SOLID DOSAGE FORMS OF VALSARTAN AND AMLODIPINE AND METHOD OF MAKING SAME

1 . A solid dosage form of valsartan comprising:

valsartan;

amlodipine; and

pharmaceutically acceptable additives suitable for the preparation of solid dosage forms of valsartan.

2 . The solid dosage form of claim 1 , wherein the amlodipine is provided in the form of amlodipine besylate.

3 . The solid dosage form of claim 1 , wherein the solid dosage form takes the form of a monolayer tablet.

4 . The solid dosage form of claim 1 , wherein the valsartan is employed in an amount ranging from about 40 mg to about 640 mg.

5 . The solid dosage form of claim 4 , wherein the valsartan is employed in an amount selected from 80 mg and 160 mg.

6 . The solid dosage form of claim 3 , wherein the amlodipine is employed in an amount ranging from about 1.25 mg to about 20 mg.

7 . The solid dosage form of claim 6 , wherein the amlodipine is employed in an amount selected from 2.5 mg, 5 mg and 10 mg.

8 . The solid dosage form of claim 1 , wherein the solid dosage form takes the form of a bilayer tablet having the valsartan in a first layer and the amlodipine in a second layer.

9 . The solid dosage form of claim 8 , wherein the valsartan is employed in an amount ranging from about 40 mg to about 640 mg.

10 . The solid dosage form of claim 9 , wherein the valsartan is employed in an amount of 320 mg.

11 . The solid dosage form of claim 8 , wherein the amlodipine is employed in an amount ranging from about 1.25 mg to about 20 mg.

12 . The solid dosage form of claim 11 , wherein the amlodipine is employed in an amount selected from 5 mg and 10 mg.

13 . The solid dosage form of claim 1 , wherein the pharmaceutically acceptable additives are selected from the group consisting of diluents, disintegrants, glidants, lubricants, colorants and combinations thereof.

14 . A method of making a solid dosage form of valsartan comprising the steps of

(a) blending valsartan, amlodipine and pharmaceutically acceptable additives to form a blended material;

(b) sieving the blended material to form a sieved material;

(c) blending the sieved material to form a blended/sieved material;

(d) compacting the blended/sieved material to form a compacted material;

(e) milling the compacted material to form a milled material;

(f) blending the milled material to form blended/milled material; and

(g) compressing the blended/milled material to form a monolayer solid dosage form.

15 . The method of claim 14 further comprising the step of:

(h) film coating the monolayer solid dosage form.

16 . A method of making a solid dosage form of valsartan comprising the steps of:

(a) granulating valsartan and pharmaceutically acceptable additives to form a valsartan granulation;

(b) blending amlodipine and pharmaceutically acceptable additives to form an amlodipine blend; and

(c) compressing the valsartan granulation and the amlodipine blend together to form a bilayer solid dosage form.

17 . The method of claim 16 , wherein step (a) comprises the steps of:

(a1) blending valsartan and pharmaceutically acceptable additives to form a blended material;

(a2) sieving the blended material to form a sieved material;

(a3) blending the sieved material to form a blended/sieved material;

(a4) compacting the blended/sieved material to form a compacted material;

(a5) milling the compacted material to form a milled material; and

(a6) blending the milled material to form the valsartan granulation.

18 . The method of claim 16 , wherein step (b) comprises a granulation process comprising the steps of:

(b1) blending amlodipine and pharmaceutically acceptable additives to form a blended material;

(b2) sieving the blended material to form a sieved material;

(b3) blending the sieved material to form a blended/sieved material;

(b4) compacting the blended/sieved material to form a compacted material;

(b5) milling the compacted material to form a milled material; and

(b6) blending the milled material to form an amlodipine granulation.

19 . The method of claim 16 further comprising the step of (d) film coating the bilayer solid dosage form.

20 . A method of treating hypertension, congestive heart failure, angina, myocardial infarction, arteriosclerosis, diabetic nephropathy, diabetic cardiac myopathy, renal insufficiency, peripheral vascular disease, stroke, left ventricular hypertrophy, cognitive dysfunction, headache, or chronic heart failure, wherein the method comprises administering a solid dosage form of valsartan as defined in claim 1 to a subject in need of such treatment.

21 . The method of treating according to claim 20 , wherein the solid dosage form is orally administered to the subject.