# US 5,192,743 A · Reconstitutable lyophilized protein formulation

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- Number: US 5,192,743 A
- Document ID: US5192743A
- Status: Granted
- Kind: A
- Application number: 07/821,206
- Filed: 1992-01-16
- Granted: 1993-03-09
- Earliest claimed: 1992-01-16
- Assignees: Genentech, Inc.
- Inventors: Chung C. Hsu; Hoc M. Nguyen; Sylvia S. Wu
- Web page: https://patentgrep.com/patent/US5192743A

## CPC

- A61K 38/36: Blood coagulation or fibrinolysis factors
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 38/2221: {Relaxins}
- A61K 47/38: Cellulose; Derivatives thereof
- 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 formulation for proteins is provided that comprises a lyophilized mixture of a protein, a water-soluble etherified cellulose in an amount that upon reconstitution of the formulation will be sufficient to form a gel, and an excipient to facilitate rehydration of the gel and to maintain protein integrity during storage of the lyophilized gel product. When reconstituted to a gel, this formulation can be applied, for example, to tissue in need of treatment.

## Claims

### Claim 1

A formulation comprising tissue factor, glycerol, and a water-soluble etherified cellulose in an amount that upon reconstitution of the mixture will form a topical gel.

### Claim 2 (depends on 1)

The formulation of claim 1 wherein the glycerol concentration in the reconstituted gel is about 1-4% weight/volume.

### Claim 3 (depends on 2)

The formulation of claim 2 wherein the tissue factor concentration in the reconstituted gel is about 0.2 to 1 mg/ml.

### Claim 4 (depends on 1)

The formulation of claim 1 wherein the etherified cellulose is hydroxyethylcellulose or methylcellulose.

### Claim 5 (depends on 1)

The formulation of claim 1 that is reconstituted to a gel with sufficient water.

### Claim 6 (depends on 5)

The formulation of claim 5 wherein the etherified cellulose is present in an amount of about 1-10% by weight/volume of the gel.

### Claim 7 (depends on 6)

The formulation of claim 6 wherein the etherified cellulose is hydroxyethylcellulose in an amount of about 1-5% by weight/volume of the gel.

### Claim 8 (depends on 7)

The formulation of claim 7 wherein the hydroxyethylcellulose is present in an amount of about 3-4% by weight/volume of the gel.

### Claim 9 (depends on 1)

A multi-unit package comprising, in one unit, the formulation of claim 1, and in another unit, a diluent for the formulation.

### Claim 10 (depends on 1)

A dual-compartment syringe wherein one compartment contains the formulation of claim 1 and the other compartment contains a diluent for the formulation.

### Claim 11

A method for treating tissue comprising the steps of:
(a) providing a formulation comprising a lyophilized mixture of tissue, factor, glycerol, and a water-soluble etherified cellulose in an amount that upon reconstitution of the mixture will form a topical gel,
(b) reconstituting the mixture in a sufficient amount of water to form a gel, and
(c) applying a therapeutically effective amount of the gel topically to the tissue.

### Claim 12 (depends on 11)

The method of claim 11 wherein the tissue is skin.

### Claim 13

A method of modulating the reproductive physiology of mammals during pregnancy and parturition comprising administering to the cervix or vagina a therapeutically effective amount of a gel that has been reconstituted from a formulation comprising a lyophilized mixture of relaxin, sucrose, and a water-soluble etherified cellulose in an amount that upon reconstitution of the mixture will form a topical gel.