Pharmaceutical compositions of pimobendan

1. A method for the preparation of a composition, the process comprising:

dispersing particulate pimobendan in a molten carrier matrix to form particles coated with the carrier matrix, wherein the molten carrier matrix comprises one or more pharmaceutically acceptable carriers selected from the group consisting of a polyglycolized glyceride, a polyethylene glycol, and combinations thereof;

atomizing the dispersion of coated particles; and

cooling and collecting the coated particles from the atomized dispersion.

2. The method of claim 1 , wherein the particulate pimobendan has a mean particle size of less than 20 μm, the carrier matrix has a melting point from 40° C. to 80° C., and the dispersing is performed in a high shear mixer to obtain a homogenous suspension of the coated particles within the carrier matrix.

3. The method of claim 1 , wherein the carrier matrix comprises a polyglycolized glyceride.

4. The method of claim 1 , wherein the polyglycolized glyceride comprises a stearoyl macrogol-32 glyceride, a lauroyl macrogolglyceride or a stearoyl macrogolglyceride.

5. The method of claim 1 , wherein the polyethylene glycol has an average molecular weight of 1,500 to 20,000 g/mol, or an average molecular weight of 4,000 to 6,000 g/mol.

6. The method of claim 1 , wherein the polyethylene glycol comprises PEG 6000.

7. The method of claim 1 , wherein the atomizing the dispersion of coated particles is performed using an atomizer selected from the group consisting of a rotary atomizer, a pressure or pneumatic nozzle, a sonic nozzle, and combinations thereof.

8. The method of claim 1 , wherein the atomizing the dispersion of coated particles is performed using a two-fluid pressure or pneumatic nozzle atomization system fitted in a spray congealing/chilling apparatus and using atomizing gas pressures of 1 to 10 bar.

9. The method of claim 1 , wherein the cooling and collecting the coated particles from the atomized dispersion comprises applying a stream of cool air or an inert gas at a temperature of 0° to 30° C. from a spray apparatus to the coated particles within a cyclone separator or a bag filter.

10. The method of claim 9 , wherein the cool air or inert gas is applied at a temperature of 5° to 15° C., or at a temperature of 4° to 8° C.

11. The method of claim 1 , further comprising:

blending the cooled and collected coated particles with one or more additional components to form a blended mixture; and

compressing the blended mixture to form a tablet.

12. The method of claim 11 , wherein the one or more additional components comprises one or more additional active ingredients.