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An Injectable and Drug-loaded Supramolecular Hydrogel for Local Catheter Injection into the Pig Heart
Published on: June 7, 2015
Development and Preclinical Testing of a Rapid, High-Volume, Auto-Injector for Subcutaneous Administration with
Robert J Connor1, Tara Nekoroski1, David W Kang2
1Halozyme Therapeutics, Inc., 12390 El Camino Real, San Diego, California, 92130, USA.
AAPS Pharmscitech
|May 16, 2025
Summary
High-volume auto-injectors (AIs) were developed to deliver 10 mL of immunoglobulin with hyaluronidase, improving injection efficiency and outcomes. This technology enables faster subcutaneous drug delivery for biologics.
Area of Science:
- Biotechnology
- Drug Delivery Systems
- Pharmacology
Background:
- Subcutaneous injections are limited to low volumes (2 mL) due to hyaluronan (HA) barrier in tissues.
- Recombinant human hyaluronidase PH20 (rHuPH20) enzyme depolymerizes HA, facilitating therapeutic dispersion.
- Existing auto-injectors (AIs) are not designed for high-volume subcutaneous delivery.
Purpose of the Study:
- To develop and preclinically test a novel high-volume auto-injector (HVAI) for subcutaneous (SC) drug delivery.
- To evaluate the efficacy of co-administering immunoglobulin (Ig) with rHuPH20 using the HVAI.
- To assess the impact of HVAI on injection site outcomes and delivery time.
Main Methods:
- Development of a prototype HVAI based on surrogate AI testing.
- Preclinical testing in a miniature pig model delivering 10 mL of Ig with rHuPH20.
- Evaluation of injection site parameters (back-leakage, bleb size, swelling, induration) and injection duration.
- Mock clinical study simulating real-world administration conditions.
Main Results:
- The HVAI successfully delivered 10 mL of Ig with rHuPH20 in ≤30 seconds.
- Co-administration with rHuPH20 improved injection site outcomes compared to Ig alone.
- Injection times were up to 30% faster with the HVAI.
- Mean injection durations of 19.8s (thin-wall 25G needle) and 30.0s (standard 25G needle) were achieved in mock clinical settings.
Conclusions:
- The prototype HVAI is feasible for rapid, high-volume subcutaneous administration of biologics.
- Co-administration with rHuPH20 enhances the performance of high-volume subcutaneous injections.
- This technology has the potential to expand therapeutic options for subcutaneous delivery.
