Claims
- 1. A quick-disintegrating tablet in the buccal cavity comprising a drug, a diluent, and a saccharide with a relatively lower melting point than said drug and said diluent, which is obtained by uniformly mixing the saccharide with a low melting point in the tablet, and wherein a bridge is formed between said drug and/or said diluent particles by the product of melting and then solidification of the saccharide with a low melting point.
- 2. The quick-disinterating tablet in the buccal cavity of claim 1, wherein the saccharide with a low melting point is one whose melting point is at least 10° C. lower than that of the drug and diluent.
- 3. The quick-disintegrating tablet in buccal cavity of claim 1 or 2, wherein the saccharide with a low melting point is one or two or more selected from the group consisting of xylitol, trehalose, maltose, sorbitol, erythritol, glucose, maltitol, mannitol, sucrose, and their hydrates.
- 4. The quick-disintegrating tablet in the buccal cavity in any one of claims 1 through 3, wherein the amount of saccharide with a low melting point is 0.5 to 25 w/w % in terms of the drug and/or the diluent.
- 5. The quick-disintegrating tablet in the buccal cavity in any one of claims 1 through 4, wherein a binder is further added.
- 6. The quick-disintegrating tablet in the buccal cavity in any one of claims 1 through 5, wherein the diluent is a saccharide with a relatively higher melting point than the saccharide with a low melting point in claims 1 through 4.
- 7. The quick-disintegrating tablet in the buccal cavity in claim 6, wherein the saccharide with a high melting point in claim 6 is one or two or more selected from the group consisting of xylitol, trehalose, maltose, sorbitol, erythritol, glucose, maltitol, mannitol, sucrose, lactose, and their hydrates.
- 8. The quick-disintegrating tablet in the buccal cavity in claim 7, wherein the saccharide with a high melting point in claim 7 is one or two or more selected from the group consisting of mannitol, sucrose, lactose, and their hydrates.
- 9. The quick-disintegrating tablet in the buccal cavity in any one of claims 1 through 8, wherein the saccharide with a low melting point is trehalose and/or erythritol and the saccharide with a high melting point is mannitol and/or lactose.
- 10. The quick-disintegrating tablet in the buccal cavity in claim 9, wherein the saccharide with a low melting point is erythritol and the saccharide with a high melting point is mannitol.
- 11. The quick-disintegrating tablet in the buccal cavity in claim 5, wherein the saccharide with high moldability and/or a water-soluble polymer serves as part of the binder.
- 12. The quick-disintegrating tablet in the buccal cavity in claim 11, wherein the binder is maltitol and/or copolyvidone.
- 13. The quick-disintegrating tablet in the buccal cavity in any one of claim 1 through 12, wherein porosity is 10 to 80%.
- 14. The quick-disintegrating tablet in the buccal cavity in claim 13, wherein porosity is 20 to 50%.
- 15. The quick-disintegrating tablet in the buccal cavity in any one of claim 1 through 14, where tablet hardness is 3 kp or higher and the friability is 1% or less.
- 16. The quick-disintegrating tablet in the buccal cavity in claim 15, where tablet hardness is 4 kp or higher and the friability is 0.8% or less.
- 17. The quick-disintegrating tablet in the buccal cavity in claim 16, wherein the friability is 0.5% or less.
- 18. The quick-disintegrating tablet in the buccal cavity in claims 1 through 17, wherein the amount of drug added is at least the effective amount in terms of treatment and no more than 80 w/w % tablet weight.
- 19. A method of manufacturing a quick-disintegrating tablet in the buccal cavity comprising a drug, a diluent and a saccharide with a relatively lower melting point than said drug and said diluent, which comprises: (a) the process whereby tablet starting materials including the drug, the diluent, and the saccharide with a relatively lower melting point than said drug and said diluent are molded under the low pressure necessary for retaining the shape of a tablet, (b) the process whereby the molded product obtained by process (a) is heated to at least the temperature at which the saccharide with a low melting point will melt, and (c) the process whereby the molded product obtained by process (b) is cooled to at least the temperature at which the molten saccharide with a low melting point solidifies.
- 20. The method of manufacturing a quick-disintegrating tablet in the buccal cavity of claim 19, wherein by means of process (a) in claim in 19, the drug, the diluent, and the saccharide with a relatively lower melting point than said drug and said diluent are physically mixed to obtain the tablet starting materials.
- 21. The method of manufacturing a quick-disintegrating tablet in the buccal cavity in claim 19, wherein by means of process (a) in claim 19, the saccharide with a low melting point is dissolved and/or suspended in a pharmaceutically acceptable solvent and sprayed as a binder for coating and/or granulation to obtain the tablet starting materials.
- 22. The method of manufacturing a quick-disintegrating tablet in the buccal cavity is claim 19, wherein by means of process (a) in claim 19, the saccharide with a low melting point is mixed with the drug and the diluent as particles and/or powder and granulation is performed using a binder solution to obtain the tablet starting materials.
- 23. The method of manufacturing a quick-disintegrating tablet in the buccal cavity in claim 19, wherein by means of process (a) in claim 19, the tablet starting materials are molded under a tableting pressure of 25 to 800 kg/punch.
- 24. The method of manufacturing a quick-disintegrating tablet in the buccal cavity in claim 19, wherein by means of process (b) in claim 19, heating is performed at a temperature between the melting point of the saccharide with a low melting point and the melting point of the drug and diluent.
- 25. The method of manufacturing a quick-disintegrating tablet and the buccal cavity in claim 19, which further comprises (d) the process whereby the molded product is humidified and dried.
- 26. The method of manufacturing a quick-disintegrating tablet in the buccal cavity in claim 25, wherein process (d) in claim 25 is between process (a) and process (b), or after process (c).
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. provisional application no. 60/290,300 filed May 10, 2001.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60290300 |
May 2001 |
US |