Abstract: The purpose of the present invention is to provide a tableted medicinal composition comprising nalfurafine or a pharmacologically acceptable acid addition salt thereof said composition having a high moldability and excellent quality control properties of analogous substances. Provided is a tableted medicinal composition comprising nalfurafine or a pharmacologically acceptable acid addition salt thereof a binder component and a carrier wherein: the content of nalfurafine or a pharmacologically acceptable acid addition salt thereof is 0.1-10 µg; and the weight of the binder component is 100000-2000000 wt% relative to the weight of nalfurafine or a pharmacologically acceptable acid addition salt thereof and 5-20 wt% relative to the total weight of the obtained medicinal composition or 20000-500000 wt% and 1-5 wt% relative to the total weight of the obtained medicinal composition.
WE CLAIM:
1. A tableted pharmaceutical composition comprising nalfurafme or a
pharmaceutically acceptable acid addition salt thereof; a binder component selected
from the group consisting of maltose, maltitol, dextrin and pullulan; and a carrier,
wherein said nalfurafme or a pharmaceutically acceptable acid addition salt thereof is contained in an amount of 0.1 to 10 jig, and
the weight of said binder component is 100,000 to 2,000,000 weight % based on the weight of said nalfurafme or a pharmaceutically acceptable acid addition salt thereof and 5 to 20 weight % based on the total weight of the resulting pharmaceutical composition.
2. A tableted pharmaceutical composition comprising nalfurafme or a
pharmaceutically acceptable acid addition salt thereof; a binder component
containing hydroxypropyl cellulose whose 2% aqueous solution has a viscosity of
greater than 5.9 mPas at 20°C; and a carrier,
wherein said nalfurafme or a pharmaceutically acceptable acid addition salt thereof is contained in an amount of 0.1 to 10 jig, and
the weight of said binder component is 20,000 to 500,000 weight % based on the weight of said nalfurafme or a pharmaceutically acceptable acid addition salt thereof and 1 to 5 weight % based on the total weight of the resulting pharmaceutical composition.
3. The pharmaceutical composition according to claim 1, wherein the weight of said binder component is 100,000 to 400,000 weight % based on the weight of said nalfurafme or a pharmaceutically acceptable acid addition salt thereof.
4. The pharmaceutical composition according to claim 2, wherein the weight of said binder component is 20,000 to 100,000 weight % based on the weight of said nalfurafme or a pharmaceutically acceptable acid addition salt thereof.
5. The pharmaceutical composition according to any one of claims 1 to 4, wherein said nalfurafme or a pharmaceutically acceptable acid addition salt thereof is contained in an amount of 1 to 5 ug.
6. The pharmaceutical composition according to any one of claims 1 to 5, wherein said carrier is selected from the group consisting of mannitol, glucose, anhydrous crystalline fructose, lactose and maltitol.
7. A tablet composed of the pharmaceutical composition according to any one of claims 1 to 6.
| # | Name | Date |
|---|---|---|
| 1 | 201947043240.pdf | 2019-10-24 |
| 2 | 201947043240-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [24-10-2019(online)].pdf | 2019-10-24 |
| 3 | 201947043240-STATEMENT OF UNDERTAKING (FORM 3) [24-10-2019(online)].pdf | 2019-10-24 |
| 4 | 201947043240-PROOF OF RIGHT [24-10-2019(online)].pdf | 2019-10-24 |
| 5 | 201947043240-PRIORITY DOCUMENTS [24-10-2019(online)].pdf | 2019-10-24 |
| 6 | 201947043240-FORM 1 [24-10-2019(online)].pdf | 2019-10-24 |
| 7 | 201947043240-DRAWINGS [24-10-2019(online)].pdf | 2019-10-24 |
| 8 | 201947043240-DECLARATION OF INVENTORSHIP (FORM 5) [24-10-2019(online)].pdf | 2019-10-24 |
| 9 | 201947043240-COMPLETE SPECIFICATION [24-10-2019(online)].pdf | 2019-10-24 |
| 10 | 201947043240-CLAIMS UNDER RULE 1 (PROVISIO) OF RULE 20 [24-10-2019(online)].pdf | 2019-10-24 |
| 11 | 201947043240-FORM-26 [31-10-2019(online)].pdf | 2019-10-31 |
| 12 | Correspondence by Agent_Proof of Right-Form 1, GPA_01-11-2019.pdf | 2019-11-01 |
| 13 | 201947043240-FORM 3 [07-04-2020(online)].pdf | 2020-04-07 |
| 14 | 201947043240-FORM 18 [01-03-2021(online)].pdf | 2021-03-01 |
| 15 | 201947043240-OTHERS [20-09-2021(online)].pdf | 2021-09-20 |
| 16 | 201947043240-Information under section 8(2) [20-09-2021(online)].pdf | 2021-09-20 |
| 17 | 201947043240-FORM 3 [20-09-2021(online)].pdf | 2021-09-20 |
| 18 | 201947043240-FER_SER_REPLY [20-09-2021(online)].pdf | 2021-09-20 |
| 19 | 201947043240-CLAIMS [20-09-2021(online)].pdf | 2021-09-20 |
| 20 | 201947043240-FER.pdf | 2021-10-18 |
| 21 | 201947043240-PatentCertificate20-10-2021.pdf | 2021-10-20 |
| 22 | 201947043240-RELEVANT DOCUMENTS [30-09-2023(online)].pdf | 2023-09-30 |
| 1 | search201947043240E_22-03-2021.pdf |