Dry Composition Comprising an Extrusion Enhancer
AssigneeFerrosan Medical Devices A/S
InventorKristian Larsen
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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.
Claims31
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.
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.
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.
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.
The method according to any of the preceding claims, wherein the biocompatible polymer is cross-linked.
The method according to any of the preceding claims, wherein the biocompatible polymer is obtained from a cross-linked sponge.
The method according to any of the preceding claims, wherein the biocompatible polymer is gelatine.
The method according to any of the preceding claims, wherein the drying is freeze-drying.
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.
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.
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.
The method according to any of the preceding claims, wherein the one or more polyols is mannitol and optionally one or more further polyols.
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.
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.
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.
The method according to any of the preceding claims, wherein the method comprises a further step of sterilising the dry composition.
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.
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.
A dry composition obtained or obtainable by the method of any of the preceding claims.
A dry composition comprising a biocompatible polymer, an extrusion enhancer such as albumin and one or more polyols.
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.
Dependencies are inferred from the claim text.