Dry-coated orally-disintegrating tablet
View Patent ↗The purpose of the present invention is to provide a press-coated orally-disintegrating tablet characterized by containing an inner core which has an excellent disintegratability in oral cavity and a suitable hardness as a whole tablet. The present invention relates to a press-coated orally-disintegrating tablet with an outer layer surrounding an inner core wherein the inner core has a thickness in the range of 10 to 90% per that of the whole tablet, and the outer layer comprises (a) microcrystalline cellulose, (b) an inorganic excipient, and (c) one or more particular ingredients selected from the group consisting of crospovidone, starches, low substituted hydroxypropylcellulose and carmellose.
1. A press-coated orally-disintegrating tablet with an inner core which is a powder/granular material with poor formability and an outer layer surrounding the inner core wherein
the inner core has a thickness in the range of 20 to 80% per that of the whole tablet, and
the outer layer consisting of (a) microcrystalline cellulose, (b) one or more inorganic excipients selected from the group consisting of calcium hydrogen phosphate, calcium hydrogen phosphate anhydrate, and monobasic calcium phosphate, (c) one or more particular ingredients selected from the group consisting of crospovidone, starches and low substituted hydroxypropylcellulose, and (d) one or more additional formulation ingredients, wherein the one or more additional formulation ingredients (d) are one or two selected from the group consisting of fillers, disintegrants, binders, sweetening agents, taste correctives/odor correctives, stabilizer, surfactant, fluidizing agents, antistatic agents, coating agents, lubricants, colorants, and flavors,
wherein the microcrystalline cellulose (a) is contained in the range of 5 to 80 wt % per 100 wt % of the outer layer,
the total content of the inorganic excipient (b) is contained in the range of 30 to 60 wt % per 100 wt % of the outer layer,
the total content of the one or more particular ingredients (c) is in the range of 1 to 40 wt % per 100 wt % of the outer layer, and
the one or more additional formulation ingredients are contained in the range of 0.01 to 25 wt % per 100 wt % of the outer layer,
wherein the absolute hardness of the press-coated orally-disintegrating tablet is 1.5 N/mm 2 or more.
2. The press-coated orally-disintegrating tablet of claim 1 wherein the starches are corn starch.
3. The press-coated orally-disintegrating tablet of claim 1 wherein the particular ingredients (c) are one or two selected from the group consisting of crospovidone and corn starch.
4. The press-coated orally-disintegrating tablet of claim 1 wherein the particular ingredients (c) are crospovidone.
5. The press-coated orally-disintegrating tablet of claim 1 wherein the porosity in the outer layer is 1 to 40%.
6. The press-coated orally-disintegrating tablet of claim 1 wherein the inner core comprises an active ingredient.