Methods and compositions comprising wettable electrospun matrix

Abstract

Disclosed herein are compositions comprising at least one degradable polymer and a hydrating compound, and methods of making and using such compositions comprising at least one degradable polymer and a hydrating compound.

Description

METHODS AND COMPOSITIONS COMPRISINGWETTABLE ELECTROSPUN MATRIXCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 638,481 filed April 25, 2024, which is hereby incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure relates to compositions comprising degradable polymer in the form of an electrospun matrix.BACKGROUND

[0003] Many degradable polymers that are used to prepare electrospun matrices or constructs are hydrophobic in nature. When water is placed on the material, it does not readily penetrate into the electrospun matrix due to the small pore size of the electrospun material, the hydrophobic property of the polymer and the high surface tension of water. Since electrospun materials are often used for medical applications in which cell growth into, onto or through the electrospun matrix is desired, having a matrix that is readily wettable is of great benefit and is needed. Electrospun materials have been made to contain water-soluble components. When electrospun materials that contain the water-soluble component have been placed in water and the water-soluble component is dissolved out, the physical properties of these materials are significantly changed. This can be a challenge for these materials. The present disclosure provides degradable compositions, related products and methods to overcome the challenges with the existing electrospun materials and that meet the need of a biocompatible material.SUMMARY

[0004] Briefly stated, the present disclosure provides polymer compositions, products made therefrom and methods of making and forming products.DETAILED DESCRIPTION

[0005] The present disclosure comprises compositions comprising a non-woven material made from degradable polymers and / or copolymers and methods of making and use of such compositions. The compositions can be in the form of an electrospun material or a melt blown material. The electrospun material is a non-woven matrix.

[0006] The electrospun material can comprise one or more polymers. Polymers that can be used include degradable and non-degradable polymers. The degradable and non-degradable polymersare not soluble in water. Non-degradable polymers that can be used include but are not limited to polyethylene terephthalate), poly (ethylene-co-vinyl alcohol), polyethylene, polypropylene, nylon, and polyurethane. Degradable polymers can be enzymatically degradable, hydrolytically degradable or a combination thereof. The degradable polymers are non-water soluble. In one aspect, the degradable polymers do not swell in water. In another aspect the degradable polymers do not swell more than 3% on a weight basis in water. Degradable polymers that can be used include but are not limited to polymers that comprise repeat units derived from at least one of the following monomers: 1-lactide, dl-lactide, glycolide, trimethylene carbonate, epsilon- caprolactone, p-dioxanone and a morpholinedione. The degradable polymer can comprise polyhydroxyalkanoate. Polyhydroxyalkanoate polymers can include, but are not limited to, poly 3-hydroxybutyrate, poly-4-hydroxybutyrate, polyhydroxyvalerate, polyhydroxyoctanoate, polyhydroxyhexanoate and copolymers thereof. In an aspect, a polyhydroxyalkanoate is poly 3- hydroxybutyrate. In an aspect, a polyhydroxyalkanoate copolymer is polyhydroxy-butyrate-co- valerate (CAS 80181-31-3), poly(3-hydroxybutyrate-co-3-hydroxyoctanoate or poly(3- hydroxybutyrate-co-hexanoate). In an aspect, a polyhydroxyalkanoate polymer may comprise one or more residues of 3 -hydroxybutyric acid, 4-hydroxybutyric acid, 5-hydroxy valeric acid, 3- hydroxy-2-butenoic acid, 3-hydroxy-4-transhexenoic acid, 3-hydroxy-5-hexenoic acid, 3- hydroxyhexanoic acid, 6-hydroxyhexanoic acid, 5 -hydroxyhexanoic acid, 4-hydroxyhexanoate or combinations thereof.

[0007] In one aspect, the polymer can be a homopolymer or a copolymer. The copolymer can be a random copolymer or a block copolymer. In one aspect, the block copolymer can be a diblock copolymer, a triblock copolymer or a multiblock copolymer. The degradable polymer can be a linear polymer, a branched polymer, a triaxial polymer, a 4-armed polymer or a multi-axial polymer. Polymers that can be used to prepare the electrospun material include those described in the patents US6462169, US6794485, US7129319, US7070858, US7026437, EP 1244725, US6342065, and US7048753 and are incorporated herein by reference. As used herein, the term polymer comprises copolymers, and those of skill in the art understand what is meant.

[0008] A multi-axial polymer is a polymer that is initiated from more than two sites on the same initiator. Initiators that can be used to make polymers disclosed herein include, but are not limited to, compounds that comprise 3 or more hydroxyl or amine groups. Examples of hydroxyl-based initiators include, but are not limited to, triethanolamine, trimethylolpropane, 1,1 ,1- tris(hydroxymethyl)ethane, pentaerythritol, dipentaerythritol, tripentaerythritol, di (trimethylolpropane), 2,2,6,6-tetrakis(hydroxymethyl)cyclohexanol, glycerol, glucose, 2-hydroxymethyl- 1,3-propanediol, triisopropanolamine, l-[N,N-bis(2-hydroxyethyl)amino]-2- propanol, and 2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)- 1,3-propanediol.

[0009] Examples of polymers disclosed herein include but are not limited to polymers that comprise poly(lactide-co-glycolide), poly(lactide-co-trimethylene carbonate), poly(dioxanone), poly(caprolactone), poly(caprolactone-co-glycolide), poly(caprolactone-co-lactide), poly(caprolactone-co-glycolide-co-trimethylene carbonate), poly(caprolactone-co-lactide-co- trimethylene carbonate), poly(lactide-co-glycolide-co-trimethylene carbonate). In one aspect the lactide component of the polymer can comprise residues of L-lactide or D,L-lactide. In another aspect, the caprolactone component of the polymer can comprise residues of gamma-caprolactone or epsilon-caprolactone.

