Protected one-vial formulation for nucleic acid molecules, methods of making the same by in-line mixing, and related products and methods

摘要

The present invention, as noted above, relates generally to the incorporation of plasmid into a conventional dosage form, and more particularly to the production of a single-vial, homogenized, plasmid/polymer complex with desirable physical characteristics. Methods of making, storing and using such a complex are also provided and described in detail below. Such products and methods will provide more convenient and cost-effective complexes, which will be protected against chemical degradation and/or physical aggregation of its components and will provide for relative ease of administration. Thus, the present invention provides a more efficient complex for plasmid delivery and a method of incorporation of that plasmid into a conventional dosage form.