# US 2016/0354512 A1 · Dry Composition Comprising an Extrusion Enhancer

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- Number: US 2016/0354512 A1
- Document ID: US20160354512A1
- Status: Published application
- Kind: A1
- Application number: 15/102,994
- Filed: 2014-12-10
- Published: 2016-12-08
- Earliest claimed: 2013-12-11
- Assignees: Ferrosan Medical Devices A/S
- Applicants: Ferrosan Medical Devices A/S
- Inventors: Kristian Larsen
- Web page: https://patentgrep.com/patent/US20160354512A1

## CPC

- A61L 26/0066: {Medicaments; Biocides}
- A61L 24/0036: {Porous materials, e.g. foams or sponges}
- A61L 24/104: {Gelatin}
- A61L 26/0009: {containing macromolecular materials}
- A61L 26/0019: {obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds}
- A61L 26/0038: {Gelatin}
- A61L 26/0047: {Specific proteins or polypeptides not covered by groups A61L26/0033 - A61L26/0042}
- A61L 26/0052: {Mixtures of macromolecular compounds}
- A61L 26/0085: {Porous materials, e.g. foams or sponges}
- A61P 7/04: Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/04: for non-specific disorders of the connective tissue
- A61P 19/08: for bone diseases, e.g. rachitism, Paget's disease
- A61L 2300/254: Enzymes, proenzymes
- A61L 2300/418: Agents promoting blood coagulation, blood-clotting agents, embolising agents
- A61L 2400/04: Materials for stopping bleeding
- A61L 2430/34: for soft tissue reconstruction
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed is a dry composition comprising one or more polyols, which upon addition of an aqueous medium forms a substantially homogenous paste suitable for use in haemostasis procedures. The paste reconstitutes spontaneously upon addition of the liquid; hence no mechanical mixing is required for said paste to form. The composition may further comprise an extrusion enhancer, such as albumin. Also disclosed are methods of preparing said dry composition, a paste obtained from said dry composition and uses of said dry composition or paste for medical and surgical purposes.

## Claims

### Claim 1

A method of preparing a dry composition suitable for use in haemostasis and wound healing comprising the sequential steps of:
a. providing a biocompatible polymer in powder form, one or more polyols, an extrusion enhancer and an aqueous medium,
b. mixing the biocompatible polymer, the one or more polyols, the extrusion enhancer and the aqueous medium to obtain a paste, and
c. drying the paste.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the extrusion enhancer is albumin, preferably human serum albumin.

### Claim 3

The method according to any of the preceding claims, wherein the paste prior to drying comprises the extrusion enhancer in an amount of between about 0.1% w/w to about 10% w/w, preferably between about 0.5% w/w to about 5.0% w/w.

### Claim 4

The method according to any of the preceding claims, wherein the dry composition comprises from about 10% w/w to about 60% w/w of one or more polyols, such as from about 20% w/w to about 50% w/w of one or more polyols, for example from about 20% w/w to about 40% w/w, such as from about 20% w/w to about 30% w/w of one or more polyols.

### Claim 5

The method according to any of the preceding claims, wherein the paste prior to drying comprises from about 3% w/w to about 20% w/w of one or more polyols, such as from about 3% w/w to about 18% w/w of one or more polyols, for example from about 3% w/w to about 17% w/w of one or more polyols, such as from about 3% w/w to about 16% w/w of one or more polyols, for example from about 3% w/w to about 15% w/w of one or more polyols.

### Claim 6

The method according to any of the preceding claims, wherein the biocompatible polymer is cross-linked.

### Claim 7

The method according to any of the preceding claims, wherein the biocompatible polymer is obtained from a cross-linked sponge.

### Claim 8

The method according to any of the preceding claims, wherein the biocompatible polymer is gelatine.

### Claim 9

The method according to any of the preceding claims, wherein the drying is freeze-drying.

### Claim 10

The method according to any of the preceding claims, wherein the paste prior to drying comprises:
a. from about 5% w/w to about 20% w/w of one or more polyols,
b. from about 0.5% w/w to about 5% w/w of an extrusion enhancer, such as albumin,
c. from about 15% w/w to about 25% w/w of biocompatible polymer, and
d. from about 60% w/w to about 80% w/w of water.

