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Tableted Medicinal Composition Comprising Nalfurafine

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.

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Patent Information

Application #
Filing Date
24 October 2019
Publication Number
44/2019
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
patent@depenning.com
Parent Application
Patent Number
Legal Status
Grant Date
2021-10-20
Renewal Date

Applicants

TORAY INDUSTRIES, INC.
1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo 703-8666, Japan

Inventors

1. MINAKAMI, Satoshi
c/o Basic Research Center, Toray Industries, Inc., 10-1, Tebiro 6-chome, Kamakura-shi, Kanagawa 248-8555, Iapan
2. TAKAKI, Suguru
c/o Basic Research Center, Toray Industries, Inc., 10-1, Tebiro 6-chome, Kamakura-shi, Kanagawa 248-8555, Japan
3. OHTA, Kotoe
c/o Basic Research Center, Toray Industries, Inc., 10-1, Tebiro 6-chome, Kamakura-shi, Kanagawa 248-8555, Japan
4. HORIUCHI, Yasuhide
c/o Basic Research Center, Toray Industries, Inc., 10-1, Tebiro 6-chome, Kamakura-shi, Kanagawa 248-8555, Japan

Specification

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.

Documents

Application Documents

# 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

Search Strategy

1 search201947043240E_22-03-2021.pdf

ERegister / Renewals

3rd: 29 Oct 2021

From 30/03/2020 - To 30/03/2021

4th: 29 Oct 2021

From 30/03/2021 - To 30/03/2022

5th: 16 Nov 2021

From 30/03/2022 - To 30/03/2023

6th: 21 Feb 2023

From 30/03/2023 - To 30/03/2024

7th: 16 Feb 2024

From 30/03/2024 - To 30/03/2025

8th: 11 Feb 2025

From 30/03/2025 - To 30/03/2026