Hyaluronidase Formulation for High-Volume Injection Consistency
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Solution Overview
Problem
Existing formulations for administering therapeutic agents suffer from high side effects, pain, discomfort, and inefficiencies in delivery, particularly when administered in high volumes subcutaneously.
Innovation Solution
A formulation comprising a hyaluronidase enzyme, such as recombinant human hyaluronidase PH20, is administered via a high volume autoinjector with controlled delivery forces and pressures, facilitating subcutaneous delivery of active ingredients like small molecules, peptides, or nanoparticles in volumes ranging from 3 mL to 50 mL, using a prefilled syringe with needles of 20 to 33 gauge, at rates of 0.08 to 1.00 mL/sec, reducing side effects and improving delivery consistency.
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, pain, and discomfort increase significantly
Solution Approach 1:
Hyaluronidase enzyme is introduced as a mediator substance that degrades hyaluronic acid in the subcutaneous tissue, creating a pathway that facilitates high volume drug delivery while reducing tissue resistance and mechanical stress, thereby minimizing pain and discomfort
Solution Approach 2:
The formulation modifies the physical-chemical parameters of the injection by changing the viscosity and flow characteristics through hyaluronidase-mediated hyaluronic acid degradation, enabling smoother delivery of high volumes at controlled rates (0.08 to 1.00 mL/sec) with reduced mechanical trauma
2Productivity
If high volume administration is performed without controlled delivery parameters, then administration speed can be increased, but back leakage and swelling increase
Solution Approach 1:
The autoinjector incorporates feedback mechanisms that monitor delivery force and pressure in real-time, automatically adjusting the injection rate to maintain optimal parameters (starting delivery force of about 3 lbf to about 50 lbf, ending delivery force of about 5 lbf to about 20 lbf), preventing back leakage and ensuring complete drug delivery
Solution Approach 2:
The delivery system transitions from static to dynamic control by continuously adjusting injection parameters based on real-time conditions, varying the delivery rate and force throughout the injection process to match tissue compliance and prevent swelling
3Quantity of substance
If high volume subcutaneous injection is performed with traditional formulations, then therapeutic dose can be delivered, but delivery time increases and efficiency decreases
Solution Approach 1:
Hyaluronidase enzyme is pre-administered or co-administered with the therapeutic agent to preliminarily degrade the hyaluronic acid barrier in the subcutaneous tissue before the main drug delivery, creating an optimized pathway that accelerates subsequent high volume injection
Solution Approach 2:
The system utilizes controlled pressure delivery (starting pressure of about 50 psi to about 200 psi, ending pressure of about 20 psi to about 75 psi) through the autoinjector mechanism to efficiently propel high volumes of formulation through the needle gauge (20 to 33 gauge) in reduced time
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 in high volume autoinjectors enhances delivery efficiency, minimizing pain, discomfort, back leakage, and swelling, while ensuring consistent and faster administration with reduced side effects compared to formulations lacking hyaluronidase.
Implementation Method 1
A formulation comprising a hyaluronidase enzyme, such as 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.