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Method for producing fine powder of loxoprofen sodium dihydrate for pharmaceutical preparations

A technology of loxoprofen sodium dihydrate and a manufacturing method, which is applied in the field of micropowder of loxoprofen sodium dihydrate, can solve problems such as hindering processing, and achieve the effects of improving productivity, increasing productivity, and lower operating costs

Active Publication Date: 2014-01-22
HAMARI CHEM LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, as described in Patent Documents 1 to 4, it is well known that the powder of loxoprofen sodium dihydrate has the following properties: it has a characteristic adhesion and fixation property to the substance, so that it adheres between drugs or on equipment, containers, etc. , fixed and significantly hinder processing
Therefore, in order to pulverize loxoprofen sodium to the required particle size or particle size distribution as a preparation raw material, it is necessary to prevent clogging of the pulverizer caused by loxoprofen sodium adhesion and fixation, and the resulting Due to the special consideration of quality deterioration due to melting due to frictional heat, it is necessary to produce fine powder of loxoprofen sodium even at the expense of productivity
[0010] It can be seen that there is no established technology for avoiding the attachment and fixation of loxoprofen sodium to the interior of the pulverizer and the pulverization unit during pulverization and to efficiently produce loxoprofen sodium fine powder

Method used

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  • Method for producing fine powder of loxoprofen sodium dihydrate for pharmaceutical preparations
  • Method for producing fine powder of loxoprofen sodium dihydrate for pharmaceutical preparations
  • Method for producing fine powder of loxoprofen sodium dihydrate for pharmaceutical preparations

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Pulverization was performed with an atomizing pulverizer which is an impact pulverizer using a pin hammer with a built-in air classification mechanism.

[0062] The crystals of loxoprofen sodium dihydrate (manufactured by Yonezawa Hamari Pharmaceutical Co., Ltd.) were pulverized using ACM Palberaiza 2EC (trade name) manufactured by Hosokawa Mikron Corporation.

[0063] Testing machine: ACM パルベライザ 2EC (trade name, manufactured by Hosokawa Micron Co., Ltd.)

[0064] Pin hammer crushing rotor: maximum speed 12000rpm

[0065] Grading rotor: maximum speed 6000rpm

[0066] Lining: Glossy Lining

[0067] Grading rotor: short type

[0068] There is no cold air in the pulverizer (room temperature is about 27° C.).

[0069] Regarding the amount of loxoprofen sodium dihydrate (used powder amount) used in the pulverization performed by the ACM パルベライザ 2EC pulverizer, the first test (Run.No.001) was 0.7 kg, and the second test ( Run.No.002) is 50kg.

[0070] Regarding the pulve...

preparation example 1

[0100] Formulation example 1 (manufacture of tablet)

[0101]

[0102] (1) to (4) were kneaded with water, vacuum-dried, and then granulated. Mix (5) with this granulated powder, and perform tableting by a tablet machine. By this method, 1600 tablets containing 70 mg of loxoprofen sodium dihydrate per 250 mg tablet were obtained.

preparation example 2

[0103] Preparation Example 2 (Manufacture of Adhesive for Adhesive Preparation)

[0104]

[0105] After mixing (2) to (4), the fine powder of loxoprofen sodium dihydrate produced in Example 1 of (1) was added and mixed to obtain a uniform adhesive.

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PUM

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Abstract

A method for producing a fine powder of loxoprofen sodium dihydrate for pharmaceutical preparations, said method comprising milling loxoprofen sodium dihydrate crystals or a crystalline powder of loxoprofen sodium dihydrate with an impact mill, preferably a pulverizer-type mill, which is provided with a built-in air-classifying system and comprises a pin hammer, to thereby continuously produce a fine powder of loxoprofen sodium dihydrate the volume-average particle size of which is in the range of 20-120 [mu]m, when measured with a laser diffraction particle size analyzer.

Description

technical field [0001] The present invention relates to a method for producing loxoprofen sodium dihydrate preparation micropowder, in particular, relates to high productivity production of loxoprofen sodium having a volume average particle diameter in the range of 20 to 120 μm when measured by a laser diffraction particle size distribution meter. Method for the micronization of Soprofen Sodium Dihydrate. Background technique [0002] Loxoprofen sodium (common name) (2-[4-(2-oxocyclopentane-1-ylmethyl) phenyl] sodium propionate (chemical name)) is a non-steroidal anti-inflammatory, analgesic, Antipyretics are widely used in the treatment of chronic joint rheumatism, osteoarthritis, low back pain, etc. [0003] Usually, the powder of the original drug used in the preparation of pharmaceuticals must be pulverized to an appropriate particle size. As the reason, the following i)-iii) etc. are mentioned. i) Uniform mixing with excipients and the like is facilitated by making t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61K9/14A61K9/20B02C13/22
CPCA61K9/2054A61K31/192A61P19/02A61P29/00A61K9/14A61K2121/00
Inventor 古山昌裕吉田幸吉
Owner HAMARI CHEM LTD
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