Quickly disintegrating solid preparations

a technology of solid preparations and dissolving liquids, applied in the field of solid preparations, can solve problems such as undesirable pulverization

Inactive Publication Date: 2005-10-27
OHKOUCHI KAZUHIRO +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0082] The preparation of the invention may contain a starch product as an excipient such as corn starch, potato starch, wheat starch, rice starch, partially gelatinized starch, gelatinized starch, porous starch, and the like, and various additives used for production of general pharmaceutical preparations, in their respective suitable amounts, unless they interfere with the effect of the invention. Such additives include excipients, binders, sour agents, foaming agents, artificial sweeteners, flavoring agents, lubricants, colorants, stabilizers, pH-modifiers, surfactants, and the like.
[0083] Excipients include inorganic excipients such as anhydrous calcium phosphate, precipitated calcium carbonate, calcium silicate, light anhydrous silicic acid, and the like.
[0084] Binders include hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, powdered acacia, gelatin, pullulan, and the like.
[0085] Sour agents include citric acid, tartaric acid, malic acid, ascorbic acid, and the like.
[0086] Foaming agents include sodium bicarbonate, sodium carbonate, and the like. Sweeteners include saccharin sodium, dipotassium glycylrrhizinate, aspartame, stevia, thaumatin, and the like.
[0087] Flavoring agents include lemon oil, orange oil, menthol, and the like.

Problems solved by technology

In addition, pulverization is undesirable not only because it strengthens the friction at the surface of the mortar wall but also from the viewpoint of handling because it reduces fluidity during the production of the tablet preparation (Summary of lectures at the 14th Symposium on Particulate Preparations and Designs, p.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0110] A 40 g portion of manidipine hydrochloride, 303.4 g of D-mannitol (Towa Chemical Industry Co., Ltd.: Mannit S, mean particle diameter of 130 μm), 50 g of crystalline cellulose (Asahi Chemical Industry Co., Ltd.), 50 g of corn starch (Japan Corn Starch), and 1 g of light anhydrous silicic acid (YKF) were placed in a fluidized bed granulating dryer (Powrex Co., LAB-1 type), and 139 g of purified water containing 18 g of D-mannitol and 0.6 g of yellow ferric oxide (Anstead) was sprayed, followed by granulating and drying processes, to give granules.

[0111] To 347 g of the granules, 25 g of crospovidone (ISP Inc.), 1 g of light anhydrous silicic acid, 10 g of magnesium stearate (Taihei Kagaku Sangyo Co. Ltd.), and 1 g of aspartame (Ajinomoto Co. Ltd.) were added, to give a mixed powder.

[0112] This mixed powder was tabletted into tablets weighing 250 mg each (Kikusui Seisakusho, Correct 12HUK, tablet size of 9.5 mmφ, compression pressure of 9.8 kN (1 ton) / cm2)

example 2

[0113] A 180 g portion of manidipine hydrochloride, 495 g of D-mannitol (Merck Co.: 1.05980, mean particle diameter of 45 μm), 225 g of corn starch, 112.5 g of crystalline cellulose, 2 g of light anhydrous silicic acid, and 56.3 g of crospovidone were placed in a fluidized bed granulating dryer (Powrex Co., FD-3SN type), and 540 g of purified water containing 42.8 g of D-mannitol and 1.4 g of yellow ferric oxide was sprayed, followed by granulating and drying processes, to give granules A.

[0114] Separately, 872.1 g of D-mannitol (Towa Chemical Industry Co., Ltd.: Mannit S), 112.5 g of crystalline cellulose, and 56.3 g of crospovidone were placed in a fluidized bed granulating dryer (Powrex Co., FD-3SN type), and 540 g of purified water containing 36.2 g of D-mannitol and 1.4 g of yellow ferric oxide was sprayed, followed by granulating and drying processes, to give granules B.

[0115] A 1003 g portion of granules A, 971 g of granules B, 6.3 g of light anhydrous silicic acid, 4.1 g o...

example 3

[0117] A 90 g portion of manidipine hydrochloride, 416 g of D-mannitol (Merck Co.: 1.05980, mean particle diameter of 45 μm), 189 g of corn starch, 94.5 g of crystalline cellulose, 1.7 g of light anhydrous silicic acid, and 47.3 g of crospovidone were placed in a fluidized bed granulating dryer (Powrex Co., FD-3SN type), and 423 g of purified water containing 33.5 g of D-mannitol and 0.4 g of yellow ferric oxide was sprayed, followed by granulating and drying processes, to give granules C.

[0118] Separately, 884 g of D-mannitol (Towa Chemical Industry Co., Ltd.: Mannit S), 105 g of crystalline cellulose, and 52.5 g of crospovidone were placed in a fluidized bed granulating dryer (Powrex Co., FD-3SN type), and 540 g of purified water containing 35.7 g of D-mannitol and 0.4 g of yellow ferric oxide was sprayed, followed by granulating and drying processes, to give granules D.

[0119] A 760 g portion of granules C, 845 g of granules D, 5.1 g of light anhydrous silicic acid, 3.9 g of asp...

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Abstract

Quickly disintegrating solid preparations which contain: a) an active ingredient; b) D-mannitol having an average particle size of 30 μm to 300 μm; c) a disintegrating agent; and d) celluloses.

Description

TECHNICAL FIELD [0001] The present invention relates to solid preparations that disintegrate quickly in the presence of saliva or a small amount of water in the oral cavity, particularly those useful as intraorally disintegrating solid preparations. BACKGROUND ART [0002] For aged people and children who are difficult to swallow drugs, solid preparations that disintegrate or dissolve quickly in the oral cavity have long been developed. For example, an intraorally disintegrating tablet preparation is described in the International Publication No. WO93 / 12769, which is obtained by suspending a drug, lactose, and mannitol in aqueous agar solution, filling the resulting suspension in a molding pocket or the like, and drying the molding under reduced pressure. This molding shows quick disintegration but is more fragile than usual tablets so that it is readily cracked, chipped, etc. and a long time is required for its production; thus the process for production is poor in productivity. In J...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K9/20A61K9/26A61K31/41A61K31/426
CPCA61K9/0056A61K9/2018A61K9/2054A61K31/426A61K9/2077A61K31/41A61K9/2059
Inventor OHKOUCHI, KAZUHIROKOYAMA, HIROYOSHI
Owner OHKOUCHI KAZUHIRO
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