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US 8,476,010 B2Granted
Propofol formulations with non-reactive container closures
AssigneeAPP Pharmaceuticals, LLC.
InventorsNeil P. Desai, Andrew Yang, Sherry Xiaopei Ci
Life of this patent
Estimating the term…
Abstract
A sterile pharmaceutical composition for parenteral administration of propofol, said composition comprising propofol, optionally albumin, and less than about 10% by weight solvent for propofol, wherein said composition is stored in a container having a closure wherein said closure is inert to propofol.
Claims70
A sterile pharmaceutical composition of propofol in a container, comprising:
- a container which includes a closure and a composition in the container, and
- the composition in the container comprising from 0.5% to 10% by weight propofol and from about 0 to about 10% by weight solvent for propofol,
- where when the composition in the container sealed with the closure is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the composition maintains a propofol concentration (w/v) measured by HPLC that is at least 93% of the starting concentration (w/v) of the propofol;
- where the closure is selected from the group consisting of siliconized bromobutyl rubber, metal, and siliconized chlorobutyl rubber.
1 more element
A sterile pharmaceutical composition of propofol in a container, comprising:
- a container which includes a closure and an oil-in-water emulsion for parenteral administration of propofol in the container,
- the emulsion comprising an oil phase comprising propofol and a solvent for propofol, and an aqueous phase comprising water for injection,
- the emulsion comprising from about 0 to about 10% by weight of the solvent,
- the emulsion further comprising a stabilizing layer for the oil phase, the stabilizing layer comprising a surfactant and a protein;
- where when the emulsion in the container sealed with the closure is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the emulsion maintains a propofol concentration (w/v) measured by HPLC that is at least 93% of the starting concentration (w/v) of the propofol;
- where the closure is selected from the group consisting of siliconized bromobutyl rubber, metal, and siliconized chlorobutyl rubber.
3 more elements
A sterile, injectable pharmaceutical composition in a container, comprising:
- a container which includes a closure and a composition in the container, the composition comprising
- a) microdroplets having a mean size of from about 20 nanometers to about 1000 nanometers, the microdroplets comprising a sphere of propofol surrounded by a stabilizing layer comprising a phospholipid and devoid of oils capable of supporting bacterial growth;
- and
- b) a pharmaceutically acceptable injectable carrier;
- where when the composition in the container sealed with the closure is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the composition maintains a propofol concentration (w/v) measured by HPLC that is at least 93% of the starting concentration (w/v) of the propofol;
- where the closure is selected from the group consisting of siliconized bromobutyl rubber, metal, and siliconized chlorobutyl rubber.
3 more elements
Dependencies are inferred from the claim text.