Orally disintegrable tablets
DC CAFCFirst Claim
1. An orally disintegrable tablet which comprises(i) fine granules having an average particle diameter of 400 μ
- m or less, wherein the 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, and (c) a coating layer comprising a water-soluble sugar alcohol outside the enteric coating layer; and
(ii) wherein the additive in (ii) is comprised in the tablet separately from said fine granules in (i) in said tablet and said additive comprises water-soluble sugar alcohol, andwherein oral disintegration time for complete disintegration of the 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.
46 Citations
30 Claims
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1. An orally disintegrable tablet which comprises
(i) fine granules having an average particle diameter of 400 μ - m or less, wherein the 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, and (c) a coating layer comprising a water-soluble sugar alcohol outside the enteric coating layer; and(ii) wherein the additive in (ii) is comprised in the tablet separately from said fine granules in (i) in said tablet and said additive comprises water-soluble sugar alcohol, and wherein oral disintegration time for complete disintegration of the 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, 23, 24, 25, 26, 27, 28, 29, 30)
- m or less, wherein the fine granules comprise;
Specification