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US 2018/0000730 A1Published application
Oral disintegrating tablet
AssigneeBoehringer Ingelheim International GmbH
InventorsManabu NAKATANI, Yohei KAWABATA, Takeshi SAWADA, Hiroshi TAKASAKI
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Abstract
A process for the preparation of an oral disintegrating tablet comprising the antihypertensive telmisartan and the tablet obtained by the process.
Claims3
An oral disintegrating tablet having 150-740 mg comprising
- 20-80 mg angiotensin II receptor antagonist telmisartan
- 20-80 mg basic excipient selected from the group consisting of alkali metal hydroxides, basic amino acids and meglumine
- 20-350 mg filler selected from the group consisting of cellulose, dibasic calcium phosphate anhydrous, erythritol, mannitol, microcrystalline cellulose, corn starch, and pregelatinized starch,
- 20-150 mg coating agent of the first granulate selected from corn starch, pregelatinized starch, lactose, D-mannitol, erythritol or microcrystalline cellulose
- 5-50 mg disintegrant selected from the group consisting of sodium starch glycolate, crospovidone, corn starch and pregelatinized starch
- 2-20 mg surfactant/emulsifier poloxamer 188
- 0.5-10 mg sweetener
- 0.12-1.2 mg flow control agent light anhydrous silicic acid
- 0-0.01 mg lubricant
- 0-0.01 mg dye or pigment
- wherein
- the basic excipient is meglumine;
- the filler is selected from the group consisting of cellulose, dibasic calcium phosphate anhydrous, erythritol, mannitol, microcrystalline cellulose corn starch and pregelatinized starch;
- the disintegrant is selected from the group consisting of sodium starch glycolate, crospovidone (cross-linked polyvinylpyrrolidone), corn starch and pregelatinized starch;
- the coating agent of the first granulate is selected from corn starch or pregelatinized starch;
- the lubricant is magnesium stearate;
- the sweetener is saccharin sodium;
- the dye or pigment is an iron oxide.
15 more elements
Dependencies are inferred from the claim text.