18420955. METHODS OF MODELING LIQUID PROTEIN COMPOSITION STABILITY simplified abstract (Regeneron Pharmaceuticals, Inc.)
Contents
- 1 METHODS OF MODELING LIQUID PROTEIN COMPOSITION STABILITY
METHODS OF MODELING LIQUID PROTEIN COMPOSITION STABILITY
Organization Name
Regeneron Pharmaceuticals, Inc.
Inventor(s)
Douglas E. Kamen of Poughquag NY (US)
Kenneth S. Graham of Tarrytown NY (US)
Caterina Riccardi of Tarrytown NY (US)
METHODS OF MODELING LIQUID PROTEIN COMPOSITION STABILITY - A simplified explanation of the abstract
This abstract first appeared for US patent application 18420955 titled 'METHODS OF MODELING LIQUID PROTEIN COMPOSITION STABILITY
The disclosure provides methods of determining an initial amount of surfactant to include in a liquid pharmaceutical composition comprising a protein, intended for administration to a subject as an IV admixture. The methods comprise determining the degradation rate of the surfactant, the minimum amount of surfactant whereby stability of the protein is maintained in IV admixture the end of shelf-life of the liquid pharmaceutical composition, and, based on the degradation rate, shelf-life, and minimum amount of surfactant, determining a target amount of surfactant to include in the composition at the time of formulation.
- Determining initial amount of surfactant for liquid pharmaceutical composition
- Considering degradation rate of surfactant and protein stability in IV admixture
- Calculating minimum amount of surfactant for shelf-life maintenance
- Establishing target amount of surfactant based on degradation rate, shelf-life, and minimum amount
- Ensuring stability and efficacy of protein in IV admixture
Potential Applications
The technology can be applied in the pharmaceutical industry for the formulation of liquid pharmaceutical compositions containing proteins for IV administration.
Problems Solved
The technology addresses the challenge of determining the appropriate amount of surfactant to maintain protein stability in liquid pharmaceutical compositions over their shelf-life.
Benefits
- Enhanced stability of proteins in IV admixtures - Improved formulation accuracy - Extended shelf-life of liquid pharmaceutical compositions
Commercial Applications
Title: "Optimized Surfactant Formulation for Protein IV Admixtures" This technology can be utilized by pharmaceutical companies for the development of protein-based IV medications, ensuring efficacy and stability throughout the shelf-life of the product.
Questions about the Technology
How does the degradation rate of surfactant impact protein stability in IV admixtures?
The degradation rate of surfactant directly affects the stability of proteins in IV admixtures, as it determines the minimum amount of surfactant required to maintain protein stability over the shelf-life of the liquid pharmaceutical composition.
What are the key considerations in determining the target amount of surfactant for formulation?
The target amount of surfactant is determined based on the degradation rate, shelf-life, and minimum amount required for protein stability, ensuring the optimal formulation of the liquid pharmaceutical composition.
Original Abstract Submitted
The disclosure provides methods of determining an initial amount of surfactant to include in a liquid pharmaceutical composition comprising a protein, intended for administration to a subject as an IV admixture. The methods comprise determining the degradation rate of the surfactant, the minimum amount of surfactant whereby stability of the protein is maintained in IV admixture the end of shelf-life of the liquid pharmaceutical composition, and, based on the degradation rate, shelf-life, and minimum amount of surfactant, determining a target amount of surfactant to include in the composition at the time of formulation.
