Dry composition comprising an extrusion enhancer
Inventors
Assignees
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Publication Number
US-11103616-B2
Publication Date
2021-08-31
Expiration Date
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.
Core Innovation
The document describes a dry composition suitable for use in haemostasis and wound healing. The dry composition comprises a frozen paste that has been freeze-dried and reconstitutes to form a paste upon addition of an aqueous medium without mechanical mixing. The dry composition comprises a biocompatible polymer, an extrusion enhancer, and one or more polyols.
The polyols are selected from sugar alcohols or sugars and are present at about 10% w/w to about 60% w/w. The extrusion enhancer is selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin, or soy bean oil. The biocompatible polymer is provided as a cross-linked biocompatible polymer in powder form.
The document also describes syringe or applicator embodiments and a haemostatic kit. The kit includes a container comprising the dry composition and a container comprising an aqueous medium, and optionally an outer packaging. The approach avoids time-consuming dilution steps and enables spontaneous reconstitution into a homogeneous flowable paste after adding the aqueous medium without mechanical mixing.
Claims Coverage
Across the provided material, the independent claims define the same dry, freeze-dried haemostasis/wound-healing concept in four form factors: a dry composition, a syringe or applicator, and a haemostatic kit in two variants. Each claim contains 3 main inventive features: a cross-linked biocompatible polymer, a specified extrusion enhancer, and one or more polyols in a defined 10% w/w to 60% w/w range, together with a no-mechanical-mixing reconstitution requirement upon addition of an aqueous medium. One claim also explicitly covers a sequential mixing-to-paste then freeze-drying method for making the dry composition.
Dry composition defined by freeze-dried frozen paste with polyols for no-mechanical-mixing reconstitution
A dry composition suitable for use in haemostasis and wound healing comprising a frozen paste that has been freeze-dried, comprising a biocompatible polymer, an extrusion enhancer and one or more polyols, wherein the dry composition is obtained by providing a cross-linked biocompatible polymer in powder form, the one or more polyols selected from sugar alcohols or sugars, the extrusion enhancer selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin or soy bean oil, and an aqueous medium; mixing to obtain a paste; and freeze-drying the paste; comprising from about 10% w/w to about 60% w/w of the one or more polyols; wherein upon addition of an aqueous medium, the dry composition reconstitutes to form a paste without mechanical mixing.
Syringe or applicator with freeze-dried dry composition reconstituting to paste without mechanical mixing
A syringe or applicator comprising a dry composition comprising a frozen paste that has been freeze-dried, comprising a biocompatible polymer, an extrusion enhancer and one or more polyols, wherein the dry composition is obtained by providing a cross-linked biocompatible polymer in powder form, one or more polyols selected from sugar alcohols or sugars, an extrusion enhancer selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin or soy bean oil, and an aqueous medium; mixing the biocompatible polymer, the one or more polyols, the extrusion enhancer and the aqueous medium to obtain a paste; and freeze-drying the paste to produce a dry composition; comprising from about 10% w/w to about 60% w/w of the one or more polyols; wherein upon addition of an aqueous medium, the dry composition reconstitutes to form a paste without mechanical mixing.
Haemostatic kit with dry composition and aqueous medium enabling paste reconstitution without mechanical mixing
A haemostatic kit comprising a container comprising a dry composition comprising a frozen paste that has been freeze-dried, said dry composition comprising a biocompatible polymer, an extrusion enhancer and from about 10% w/w to about 60% w/w of one or more polyols, wherein the dry composition is obtained by sequentially providing a cross-linked biocompatible polymer in powder form, one or more polyols selected from sugar alcohols or sugars, an extrusion enhancer selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin or soy bean oil, and an aqueous medium; mixing to obtain a paste; and freeze-drying the paste, wherein upon addition of an aqueous medium, the dry composition reconstitutes to form a paste without mechanical mixing; a container comprising an aqueous medium; and optionally an outer packaging.
Dry composition with cross-linked polymer, specified extrusion enhancer and polyols for no-mechanical-mixing reconstitution
A dry composition suitable for use in haemostasis and wound healing comprising a frozen paste that has been freeze-dried, comprising a cross-linked biocompatible polymer, an extrusion enhancer selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin or soy bean oil, and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols or sugars; wherein upon addition of an aqueous medium, the dry composition reconstitutes to form a paste without mechanical mixing.
Syringe or applicator with cross-linked polymer, specified extrusion enhancer and polyols for no-mechanical-mixing reconstitution
A syringe or applicator comprising a dry composition comprising a frozen paste that has been freeze-dried, comprising a cross-linked biocompatible polymer, an extrusion enhancer selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin or soy bean oil, and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols or sugars; wherein upon addition of an aqueous medium, the dry composition reconstitutes to form a paste without mechanical mixing.
Haemostatic kit with cross-linked polymer and polyols in freeze-dried dry composition plus aqueous medium
A haemostatic kit comprising a container comprising a dry composition comprising a frozen paste that has been freeze-dried, comprising a cross-linked biocompatible polymer, an extrusion enhancer selected from albumin, phosphatidylcholine, phosphatidylserine, lecithin or soy bean oil, and from about 10% w/w to about 60% w/w of one or more polyols selected from sugar alcohols or sugars; a container comprising an aqueous medium; and optionally an outer packaging; wherein upon addition of an aqueous medium, the dry composition reconstitutes to form a paste without mechanical mixing.
The claims consistently cover freeze-dried haemostasis/wound-healing formulations made from a frozen paste that include a cross-linked biocompatible polymer, an extrusion enhancer selected from albumin or specified phospholipid/lecithin/soy bean oil options, and one or more polyols present at about 10% w/w to about 60% w/w. The defining reconstitution requirement across the claims is that addition of an aqueous medium reconstitutes the dry composition into a paste without mechanical mixing. The claim set also defines these formulations in delivery forms and in a kit format comprising separate containers for the dry composition and the aqueous medium, with optional outer packaging. One claim additionally specifies the sequential method of providing ingredients, mixing to obtain a paste, and freeze-drying to obtain the dry composition.
Stated Advantages
Reconstitutes to form a paste upon addition of an aqueous medium without mechanical mixing.
Enables spontaneous reconstitution into a homogeneous flowable paste after adding the aqueous medium without mechanical mixing.
Avoids time-consuming dilution steps.
Documented Applications
Haemostasis and wound healing.
Dispensing the flowable haemostatic composition using a syringe or applicator.
Use in a haemostatic kit comprising a container with the dry composition and a container with an aqueous medium.
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