Oral pharmaceutical composition for soft capsules containing vinorelbine and method of treatment

1. A liquid oral pharmaceutical composition suitable as a liquid fill composition for a soft capsule dosage form, said composition comprising:

a) vinorelbine or a pharmaceutically acceptable salt thereof;

b) ethanol present in an amount ranging from about 0.3% to about 7.5% by weight of the total weight of the fill composition;

c) water;

d) glycerol; and

e) polyethylene glycol;

wherein the weight ratio of water to ethanol in the composition ranges from about 2:1 to about 3:1.

2. The pharmaceutical composition according to claim 1 ,

wherein said soft capsule dosage form is a soft gelatin capsule.

3. The pharmaceutical composition according to claim 2

wherein said gelatin is a mixture of porcine and bovine gelatin.

4. The pharmaceutical composition according to claim 1 ,

wherein said pharmaceutically acceptable salt of vinorelbine is vinorelbine tartrate.

5. The pharmaceutical composition according to claim 1 ,

wherein said polyethylene glycol has an average molecular weight ranging from about 200 to about 600.

6. The pharmaceutical composition according to claim 5

wherein the polyethylene glycol is polyethylene glycol 400.

7. The pharmaceutical composition according to claim 1 ,

wherein said composition comprises:

a) vinorelbine tartrate present in an amount ranging from about 5 mg to about 100 mg per capsule;

b) ethanol present in an amount ranging from about 0.3% by weight to about 7.5% by weight of the total weight of the fill composition;

c) water present in an amount ranging from about 1% by weight to about 15% by weight of the total weight of the fill composition;

d) glycerol present in an amount ranging from about 0.1% by weight to about 20% by weight of the total weight of the fill composition;

e) polyethylene glycol 400 present in an amount ranging from about 66% by weight to about 78% by weight of the total weight of the fill composition.

8. The pharmaceutical composition according to claim 7 ,

wherein said composition comprises:

a) vinorelbine tartrate present in an amount ranging from about 5 mg to about 100 mg per capsule;

b) ethanol present in an amount ranging from about 1.6% by weight to about 5% by weight of the total weight of the fill composition;

c) water present in an amount ranging from about 1% by weight to about 15% by weight of the total fill composition;

d) glycerol present in an amount ranging from about 0.2% by weight to about 12% by weight of the total weight of the fill composition;

e) polyethylene glycol 400 present in an amount ranging from about 66% by weight to about 78% by weight of the total weight of the fill composition.

9. The pharmaceutical composition according to claim 1 wherein the weight ratio of water to ethanol in the composition ranges from about 2.3:1 to about 2.7:1.

10. The pharmaceutical composition according to claim 1 wherein the weight ration of water to ethanol in the composition is about 2.5:1.

11. A method of treating cancer comprising orally administering, to a patient in need of treatment thereof, a pharmaceutical composition comprising:

a) a pharmaceutically effective amount of vinorelbine or a pharmaceutically acceptable salt thereof;

b) ethanol present in an amount ranging from about 0.3% to about 7.5% by weight of the total weight of the fill composition;

c) water;

d) glycerol; and

e) polyethylene glycol present in an amount ranging from about ranging from about 66% by weight to about 78% by weight of the total weight of the fill composition;

wherein said composition is encapsulated within a soft capsule; and

wherein the weight ratio of water to ethanol in the composition ranges from about 2:1 to about 3:1.

12. The pharmaceutical composition according to claim 8 wherein said composition comprises:

a) about 15.8% by weight of vinorelbine tartrate;

b) about 2.9% by weight ethanol;

c) about 7.1% by weight water;

d) about 1.1% by weight glycerol; and

e) about 73.1% by weight polyethylene glycol 400.