Rapidly solubilized AHF composition and process for preparing same

Claim 2

A solid material comprising AHF, fibrinogen and a water soluble carbohydrate, said AHF being present in an amount sufficient to provide a therapeutically useful solution of AHF upon reconstitution in aqueous media and said carbohydrate being present in an amount sufficient to provide in said solution a carbohydrate concentration of at least about 2 grams per 100 milliliters.

Claim 3

The material of claim 1 wherein the carbohydrate is a monosaccharide.

Claim 4

The material of claim 2 wherein the carbohydrate is selected from the group consisting of dextrose, mannose, galactose and fructose.

Claim 5

The material of claim 1 wherein the carbohydrate is a disaccharide.

Claim 6

The material of claim 4 wherein the carbohydrate is selected from the group consisting of lactose, sucrose and maltose.

Claim 7

The material of claim 1 wherein the carbohydrate concentration is about 2 to about 10 grams per 100 milliliters.

Claim 8

The material of claim 1 wherein the carbohydrate concentration is about 3 grams per 100 milliliters.

Claim 9

A solid material comprising AHF and an amount of at least one water soluble carbohydrate sufficient to solubilize the material in an aqueous medium within about 90 seconds, the AHF being present in an amount sufficient to form a therapeutically effective AHF concentration upon solubilization of the material.

Claim 10

A solid material comprising AHF and an amount of at least one water soluble carbohydrate sufficient to solubilize the material in an aqueous medium within about 90 seconds, the AHF being present in an amount sufficient to form a therapeutically effective AHF concentration upon solubilization of the material.

Claim 11

The material of claim 8 wherein the carbohydrate is dextrose.

Claim 12

A lyophilized material comprising AHF, fibrinogen and an amount of water soluble carbohydrate sufficient to solubilize the material in an aqueous solution within about 65 seconds, the AHF being present in an amount sufficient to form a therapeutically effective AHF concentration upon solubilization of the material.

Claim 13

A lyophilized material comprising AHF, fibrinogen and an amount of water soluble carbohydrate sufficient to solubilize the material in an aqueous solution within about 65 seconds, the AHF being present in an amount sufficient to form a therapeutically effective AHF concentration upon solubilization of the material.

Claim 14

The material of claim 10 wherein the material is dextrose.

Claim 15

A solid material comprising proteins, including AHF, and at least one water soluble carbohydrate, the amount of carbohydrate being about from 1.6 to 7.5 times the amount by weight of protein in the material.

Claim 16

A solid material comprising proteins, including AHF, and at least one water soluble carbohydrate, the amount of carbohydrate being about from 1.6 to 7.5 times the amount by weight of protein in the material.

Claim 17

The material of claim 12 wherein the amount of carbohydrate is about from 2 to 5 times the amount by weight of protein.

Claim 18

The material of claim 12 wherein the amount of carbohydrate is about 2 times the amount by weight of protein.

Claim 19

The material of claim 12 wherein the carbohydrate is dextrose.

Claim 20

The material of claim 12 wherein the AHF is present in an activity of about from 2 to 200 International Units/gm protein.

Claim 21

The material of claim 16 wherein the AHF is present in an activity of about 16 International Units/gm protein.

Claim 22

A lyophilized material comprising about 31 parts by weight of dextrose, about 16 parts by weight of protein including AHF in an activity of about 270 International Units/gm of material, and about 53 parts by weight of salts.

Claim 23

A lyophilized material comprising about 31 parts by weight of dextrose, about 16 parts by weight of protein including AHF in an activity of about 270 International Units/gm of material, and about 53 parts by weight of salts.

Claim 24

In a method for producing a clinically useful freeze-dried solid composition containing AHF and fibrinogen from blood plasma or an AHF-containing fraction thereof including the steps of fractionating the plasma to obtain a solid mixture comprising AHF and fibrinogen, dissolving the solid mixture in an aqueous medium and freeze-drying the resulting solution to obtain a clinically useful freeze-dried solid composition which is then reconstituted in a reconstitution liquid for use, the improvement comprising rendering the freeze-dried, solid composition rapidly soluble in an aqueous medium at room temperature by adding water soluble carbohydrate to the mixture, the amount of carbohydrate added being an amount sufficient to produce at least about 2 grams per 100 milliliters concentration of carbohydrate upon reconstitution of the composition in a suitable medium to produce a therapeutically useful solution of AHF.

