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Claims for Patent: 5,688,529

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Claims for Patent: 5,688,529

Title: Mycophenolate mofetil high dose oral suspensions
Abstract:High dose, dry granulations or powder blends and aqueous oral suspensions of mycophenolate mofetil or mycophenolic acid, contain: active compound (7.5-30%), suspending/viscosity agent, sweetener, flavor, buffer (to a pH of 5-7.5), and optionally contain flavor enhancer, wetting agent, antimicrobial agent and color.
Inventor(s): Lidgate; Deborah Marilyn (Los Altos, CA), Wang-Kessler; Li-hua (Palo Alto, CA), Joshi; Bindu (Milpitas, CA), Hegde; Sayee Gojanan (Los Angeles, CA), Gu; Leo (Saratoga, CA)
Assignee: Syntex (U.S.A) Inc. (Palo Alto, CA)
Application Number:08/412,645
Patent Claims: 1. A pharmaceutical formulation comprising:

as a liquid suspension suitable for oral administration.

2. A pharmaceutical formulation consisting essentially of:

adjusted to a pH of 7, as a liquid suspension suitable for oral administration.

3. A pharmaceutical formulation comprising:

as a liquid suspension suitable for oral administration.

4. The pharmaceutical formulation of claim 3, consisting essentially of:

adjusted to a pH of 7, as a liquid suspension suitable for oral administration.

5. A process for the preparation of a pharmaceutical formulation comprising:

as a liquid suspension for oral administration, the process comprising:

I. a. adding and dispersing the antimicrobial agent to heated water, followed by adding the suspending and/or viscosity agent(s);

b. dissolving, with mixing, the buffer(s), followed by adding the sweetener(s), wetting agent(s), dye(s), flavor enhancer(s), and flavor(s); and

c. adding the active compound to the mixture from step b, followed by mixing the liquids well to form a suspension; or

II. a. adding and dissolving with mixing the antimicrobial agent and water;

b. dispersing the suspending and/or viscosity increasing agent(s) in the dispersion of step a;

c. adding with mixing the sweetener(s) to the dispersion of step b; followed by adding the suspending and/or viscosity agent(s) with mixing; followed by adding the sweetener(s) with mixing;

d. dissolving the buffer(s) in water, followed by adding and dissolving sweetener(s), followed by adding and dispersing the wetting agent(s), followed by adding and dispersing the active compound;

e. combining the dispersions of steps c and d with mixing;

f. adding the dye(s) and flavor(s) to the dispersion of step e; and

g. bringing the dispersion of step f to volume with purified water.

6. A pharmaceutical formulation comprising:

as a dry granulation or powder blend suitable, when constituted with water, for forming a suspension for oral administration, where mg/mL represents concentration after constitution with water.

7. The pharmaceutical formulation of claim 6 provided in a container marked to be filled with purified water to a final predetermined volume.

8. The pharmaceutical formulation of claim 7, comprising:

in a container marked to be filled with purified water to a final predetermined volume of 450 mL.

9. The pharmaceutical formulation of claim 7, comprising:

in a container marked to be filled with purified water to a final predetermined volume of 450 mL.

10. The pharmaceutical formulation of claim 7, comprising:

in a container marked to be filled with purified water to a final predetermined volume of 450 mL.

11. The pharmaceutical formulation of claim 7, comprising:

in a container marked to be filled with purified water to a final predetermined volume of 450 mL.

12. The pharmaceutical formulation of claim 7, comprising

in a container marked to be filled with purified water to a final predetermined volume of 240 mL.

13. The pharmaceutical formulation of claim 7, comprising

in a container marked to be filled with purified water to a final predetermined volume of 120 mL.

14. The pharmaceutical formulation of claim 7, comprising:

in a container marked to be filled with purified water to a final predetermined volume of 450 mL.

15. A pharmaceutical formulation, comprising:

as a dry granulation or powder blend suitable, when constituted with water, for forming a suspension for oral administration, where mg/mL represents concentration after constitution with water.

16. The pharmaceutical formulation of claim 15 provided in a container marked to be filled with purified water to a final predetermined volume.

17. The pharmaceutical formulation of claim 16, comprising:

in a container marked to be filled with purified water to a final predetermined volume of 450 mL.

18. A process for the preparation of a pharmaceutical formulation comprising:

as a dry granulation or powder blend suitable, when constituted with water, for forming a suspension for oral administration, where mg/mL represents concentration after constitution with water, the process comprising:

I. a. combining the active compound, sweetener(s), wetting agent(s), suspending and/or viscosity increasing agent(s), flavor(s) and antimicrobial agent(s) in a mixer;

b. dissolving the dye(s) and buffer(s) in water;

c. combining the solution of step (b) to the mixer bowl of step (a) and mixing until a desired granulation size is obtained;

d. drying the granulation then milling to reduce particle size;

e. adding the suspending and/or viscosity increasing agent(s) to the granulation of step (d) using a blender; or

II. a. combining the active compound, sweetener(s), wetting agent(s), suspending and/or viscosity increasing agent(s), dye(s), and buffer(s) and mixing to form a powder blend.
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