Orally disintegrating tablet and method for producing same
AssigneeFUJIFILM Corporation
InventorsKotaro OKADA, Hisahiro MORI, Shigetomo TSUJIHATA, Yoshinori SAKATA
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Abstract
An orally disintegrating tablet including: fine granules, each fine granule having, at its center, an active pharmaceutical ingredient-containing core that includes butylscopolamine bromide and water-insoluble particles, and having an intermediate layer that includes water-insoluble particles and coats the active pharmaceutical ingredient-containing core, and a bitterness-masking layer that includes talc and at least one water-insoluble polymer, in sequence from the active pharmaceutical ingredient-containing core side; and an excipient component positioned on the outside of the fine granules, and a method for producing the same.
Claims20
An orally disintegrating tablet comprising:
- fine granules, each fine granule having, at its center, an active pharmaceutical ingredient-containing core that comprises butylscopolamine bromide and water-insoluble particles, and having an intermediate layer that comprises water-insoluble particles and coats the active pharmaceutical ingredient-containing core, and a bitterness-masking layer that comprises talc and at least one water-insoluble polymer, in sequence from the active pharmaceutical ingredient-containing core side;
- and
- an excipient component positioned on the outside of the fine granules.
A method for producing an orally disintegrating tablet, the method comprising:
- obtaining fine granules by a production process comprising:
- (A) spraying, onto a core particle that is configured to serve as a center of an active pharmaceutical ingredient-containing core, a spray liquid that comprises butylscopolamine bromide and water-insoluble particles and that is for forming an active pharmaceutical ingredient layer, so as to coat the core particle with the active pharmaceutical ingredient layer;
- (B) spraying, onto the active pharmaceutical ingredient-containing core in which the core particle has been coated with the active pharmaceutical ingredient layer, a spray liquid that comprises water-insoluble particles and that is for forming an intermediate layer, so as to coat the active pharmaceutical ingredient-containing core with the intermediate layer;
- and
- (C) spraying, onto the active pharmaceutical ingredient-containing core that has been coated with at least the intermediate layer, a spray liquid that comprises talc and at least one water-insoluble polymer and that is for forming a bitterness-masking layer, so as to coat the active pharmaceutical ingredient-containing core with the bitterness-masking layer;
- and
- mixing the obtained fine granules with an excipient component.
Dependencies are inferred from the claim text.