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Quick disintegrated tablet or oral cavity disintegrated tablet containing L-glutamic acid and azulene sodium sulfonate and making method thereof

A technology for sodium azulene sulfonate and its manufacturing method, which can be applied to medical preparations containing active ingredients, pill delivery, pharmaceutical formulations, etc., and can solve the problems of sodium azulene sulfonate, such as inhomogeneous dispersion, irritation, and tablet fragmentation

Inactive Publication Date: 2003-05-21
KYOWA HAKKO KIRIN CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the oral tablet of sodium azulene sulfonate glutamic acid described in JP-A-2000-26286 contains metal carbonate salt and organic acid in the tablet, and after contacting with saliva in the oral cavity, the metal carbonate salt decomposes to produce carbonic acid Gas (CO 2 Gas), promote the disintegration of the tablet, because it becomes a so-called effervescent agent, it is irritating to the oral cavity
[0008] In addition, in the rapidly disintegrating tablet or the orally disintegrating tablet containing L-glutamic acid and sodium azulenesulfonate, the content of sodium azulenesulfonate is significantly less than the content of L-glutamic acid. Therefore, When a molding material is prepared by simply mixing L-glutamic acid, sodium azulene sulfonate, metal carbonate, and organic acid, and then compression-molded, the manufactured tablet may not be uniformly dispersed in the tablet
[0009] In addition, for fast-disintegrating tablets or orally disintegrating tablets, in order to shorten the disintegration time to water or saliva, if the compression force is reduced when compressing the molding material, the force applied from the outside during storage and transportation of the tablet , also prone to the problem of tablet fragmentation

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Embodiment 1

[0049] 4534 g of L-glutamic acid (manufactured by Kyowa Hakko Kogyo Co., Ltd.), 15 g of sodium azulene sulfonate (manufactured by Kotobuki Pharmaceutical Co., Ltd.), and 250 g of polyvinylpyrrolidone (trade name: polyprasdone XL-10, manufactured by ISP Japan Co., Ltd.) were put into stirring granulation machine (trade name: Vertical Granulator VG-25, manufactured by Powrex), and mixed for 5 minutes. Dissolve 150 g of lactose (Japanese Pharmacopoeia) in 750 g of purified water heated at a temperature range of 60 to 70°C, cool to room temperature, add to the mixture, mix for 5 minutes, and put it into the extruder equipped with a sieve with a diameter of 0.8 mm. The pellets were extruded and pelletized in a pelletizer (trade name: DGL-1 type, manufactured by Fuji Paudal Co., Ltd.). Thereafter, it was quickly transferred to a fluidized bed dryer (WSG-5 type, manufactured by Glatt), and dried at a suction temperature of 80° C. for about 15 minutes. The dried product obtained was ...

Embodiment 2

[0051] Put 4534 g of L-glutamic acid (manufactured by Kyowa Hakko Kogyo Co., Ltd.), 15 g of sodium azulene sulfonate (manufactured by Kotobuki Pharmaceutical Co., Ltd.), and 125 g of polyvinylpyrrolidone (manufactured by ISP Co., Ltd.) into a stirring granulator (VG-25 type, Powrex Co., Ltd. system), mix for 5 minutes. 150 g of lactose was dissolved in 750 g of heated purified water, cooled to room temperature, added to the mixture, mixed for 5 minutes, and dropped into an extrusion granulator equipped with a 0.8 mm caliber sieve (DGL-1 type, Fuji Paudal Co. system), extrusion granulation. Thereafter, it was quickly transferred to a fluidized bed dryer (WSG-5 type, manufactured by Glatt), and dried at a suction temperature of 80° C. for about 15 minutes. The obtained dried product was sized with a No. 28 wire mesh sieve, and 1950 g of the sized product, 50 g of polyvinylpyrrolidone, and 1 g of L-menthol were mixed to prepare granules for tableting. On a rotary tablet machine...

Embodiment 3

[0053] Mix 1980 g of dry granules prepared in Example 1 and 20 g of magnesium stearate as granules for tableting. With a rotary tablet machine (AP-15 type, manufactured by Hata Iron Works) equipped with a flat punch of φ 13mm, the tablet weighs 728mg and the tablet pressure is 20kN for compression molding to obtain fast-disintegrating tablets or oral cavity tablets. Disintegrating tablet. Comparative example 1

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PUM

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Abstract

Quick disintegrated tablet or oral cavity disintegrated tablet containing L-glutamic acid and azulene sodium sulfonate and making method thereof are peovided. The method includes that: granulating substance is produced by pelleting the mixture of L-glutamic acid and azulene sodium sulfonate using lactose-containing water solution as adhesive and drying it, then the tablet is produced by compression moulding. The tablet is quickly disintegrable in contact with the spit in the the oral cavity without water, while it has high strength.

Description

technical field [0001] The invention relates to a rapidly disintegrating tablet or an orally disintegrating tablet containing L-glutamic acid and sodium azulene sulfonate and a manufacturing method thereof. Background technique [0002] Oral tablets containing L-glutamic acid and sodium azulenesulfonate are widely used in the form of oral tablets or powders as drugs for treating gastrointestinal disorders such as gastric ulcer, duodenal ulcer, and gastritis. [0003] However, there is a problem that a large amount of water is required when oral tablets are taken, and it is inconvenient for elderly people or children with weak swallowing power to take them. [0004] In addition, the powder has the problems of needing water and spilling the powder when taking it. [0005] Therefore, from the perspective of patients, doctors, pharmacists, etc., it is desired to provide preparations containing L-glutamic acid and sodium azulenesulfonate that can be taken without water or with a...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/255A61P1/04
Inventor 富山格富山泰竹下通广岛田知则太田元洋渡边靖吉本博一齐藤直浩森本清
Owner KYOWA HAKKO KIRIN CO LTD
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