- Patent Number:
11433,031
- Appl. No:
17/222237
- Application Filed:
April 05, 2021
- نبذة مختصرة :
A method for manufacturing a preparation which contains acetaminophen at a high content, in particular, a miniaturized tablet (conventional tablets, sustained-release tablets, etc.) which have excellent elution properties, preferable hardness and high drug content uniformity, and a premix drug substance of acetaminophen which has improved manufacturability. According to the method in which acetaminophen having a preset particle size is used for manufacturing a preparation, the flowability of acetaminophen can be improved so that secondary agglomeration can be suppressed and manufacturing efficiency can be elevated. Thus, this method is highly useful for manufacturing an acetaminophen preparation having improved administrability, for example, a reduced size.
- Inventors:
NIPPON ZOKI PHARMACEUTICAL CO., LTD. (Osaka, JP)
- Assignees:
NIPPON ZOKI PHARMACEUTICAL CO., LTD. (Osaka, JP)
- Claim:
1. A method for manufacturing a premix drug substance, wherein the method includes the steps of blending a dispersant in an amount of 0.1 to 3% relative to 100% by weight of the premix drug substance and optionally a solubilizing agent in an amount of 0 to 0.8% by weight relative to 100% by weight of the premix drug substance into unpulverized acetaminophen having a particle size distribution that d10 is 5 to 300 μm, d50 is about 120 to about 500 μm, and d90 is 200 to 900 μm in an amount of 90 to 99.9% by weight relative to 100% by weight of the premix drug substance; and then carrying out deagglomeration and/or sizing to disperse and make adhere the dispersant, or the dispersant and the solubilizing agent in and onto the surfaces of the acetaminophen particles uniformly to make powder and wherein the process prevents deterioration of agglomeration and poor flowability, wherein the dispersant is at least one of hydrated silicon dioxide or light anhydrous silicic acid.
- Claim:
2. The manufacturing method according to claim 1 , wherein the acetaminophen has the particle size distribution that d10 is 10 to 200 μm and d90 is 250 to 800 μm.
- Claim:
3. The manufacturing method according to claim 1 , wherein the dispersant is hydrated silicon dioxide.
- Claim:
4. The manufacturing method according to claim 1 , wherein the solubilizing agent is macrogol or sodium lauryl sulfate.
- Patent References Cited:
2001/0044472 November 2001 Upadhyay et al.
2012/0129878 May 2012 Murakawa et al.
102548556 July 2012
1 161 941 December 2001
S61-145111 July 1986
H10-506412 June 1998
2003-081876 March 2003
2003-509368 March 2003
2012-144520 August 2012
97/017947 May 1997
00/54752 September 2000
2001/019363 March 2001
2010/081722 July 2010
- Other References:
Japanese Pharmaceutical Excipients Directory 2007, Yakuji Nippo Ltd., pp. 65, 67, 68, 93, 100, 101, 181, 281, 282 and 318. cited by applicant
Jun. 6, 2017 International Search Report issued in International Patent Application No. PCT/JP2017/017603. cited by applicant
Nov. 13, 2018 International Preliminary Reporton Patentability issued in International Patent Application No. PCT/JP2017/017603. cited by applicant
Feb. 13, 2018 Decision to Grant a Patent issued in Japanese Application No. 2017-545607. cited by applicant
Dec. 5, 2017 Office Action issued in Japanese Application No. 2017-545607. cited by applicant
Nov. 11, 2019 Search Report issued in European Patent Application No. 17796157.0. cited by applicant
Bowen; “Particle Size Distribution Measurement from Millimeters to Nanometers and from Rods to Platelets;” Journal of Dispersion Science and Technology; vol. 23, No. 5; pp. 631-662; 2002. cited by applicant
- Primary Examiner:
Maewall, Snigdha
- Attorney, Agent or Firm:
Oliff PLC
- الرقم المعرف:
edspgr.11433031
Processing Request
No Comments.