| 摘要 |
1. Granulate for the preparation of fast-disintegrating, and fast-dissolving compositions, containing an active ingredient, having a solubility in water of 1: > 10, in admixture with a water dispersible cellulose, which is a microcrystalline cellulose and sodium carboxymethyl cellulose, characterised in that the water dispersible cellulose is present in an amount of < 15 wt%, the percentage based on the weight of the active ingredient. 2. Granulate according to claim 1, characterised in that it contains 1-7.5 wt% of the water dispersible cellulose. 3. Granulate according to claim 1 or 2, characterised in that it contains 2-5 wt% of the water dispersible cellulose. 4. Granulate according to any one of claims 1-3, characterised in that the water dispersible cellulose contains 8,3-13,8 wt% of sodium carboxymethyl cellulose. 5. Granulate according to any one of claims 1-4, characterised in that it has been prepared by a conventional wet granulation technique. 6. Fast-disintegrating and fast-dissolving composition, containing at least one granulate according to any one of claims 1-5 in admixture with a first disintegrant and a second disintegrant, further pharmaceutically acceptable excipients and optionally a drug or a compound, enhancing the activity of the active ingredient incorporated in the granulate. 7. Composition according to claim 6, characterised in that one or more of the granulates according to any one of claims 1-5 are present in a total amount of > 80 wt%, in admixture with 2-8 wt% of a first disintegrant and 2-8 wt% of a second disintegrant, the percentages based on the weight of the composition. 8. Composition according to claim 7, characterised in that the first disintegrant is microcrystalline cellulose, microfine cellulose or a mixture thereof and the second disintegrant is starch or a starch derivative, cross-linked polyvinylpyrrolidone or lowsubstituted hydroxypropyl cellulose. 9. Composition according to claim 7 or 8, characterised in that the first disintegrant and the second disintegrant are present in a ratio of 1:1. |