[0010] Disclosed electrospun material can comprise a water-soluble compound that has one or more hydroxyl groups or carboxylic acid groups. Disclosed electrospun material can comprise a water-soluble compound that has two or more hydroxyl groups or carboxylic acid groups. Disclosed electrospun material can comprise a water-soluble compound that the sum of hydroxyl groups and carboxylic acid groups being equal or greater than two. In one aspect, the disclosed electrospun material can comprise a water-soluble compound that is a polyether. In one aspect, the hydrating compound is a polyol. These water-soluble compounds described above will be defined as hydrating compounds. In one aspect, disclosed electrospun material comprises more than one hydrating compounds. In another aspect the electrospun material comprises two hydrating compounds that are different in chemical composition or molecular weight. In one aspect, the electrospun material comprises two different fiber populations that comprise the same hydrating compound. In another aspect, the electrospun material comprises two different fiber populations that comprise the different hydrating compounds. In one aspect, the hydrating agent is soluble in water and an organic solvent. In one aspect, the organic solvent includes but is not limited to an alcohol, a fluorinated alcohol, acetone, tetrahydrofuran, dichloromethane, hexafluoroisopropanol, or combinations thereof. Alcohols include but are not limited to methanol, ethanol, isopropyl alcohol, propanol or combinations thereof. In one aspect, the hydrating agent is soluble in water and hexafluoroisopropanol (HFIP). In another aspect, the hydrating agent is soluble in water and methanol. In one aspect, the hydrating agent is soluble in water and acetone.

[0011] Hydrating compounds can include but are not limited to poly(ethylene oxide), poly(ethylene glycol), poly(ethylene glycol) methyl ether, poly(ethylene glycol) dimethyl ether, poly(ethylene oxide)-poly(propylene oxide) copolymers, copolymers of poly(ethylene glycol) and repeat units derived from at least one of the following monomers: l-lactide, dl-lactide, glycolide, trimethylene carbonate, epsilon-caprolactone, p-dioxanone and a morpholinedione, poly(vinylalcohol), sucrose, sorbitol, fructose, erythritol, mannitol, xylitol, raffinose, maltose, propylene glycol, ethylene glycol, glycerol, glucose, chloral hydrate, betaine, 1-proline, dl-malic acid, citric acid, lactose, and water-soluble surfactants. Examples of water-soluble surfactants include but are not limited to polysorbate 20, polysorbate 80, poloxamer 188, and 2-hydroxypropyl-beta- cyclodextrin.

[0012] Hydrating compounds can include surfactants. Surfactants that can be used for this application include but are not limited to nonionic surfactants such as Brij58, Brij56, Brij 35, and Brij30, cationic surfactants such as cetyltrimethylamonium bromide (CTAB); tetradecyltrimethylammonium bromide (TTAB), dodecyltrimethylammonium bromide (DTAB), and anionic surfactants such as sodium dodecylbenzenesulfonate (SDBS), and sodium dodecylsulfate (SDS). In one aspect, poly(ethylene glycol) or poly(ethylene glycol) methyl ether or polyethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 20,000. In another aspect, poly(ethylene glycol) or poly(ethylene glycol) methyl ether or poly(ethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 10,000. In another aspect, polyethylene glycol) or poly(ethylene glycol) methyl ether or poly(ethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 5,000. In another aspect, poly (ethylene glycol) or poly (ethylene glycol) methyl ether or poly(ethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 2,000. In another aspect, polyethylene glycol) or poly(ethylene glycol) methyl ether or poly(ethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 1 ,000. In another aspect, poly(ethylene glycol) or poly(ethylene glycol) methyl ether or poly(ethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 500. In another aspect, poly(ethylene glycol) or poly(ethylene glycol) methyl ether or poly(ethylene glycol) dimethyl ether that is used as the hydrating compound has an average molecular weight of less than about 5,000 and more than about 300.

[0013] The hydrating compound is a minor component of the electrospun matrix, In one aspect, the hydrating compound comprises less than about 10% of the electrospun matrix. In another aspect, the hydrating compound comprises less than about 5% of the electrospun matrix. In another aspect, the hydrating compound comprises less than about 2% of the electrospun matrix. In another aspect, the hydrating compound comprises less than about 1 % of the electrospun matrix. In another aspect, the hydrating compound comprises less than about 0.5% of the electrospun matrix.

[0014] Disclosed electrospun material can comprise a fiber population that has the same composition. In one aspect, the polymer used to generate the fiber population of the electrospun material is a homopolymer. In one aspect, the polymer used to generate the fiber population of the electrospun material is a copolymer. In another aspect, the electrospun material can comprise a fiber population that comprises a blend of two or more polymers that have a different composition to each other. In another aspect, the electrospun material can comprise a fiber population that has two or more fiber populations that have different composition to each other. In another aspect, the electrospun material can comprise a fiber population that has two or more fiber populations that have different molecular weights to each other. Examples of electrospun materials that can be used in the current invention include but are not limited to those disclosed in US10441403, US10632228, US11224677, US11826487 and US11739452 and are incorporated herein by reference. In one aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises glycolide residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises caprolactone residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises lactide residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises trimethylene carbonate residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a multiaxial polymer. In another aspect, the electrospun material can comprise a fiber population that comprises a polymer that comprises glycolide residues and second fiber population that comprises a polymer that comprises caprolactone residues. In another aspect, the electrospun material can comprise a fiber population that comprises a polymer that comprises lactide residues and second fiber population that comprises a polymer that comprises caprolactone residues. In another aspect, the electrospun material can comprise a fiber population that comprises a polymer that comprises glycolide residues and second fiber population that comprises a polymer that comprises lactide residues. In another aspect, the electrospun material can comprise a fiber population that comprises a polymer that comprises glycolide residues and second fiber population that comprises a polymer that comprises trimethylene carbonate residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises trimethylene carbonate residues and glycolide residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises trimethylene carbonate residuesand lactide residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises trimethylene carbonate residues and caprolactone residues. In another aspect, the electrospun material can comprise a polydioxanone fiber population and second fiber population that comprises a polymer that comprises lactide residues and glycolide residues. In another aspect, the first fiber population can comprise between 51% and 95% on a weight basis of the electrospun material. In another aspect, the first fiber population and the second fiber population have about an equal percentage on a weight basis of the electrospun material. In another aspect, the first fiber population can comprise between 49% and 55% on a weight basis of the electrospun material.

