KR-20260066100-A - Hemodialysis Agent A and hemodialysis preparations

Abstract

One of the objectives of the present invention is to provide a hemodialysis agent A having excellent solubility. A solid-phase hemodialysis agent A comprising a coated particle having a coating layer comprising calcium chloride and/or magnesium chloride, wherein the core particle of the coated particle comprises potassium chloride and the coating layer substantially does not comprise acetate.

Inventors

• 나카마 료타
• 요시모토 유스케
• 후지이 야스타카
• 야마다 마유
• 오하라 미유

Assignees

• 후소 야쿠힝 고교 가부시끼가이샤

Dates

Publication Date

20260512

Application Date

20240808

Priority Date

20230907

Claims (10)

1. A solid-phase hemodialysis agent A comprising coated particles having a coating layer containing calcium chloride and/or magnesium chloride, and The nucleus particles of the above-mentioned coating particles contain potassium chloride, and The above coating layer substantially does not contain acetate, Solid phase hemodialysis agent A.
2. In paragraph 1, A hemodialysis agent A in which the above-mentioned nuclear particles substantially do not contain sodium chloride.
3. In paragraph 1 or 2, A hemodialysis agent A, wherein the above coating layer substantially does not contain potassium chloride.
4. In paragraph 1 or 2, A hemodialysis agent A, wherein the above coating layer comprises calcium chloride and magnesium chloride.
5. In paragraph 1 or 2, Hemodialysis agent A, further containing sodium chloride.
6. In paragraph 1 or 2, Hemodialysis agent A, further comprising acetic acid and acetate.
7. In paragraph 1 or 2, Agent A for hemodialysis, further comprising citric acid and/or citrate.
8. In paragraph 1 or 2, Hemodialysis agent A containing additional glucose.
9. A bicarbonate-type hemodialysis preparation comprising a hemodialysis agent A described in paragraph 1 or 2 and a hemodialysis agent B containing sodium bicarbonate.
10. A method for manufacturing a solid-phase hemodialysis agent A described in claim 1, comprising the following first and second processes: A first process for obtaining coating particles by spraying an aqueous solution for forming a coating layer in which calcium chloride and/or magnesium chloride is dissolved in potassium chloride, and A second process for manufacturing a solid-phase hemodialysis agent A by mixing the coating particles obtained in the first process above.

Description

Hemodialysis Agent A and hemodialysis preparations The present invention relates to a hemodialysis agent A having excellent solubility and a hemodialysis preparation comprising said hemodialysis agent A. Currently, bicarbonate dialysis preparations are mainly used as hemodialysis preparations, and a two-drug type combining hemodialysis preparation A, which contains glucose and multiple electrolyte components including sodium chloride, and hemodialysis preparation B, which contains sodium bicarbonate, is commercially available as a general hemodialysis preparation. Conventionally, hemodialysis preparation A included a liquid type containing electrolyte components in a concentrated form and a solid type containing electrolyte components in a solid state; however, the liquid type has been problematic in terms of transportation costs, storage space in hospitals, workability within hospitals, and disposal of containers after use, so recently, solid hemodialysis preparation A has become the mainstream in Korea. In a general two-drug type bicarbonate dialysis preparation, hemodialysis agent A contains sodium chloride, potassium chloride, calcium chloride, magnesium chloride, a pH regulator, and glucose. Furthermore, if solid-phase hemodialysis preparations solidify, they may aggregate when water is added to prepare the dialysis solution, leading to poor solubility. In this case, poor solubility refers to the dissolved residue generated when dissolving the hemodialysis preparation; the risk of such poor solubility increases with hemodialysis preparations that have a slow dissolution rate. If dissolved residue is generated during the preparation of the hemodialysis solution, the concentrations of each electrolyte in the prepared solution do not reach the preset levels, resulting in concentration abnormalities. If dialysis is performed using such abnormally concentrated solution, the body's electrolytes are not corrected to within the normal range, and in some cases, there is a possibility of causing serious electrolyte concentration abnormalities. To prevent this, safety devices are equipped in the dissolution devices and dialysis equipment; however, activating these safety devices in the first place is not advisable. Therefore, in order to avoid causing poor solubility, it is important to use a preparation with good solubility (good dissolution rate), and it is necessary to design the device so that the entire amount of the hemodialysis preparation used is reliably dissolved within the dissolution time set in the existing dissolution device. Examples of dissolution devices widely used in dialysis facilities include the fully automatic dissolution device DAD-50NX-ST (manufactured by Nikkiso Co., Ltd.), in which the dissolution time is set to approximately 4 minutes. In addition, the A-drug dissolution device AHI-502 (manufactured by Doa DKK Co., Ltd.) is also widely used as a dissolution device, and this dissolution device employs a system that adds the hemodialysis preparation little by little to a predetermined amount of water stored in the device and automatically stops adding when the dialysis fluid reaches a predetermined conductivity, and the dissolution time is set to approximately 9 minutes. If a hemodialysis agent with poor solubility (slow dissolution rate) is used in this dissolution device, the residual dissolved agent dissolves belatedly after the dialysis fluid reaches a predetermined conductivity and the addition of the agent is stopped. Consequently, the supplied dialysis fluid acquires a conductivity value different from the predetermined one, resulting in a concentration anomaly. Furthermore, poor dissolution of the hemodialysis agent leads to a failure to reach the predetermined conductivity within the set dissolution time; thus, even if the appropriate amount is injected into the device, an abnormality may be detected, triggering an alarm. As such, in dissolution devices generally used in clinical settings, poor solubility of the hemodialysis agent used poses a significant risk of affecting the quality of the obtained hemodialysis fluid and the preparation efficiency. Conventionally, various technologies to improve the solubility of hemodialysis preparations have been considered. For example, Patent Document 1 describes a solid dialysis preparation comprising an electrolyte composition consisting of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, and sodium acetate, and a pH adjuster, wherein the solid dialysis preparation has a two-layer structure comprising a core layer containing at least one selected from the group consisting of sodium chloride and potassium chloride as a main component, and a double salt layer containing a double salt produced by the reaction of sodium acetate and calcium chloride, another electrolyte composition, and a pH adjuster, which can have excellent solubility. According to the formulation technology described in Patent Document 1, excellen