Botulinum Neurotoxin E Complex Stability via Binding Proteins
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Solution Overview
Problem
There is a need for improved formulations of botulinum neurotoxin type E that provide stability against denaturation and protection during storage and ingestion, with a focus on the L-complex or M-complex forms.
Innovation Solution
The development of a composition comprising a complex of botulinum neurotoxin E and its associated neurotoxin binding protein, specifically the L complex and M complex, which are isolated and used as pharmaceutical and cosmetic formulations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If botulinum neurotoxin type E is used as an isolated form, then the formulation is simpler to manufacture, but the stability against denaturation and protection during storage is reduced
Solution Approach 1:
The patent applies composite materials by formulating botulinum neurotoxin type E as a complex with neurotoxin binding proteins (such as HNA or NTNH). This composite structure provides enhanced stability against denaturation and protection during storage and ingestion, while maintaining therapeutic efficacy. The binding proteins act as protective components that stabilize the toxin complex without requiring additional excipients or stabilizers.
2Quantity of substance
If botulinum neurotoxin type E is used as an isolated form, then the potency per unit mass is higher, but the protection during storage and ingestion is reduced
Solution Approach 1:
The patent uses neurotoxin binding proteins as intermediary components that form a protective complex with botulinum neurotoxin type E. These binding proteins (HNA or NTNH) act as mediators that protect the toxin during storage and ingestion while maintaining its biological activity. The complex structure ensures reliable protection without compromising the potency of the active toxin component.
3Stability of the object's composition
If a complex formulation with neurotoxin binding protein is used, then the stability and protection are enhanced, but the device complexity increases
Solution Approach 1:
The patent merges botulinum neurotoxin type E with neurotoxin binding proteins (HNA or NTNH) into a single complex formulation. This combining approach integrates the stabilizing function directly into the active ingredient complex, eliminating the need for separate stabilizers, excipients, or complex formulation systems. The merged complex provides both therapeutic activity and stability in a unified structure.
Data Source
AI summary
Methods of making the M or L complex of the botulinum neurotoxin E with its associated neurotoxin binding protein(s) (NBP), and methods of using to treat pain and wrinkles by injecting locally. Methods of making and isolating the L and M complex comprise a multi-step process of: providing a bacterial cultured media comprising the complex of botulinum neurotoxin E and neurotoxin binding proteins; centrifuging and pelletizing the cultured media; stirring the pelletized culture at 0 to 10° C. over a period of 4 to 24 hours; centrifuging the stirred solution to obtain a supernatant; precipitating the supernatant and filtering to obtain the precipitate; and dissolving the precipitate, centrifuging and filtering to obtain a solution comprising M complex and/or L complex of botulinum neurotoxin E and its NBP; and passing the solution through a functionalized sephadex ion exchange column to isolate the complex.