[0015] In one aspect the entire disclosed electrospun matrix comprises a hydrating compound. In another aspect, a portion of the electrospun matrix comprises a hydrating compound. In another aspect, one fiber population comprises a hydrating compound. In another aspect, one fiber population comprises a hydrating compound and the second fiber population comprises a hydrating compound of a different composition or the same composition but a different molecular weight. In another aspect, one fiber population comprises a hydrating compound and the second fiber population comprises the same hydrating compound.

[0016] The orientation of the fibers within a disclosed electrospun material can he varied. In one aspect, the fiber orientation is essentially random throughout the entire electrospun material. In another aspect, the more than 80% of the fibers are aligned in one general direction. In another aspect, a portion of the fibers can be randomly oriented while another portion of the fibers can be aligned in one general direction. In another aspect, a portion of the fibers are aligned in one general direction and a second portion of the fibers are aligned in a general direction that is different to the first portion of fibers.

[0017] Disclosed electrospun material comprises many fibers. The fibers have a diameter associated with them. In one aspect, the fibers have a mean fiber diameter of less than 20 microns. In another aspect, the fibers have a mean fiber diameter of less than 10 microns. In another aspect, the fibers have a mean fiber diameter of less than 5 microns. In another aspect, the fibers have a mean fiber diameter of less than 1 micron. In another aspect, the electrospun material comprises two or more distinct fiber populations in which the distinct fiber populations have different mean fiber diameters.

[0018] Disclosed electrospun material can be prepared such that the thickness of the material can be varied. In one aspect the electrospun material can have an average thickness in which the average thickness is the average of five individual thickness measurements taken at different locations on the same piece of the electrospun material. In one aspect, the electrospun material hasan average thickness ranging from about 0. 1 mm to about 6 mm. In another aspect, the material has a thickness of less than 1 mm. In another aspect, the material has a thickness of between about 0.2 mm and about 1 mm. In another aspect, the material has a thickness of between about 0.4 mm and 0.8 mm.

[0019] Disclosed electrospun material has pores that are interconnected. The pores have a size ranging from about 10 pm2to about 11,000 pm2. In one aspect, the average pore size, as measured by measuring five pores at different locations on the electrospun material, is less than about 2,000 pm2. In another aspect the average pore size is less than about 500 pm2. Another manner to characterize the pore size of the electrospun material is to measure the longest distance of a pore based on a two dimensional image of the electrospun material. This is defined as the pore length. The average pore length is the average of ten pore length measurements takes from different locations on the electrospun material. The average pore length has a value in the range of 0.2 pm to about 250 pm. In one aspect, the average pore length is less than about 150 pm. In another aspect, the average pore length is less than about 100 pm. In another aspect, the average pore length is less than about 50 pm. In another aspect, the average pore length is between about 0.2 pm and about 100 pm. In another aspect, the average pore length is between about 0.5 pm and about 50 pm.

[0020] Disclosed electrospun material can have a uniform surface. In one aspect, the electrospun material can have a pattern on the entire surface, in another aspect, the electrospun material can have one pattern on one surface and a different pattern on the second surface. In another aspect, a portion of the surface can have a pattern on the surface. In one aspect the pattern on one of the surfaces can mimic the pattern of the collector surface that is used to prepare the electrospun material.

[0021] Disclosed electrospun material can have a uniform density across the material. Disclosed electrospun material can comprise regions that have distinctly different densities. In one aspect, the electrospun material has the density of one of the surfaces that is greater than the density of the center region of the electrospun material. In another aspect, the electrospun material has the density of one of the surfaces that is less than the density of the center region of the electrospun material. In another aspect, the electrospun material has the density of one surface being distinctly different than the density of the second surface.

[0022] In order to ensure that the materials used in the manufacture of the electrospun material are biocompatible, the total residual monomer in the electrospun material should be less than 3 %. In one aspect, the total residual monomer in the electrospun material should be less than 2 %. Inone aspect, the total residual monomer in the electrospun material should be less than 1 %. In one aspect, the total residual monomer in the electrospun material should be less than 0.5%.

[0023] Disclosed electrospun material can have a suture pullout strength of greater than 0.5N. In one aspect, the disclosed electrospun material can have a suture pullout strength of greater than IN. In another aspect, the disclosed electrospun material can have a suture pullout strength of greater than 2N. In another aspect, the disclosed electrospun material can have a suture pullout strength of greater than 4N. In another aspect, the disclosed electrospun material can have a suture pullout strength of greater than 6N. In another aspect, the disclosed electrospun material can have a suture pullout strength of between about 0.5N to about 6N.

[0024] The hydrating compound can be incorporated into or onto the electrospun material during the electrospinning process. In one aspect, the hydrating compound is dissolved in one or more of the polymer solutions that are used to prepare the electrospun matrix. In another aspect, a solution of the hydrating compound is sprayed onto the electrospun material as it is being formed on a collector plate or collector drum. In another aspect, a solution of the hydrating compound is sprayed onto the electrospun material once the electrospinning process has been completed. In another aspect, the hydrating compound is applied to the electrospun material by dip coating the electrospun material into a solution of the hydrating compound. In one aspect, the hydrating compound can be dissolved using the same solvent that is used to dissolve the polymer that is used to prepare the electrospun material. In another aspect, the hydrating compound can be dissolved in a solvent that is different to the solvent that is used to dissolve the polymer that is used to prepare the electrospun material. In another aspect, the hydrating compound can be dissolved in a solvent that is different to the solvent that is used to dissolve the polymer that is used to prepare the electrospun material and is a solvent that the polymer that is used to prepare the electrospun material is not soluble in.|0025 | Electrospun materials that are prepared from the polymer listed above are generally hydrophobic and as such do not absorb water rapidly. The hydrating agent is added to increase the rate at which the electrospun material absorbs water. In one aspect, the electrospun material that comprises the hydrating compound absorbs water in less than about half the time it takes the same electrospun material without the hydrating compound to absorb water. In another aspect, the electrospun material that comprises the hydrating compound absorbs water in less than about a quarter of the time it takes the same electrospun material without the hydrating compound to absorb water. In one aspect, a 1 inch by 1 inch piece of the electrospun material that comprises the hydrating compound, absorbs 100 pL of water in less than 30 seconds. In another aspect, a 1 inch by 1 inch piece of the electrospun material that comprises the hydrating compound, absorbs 100p L of water in less than 20 seconds. In another aspect, a 1 inch by 1 inch piece of the electrospun material that comprises the hydrating compound, absorbs 100 L of water in less than 10 seconds. In another aspect, a 1 inch by 1 inch piece of the electrospun material that comprises the hydrating compound, absorbs 100 pL of water in less than 5 seconds. In another aspect, a 1 inch by 1 inch piece of the electrospun material that comprises the hydrating compound, absorbs 100 p L of water in less than 2 seconds. In another aspect, a 1 inch by 1 inch piece of the electrospun material that comprises the hydrating compound, absorbs 100 pL of water in less than 1 second.

