METHODS OF MANUFACTURING VISCOUS LIQUID PHARMACEUTICAL FORMULATIONS

1 . A liquid composition in an osmotic drug delivery system comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.

2 . The composition of claim 1 , wherein the amphiphilic molecule is selected from lipid, surfactant, amphiphilic block polymer, or amphiphilic proteins or peptides.

3 . The composition of claim 1 , wherein said pharmaceutically active agent is suspended in a particle within said liquid composition.

4 . The composition of claim 1 , further comprising an anti-oxidant lipid compound selected from vitamin E, α-tocopherol, or ascorbic acid.

5 . The composition of claim 1 wherein the pharmaceutically active agent is selected from a protein, peptide, small molecule drug, lipid drug or nucleic acid drug, DNA drug, RNA drug, antisense drug, ribozyme drug, DNAzyme drug.

6 . The composition of claim 1 wherein an amphiphilic molecule weight percent is from about 1 to about 100 weight percent.

7 . The composition of claim 1 wherein the non-aqueous liquid solvent weight percent is from about 0 to about 99 weight percent.

8 . The composition of claim 1 , wherein viscosity of the composition is from about 1 to about 100,000 poise.

9 . The composition of claim 1 , wherein the pharmaceutically active agent is selected from biologically or pharmacologically active substance.

10 . A dosage form comprising a dosage form selected from the group consisting of:

(i) a drug dosage form for osmotic drug delivery comprising:

a capsule including a first chamber containing a viscous liquid pharmaceutical composition and a second chamber containing an osmotic agent, said first chamber having an opening through which the pharmaceutical composition can be delivered from the first chamber to a location external of the first chamber;

a movable separating member positioned in the capsule between the first chamber and the second chamber;

a wall of the second chamber including a fluid permeable portion allowing fluid to pass from a surrounding environment into the second chamber; and

an incompressible fluid additive located within the second chamber and substantially surrounding the osmotic agent; and

(ii) a dosage form

dosage form comprising:

a first wall that maintains its physical and chemical integrity during the life of the dosage form and is substantially impermeable to a pharmaceutical suspension;

a second wall that is partially permeable to an exterior fluid;

a compartment defined by the first wall and the second wall;

a pharmaceutical suspension that is positioned within the compartment and comprises an amphiphilic molecule, a non-aqueous solvent, a performance modifier, and a pharmaceutically active agent; and

an exit port in the wall in communication with the compartment.

11 . The dosage form of claim 10 , wherein the viscous liquid pharmaceutical composition comprises an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.

12 . The dosage form of claim 10 , wherein the osmotic agent is in a tabular form and the fluid additive surrounds the tabular osmotic agent.

13 . The dosage form of claim 10 , wherein the separating member is a slidable piston.

14 . The dosage form of claim 10 , wherein the fluid permeable portion is a membrane.

15 . A suspending vehicle in a pump-driven dosage form comprising an amphiphilic molecule, a non-aqueous solvent, and a performance modifier.

16 . The suspending vehicle of claim 15 which is substantially non-aqueous.

17 . The suspending vehicle of claim 15 wherein the amphiphilic molecule comprises a lipid.

18 . A method comprising:

identifying an amphiphilic molecule;

identifying a non-aqueous solvent;

identifying a performance modifier;

mixing the amphiphilic molecule, the non-aqueous solvent, and the performance modifier to create a suspending vehicle.

19 . The method of claim 18 further comprising adding a pharmaceutically active agent to the suspending vehicle to create a pharmaceutical suspension.

20 . A method comprising administering the dosage form of claim 10 to a mammal.

21 . A kit comprising a dosage form of claim 10 and instructions for administering the dosage form.