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US 2006/0217341 A1Published application
DNA vaccine formulations
AssigneeMerck Sharp & Dohme Corp.
InventorsDavid Volkin, Robert Evans, Mark Bruner
Life of this patent
Estimating the term…
Abstract
This invention relates to novel methods and formulations of nucleic acid pharmaceutical products, specifically formulations of nucleic acid vaccine products and nucleic acid gene therapy products. The formulations of the disclosure stabilize the conformation of DNA pharmaceutical products.
Claims8
1-41. (canceled)
A plasmid DNA formulation which comprises:
- a) purified plasmid DNA whereby metal ions have been optionally removed;
- b) at least one metal ion chelator selected from the group consisting of EDTA, DTPA, NTA, inositol hexaphosphate, tripolyphosphate, polyphosphoric acid, sodium succinate, potassium succinate, lithium succinate, sodium malate, potassium malate, lithium malate and combinations thereof, at a concentration from 0.5 μM to 1000 μM.
- c) ethanol at a weight to volume concentration from 0.5% to 2.5%;
- d) a buffer in the pH range from 7.0 to 9.5;
- wherein the buffer is selected from the group consisting of Tris-HCl, glycine, sodium phosphate, potassium phosphate, lithium phosphate, sodium succinate, potassium succinate, lithium succinate, sodium malate, potassium malate, lithium malate, sodium bicarbonate, potassium bicarbonate, lithium bicarbonate and combinations thereof, at a concentration from about 0.5 mM to about 50 mM;
- and,
- e) a salt selected from the group consisting of NaCl, KCl, LiCl and combinations thereof at a concentration from 50 mM to 300 mM.
4 more elements
A plasmid DNA formulation which comprises:
- (a) purified plasmid DNA whereby metal ions have been optionally removed;
- (b) Tris-HCl buffer at a pH from 7.0 to 9.5;
- (c) ethanol from 0.5% to 2.5% w/v;
- (d) EDTA in a concentration range up to 5 mM;
- and,
- (e) NaCl at a concentration from 50 mM to 300 mM.
3 more elements
Dependencies are inferred from the claim text.