[0026] An essential feature of the electrospun material that comprises the hydrating compound is that the properties of the electrospun material are not changed by more than 10% as compared to the properties of the material in which the hydrating compound is leeched out of the electrospun matrix or not incorporated into the electrospun material. In one aspect, the difference in areal density of a 2 inch by 2 inch sample of the electrospun matrix that comprises the hydrating compound and that has been dried under vacuum for 24 hours, is less than about 10% different from the same 2 inch by 2 inch sample of the electrospun matrix that comprises the hydrating compound in which the hydrating compound has been leeched out of the sample using a solvent that dissolves the hydrating compound but does not dissolve the fibers of the electrospun material followed by drying under vacuum for 24 hours. In one aspect, the difference in areal density of a 2 inch by 2 inch sample of the electrospun matrix that comprises the hydrating compound and that has been dried under vacuum for 24 hours, is less than about 5% different from the same 2 inch by 2 inch sample of the electrospun matrix that comprises the hydrating compound in which the hydrating compound has been leeched out of the sample using a solvent that dissolves the hydrating compound but does not dissolve the fibers of the electrospun material followed by drying under vacuum for 24 hours. In another aspect, the areal density difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 10%. In another aspect, the areal density difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 5%. In another aspect, the areal density difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 2%. Other properties in which the change differences are less than 10 % include but are not limited to tensile strength, density, suture pullout force, average pore size, mean fiber diameter, average pore length, and percent length change upon heating at 37°C for 60 minutes. In another aspect, the tensile strength difference between the electrospun material that comprises the hydrating compound and the same electrospun material that does not comprise the hydratingcompound is less than about 10%. In another aspect, the tensile strength difference between the electrospun material that comprises the hydrating compound and the same electrospun material that does not comprise the hydrating compound is less than about 5%. In another aspect, the tensile strength difference between the electrospun material that comprises the hydrating compounds and the same electrospun material that does not comprise the hydrating compound is less than about 3%. In another aspect, the density difference between the electrospun material that comprises the hydrating compound and the same electrospun material that does not comprise the hydrating compound is less than about 10%. In another aspect, the density difference between the electrospun material that comprises the hydrating compound and the same electrospun material that does not comprise the hydrating compound is less than about 5%. In another aspect, the density difference between the electrospun material that comprises the hydrating compound and the same electrospun material that does not comprise the hydrating compound is less than about 3%.

[0027] In one aspect, the difference in suture pull out force of sample of the electrospun matrix that comprises the hydrating compound and that has been dried under vacuum for 24 hours, is less than about 10% different from the same sample of the electrospun matrix that comprises the hydrating compound in which the hydrating compound has been leeched out of the sample using a solvent that dissolves the hydrating compound but does not dissolve the fibers of the electrospun material followed by drying under vacuum for 24 hours. In one aspect, the difference in suture pull out force of sample of the electrospun matrix that comprises the hydrating compound and that has been dried under vacuum for 24 hours, is less than about 5% different from the same sample of the electrospun matrix that comprises the hydrating compound in which the hydrating compound has been leeched out of the sample using a solvent that dissolves the hydrating compound but does not dissolve the fibers of the electrospun material followed by drying under vacuum for 24 hours. In another aspect, the suture pull out force difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 10%. In another aspect, the suture pull out force difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 5%. In another aspect, the suture pull out force difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 2%.

[0028] In one aspect, the difference in percent length change upon heating at 37°C for 60 minutes of sample of the electrospun matrix that comprises the hydrating compound and that has beendried under vacuum for 24 hours, is less than about 10% different from the same sample of the electrospun matrix that comprises the hydrating compound in which the hydrating compound has been leeched out of the sample using a solvent that dissolves the hydrating compound but does not dissolve the fibers of the electrospun material followed by drying under vacuum for 24 hours. In one aspect, the difference in percent length change upon heating at 37°C for 60 minutes of sample of the electrospun matrix that comprises the hydrating compound and that has been dried under vacuum for 24 hours, is less than about 5% different from the same sample of the electrospun matrix that comprises the hydrating compound in which the hydrating compound has been leeched out of the sample using a solvent that dissolves the hydrating compound but does not dissolve the fibers of the electrospun material followed by drying under vacuum for 24 hours. In another aspect, the percent length change upon heating at 37°C for 60 minutes difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 10%. In another aspect, the percent length change upon heating at 37°C for 60 minutes difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 5%. In another aspect, the percent length change upon heating at 37°C for 60 minutes difference between the electrospun material that comprises the hydrating compound and the electrospun material that does not comprise the hydrating compound is less than about 2%.

[0029] Disclosed electrospun material of the current disclosure can be in the form of a flat sheet, a round disc, an oval disc, a rectangle, a square, a polygon, a shape that has corners, straight edges, arcs or combinations thereof, or a non-uniform shape. In one aspect, the electrospun material can be in the form of a pouch, a tube, or a rolled sheet. In another aspect, the electrospun material can have holes, slices, fenestrations, flaps, or shaped voids in the material. The holes, slices, fenestrations, flaps, or shaped voids can occur over the entire electrospun material or a portion of the electrospun material. In another aspect, the electrospun material can be in the form of particles. The particles can be less than 10 mm in length. In another aspect, the particles can be less than 5 mm in length. In another aspect, the particles can be less than 2 mm in length. In another aspect, the particles can be less than 1 mm in length. In another aspect, the particles can be less than 0.5 mm in length. In another aspect, the particles can be less than 10 mm in length but greater than 0.1 mm in length. In another aspect, the particles can be less than 10 mm in length but greater than 0.5 mm in length.

