Patent ID: 8158152

Claim:
A method of lyophilizing a hydrophilic pharmaceutical compound comprising: (a) dissolving the hydrophilic pharmaceutical compound in one or more hydrophilic solvents to form a solution, wherein the one or more hydrophilic solvents is a liquid in which the hydrophilic pharmaceutical compound dissolves; (b) adding one or more lipophilic non-solvents for the hydrophilic pharmaceutical compound to the solution, wherein: (i) the one or more lipophilic non-solvents is a liquid in which the hydrophilic pharmaceutical compound is essentially insoluble, (ii) the one or more lipophilic non-solvents is miscible with the one or more hydrophilic solvents, (iii) the one or more lipophilic non-solvents is volatilizable under freeze-drying conditions, and (iv) the hydrophilic pharmaceutical compound at least partially precipitates; (c) freezing the hydrophilic pharmaceutical compound, the one or more hydrophilic solvents and the one or more lipophilic non-solvents of step (b) to yield a frozen result, the frozen result comprising a frozen portion; and (d) vacuum drying the frozen result of step (c) to yield a lyophilizate.