Tablet quickly disintegrating in the oral cavity and method for producing the same
a technology of oral cavity and tablet, which is applied in the direction of biocide, drug composition, peptide/protein ingredients, etc., can solve the problems of difficult to achieve good disintegrability and tablet strength, and achieve rapid disintegration, good disintegrability, and sufficient strength in combination
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example 1
Preparation of Tablet of Example 1
[0055]To heated purified water were added D-mannitol (200 g) and AMICOL C (7 g) to give a binding solution (1000 g) for active ingredient. Using Multiplex MP-01 (manufactured by POWREX CORPORATION), only the active ingredient was granulated with the above-mentioned binding solution for active ingredient to give active ingredient granules. Separately, to heated purified water was added AMICOL C (7 g) to give a binding solution (360 g) for placebo granules. Each component other than the active ingredient was charged in a container, and granulated using the above-mentioned binding solution for placebo granules to give placebo granules. Table 1 shows the composition of the mixture before the granulation step.
TABLE 1active ingredientplacebocomponentsgranulesgranulesdroxidopa500 g—D-mannitol—432 g cornstarch—88 ganhydrous—10 gcitric acidaspartame—10 g
[0056]The active ingredient granules (282.8 g), placebo granules (89.2 g), cornstarch (20.0 g) and sodium ...
example 2
[0059]To heated purified water were added D-mannitol (4500 g) and AMICOL C (300 g) to give a binding solution (22500 g). Each component indicated in Table 3 was charged in FLO-COATER FLF-30 (manufactured by Freund Corporation), and granulated with the above-mentioned binding solution. After drying, the resulting granules (28440 g) and cornstarch (1500 g) were mixed, and the mixture was tableted by a rotary tableting machine and an external lubrication system (manufactured by Kikusui Seisakusho Ltd.) using a small amount of magnesium stearate as a lubricant at a tableting pressure of 15 kN, whereby tablets (diameter 10 mm, weight about 400 mg) were obtained. The content of magnesium stearate is about 0.4-0.8 mg per 200 tablets.
[0060]Droxidopa used here was micronized in advance, and used was that having an average particle size of 50-100 μm.
TABLE 3componentsExample 2droxidopa15000 g D-mannitol7080 gcornstarch1500 gaspartame 75 g
example 3
[0061]To heated purified water were added D-mannitol (4500 g) and AMICOL C (300 g) to give a binding solution (22500 g). Each component indicated in Table 4 was charged in FLO-COATER FLF-30 (manufactured by Freund Corporation), and granulated using the above-mentioned binding solution. After drying, the resulting granules (26955 g) and cornstarch (3000 g) were mixed, and the mixture was tableted by a rotary tableting machine and an external lubrication system (manufactured by Kikusui Seisakusho Ltd.) using, in the same manner as in Example 2, magnesium stearate as a lubricant and a 10-mm-diameter R-surface punch at a tableting pressure of 12 kN, whereby tablets (weight about 400 mg) were obtained.
[0062]Droxidopa used here were that micronized in advance in the same manner as in Example 2.
TABLE 4componentsExample 3droxidopa15000 gD-mannitol 7080 gaspartame 75 g
(Properties of Tablet)
[0063]The tablet properties of the samples of Examples 2 and 3 are shown in Table 5. The friability wa...
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