[0030] The electrospun materials of this disclosure, can be used as a drug delivery device, a tissue scaffold, a wound healing matrix, a bum covering, a wound covering, a tissue support, a nervegrowth matrix, a tissue barrier, a void filler, a container for another medical device or a combination of these applications. In one aspect, the electrospun material can be approximated to healthy tissue, injured tissue, burned tissue, dead tissue, bone, tendons, cartilage, muscles, skin, ocular tissue, brain tissue, soft tissue, another medical device, a drug product, or a combination thereof. Medical devices can include but are not limited to breast implants, facial implants, dental implants, orthopedic implants, spinal implants, cardiac implantable electronic devices, collagen implants, meshes, braids, or combinations thereof.

[0031] In one aspect, the electrospun material of the current disclosure is sterile. In one aspect, the electrospun material has an endotoxin level that is less than 20 endotoxin units (EU) per electrospun material that is tested. In another aspect, the electrospun material has an endotoxin level that is less than 3 EU per electrospun material that is tested. In another aspect, the electrospun material has an endotoxin level that is less than 0.2 EU per electrospun material that is tested. In another aspect, the electrospun material is a medical device and the medical device has an endotoxin level that is less than 20 EU per device. In another aspect, the electrospun material is a component of a medical device and the medical device has an endotoxin level that is less than 20 EU per device. In another aspect, the electrospun material is a component of a medical device and the medical device is sterile.

[0032] The electrospun material of the present disclosure can be manufactured using a method in which the hydrating compound is incorporated into or onto the electrospun material during the electrospinning process. In one aspect, the method comprises dissolving the hydrating compound in one or more of the polymer solutions that are used to prepare the electrospun matrix and then using this prepared solution to electrospin the material onto a collector device, removing the electrospun material from the collector device and then drying the electrospun material. In another aspect, the method comprises preparing a solution of the hydrating compound, spraying the solution onto the electrospun material as it is being formed on a collector plate or collector drum, removing the electrospun material and drying the electrospun material. In another aspect, the method comprises preparing a solution of the hydrating compound, spraying the solution onto the electrospun material once the electrospinning process has been completed and drying the electrospun material. In another aspect, the method comprises dissolving the hydrating compound into a solvent, dipping or immersing the electrospun material into the solution of the hydrating compound, removing the electrospun material from the solution and drying the electrospun material. In one aspect, the method comprises dissolving the hydrating compound using the same solvent that is used to dissolve the polymer that is used to prepare the electrospun material. In another aspect, the method comprises dissolving the hydrating compound in a solvent that isdifferent to the solvent that is used to dissolve the polymer that is used to prepare the electrospun material. In another aspect, the method comprises dissolving the hydrating compound in a solvent that is different to the solvent that is used to dissolve the polymer that is used to prepare the electrospun material and is a solvent that the polymer that is used to prepare the electrospun material is not soluble in.

[0033] The electrospun material of the current disclosure can further comprise a biological agent. In one aspect, the electrospun material can comprise more than one biologically active agent. Exemplary biologically active agents include, without limitation, small molecule drugs, peptides, proteins, growth factors, hormones, antibodies, agonists, antagonists, anti-bacterial and / or antifungal agents.

[0034] Biologically active agents that can be incorporated into or onto the electrospun material described include: anti androgens, antibacterial, antioestrogens, androgens and anabolic agents, antibiotics, antimigraine drugs, antihistamines, antianxiety drugs, antidiuretics, antihistamines, antirheumatoid agents, antigens, analgesics, antidepressants, antiinflammatories, anesthetics, aminoglycosides antibodies, antiviral, adrenergic stimulants, anticonvulsants, antiangina agents, antiarrhyrthmics, antimalarials, anti-mitotic, anthelmintics, anoretic agents, antitussives, antipruritics, antipyretics, anti-alzheimer's agents, anti-Parkinson's agents, antiemetics and antinauseants, antihypertensives, anticoagulants, antifungals, antimicrobials, allergens, antidiarrheals, antihyperuricaemia agents, adrenergic stimulants, antiparasitic agents, antiproliferative agents, antipsychotic drugs, antithyroid agents, beta-adrenergic blocking agents, bronchodilators; bronchospasm relaxants, blood clotting factors, blood coagulation factors, cytotoxic agents, cytostatic agents, chemotherapeutics, clot inhibitors, clot dissolving agents, cells, CNS stimulants, Corticosteroids, calcium channel blockers, cofactors, ceramides, cardiotonic glycosides, cytokines (e.g., lymphokines, monokines, chemokines); colony stimulating factors (e.g., GCSF, GM-CSF, MCSF); dermatological agents, decongestants, diuretics, expectorants, endectocide agents, growth factors, hemostatic agents, hypoglycemic agents, hormones and hormone analogs, hypercalcemia, Hypnotics, interleukins (IL-2, IL-3, IL-4, IL-6); interferons (.beta.-IFN, .alpha.-IFN and .gamma.-IFN); immunosuppressants, muscle relaxants, microorganisms, non-steroidal anti-inflammatory agents, nucleic acids, nutritional agents, neuromuscular blocking agents, neuroleptics, Neurotoxins, nutraceuticals, oligonucleotides, oestrogens, obstetric drugs, ovulation inducers, opioids, progestagens, pituitary hormones, Pituitary inhibitors proteins, peptides, polysaccharides, protease inhibitors, prostaglandins, quinolones, reductase inhibitors, sulfa drugs, sclerosant, sedatives, sodium channel blockers,steroids, steroidal anti-inflammatory agents, smoking cessation agents, toxins, thrombolytic agents, thyroid hormones, tumor necrosis factor; vesicles, vitamins, viruses, vasodilators, vaccines

