Solid oral dosage forms of valsartan
AssigneeNovartis AG
InventorsRobert Frank Wagner, Yoshimitsu Katakuse, Takashi Taike, Fujiki Yamato, Manfred Kohlmeyer
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Abstract
The present invention is concerned with solid dosage forms comprising a) valsartan and optionally HCTZ, and b) pharmaceutically acceptable additives suitable for the preparation of solid oral dosage forms by compression methods.
Claims53
A compressed solid dosage form comprising
- a) an active agent containing 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.
A compressed solid dosage form which comprises an effective amount of valsartan or a pharmaceutically acceptable salt thereof;
- an effective amount of HCTZ;
- and,
- at least one pharmaceutically acceptable additive.
A process of forming a compressed solid dosage form containing more than 35% by weight of valsartan or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable additive wherein the process comprises the steps of:
- i) blending the valsartan and at least one pharmaceutically acceptable additive to form a mixture;
- ii) subjecting the mixture to compression to form a coprimate;
- iii) converting the coprimate into a granulate;
- and,
- iv) compressing the granulate to form the compressed solid dosage form.
A process of forming a compressed solid dosage from containing more than 35% by weight of valsartan or a pharmaceutically acceptable salt thereof, an effective amount of HCTZ and at least one pharmaceutically acceptable additive wherein the process comprises the steps of:
- i) blending the valsartan, HCTZ and at least one pharmaceutically acceptable additive to form a mixture;
- ii) subjecting the mixture to compression to form a coprimate;
- iii) converting the coprimate into a granulate;
- and,
- iv) compressing the granulate to form the compressed solid dosage form.
Dependencies are inferred from the claim text.