Subcutaneous Anti-TNFα Antibody Formulation for Self-Administration
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current treatments for TNFα-related diseases require intravenous administration of anti-TNFα antibodies, which are inconvenient for patients due to the need for hospital visits and trained medical personnel, and there is a lack of a stable liquid formulation for subcutaneous administration of infliximab.
Innovation Solution
A pharmaceutical composition containing an anti-TNFα antibody or antigen-binding fragment, formulated with surfactants, sugars, and buffers, specifically designed for subcutaneous administration, allowing for self-injection and improved stability and convenience.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravenous administration of anti-TNFα antibody is used, then clinical efficacy is achieved, but patient convenience deteriorates due to hospital visits and long treatment time
Solution Approach 1:
The patent enables patients to perform self-injection at home through subcutaneous administration of the antibody formulation, eliminating the need for hospital visits and trained medical personnel. The formulation is designed to be stable and easy to administer, allowing patients to independently manage their treatment.
2Quantity of substance
If intravenous administration method is used, then adequate dosing is achieved, but treatment time increases to 2-4 hours including waiting time
Solution Approach 1:
The patent extracts the antibody from the intravenous administration system and reformulates it for subcutaneous injection. This removes the need for complex intravenous infusion equipment and hospital-based administration, reducing treatment time from 2-4 hours to just 2-5 minutes while maintaining adequate dosage delivery.
3Ease of operation
If subcutaneous administration is implemented, then administration convenience is improved, but formulation stability becomes challenging due to high concentration requirements
Solution Approach 1:
The patent changes the formulation parameters including pH, ionic strength, and excipient composition to create a stable liquid formulation capable of accommodating high antibody concentrations (90-200 mg/ml) for subcutaneous administration. The formulation includes specific buffers, surfactants, and stabilizers that prevent aggregation and degradation.
4Stability of the object's composition
If lyophilized powder formulation is used, then storage stability is maintained, but administration complexity increases requiring reconstitution and dilution
Solution Approach 1:
The patent transitions from a lyophilized powder formulation (solid phase) to a liquid formulation (liquid phase) that maintains storage stability. This eliminates the need for reconstitution and dilution steps, simplifying the administration procedure while preserving the stability benefits of the original formulation approach.
Data Source
AI summary
The present prevention relates to methods for treating TNFα-related diseases by subcutaneously administering an antibody binding to TNFα (anti-TNFα antibody) or an antigen-binding fragment thereof. The treatment method, composition, kit or use according to the present invention provide an advantage of improving patient satisfaction, by improving convenience and quality of life, that is, by reducing the time required for administration and decreasing the length of stay of patients in a hospital compared to intravenous injection.