharmSciTech2025
Development and Preclinical Testing of a Rapid, High-Volume, Auto-Injector for Subcutaneous Administration with Recombinant Human Hyaluronidase.
Article in AAPS PharmSciTech, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Transitioning Therapeutic Antibodies in Oncology from Intravenous to Hyaluronidase-Facilitated Subcutaneous Administration.Clinical pharmacokinetics · 2026Review
- Translatability of a miniature pig model to predict subcutaneous clinical injection times with a high-volume auto-injector and recombinant human hyaluronidase.Drug delivery and translational research · 2026Article
- A phase I clinical study to evaluate rapid, high-volume, subcutaneous auto-injector tolerability with recombinant human hyaluronidase.Drug delivery and translational research · 2026Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Handheld auto-injectors (AIs) provide a convenient method for subcutaneous (SC) administration of therapeutics in clinical settings or at home via a caregiver or self-administration. However, AIs have been limited to low volumes (< 2 mL), partly due to hyaluronan (HA), a glycosaminoglycan that acts as a barrier to bulk fluid flow in the SC tissue. Recombinant human hyaluronidase PH20 (rHuPH20) is an enzyme that temporarily depolymerizes HA to facilitate the dispersion of SC-administered therapeutics and may enhance the use of AIs capable of delivering high volumes. These studies detail the development and preclinical testing of a novel high-volume AI (HVAI) that successfully delivered 10 mL of a representative macromolecule (immune globulin; Ig) co-administered with rHuPH20 in ≤ 30 s (s) in a miniature pig model. Testing of a surrogate AI informed the development of a novel, clinically-ready prototype HVAI. HVAI injections of Ig co-administered with 2,000 U/mL rHuPH20 improved injection site outcomes (back-leakage, bleb size, swelling, induration) and yielded up to 30% faster injection times compared with injections of Ig alone. In a mock clinical study that replicated clinical settings, the HVAI delivered 10 mL of Ig with 4,000 U/mL rHuPH20 with mean (± standard error of the mean) injection durations of 19.8 s (± 0.5) using a thin-wall 25-gauge (G) needle and 30.0 s (± 1.1) using a standard 25G needle. The data presented here demonstrate the feasibility of the prototype HVAI for rapid, high-volume administration of a concentrated biologic with rHuPH20, and will inform future clinical testing.
Indexed as
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.