Self-buffering protein formulations for pH stability
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Solution Overview
Problem
Current pharmaceutical formulations face challenges in maintaining the correct pH for pharmaceutical proteins, as existing buffering agents often interfere with protein stability, safety, and efficacy, and there is a need for self-buffering solutions that do not require additional buffering agents.
Innovation Solution
Development of self-buffering protein formulations where the protein itself provides the necessary buffer capacity, with specific concentrations and combinations of proteins, polyols, surfactants, and excipients to maintain pH within a desired range, reducing the need for external buffering agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If conventional buffering agents are used to maintain pH, then pH stability is improved, but protein stability and safety deteriorate due to interference and adverse reactions
Solution Approach 1:
The protein formulation serves its own buffering needs through the inherent buffering capacity of the protein molecules themselves, eliminating the need for external buffering agents. The protein acts as both the buffered substance and the buffering agent, resolving the contradiction between pH stability and protein safety.
Solution Approach 2:
The invention extracts and eliminates conventional buffering agents from the formulation, relying solely on the protein's intrinsic buffering capacity. This removal of harmful external buffers resolves the conflict between maintaining pH stability and ensuring protein stability.
2Stability of the object's composition
If additional buffering agents are used to maintain pH, then pH control is improved, but formulation complexity and number of components increases
Solution Approach 1:
The invention merges the functions of the protein and the buffering agent into a single substance. The protein formulation simultaneously provides both the therapeutic protein and the buffering capacity, eliminating the need for separate buffering components and simplifying the overall formulation.
Solution Approach 2:
The protein serves multiple functions: it acts as the therapeutic agent, the buffered substance, and the buffering agent itself. This multi-functionality eliminates the need for additional specialized buffering components, reducing formulation complexity.
3Stability of the object's composition
If conventional buffering agents are used, then pH maintenance is improved, but adverse reactions and safety risks increase
Solution Approach 1:
The protein formulation buffers its own pH using its intrinsic buffering capacity, eliminating exposure to external buffering agents that could cause adverse reactions. This self-buffering approach ensures pH maintenance while improving safety by removing harmful substances.
Solution Approach 2:
The invention converts the previously harmful effect of requiring external buffers into a benefit by utilizing the protein's own buffering capacity. What was once a necessity (external buffers) becomes a potential source of harm, which is resolved by using the protein's inherent properties.
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 self-buffering protein formulations effectively maintain pH stability, enhancing protein stability and safety, and reducing the risk of adverse reactions, while minimizing the use of additional buffering agents, thus improving the overall efficacy and shelf-life of pharmaceutical products.
Implementation Method 1
The buffer or buffers for a given application must be effective at the desired pH. They must also provide sufficient buffer capacity to maintain the desired pH for as long as necessary.
Data Source
AI summary
The invention herein described, provides, among other things, self-buffering protein formulations. Particularly, the invention provides self-buffering pharmaceutical protein formulations that are suitable for veterinary and human medical use. The self-buffering protein formulations are substantially free of other buffering agents, stably maintain pH for the extended time periods involved in the distribution and storage of pharmaceutical proteins for veterinary and human medical use. The invention further provides methods for designing, making, and using the formulation. In addition to other advantages, the formulations avoid the disadvantages associated with the buffering agents conventionally used in current formulations of proteins for pharmaceutical use. The invention in these and other respects can be productively applied to a wide variety of proteins and is particularly useful for making and using self-buffering formulations of pharmaceutical proteins for veterinary and medical use, especially, in particular, for the treatment of diseases in human subjects.