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Solid formulation for dialysis and process for producing the same

A solid preparation and particle technology, applied in the field of 3-dosage dialysis solid preparations and dialysis solid preparations, to achieve the effects of easy handling, stable long-term storage, inhibition of coagulation and consolidation

Inactive Publication Date: 2009-11-11
NIPRO CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since each patient needs about 300 L of dialysate in one dialysis, when dialysis treatment is performed on multiple patients, a large amount of concentrated solution must be used and must be diluted with water.

Method used

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  • Solid formulation for dialysis and process for producing the same
  • Solid formulation for dialysis and process for producing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] 32.0 parts by weight of magnesium chloride and 103.35 parts by weight of anhydrous sodium acetate are uniformly dissolved in 323.2 parts by weight of purified water to prepare an aqueous solution. 984.9 parts by weight of sodium chloride with an average particle size of 300 μm flowing in a rotating fluidized bed granulator (MP-01, manufactured by Pak Rec Co., Ltd.), under the conditions of an intake air temperature of 80°C and a rotor speed of 300 rpm , Spraying with the above-mentioned aqueous solution and drying it to produce granular granules of first particles with an average particle diameter of 500 μm.

[0071]Then, 47.0 parts by weight of potassium chloride, 69.5 parts by weight of calcium chloride, and 103.35 parts by weight of anhydrous sodium acetate were uniformly dissolved in 525.4 parts by weight of purified water to prepare an aqueous solution. 984.9 parts by weight of sodium chloride with an average particle diameter of 300 μm flowing in a fluidized bed granu...

Embodiment 2

[0074] 47.0 parts by weight of potassium chloride, 32.0 parts by weight of magnesium chloride, and 103.35 parts by weight of anhydrous sodium acetate were uniformly dissolved in 435.8 parts by weight of purified water to prepare an aqueous solution. 984.9 parts by weight of sodium chloride with an average particle diameter of 300 μm flowing in a fluidized bed granulator (MP-01, manufactured by Pak Rec Co., Ltd.) at an intake temperature of 80°C, a rotor speed of 300 rpm, and an exhaust temperature Under the conditions of 40 to 50°C, the above-mentioned aqueous solution is sprayed and dried to produce granular granules of first particles having an average particle diameter of 500 μm. Then, 69.5 parts by weight of potassium chloride and 103.35 parts by weight of anhydrous sodium acetate were uniformly dissolved in 413 parts by weight of purified water to prepare an aqueous solution. 984.9 parts by weight of sodium chloride with an average particle size of 300 μm flowing in a fluidiz...

Embodiment 3

[0076] In the same manner as in Example 1, first and second particles (the average particle size of either one was about 500 μm) were obtained.

[0077] Separately from this, 1000 parts by weight of 25w / w% glucose aqueous solution were prepared. 1000 parts by weight of glucose powder with an average particle diameter of 180μm was put into a rotating fluidized bed granulator (MP-01, manufactured by Poretec), the counter-flowing glucose particles were at an intake temperature of 60°C, and the number of rotations of the rotor was Under conditions of 300 rpm and an exhaust temperature of 37 to 42°C, 500 parts by weight of the above-mentioned aqueous glucose solution was sprayed to obtain glucose granules (third granules) having an average particle diameter of 450 μm. To the mixture of 315 parts by weight of glucose particles and the first and second particles, 42.0 parts by weight of acetic acid was added and mixed in a V-type mixer to produce the formulation of the present invention....

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Abstract

The present invention relates to a solid formulation for dialysis and a method for producing the same. The formulation is a mixture of: first particles having a coating layer containing magnesium chloride and sodium acetate on surfaces of sodium chloride particles; and second particles having a coating layer containing calcium chloride and sodium acetate on the surfaces of sodium chloride particles, at least one of the coating layers of the first and second particles further including potassium chloride. In the formulation of the present invention, aggregation or agglomeration between particles due to moisture absorption thereof can be suppressed. Besides, the content of each component in the formulation becomes uniform, so as to quickly dissolve in water when used. In addition, the formulation of the present invention is an extremely stable solid formulation in which decomposition of glucose hardly occurs even when a formulation containing electrolyte components and acetic acid further contains glucose.

Description

Technical field [0001] The invention relates to a solid preparation of bicarbonate for dialysis. In more detail, it relates to a solid preparation for dialysis, which consists of first particles containing magnesium chloride but not calcium chloride on the surface of sodium chloride core particles, and calcium chloride on the surface of sodium chloride core particles. , But the second particles not containing magnesium chloride are mixed. [0002] The solid preparation for dialysis of the present invention is used for a two-part bicarbonate dialysis solid preparation composed of a preparation containing sodium bicarbonate and a preparation containing electrolytes, acids, and glucose other than sodium bicarbonate, and a solid preparation containing sodium bicarbonate A solid preparation for dialysis consisting of a preparation, a preparation containing electrolytes and acids other than sodium bicarbonate, and a preparation containing glucose. Background technique [0003] When hem...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K33/14A61K31/7004A61P7/08A61J3/06A61K31/19
CPCA61K31/19A61K31/7004A61K33/14A61P7/08A61K2300/00A61K9/16
Inventor 甲斐俊哉片山直久横江淳一佐藤诚
Owner NIPRO CORP
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