Subcutaneous Anti-TNF-Alpha Antibody Formulation for Self-Administration
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Solution Overview
Problem
Current treatments for TNF-α-related diseases, such as rheumatoid arthritis and Crohn's disease, require intravenous administration of anti-TNF-α antibodies like infliximab, which is inconvenient and burdensome for patients due to the need for hospital visits and limited administration to medically trained personnel.
Innovation Solution
Development of a subcutaneous formulation of anti-TNF-α antibodies, including infliximab, in a stable liquid form that can be self-administered by patients, reducing administration time and improving convenience, using a composition comprising the antibody, surfactants like polysorbate, sugars like sorbitol, and buffers like acetate, without the need for reconstitution or dilution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intravenous administration of anti-TNF-α antibodies is used, then clinical efficacy is achieved, but patient convenience deteriorates due to hospital visits and lengthy administration time
Solution Approach 1:
The patent changes the route of administration parameter from intravenous to subcutaneous, and modifies the formulation parameters (lyophilized powder to stable liquid formulation) to enable self-administration while maintaining clinical efficacy
Solution Approach 2:
The patent enables patients to self-administer the medication at home through subcutaneous injection, eliminating the need for hospital visits and administration by medical personnel, thus improving patient convenience while maintaining treatment efficacy
2Reliability
If intravenous administration is used, then drug delivery is effective, but administration time increases to 2-4 hours including waiting time
Solution Approach 1:
The patent changes the administration route from intravenous to subcutaneous and modifies the formulation to stable liquid form, reducing administration time from 2-4 hours to 2-5 minutes while maintaining drug delivery effectiveness
Solution Approach 2:
The patent prepares the medication in advance as a stable liquid formulation that can be stored and administered at home, eliminating the need for hospital waiting time and enabling immediate administration when needed
3Stability of the object's composition
If conventional intravenous formulation is used, then drug stability is maintained, but formulation complexity increases due to reconstitution and dilution requirements
Solution Approach 1:
The patent changes the formulation state from lyophilized powder requiring reconstitution to stable liquid formulation, maintaining drug stability while eliminating the complexity of reconstitution and dilution steps
Solution Approach 2:
The patent extracts and eliminates the problematic steps of reconstitution and dilution from the administration process by providing a ready-to-use stable liquid formulation, simplifying the overall treatment protocol
4Ease of operation
If subcutaneous administration is implemented, then patient convenience is improved, but formulation stability becomes challenging for high concentration antibody solutions
Solution Approach 1:
The patent optimizes formulation parameters including pH, buffer composition, and excipients to achieve stability of high concentration antibody solutions in liquid form for subcutaneous administration, balancing both convenience and stability requirements
Data Source
AI summary
The present invention relates to a method of TNF-α-related disease by subcutaneously administering an antibody binding to TNF-α (anti-TNF-α antibody). A treatment method, composition, kit or use according to the present invention reduces the time for administration and the time for patients to stay in hospitals, thereby improving patient convenience and the quality of life of the patient. This provides the advantage of improving the patient's satisfaction.