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|Title:||Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same|
|Abstract:||Monolayer, bilayer and trilayer solid dosage forms of a combination of valsartan, amlodipine and hydrochlorothiazide are made.|
|Inventor(s):||Cao; Yu (Parsippany, NJ), Joshi; Yatindra (Princeton, NJ), Li; Ping (Basking Ridge, NJ), Pudipeddi; Madhusudhan (Mumbai, IN), Royce; Alan E (Saylorsburg, PA), Wagner; Robert F (Hillsborough, NJ), Zhu; Jiahao (Whippany, NJ)|
|Assignee:||Novartis AG (Basel, CH)|
1. A solid dosage form comprising: valsartan; amlodipine; hydrochlorothiazide; and pharmaceutically acceptable additives suitable for the preparation of solid dosage
forms of valsartan, wherein the solid dosage form of valsartan/hydrochlorothiazide/amlodipine is selected from 160 mg/12.5 mg/5 mg, 160 mg/12.5 mg/10 mg, 160 mg/25 mg/10 mg, 160 mg/25 mg/5 mg and 320 mg/25 mg/10 mg, said solid dosage either in the form
of a monolayer tablet or a bilayer tablet.
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 solid dosage form takes the form of a bilayer tablet.
5. The solid dosage form of claim 4, wherein the bilayer tablet has the valsartan and the hydrochlorothiazide in a first layer and the amlodipine in a second layer.
6. The solid dosage form of claim 4, wherein the bilayer tablet has the valsartan in a first layer and the amlodipine and the hydrochlorothiazide in a second layer.
7. The solid dosage form of claim 1, wherein the pharmaceutically acceptable additives are selected from the group consisting of diluents, disintegrants, glidants, lubricants, binders, colorants and combinations thereof.
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