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Details for Patent: 6,485,745

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Details for Patent: 6,485,745

Title: Solid oral dosage forms of valsartan
Abstract:The present invention is concerned with solid oral dosage forms of comprising a) an active agent selected from valsartan and optionally HCTZ , and b) Pharmaceutically acceptable additives suitable for the preparation of solid oral dosage forms by compression methods.
Inventor(s): Wagner; Robert Frank (Neshanic Station, NJ), Katakuse; Yoshimitsu (Hirakata, JP), Taike; Takashi (Kobe, JP), Yamato; Fujiki (Takarazuka, JP), Kohlmeyer; Manfred (Basel, CH)
Assignee: Novartis AG (Basel, CH)
Filing Date:Aug 01, 2001
Application Number:09/920,159
Claims:1. A compressed solid dosage form comprising: (a) an active agent comprising an effective amount of valsartan or a pharmaceutically acceptable salt thereof; and, (b) at least one pharmaceutically acceptable additive;

wherein the active agent is present in an amount of more than 35% by weight based on the total weight of the compressed solid dosage form and wherein said dosage form exhibits accelerated release of the active agent.

2. The compressed solid dosage form according to claim 1 wherein the accelerated release constitutes about 90% release within a 10 minute period.

3. The compressed solid dosage form according to claim 1 wherein the additive is microcrystalline cellulose, cross-linked polyvinyl pyrrolidone, pregelatinized starch or hydroxypropyl cellulose.

4. The compressed solid dosage form according to claim 1, wherein the additive is an acid in a solid form.

5. The compressed solid dosage form according to claim 1, wherein the additive is citric acid.

6. A compressed solid dosage form comprising an active agent comprising an effective amount of valsartan or a pharmaceutically acceptable salt thereof an effective amount of HCTZ; and, at least one pharmaceutically acceptable additive wherein the active agent is present in an amount of more than 35% by weight based on the total weight of the compressed solid dosage form and wherein said dosage form exhibits accelerated release of the active agent.

7. The compressed solid dosage form according to claim 6 wherein the accelerated release constitutes about 90% release within a 10 minute period.

8. The compressed solid dosage form according to claim 6 wherein the additive is microcrystalline cellulose, cross-linked polyvinyl pyrrolidone, pregelatinized starch or hydroxypropyl cellulose.

9. The compressed solid dosage form according to claim 6 wherein the additive is an acid in solid form.

10. The compressed solid dosage form according to claim 6 wherein the additive is citric acid.

11. A compressed solid dosage form comprising; (a) an active agent comprising an effective amount of valsartan or a pharmaceutically acceptable salt thereof; and, (b) at least one pharmaceutically acceptable additive;

wherein the active agent is present in an amount of more than 35% by weight based on the total weight of the compressed solid dosage form, and wherein said damage form exhibits delayed release of the active agent.

12. The solid dosage form according to claim 11 wherein the additive is hydroxypropyl methylcellulose.

13. A compressed solid dosage form comprising an active agent comprising an effective amount of valsartan or a pharmaceutically acceptable salt thereof; an effective amount of HCTZ; and, at least one pharmaceutically acceptable additive wherein the active agent is present in an amount of more than 35% by weight based on the total weight of the compressed solid dosage form and wherein said dosage form exhibits delayed release of the active agent.

14. The solid dosage form according to claim 13 wherein the additive is hydroxypropyl methylcellulose.

15. 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 compressed solid dosage form as defined in claim 1 to a subject in need of such treatment.

16. A method of treating according to claim 15 wherein the compressed solid dosage form is orally administered to the subject.

17. 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 compressed solid dosage form as defined in claim 6 to a subject in need of such treatment.

18. A method of treating according to claim 17 wherein the compressed solid dosage form is orally administered to the subject.

19. 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 compressed solid dosage form as defined in claim 11 to a subject in need of such treatment.

20. A method of treating according to claim 19 wherein the compressed solid dosage form is orally administered to the subject.

21. 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 compressed solid dosage form as defined in claim 13 to a subject in need of such treatment.

22. A method of treating according to claim 21 wherein the compressed solid dosage form is orally administered to the subject.

23. The compressed solid dosage form according to claim 6 wherein the accelerated release constitutes about 90% release within a 5 minute period.

24. The compressed solid dosage form according to claim 6 wherein the accelerated release constitutes about 90% release within a 5 minute period.
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