Hyaluronidase Formulation for High-Volume Subcutaneous Delivery
Find Innovative SolutionsGenerate Solutions
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 hyaluronidase enzyme, particularly recombinant human hyaluronidase PH20, administered via a high volume autoinjector with controlled delivery forces and pressures, facilitating subcutaneous delivery of active ingredients like small molecules, peptides, biologics, or nanoparticles in volumes ranging from 3 mL to 50 mL, using needles of 20 to 33 gauge.
Engineering Contradictions & Design Principles
Engineering 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
Solution Approach 1:
Hyaluronidase enzyme is introduced as an intermediary substance that degrades hyaluronic acid in the subcutaneous tissue, temporarily increasing tissue permeability and facilitating high-volume drug delivery while reducing resistance and preventing back leakage. The enzyme acts as a mediator between the injected formulation and the subcutaneous tissue, enabling improved delivery without the harmful side effects.
2Productivity
If high volume formulation is administered rapidly, then administration time is reduced, but delivery force and pressure requirements increase
Solution Approach 1:
Hyaluronidase enzyme is co-administered with the formulation to pre-degrade hyaluronic acid barriers in the subcutaneous tissue before and during the injection process. This preliminary enzymatic action reduces tissue resistance in advance, allowing rapid administration without requiring excessive delivery force or pressure.
3Device complexity
If high volume formulation is administered without hyaluronidase, then formulation complexity is reduced, but delivery consistency and patient comfort deteriorate
Solution Approach 1:
The formulation includes hyaluronidase enzyme at optimized concentrations (e.g., 150-15,000 U/mL) to temporarily modify the physical-chemical parameters of subcutaneous tissue, specifically increasing permeability and reducing viscosity resistance. This parameter change enables consistent high-volume delivery while maintaining formulation stability and predictable performance.
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 use of hyaluronidase enzyme reduces pain, discomfort, back leakage, and swelling at the injection site, providing more consistent delivery and faster administration compared to formulations without hyaluronidase.
Implementation Method 1
A formulation comprising a hyaluronidase enzyme, particularly recombinant human hyaluronidase PH20
Data Source
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.