[0035] Additional representative examples of biologically active agents that may be suitable for use in the compositions of the present invention include, but are not limited to: Antidiarrheals such as diphenoxylate, loperamide and hyoscyamine; Antihypertensives such as hydralazine, minoxidil, captopril, enalapril, clonidine, prazosin, debrisoquine, diazoxide, guanethidine, methyldopa, reserpine, trimethaphan; Calcium channel blockers such as diltiazem, felodipine, amlodipine, nitrendipine, nifedipine and verapamil; Antiarrhyrthmics such as amiodarone, flecainide, disopyramide, procainamide, mexiletene and quinidine, Antiangina agents such as glyceryl trinitrate, erythrityl tetranitrate, pentaerythritol tetranitrate, mannitol hexanitrate, perhexilene, isosorbide dinitrate and nicorandil; Beta-adrenergic blocking agents such as alprenolol, atenolol, bupranolol, carteolol, labetalol, metoprolol, nadolol, nadoxolol, oxprenolol, pindolol, propranolol, sotalol, timolol and timolol maleate; Cardiotonic glycosides such as digoxin and other cardiac glycosides and theophylline derivatives; Adrenergic stimulants such as adrenaline, ephedrine, fenoterol, isoprenaline, orciprenaline, rimeterol, salbutamol, salmeterol, terbutaline, dobutamine, phenylephrine, phenylpropanolamine, pseudoephedrine and dopamine; Vasodilators such as cyclandelate, isoxsuprine, papaverine, dipyrimadole, isosorbide dinitrate, phentolamine, nicotinyl alcohol, co-dergocrine, nicotinic acid, glycerl trinitrate, pentaerythritol tetranitrate and xanthinol; Antiproliferative agents such as paclitaxel, estradiol, actinomycin D, sirolimus, tacrolimus, everolimus, 5 -fluorouracil and dexamethasone; Antimigraine preparations such as ergotanmine, dihydroergotamine, methysergide, pizotifen and sumatriptan; Anticoagulants and thrombolytic agents such as warfarin, dicoumarol, low molecular weight heparins such as enoxaparin, streptokinase and its active derivatives; Hemostatic agents such as aprotinin, tranexamic acid and protamine; Analgesics and antipyretics including the opioid analgesics such as buprenorphine, dextromoramide, dextropropoxyphene, fentanyl, alfentanil, sufentanil, hydromorphone, methadone, morphine, oxycodone, papaveretum, pentazocine, pethidine, phenopefidine, codeine, dihydrocodeine; acetylsalicylic acid (aspirin), paracetamol, synthetic alpha2 -adrenoreceptor agonist, dexmedetomidine hydrochloride, flunixin meglumine, meperidine, phenylbutazone and phenazone; Immunosuppressants, antiproliferatives and cytostatic agents such as rapamycin (sirolimus) and its analogs (everolimus and tacrolimus); Neurotoxins such as capsaicin, botulinum toxin (botox); Hypnotics and sedatives such as the barbiturates amylobarbitone, butobarbitone and pentobarbitone and other hypnotics and sedatives such as chloral hydrate, chlormethiazole, hydroxyzine and meprobamate; Antianxiety agents such as the benzodiazepines alprazolam, bromazepam, chlordiazepoxide, clobazam, chlorazepate,diazepam, flunitrazepam, flurazepam, lorazepam, nitrazepam, oxazepam, temazepam and triazolam; Neuroleptic and antipsychotic drugs such as the phenothiazines, chlorpromazine, fluphenazine, pericyazine, perphenazine, promazine, thiopropazate, thioridazine, trifluoperazine; and butyrophenone, droperidol and haloperidol; and other antipsychotic drugs such as pimozide, thiothixene and lithium; Antidepressants such as the tricyclic antidepressants amitryptyline, clomipramine, desipramine, dothiepin, doxepin, imipramine, nortriptyline, opipramol, protriptyline and trimipramine and the tetracyclic antidepressants such as mianserin and the monoamine oxidase inhibitors such as isocarboxazid, phenelizine, tranylcypromine and moclobemide and selective serotonin re-uptake inhibitors such as fluoxetine, paroxetine, citalopram, fluvoxamine and sertraline; CNS stimulants such as caffeine and 3-(2-aminobutyl) indole; Antipruritics can include compounds such as synthetic Janus Kinase (JAK) inhibitors, NK- 1 receptor antagonists, antibodies that neutralize interleukin-31 (IL-31). These can include oclacitinib maleate, Serlopitant, and Lokivetmab, Anti-alzheimer's agents such as tacrine; AntiParkinson's agents such as amantadine, benserazide, carbidopa, levodopa, benztropine, biperiden, benzhexol, procyclidine and dopamine-2 agonists such as S (-)-2-(N-propyl-N-2- thienylethylamino)-5-hydroxytetralin (N-0923), Anticonvulsants such as phenytoin, valproic acid, primidone, phenobarbitone, methylphenobarbitone and carbamazepine, ethosuximide, methsuximide, phensuximide, sulthiame and clonazepam, Antiemetics and antinauseants such as the phenothiazines prochloperazine, thiethylperazine, a neurokinin (NK1) receptor antagonist, maropitant citrateand 5HT-3 receptor antagonists such as ondansetron and granisetron, as well as dimenhydrinate, diphenhydramine, metoclopramide, domperidone, hyoscine, hyoscine hydrobromide, hyoscine hydrochloride, clebopride and brompride; Non-steroidal antiinflammatory agents including their racemic mixtures or individual enantiomers where applicable, preferably which can be formulated in combination with dermal and / or mucosal penetration enhancers, such as