### Claim 11

The method according to any of the preceding claims, wherein the dry composition comprises less than about 5% w/w of water, preferably less than about 3% w/w of water, more preferred less than about 2% w/w of water, such as less than about 1% w/w of water.

### Claim 12

The method according to any of the preceding claims, wherein the one or more polyols is selected from sugar alcohols, sugars and/or derivatives thereof.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the one or more sugar alcohols is selected from the group consisting of glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, dulcitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol and polyglycitol.

### Claim 14

The method according to any of the preceding claims, wherein the one or more polyols is mannitol and optionally one or more further polyols.

### Claim 15

The method according to any of the preceding claims, wherein the dry composition further comprises one or more bioactive agents that stimulate haemostasis or wound, bone, tendon and/or tissue healing.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the bioactive agent is thrombin.

### Claim 17

The method according to any of the preceding claims, wherein the aqueous medium is selected from the group consisting of water, saline, a calcium chloride solution and a buffered aqueous medium.

### Claim 18

The method according to any of the preceding claims, wherein the method comprises a further step of placing the dry composition into an outer packaging, such as an aluminium foil packaging.

### Claim 19

The method according to any of the preceding claims, wherein the method comprises a further step of sterilising the dry composition.

### Claim 20

The method according to any of the preceding claims, wherein the paste is filled into and dried within an applicator suitable for dispensing compositions in paste form, such as a syringe.

### Claim 21

The method according to any of the preceding claims, wherein the dry composition reconstitutes to form a paste without mechanical mixing within less than about 30 seconds, preferably within less than about 20 seconds, more preferred within less than about 10 seconds, even more preferred within less than about 5 seconds.

### Claim 22

A dry composition obtained or obtainable by the method of any of the preceding claims.

### Claim 23

A dry composition comprising a biocompatible polymer, an extrusion enhancer such as albumin and one or more polyols.

### Claim 24 (depends on 23)

The dry composition according to claim 23, wherein the composition comprises:
a. from about 10% w/w to about 60% w/w of one or more polyols,
b. from about 0.3% w/w to about 30% w/w of an extrusion enhancer such as albumin, preferably about 2% w/w to about 15% w/w,
c. from about 40% w/w to about 80% w/w of a biocompatible polymer, and
d. from about 0.1% w/w to about 5% w/w of water.

### Claim 25 (depends on 22, 23, 24)

The dry composition according to any of claims 22 to 24, wherein the dry composition is present in an applicator suitable for dispensing compositions in paste form, such as a syringe.

### Claim 26 (depends on 22, 23, 24)

The dry composition according to any of claims 22 to 24, wherein the dry composition is in the form of a sheet.

### Claim 27 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)

Use of the dry composition obtained by the method of any of claims 1 to 21 or the dry composition of any of claims 22 to 25 in the preparation of a paste.

### Claim 28 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)

The dry composition obtained by the method of any of claims 1 to 21 or the dry composition of any of claims 22 to 26 for use in the promotion of haemostasis and/or wound, bone, tendon and/or tissue healing in an individual in need thereof.

### Claim 29 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)

A kit comprising:
a. a container comprising the dry composition obtained by the method of any of claims 1 to 21 or the dry composition according to any of claims 22 to 25,
b. a container comprising an aqueous medium, and
c. optionally an outer packaging.

### Claim 30

A method for reconstituting a dry composition comprising the steps of:
a. providing a dry composition comprising a biocompatible polymer, one or more polyols, and optionally an extrusion enhancer such as albumin,
b. adding an aqueous medium to the dry composition, wherein the aqueous medium optionally comprises an extrusion enhancer such as albumin, with the proviso that an extrusion enhancer is present in the dry composition and/or in the aqueous medium.

### Claim 31 (depends on 22, 23, 24, 25, 26, 30)

The method according to claim 30, wherein the dry composition is as defined in any of claims 22 to 26.