Hyaluronidase Formulation for High-Volume Injection Comfort

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Solution Overview

Problem

Existing formulations for administering active ingredients subcutaneously face challenges with high volume delivery, leading to significant side effects such as pain, discomfort, back leakage, and swelling at the injection site.

Innovation Solution

A formulation comprising a therapeutically effective amount of an active ingredient, optionally with a hyaluronidase enzyme, administered via a high volume autoinjector with controlled delivery forces and pressures, using a prefilled syringe with a needle gauge of 20 to 33, to facilitate efficient and minimally invasive high volume administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If high volume subcutaneous administration is performed without hyaluronidase enzyme, then delivery volume can be increased, but side effects such as pain, discomfort, back leakage, and swelling increase significantly

Engineering Contradiction:
Improvedelivery volumeVSAvoidside effects (pain, discomfort, back leakage, swelling)
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent introduces hyaluronidase enzyme as an intermediary substance that facilitates the breakdown of hyaluronic acid in the subcutaneous tissue. This enzyme mediator creates a pathway that allows high volume delivery while reducing resistance and preventing the harmful side effects that would otherwise occur with large volume injections

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent changes the chemical environment by introducing hyaluronidase enzyme that modifies the physical properties of the subcutaneous tissue. The enzyme catalyzes the hydrolysis of hyaluronic acid, changing the viscosity and resistance parameters of the tissue matrix, thereby enabling smoother high volume flow and reducing injection-related side effects

Inventive Principle:
Principle #35Parameter changes

2Quantity of substance

If high volume formulation is administered without optimized delivery parameters, then treatment efficacy can be improved, but administration time and patient discomfort increase

Engineering Contradiction:
Improveformulation volumeVSAvoidadministration time
Core Design Contradiction:
Quantity of substanceVSLoss of time

Solution Approach 1:

The patent employs dynamic delivery parameters including controlled pressure gradients and flow rate optimization during administration. The system adapts delivery conditions in real-time, using higher initial pressure to overcome tissue resistance followed by controlled pressure reduction, thereby reducing overall administration time while maintaining comfort and efficacy

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent applies preliminary action by pre-treating the injection site or pre-formulating with hyaluronidase enzyme that begins breaking down hyaluronic acid barriers before the main drug delivery. This preliminary enzymatic action reduces subsequent resistance to flow, enabling faster administration of high volumes without increasing discomfort

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The solution enables faster, more consistent delivery with reduced side effects, including less pain, discomfort, back leakage, and swelling, compared to formulations without hyaluronidase enzyme.

Implementation Method 1

A formulation comprising a therapeutically effective amount of an active ingredient and a hyaluronidase enzyme

Methodology Applied
Scientific EffectEnzyme: Enzyme

Data Source

PatentUS12551539B2Hyaluronidase enzyme formulations for high volume administration
Publication Date: 2026.02.17 HALOZYME INC
  • US12551539B2 patent drawing
  • US12551539B2 patent drawing
  • US12551539B2 patent drawing

AI summary

In one aspect, the present disclosure provides a formulation comprising a hyaluronidase enzyme and a therapeutically effective amount of an active ingredient. In another aspect, the present disclosure provides a method of administering a high volume of the formulation in a single administration to treat a disease or disorder in a subject.