Claim 25

In a method for producing a clinically useful freeze-dried solid composition containing AHF and fibrinogen from blood plasma or an AHF-containing fraction thereof including the steps of fractionating the plasma to obtain a solid mixture comprising AHF and fibrinogen, dissolving the solid mixture in an aqueous medium and freeze-drying the resulting solution to obtain a clinically useful freeze-dried solid composition which is then reconstituted in a reconstitution liquid for use, the improvement comprising rendering the freeze-dried, solid composition rapidly soluble in an aqueous medium at room temperature by adding water soluble carbohydrate to the mixture, the amount of carbohydrate added being an amount sufficient to produce at least about 2 grams per 100 milliliters concentration of carbohydrate upon reconstitution of the composition in a suitable medium to produce a therapeutically useful solution of AHF.

Claim 26

The method of claim 19 wherein the carbohydrate is added to a solid mixture consisting essentially of fibrinogen and AHF.

Claim 27

The method of claim 19 wherein the carbohydrate is selected from the group consisting of dextrose, maltose, lactose and sucrose.

Claim 28

The method of claim 21 wherein the carbohydrate is dextrose.

Claim 29

The method of claim 19 wherein the amount of carbohydrate is sufficient to produce a solution having about from 2 to 5 grams of carbohydrate per 100 milliliters of solution.

Claim 30

In a method for producing a clinically useful freeze-dried solid composition containing AHF and fibrinogen from blood plasma or an AHF-containing fraction thereof including the steps of fractionating the plasma to obtain a solid mixture comprising AHF and fibrinogen, dissolving the solid mixture in an aqueous medium and freeze-drying the resulting solution to obtain a clinically useful freeze-dried solid composition which is then reconstituted in a reconstitution liquid for use, the improvement comprising rendering the freeze-dried, solid composition rapidly soluble in an aqueous medium at room temperature by adding water soluble carbohydrate to the composition, the amount of carbohydrate added being sufficient to solubilize the freeze-dried composition within about 90 seconds, the AHF being present in an amount sufficient to form a therapeutically effective AHF concentration upon solubilization of the composition.

Claim 31

In a method for producing a clinically useful freeze-dried solid composition containing AHF and fibrinogen from blood plasma or an AHF-containing fraction thereof including the steps of fractionating the plasma to obtain a solid mixture comprising AHF and fibrinogen, dissolving the solid mixture in an aqueous medium and freeze-drying the resulting solution to obtain a clinically useful freeze-dried solid composition which is then reconstituted in a reconstitution liquid for use, the improvement comprising rendering the freeze-dried, solid composition rapidly soluble in an aqueous medium at room temperature by adding water soluble carbohydrate to the composition, the amount of carbohydrate added being sufficient to solubilize the freeze-dried composition within about 90 seconds, the AHF being present in an amount sufficient to form a therapeutically effective AHF concentration upon solubilization of the composition.

Claim 32

The method of claim 24 wherein the amount of carbohydrate is sufficient to solubilize the composition within about 65 seconds.

Claim 33

The method of claim 24 wherein the carbohydrate is selected from the group consisting of dextrose, maltose, lactose and sucrose.

Claim 34

The method of claim 26 wherein the carbohydrate is dextrose.

Claim 35

In a method for producing a clinically useful freeze-dried solid composition which contains protein, including AHF, comprising the steps of fractionating blood plasma or an AHF-containing fraction thereof to obtain a solid mixture comprising protein, dissolving the mixture in an aqueous medium and freeze-drying the resulting solution to obtain a clinically useful freeze-dried solid composition, the improvement comprising adding water soluble carbohydrate to the composition in a proportion of about from 1.6 to 7.5 times the amount by weight of protein in the composition.

Claim 36

In a method for producing a clinically useful freeze-dried solid composition which contains protein, including AHF, comprising the steps of fractionating blood plasma or an AHF-containing fraction thereof to obtain a solid mixture comprising protein, dissolving the mixture in an aqueous medium and freeze-drying the resulting solution to obtain a clinically useful freeze-dried solid composition, the improvement comprising adding water soluble carbohydrate to the composition in a proportion of about from 1.6 to 7.5 times the amount by weight of protein in the composition.

Claim 37

The method of claim 28 wherein the proportion is about from 2 to 5 times the amount by weight of protein.

Claim 38

The method of claim 28 wherein the proportion is about 2 times the amount by weight of protein.

Claim 39

The method of claim 28 wherein the carbohydrate is selected from the group consisting of lactose, dextrose, maltose and sucrose.

Claim 40

The method of claim 31 wherein the carbohydrate is dextrose.

Claim 43

The method of claim 33 wherein the carbohydrate is added as an aqueous solution.

Claim 46

The method of claim 35 wherein the method includes lyophilizing the composition and said carbohydrate is added before the composition is lyophilized.