Orally disintegrable tablets
DC CAFC
First Claim
1. An orally disintegrable tablet which comprises(i) fine granules having an average particle diameter of 300 to 400 μ
- m, which fine granules comprise;
(a) a core composition comprising excipient and 10 weight % or more of an acid-labile physiologically active substance, (b) an enteric coating layer for the core composition comprising a first component that is an enteric coating agent and a second component that is a sustained-release agent, and (c) a coating layer comprising mannitol outside the enteric coating layer; and
(ii) a water-soluble sugar alcohol, wherein said water-soluble sugar alcohol is comprised in the tablet separately from said fine granules (i) in said tablet and wherein the water-soluble sugar alcohol separate from said fine granules is in an amount of 5 to 97 weight % relative to 100 weight % of the orally disintegrable tablet apart from the fine granules;
wherein said tablet having a hardness strength of about 1 to about 20 kg is orally disintegrable;
and wherein the oral disintegration time for complete disintegration of said tablet is one minute or less.
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Abstract
An orally disintegrable tablet of the present invention, which comprises (i) fine granules having an average particle diameter of 400 μm or less, which fine granules comprise a composition coated by an enteric coating layer, said composition having 10 weight % or more of an acid-labile physiologically active substance and (ii) an additive, has superior disintegrability or dissolution in the oral cavity so that it can be used for treatment or prevention of various diseases, as an orally disintegrable tablet capable of being administered to the aged or children and easily administered without water. Also, because the tablet of the present invention contains fine granules having the average particle diameter such that it will not impart roughness in mouth, it can be administered easily without discomfort at the administration.
65 Citations
22 Claims
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1. An orally disintegrable tablet which comprises
(i) fine granules having an average particle diameter of 300 to 400 μ - m, which fine granules comprise;
(a) a core composition comprising excipient and 10 weight % or more of an acid-labile physiologically active substance, (b) an enteric coating layer for the core composition comprising a first component that is an enteric coating agent and a second component that is a sustained-release agent, and (c) a coating layer comprising mannitol outside the enteric coating layer; and(ii) a water-soluble sugar alcohol, wherein said water-soluble sugar alcohol is comprised in the tablet separately from said fine granules (i) in said tablet and wherein the water-soluble sugar alcohol separate from said fine granules is in an amount of 5 to 97 weight % relative to 100 weight % of the orally disintegrable tablet apart from the fine granules; wherein said tablet having a hardness strength of about 1 to about 20 kg is orally disintegrable; and wherein the oral disintegration time for complete disintegration of said tablet is one minute or less. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
- m, which fine granules comprise;
Specification
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- Resources
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Current AssigneeTakeda Pharmaceutical Company Limited
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Original AssigneeTakeda Pharmaceutical Company Limited
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InventorsTabata, Tetsuro, Morimoto, Shuji, Shimizu, Toshihiro
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Primary Examiner(s)TRAN, SUSAN T
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Application NumberUS10/017,755Publication NumberTime in Patent Office2,534 DaysField of Search424/466, 424/468, 424/471, 424/472, 424/473, 424/490, 424/491, 424/493US Class Current424/466CPC Class CodesA61K 31/4439 containing a five-membered ...A61K 9/0056 Mouth soluble or dispersibl...A61K 9/1611 Inorganic compoundsA61K 9/1652 Polysaccharides, e.g. algin...A61K 9/2081 with microcapsules or coate...A61K 9/28 Dragees; Coated pills or ta...A61K 9/5026 obtained by reactions only ...A61K 9/5042 Cellulose; Cellulose deriva...A61K 9/5073 having two or more differen...A61P 1/04 for ulcers, gastritis or re...A61P 43/00 Drugs for specific purposes...
