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Claims for Patent: 8,618,172

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Claims for Patent: 8,618,172

Title:Galenical formulations of organic compounds
Abstract: The present invention relates to a solid oral dosage form comprising a therapeutically effective amount of aliskiren or a pharmaceutically acceptable salt thereof, a therapeutically effective amount of HCTZ and a hydrophilic filler selected from the group a carbohydrate or combinations thereof, e.g. sugars, sugar alcohols and starches or combinations of these.
Inventor(s): Willmann; Matthias (Basel, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:12/304,244
Patent Claims: 1. A solid oral dosage form comprising (i) 28-44% aliskiren, or a pharmaceutically acceptable salt thereof, by weight based on the total weight of the oral dosage form; (ii) 1.4-5.5% hydrochlorothiazide by weight based on the total weight of the oral dosage form; and (iii) 5-25% carbohydrate hydrophilic filler by weight based on the total weight of the oral dosage form, wherein the carbohydrate hydrophilic filler is a mixture of wheat starch and lactose; (iv) 22-33% microcrystalline cellulose, by weight based on the total weight of the oral dosage form; (v) 9-13% crosslinked polyvinylpyrrolidone, by weight based on the total weight of the oral dosage form; (vi) 0.6-1.8% colloidal silicon dioxide, by weight based on the total weight of the oral dosage form; (vii) 0.4-1.8% talc, by weight based on the total weight of the oral dosage form; (viii) 1-1.5% magnesium stearate, by weight based on the total weight of the oral dosage form; and (ix) 2.1-3.2% polyvinylpyrrolidone, by weight based on the total weight of the oral dosage form.

2. The solid oral dosage form of claim 1 wherein aliskiren comprises about 75 to about 600 mg of the free base per unit dosage form.

3. The solid oral dosage form of claim 2 wherein aliskiren comprises about 83 mg per unit dosage form.

4. The solid oral dosage form of claim 2 wherein aliskiren comprises about 166 mg per unit dosage form.

5. The solid oral dosage form of claim 2 wherein aliskiren comprises about 332 mg per unit dosage form.

6. The solid oral dosage form of claim 1 wherein hydrochlorothiazide comprises about 12.5 to about 25 mg per unit dosage form.

7. The solid oral dosage form of claim 1 wherein the carbohydrate hydrophilic filler comprises about 30 to about 150 mg per unit dosage form.

8. The solid oral dosage form of claim 7 wherein the carbohydrate hydrophilic filler comprises about 50 to about 100 mg per unit dosage form.

9. The solid oral dosage form of claim 1 in the form of a film coated tablet.

10. The solid oral dosage form of claim 1 comprising (i) 82.875 mg aliskiren hemifumarate; (ii) 12.5 mg hydrochlorothiazide; (iii) 25 mg lactose and 24.5 mg wheat starch; (iv) 67.125 mg microcrystalline cellulose; (v) 25.1 mg crosslinked polyvinylpyrrolidone; (vi) 4.4 mg colloidal silicon dioxide; (vii) 4.15 mg talc; (viii) 3.35 mg magnesium stearate; and (ix) 6 mg polyvinylpyrrolidone.

11. The solid oral dosage form of claim 1 comprising (i) 165.75 mg aliskiren hemifumarate; (ii) 25 mg hydrochlorothiazide; (iii) 50 mg lactose and 49 mg wheat starch; (iv) 134.25 mg microcrystalline cellulose; (v) 50.2 mg crosslinked polyvinylpyrrolidone; (vi) 8.8 mg colloidal silicon dioxide; (vii) 8.3 mg talc; (viii) 6.7 mg magnesium stearate; and (ix) 12 mg polyvinylpyrrolidone.

12. The solid oral dosage form of claim 1 comprising (i) 165.75 mg aliskiren hemifumarate; (ii) 12.5 mg hydrochlorothiazide; (iii) 25 mg lactose and 24.5 mg wheat starch; (iv) 120.75 mg microcrystalline cellulose; (v) 49.7 mg crosslinked polyvinylpyrrolidone; (vi) 5.3 mg colloidal silicon dioxide; (vii) 4.15 mg talc; (viii) 5.35 mg magnesium stearate; and (ix) 12 mg polyvinylpyrrolidone.

13. The solid oral dosage form of claim 1 comprising (i) 331.5 mg aliskiren hemifumarate; (ii) 25 mg hydrochlorothiazide; (iii) 50 mg lactose and 49 mg wheat starch; (iv) 241.5 mg microcrystalline cellulose; (v) 99.4 mg crosslinked polyvinylpyrrolidone; (vi) 10.6 mg colloidal silicon dioxide; (vii) 8.3 mg talc; (viii) 10.7 mg magnesium stearate; and (ix) 24 mg polyvinylpyrrolidone.

14. The solid oral dosage form of claim 1 comprising (i) 331.5 mg aliskiren hemifumarate; (ii) 12.5 mg hydrochlorothiazide; (iii) 25 mg lactose and 24.5 mg wheat starch; (iv) 241.5 mg microcrystalline cellulose; (v) 100.4 mg crosslinked polyvinylpyrrolidone; (vi) 7.1 mg colloidal silicon dioxide; (vii) 4.15 mg talc; (viii) 9.35 mg magnesium stearate; and (ix) 24 mg polyvinylpyrrolidone.
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