# US 4,396,608 A · Intravenously injectable immune serum globulin

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 4,396,608 A
- Document ID: US4396608A
- Status: Granted
- Kind: A
- Application number: 06/295,916
- Filed: 1981-08-24
- Granted: 1983-08-02
- Earliest claimed: 1981-08-24
- Assignees: Cutter Laboratories, Inc.
- Inventors: Robert A. Tenold
- Web page: https://patentgrep.com/patent/US4396608A

## CPC

- A61K 39/39591: {Stabilisation, fragmentation}
- 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)

## Abstract

A composition is disclosed which comprises a solution in a pharmaceutically acceptable carrier of an immune serum globulin, said solution having an ionic strength and a pH to maintain the monomer content and the actual and latent anticomplement activity of the immune serum globulin such that the composition is intravenously injectable. Novel methods are disclosed for preparing the above composition.

## Claims

### Claim 1

A stable, sterile, intravenously injectable pharmaceutical composition comprising an aqueous solution of a therapeutic amount of an immune serum globulin, said solution having an ionic strength such that the solution at 5% protein concentration has a nephelometric reading less than 15 NTU, a pH of about 3.5-5.0, and a physiologically-acceptable tonicity.

### Claim 2 (depends on 1)

The composition of claim 1 which further includes other blood products.

### Claim 3 (depends on 1)

The composition of claim 1 which includes a material selected from the group consisting of carbohydrates, sugar alcohols, and amino acids in an amount sufficient to render physiologically-acceptable tonicity to the solution.

### Claim 4 (depends on 3)

The composition of claim 3 wherein the carbohydrate is maltose.

### Claim 5 (depends on 3)

The composition of claim 3 wherein the amino acid is glycine.

### Claim 6

A method for treating immune serum globulin which comprises
(a) forming an aqueous solution of an immune serum globulin,
(b) adjusting the pH of said solution to about 3.5-5.0 by addition of a physiologically acceptable acid,
(c) treating the solution to reduce its ionic strength (.GAMMA./2) while maintaining the pH of said solution at 5% protein concentration has a nephelometric reading less than 15 NTU, and
(d) adjusting the tonicity of the solution to a physiologically acceptable level by addition of an agent selected from the group consisting of amino acids, carbohydrates, and sugar alcohols.

### Claim 7 (depends on 6)

The method of claim 6 wherein the solution in Step a has a protein concentration of about 0.5-20% by weight.

### Claim 8 (depends on 6)

The method of claim 6 wherein the pH is adjusted to about 3.8-4.2 in Step b and maintained thereat in Step c.

### Claim 9 (depends on 6)

The method of claim 6 wherein the solution is diafiltered in Step c.

### Claim 10 (depends on 6)

The method of claim 6 which further includes the step of
(e) sterilizing the solution.

### Claim 11 (depends on 6)

A composition comprising the product of claim 6.

### Claim 12 (depends on 6)

The method of claim 6 which further includes the step of lyophilizing the solution of Step c.

### Claim 13 (depends on 12)

A composition comprising the product of claim 12.

### Claim 14

A dry composition comprising immune serum globulin which upon solution in water has a pH of about 3.5-5.0 and an ionic strength (.GAMMA./2) such that the solution at 5% protein concentration has a nephelometric reading less than about 15 NTU.