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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AI-Extracted 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 t...

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.

Application Domain

Organic active ingredientsDigestive system +1

Technology Topic

Aqueous solutionAdhesive +5

Examples

Experimental program(3)
Comparison scheme(3)
Effect test(1)

Example

[0048] Example Example 1

[0049] Put 4534 g of L-glutamic acid (manufactured by Kyowa Fermentation Industry 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) into stirring and granulation. Mixer (trade name: Vertical Granulator VG-25, manufactured by Powrex), and mix for 5 minutes. Dissolve 150 g of lactose (Japanese Pharmacopoeia) in 750 g of purified water heated in the temperature range of 60 to 70°C, cool to room temperature, add to the mixture, mix for 5 minutes, and put in a 0.8mm diameter sieve for extrusion Extrusion granulation in a granulator (trade name: Model DGL-1, manufactured by Fuji Paudal). After that, it was quickly transferred to a fluidized bed dryer (Model WSG-5, 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 metal mesh sieve to prepare granules for tableting. On a rotary tableting machine (trade name: AP-15 type, manufactured by Hata Iron Works) equipped with a φ13mm flat punch, the tableting granules are installed on the surface of the upper and lower punches before they are filled into the die. , The device for coating magnesium stearate on the compression mold wall, compressed and molded with a tablet weight of 728mg and a tableting pressure of 20kN to prepare oral fast-disintegrating tablets or oral-disintegrating tablets.

Example Embodiment

[0050] Example 2

[0051] Put 4534 g of L-glutamic acid (manufactured by Kyowa Fermentation Industry Co., Ltd.), 15 g of sodium azulene sulfonate (manufactured by Kotobuki Pharmaceutical Co., Ltd.), and 125 g of polyvinylpyrrolidone (manufactured by ISP) into a stirring granulator (VG-25 type, Powrex) Preparation), mixing for 5 minutes. 150g of lactose was dissolved in 750g of heated purified water, cooled to room temperature, added to the mixture, mixed for 5 minutes, and put into an extrusion granulator (DGL-1 type, Fuji Paudal) equipped with a 0.8mm diameter sieve Manufacture), extrusion granulation. After that, it was quickly transferred to a fluidized bed dryer (Model WSG-5, 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 metal mesh sieve, and 1950 g of the sized product, 50 g of polyvinylpyrrolidone, and 1 g of L-menthol were mixed to form granules for tableting. On a rotary tableting machine (trade name: AP-15 type, manufactured by Hata Iron Works) equipped with a φ13mm plane punch, the tableting granules are installed on the surface of the upper and lower punches before the pellets are filled into the die. A device for coating magnesium stearate on the compression mold wall is compressed and molded with a tablet weight of 728 mg and a tableting pressure of 20 kN to produce fast-disintegrating tablets or oral-disintegrating tablets.

Example Embodiment

[0052] Example 3

[0053] 1980 g of the dried granular product prepared in Example 1 and 20 g of magnesium stearate were mixed to form granules for tableting. Use a rotary tableting machine (AP-15 type, manufactured by Hata Iron Works) equipped with a φ13mm flat punch to compress and shape the tablet with a tablet weight of 728mg and a tableting pressure of 20kN to make quick-disintegrating tablets or intraoral Disintegrate the tablet. Comparative example 1

PUM

Description & Claims & Application Information

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