# US 2014/0197106 A1 · Dialysis preparation

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- Number: US 2014/0197106 A1
- Document ID: US20140197106A1
- Status: Published application
- Kind: A1
- Application number: 14/218,427
- Filed: 2014-03-18
- Published: 2014-07-17
- Earliest claimed: 2005-01-07
- Assignees: Ajinomoto Co., Inc.
- Applicants: Ajinomoto Co., Inc.
- Inventors: Hirotoshi IWASHINA; Kiyonobu Kamiya
- Web page: https://patentgrep.com/patent/US20140197106A1

## CPC

- A61M 1/1654: {Dialysates therefor}
- A61K 9/08: Solutions {(composition of solutions A61K47/00)}
- A61K 47/02: Inorganic compounds
- A61P 7/08: Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock (artificial tears A61P27/04)
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention provides a pharmaceutical composition for dialysis wherein the decline of ionized calcium concentration in an acetate-free bicarbonate dialysate comprising no acetic acid and/or sodium acetate is controlled. The present invention further provides a dialysis agent A that comprises electrolytes, citric acid and/or citrate as pH adjuster, and/or glucose, for preparation of bicarbonate dialysate; the agent A characterized by being adjusted by citric acid and/or citrate so as to keep the electrolyte ionized calcium concentration not less than 1 mmol/L in a prepared bicarbonate dialysate. In a specific aspect of the present invention, sodium citrate is used as citrate, and the present invention provides a dialysate obtained from above.

## Claims

### Claim 1

A dialysate characterized in that the citric acid and/or citrate content thereof is adjusted so as to keep the electrolyte ionized calcium concentration not less than 1 mmol/L in a bicarbonate dialysate comprising citric acid and/or citrate as pH adjuster.

### Claim 2 (depends on 1)

The dialysate of claim 1 characterized in that the electrolyte ionized calcium concentration is adjusted so as to be not less than 1 mmol/L by a combination of citric acid and/or sodium citrate as pH adjuster, the combination comprising; setting the citric acid concentration of a dialysate not more than 1.5 mEq/L; and combining therewith sodium citrate having the concentration within a range of 0.2 to 0.5 mEq/L.

### Claim 3

A method of adjusting the electrolyte ionized calcium concentration, by citric acid and/or citrate, so as to be not less than 1.0 mmol/L in a bicarbonate dialysate that comprises no acetic acid and/or acetate and comprises citric acid and/or citrate as pH adjuster.

### Claim 4 (depends on 3)

The method of claim 3 wherein the electrolyte ionized calcium concentration is adjusted so as to be not less than 1 mmol/L by a combination of citric acid and/or sodium citrate as pH adjuster, the combination comprising; setting the citric acid concentration of a dialysate not more than 1.5 mEq/L; and combining therewith sodium citrate having the concentration within a range of 0.2 to 0.5 mEq/L.

### Claim 5

A dialysis agent A for preparation of bicarbonate dialysates, the agent A comprising electrolytes, citric acid and/or citrate as pH adjuster, and/or glucose; the agent A characterized in that the electrolyte ionized calcium concentration is adjusted so as to be not less than 1 mmol/L in a bicarbonate dialysate after preparation by citric acid and/or citrate.

### Claim 6 (depends on 5)

The dialysis agent A of claim 5 wherein the electrolyte ionized calcium concentration is adjusted so as to be not less than 1 mmol/L by; setting the citrate acid concentration not more than 1.5 mEq/L; and combining therewith sodium citrate having the concentration within a range of 0.2 to 0.5 mEq/L.

### Claim 7 (depends on 6)

The dialysis agent A of claim 6 characterized in that the formulation thereof is powder.

### Claim 8 (depends on 6)

The dialysis agent A of claim 6 characterized in that the formulation thereof is liquid.

### Claim 9

A method of hemodialysis characterized in that a bicarbonate dialysate is prepared to obtain the ionized calcium concentration thereof being not less than 1 mmol/L without comprising acetic acid and/or acetate.

### Claim 10 (depends on 3, 4, 9)

The method of hemodialysis of claim 9 wherein the ionized calcium concentration is adjusted by the methods of claim 3 or claim 4.
