Warming Concentrated IgG Formulations for Subcutaneous Infusion
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Solution Overview
Problem
Current subcutaneous infusion methods for concentrated IgG formulations face challenges in achieving high infusion rates without causing discomfort or tolerability issues due to the high viscosity of the solutions, which limits the feasibility of rapid infusion and patient compliance.
Innovation Solution
A dosing regimen and kit that includes a 20% IgG pharmaceutical formulation with a pharmaceutical formulation of hyaluronidase, allowing for infusion at unexpectedly high rates by warming the solution to reduce viscosity and using a combination of administration components to facilitate smooth infusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If concentrated IgG formulations (20% w/v) are used to reduce infusion volume, then the infusion volume is reduced by 50%, but the viscosity increases significantly making high-rate infusion difficult
Solution Approach 1:
The patent applies temperature as a parameter change to reduce viscosity. The concentrated IgG formulation is warmed to a temperature between 30-40°C before infusion, which significantly reduces the viscosity of the 20% w/v solution, enabling high-rate infusion at rates of 3-7.5 mL/min without excessive back pressure.
2Loss of time
If high infusion rates are used to reduce infusion time, then infusion time is reduced, but patient discomfort and tolerability issues increase
Solution Approach 1:
The patent applies preliminary action by warming the concentrated IgG formulation to 30-40°C before infusion begins. This pre-heating step reduces the viscosity of the solution in advance, allowing high infusion rates to be achieved without generating excessive back pressure that would cause patient discomfort, thereby enabling infusion rates of 3-7.5 mL/min with good tolerability.
3Stability of the object's composition
If concentrated IgG formulations are infused without warming, then the formulation remains stable, but the viscosity is too high for rapid infusion
Solution Approach 1:
The patent applies temperature parameter change by warming the concentrated IgG formulation to 30-40°C. This temperature increase reduces the viscosity of the 20% w/v formulation from its room temperature state, enabling infusion rates of 3-7.5 mL/min while maintaining formulation stability and integrity throughout the infusion process.
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 method enables infusion of a standard IgG dose in 50% of the standard volume, significantly reducing infusion time with improved tolerability and patient compliance, and is compatible with various infusion devices and settings.
Implementation Method 1
The method comprises: facilitating subcutaneous infusion of a concentrated pharmaceutical formulation of an immune globulin (IgG) to a subject in need thereof; and administering to the subject a formulation of hyaluronidase
Implementation Method 2
The pharmaceutical formulation is at a temperature of at least about 30° C., at least about 32, at least about 34, at least about 36, at least about 38 or at least about 40° C. when infused
Data Source
AI summary
Provided is a concentrated pharmaceutical formulation of an immune globulin (IG), and convenient methods for the subcutaneous administration of this pharmaceutical formulation in a warmed state. Such products can be used in methods of treating IG-treatable diseases or conditions. Also provided are combinations, compositions and kits containing an immune globulin (IG) composition and a soluble hyaluronidase composition formulated for subcutaneous administration.