Liquid Botulinum Neurotoxin Composition Without Reconstitution
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Solution Overview
Problem
Current botulinum neurotoxin formulations for treating glabellar and lateral canthal lines are lyophilized, requiring reconstitution, which is time-consuming and prone to errors and contamination, necessitating a stable, ready-to-use liquid formulation.
Innovation Solution
A liquid composition of botulinum neurotoxin with buffering agents, stabilizers, and surfactants, formulated to be stable and suitable for direct administration without reconstitution, comprising specific concentrations of sodium and phosphate ions, amino acids, and surfactants like polysorbate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If lyophilized botulinum neurotoxin formulations are used, then stability is improved, but ease of operation deteriorates due to required reconstitution
Solution Approach 1:
The patent changes the physical state parameter of the formulation from lyophilized (solid) to liquid form, eliminating the need for reconstitution while maintaining stability through specific formulation components including buffering agents, stabilizers, and surfactants
2Manufacturing precision
If reconstitution step is required, then manufacturing precision is improved through controlled preparation, but loss of time increases due to additional preparation steps
Solution Approach 1:
The formulation is prepared in advance in liquid form with all necessary components (buffering agents, stabilizers, surfactants) already incorporated at correct concentrations, eliminating the need for physician reconstitution and reducing administration time
3Ease of manufacture
If reconstitution is required, then ease of manufacture is improved through standardized lyophilization, but reliability deteriorates due to risks of dilution error and contamination
Solution Approach 1:
The patent extracts and eliminates the reconstitution step from the administration process by providing a ready-to-use liquid formulation, thereby removing the sources of error and contamination associated with dilution and handling of lyophilized powder
Data Source
AI summary
Disclosed herein are methods of treatment of moderate to severe and very severe glabellar lines and lateral canthal lines using liquid botulinum neurotoxin compositions. Also disclosed are liquid compositions of botulinum neurotoxin.