ibuprofen, flurbiprofen, ketoprofen, aclofenac, diclofenac, aloxiprin, aproxen, aspirin, diflunisal, fenoprofen, indomethacin, mefenamic acid, naproxen, phenylbutazone, piroxicam, salicylamide, salicylic acid, sulindac, desoxysulindac, tenoxicam, tramadol, ketoralac, fhifenisal, salsalate, triethanolamine salicylate, aminopyrine, antipyrine, oxyphenbutazone, apazone, cintazone, flufenamic acid, clonixerl, clonixin, meclofenamic acid, 6-chloro-a-methyl- 9H-carbazole-2-acetic acid (carprofen), flunixin, coichicine, demecolcine, allopurinol, oxypurinol, benzydamine hydrochloride, dimefadane, indoxole, intrazole, mimbane hydrochloride, paranylene hydrochloride, tetrydamine, benzindopyrine hydrochloride, fluprofen, ibufenac, naproxol, fenbufen, cinchophen, diflumidone sodium, fenamole, flutiazin, metazamide, letimide hydrochloride, nexeridine hydrochloride, octazamide, molinazole, neocinchophen,nimazole, proxazole citrate, tesicam, tesimide, tolmetin, and triflumidate; Antirheumatoid agents such as penicillamine, aurothioglucose, sodium aurothiomalate, methotrexate and auranofin; Muscle relaxants such as baclofen, diazepam, cyclobenzaprine hydrochloride, dantrolene, methocarbamol, orphenadrine and quinine; Agents used in gout and hyperuricaemia such as allopurinol, colchicine, probenecid and sulphinpyrazone; Oestrogens such as estradiol, oestriol, estrone, ethinylestradiol, mestranol, stilbestrol, dienestrol, epiestriol, estropipate and zeranol; Progesterone and other progestagens such as allylestrenol, dydrgesterone, lynestrenol, norgestrel, norethyndrel, norethisterone, norethisterone acetate, gestodene, levonorgestrel, medroxyprogesterone and megestrol; Antiandrogens such as cyproterone acetate and danazol; Antioestrogens such as tamoxifen and epitiostanol and the aromatase inhibitors, exemestane and 4-hydroxy-androstenedione and its derivatives; Androgens and anabolic agents such as testosterone, methyltestosterone, clostebol acetate, drostanolone, furazabol, nandrolone oxandrolone, stanozolol, trenbolone acetate, dihydro-testosterone, 17-(.alpha.-methyl-19- noriestosterone and fluoxymesterone; 5-alpha reductase inhibitors such as finasteride, turosteride, LY-191704 and MK-306; Corticosteroids such as betamethasone, betamethasone valerate, cortisone, dexamethasone, dexamethasone 21 -phosphate, fludrocortisone, flumethasone, fluocinonide, fluocinonide desonide, fluocinolone, fluocinolone acetonide, fluocortolone, halcinonide, halopredone, hydrocortisone, hydrocortisone 17-valerate, hydrocortisone 17- butyrate, hydrocortisone 21-acetate, methylprednisolone, prednisolone, prednisolone 21- phosphate, prednisone, triamcinolone, triamcinolone acetonide; Glycosylated proteins, proteoglycans, glycosaminoglycans such as chondroitin sulfate; chitin, acetyl-glucosamine, hyaluronic acid; Complex carbohydrates such as glucans; Further examples of steroidal antiinflammatory agents such as cortodoxone, fludroracetonide, fludrocortisone, difluorsone diacetate, flurandrenolone acetonide, medrysone, amcinafel, amcinafide, betamethasone and its other esters, chloroprednisone, clorcortelone, descinolone, desonide, dichlorisone, difluprednate, flucloronide, flumethasone, flunisolide, flucortolone, fluoromethalone, fluperolone, fluprednisolone, meprednisone, methylmeprednisolone, paramethasone, cortisone acetate, hydrocortisone cyclopentylpropionate, cortodoxone, flucetonide, fludrocortisone acetate, flurandrenolone, aincinafal, amcinafide, betamethasone, betamethasone benzoate, chloroprednisone acetate, clocortolone acetate, descinolone acetonide, desoximetasone, dichlorisone acetate, difluprednate, flucloronide, flumethasone pivalate, flunisolide acetate, fluperolone acetate, fluprednisolone valerate, paramethasone acetate, prednisolamate, prednival, triamcinolone hexacetonide, cortivazol, formocortal and nivazol; Pituitary hormones and their active derivatives or analogs such as corticotrophin, thyrotropin, follicle stimulating hormone(FSH), a Gonadotropin-releasing hormone (GnRH) analog, u deslorelin acetate, cetrorelix acetate, Gonadorelin acetate, clomiphene, Human chorionic gonadotropin (HCG), luteinizing hormone (LH) and gonadotrophin releasing hormone (GnRH); Hypoglycemic agents such as insulin, chlorpropamide, glibenclamide, gliclazide, glipizide, tolazamide, tolbutamide and metformin; Thyroid hormones such as calcitonin, thyroxine and liothyronine and antithyroid agents such as carbimazole and propylthiouracil; Other miscellaneous hormone agents such as octreotide; Pituitary inhibitors such as bromocriptine; Ovulation inducers such as clomiphene; Diuretics such as the thiazides, related diuretics and loop diuretics, bendrofluazide, chlorothiazide, chlorthalidone, dopamine, cyclopenthiazide, hydrochlorothiazide, indapamide, mefruside, methycholthiazide, metolazone, quinethazone, bumetanide, ethacrynic acid and frusemide and potasium sparing diuretics, spironolactone, amiloride and triamterene; Antidiuretics such as desmopressin, lypressin and vasopressin including their active derivatives or analogs; Obstetric drugs including agents acting on the uterus such as ergometrine, oxytocin and gemeprost; Prostaglandins such as alprostadil (PGE1), prostacyclin (PGI2), dinoprost (prostaglandin F2- alpha) and misoprostol; Antimicrobials including the cephalosporins such as cephalexin, cefoxytin and cephalothin; Penicillins such as amoxycillin, amoxycillin with clavulanic acid, ampicillin, bacampicillin, benzathine penicillin, benzylpenicillin, carhenicillin, cloxacillin, methicillin, phenethicillin, phenoxymethylpenicillin, flucioxacillin, meziocillin, piperacillin, ticarcillin and azlocillin; Tetracyclines such as minocycline, chlortetracycline, tetracycline, demeclocycline, doxycycline, methacycline and oxytetracycline and other tetracycline- type antibiotics; Amnioglycoides such as amikacin, amikin sulfate, gentamicin, kanamycin, neomycin, netilmicin and tobramycin; Antifungals such as amorolfine, isoconazole, clotrimazole, econazole, miconazole, nystatin, terbinafine, bifonazole, amphotericin, griseofulvin, ketoconazole, fluconazole and flucytosine, salicylic acid, fezatione, ticlatone, tolnaftate, triacetin, zinc, pyrithione and sodium pyrithione; Quinolones such as nalidixic acid, cinoxacin, ciprofloxacin, enoxacin and norfloxacin; Sulphonamides such as phthalysulphthiazole, sulfadoxine, sulphadiazine, sulphamethizole and sulphamethoxazole; Sulphones such as dapsone; Other miscellaneous antibiotics such as chloramphenicol, clindamycin, erythromycin, erythromycin ethyl carbonate, erythromycin estolate, erythromycin glucepate, erythromycin ethylsuccinate, erythromycin lactobionate, roxithromycin, lincomycin, natamycin, nitrofurantoin, spectinomycin, vancomycin, aztreonam, colistin IV, metronidazole, tinidazole, secnidazole, omidazole, fusidic acid, trimethoprim, and 2-thiopyridine N-oxide; halogen compounds, particularly iodine and iodine compounds such as iodine-PVP complex and diiodohydroxyquin, hexachlorophene; chlorhexidine; chloroamine compounds, silver sulfadiazine, silver, nanoparticulate silver, silvernitrate, silver zeolites, silver cations, AgPO3, Ag3PO4, Ag4P2O7, exsalt®SD7 (Exciton Technologies) exsalt®T7 (Exciton Technologies); Lincomycin Hydrochloride, tricyclic tetrahydroquinoline antibacterial agents, 8-pyrazinyl-S-spiropyrimidinetrione-oxazinoquinoline derivatives, 3-spiropyrimidinetrione-quinoline derivatives, thiadiazol-spiropyrimidinetrione- quinoline derivatives, (2R,4S,4aS)-10-fluoro-2,4-dimethyl-8-(4-methyloxazol-2-yl)-2,4,4a,6- tetra- hydro-lH,rH-spiro[[l,4]oxazino[4,3-a]quinoline-5,5’-pyrimidine]-2',4’,6'(- 3'H)-trione, (2R,4S,4aS)-9,10-difluoro-2,4-dimethyl-8-(3-methylisoxazol-5-yl)-2,4,4a,6- -tetrahydro- 1H,1’H- spiro[[l,4]oxazino[4,3-a]quinoline-5,5'-pyrimidine]-2’,- 4',6'(3'H)-trione, (2R,4S,4aS)-10-fluoro- 2,4-dimethyl-8-(oxazol-2-yl)-2,4,4a,6-tetrahydro-lH-,l'H-spiro[[l,4]oxazino[4,3-a]quinoline- 5,5’-pyrimidine]-2',4’,6'(3'H)-tri- one, (2R,4S,4aS)-9,10-difluoro-2,4-dimethyl-8-(2- methyloxazol-5-yl)-2,4,4a,6-t- etrahydro-lH,l'H-spiro[[l,4]oxazino[4,3-a]quinoline-5,5’- pyrimidine]-2',4'-,6'(3'H)-trione, (2R,4S,4aS)-9,10-difluoro-2,4-dimethyl-8-(oxazol-4-yl)- 2,4,4a,6-tetrahydr- o-lH,rH-spiro[[l,4]oxazino[4,3-a]quinoline-5,5'-pyrimidine]-2',4',6'(3'H)- - trione, (2R,4S,4aS)-9-fluoro-2,4-dimethyl-8-(4-methyloxazol-2-yl)-2,4,4a,6-tetrah- ydro-lH,l'H- spiro[[l,4]oxazino[4,3-a]quinoline-5,5'-pyrimidine]-2’,4',6'(3- ’H)-trione, (2R,4S,4aS)-9,10- difluoro-8-(4-(4-fluorophenyl)oxazol-5-yl)-2,4-dimethyl- 2,4,4a,6-tetrahydro-lH,l’H- spiro[[l,4]oxazino[4,3-a]quinoline-5,5'-pyrimid- ine]-2',4',6'(3'H)-trione, (2S,4R,4aR)-2,4- dimethyl-8-(oxazol-5-yl)-2,4,4a,6-tetrahydro-lH,l'H-spiro- [[l,4]oxazino[4,3-a]quinoline-5,5'- pyrimidine]-2',4',6’(3'H)-trione, (2S,4R,4aR)-8-(4-ethyloxazol-2-yl)-9,10-difluoro-2,4-dimethyl- 2,4,4a,6-te- trahydro-lH,rH-spiro[[l,4]oxazino[4,3-a]quinoline-5,5’-pyrimidine]-2',4’,- 6'(3'H)- trione, (2R,4S,4aS)-9,10-difluoro-2,4-dimethyl-8-(oxazol-2-yl)-2,4,4a,6-tetrahydr- o-lH, 1'H- spiro[[l,4]oxazino[4,3-a]quinoline-5,5'-pyrimidine]-2’,4',6'(3'H)- -trione, benzoyl peroxide; Antituberculosis drugs such as ethambutol, isoniazid, pyrazinamide, rifampicin and clofazimine; Antimalarials such as primaquine, pyrimethamine, chloroquine, hydroxychloroquine, quinine, mefloquine and halofantrine; compounds such as Azithromycin, Aztreonam, Cefaclor, Cefadroxil, Cefazolin, Cefdinir, Cefepime Hydrochloride, (cefoperazone sodium, Ceftaroline fosamil, avibactam, Ceftazidime sodium, Ceftibuten, ceftiofur, Tazobactam, cefovecin sodium [(6R,7R)- 7-[[(2Z)-(2-amino-4-thiazolyl)(methoxyimino)acetyl]amino]-8-oxo-3-[(2S)-tetrahydro-2- furanyl]-5-thia-l-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, monosodium salt] Cefuroxime Axetil, Cefuroxime, Cephalexin, Chloramphenicol Sodium, Ciprofloxacin HC1, Clarithromycin, Clindamycin hydrochloride, Clindamycin Palmitate hydrochloride, Clindamycin phosphate, Dalbavancin Hydrochloride, Daptomycin, Demeclocycline hydrochloride, Dicloxacillin, Doripenem, Doxycycline, Doxycycline calcium, Doxycycline hyclate, Doxycycline monohydrate, Ertapenem sodium, Erythromycin, Erythromycin Ethylsuccinate, Erythromycin lactobionate,Erythromycin stearate, Erythromycin, Fosfomycin tromethamine, Gemifloxacin mesylate, Gentamicin Sulfate, Imipenem, Kanamycin, Levofloxacin, Lincomycin hydrochloride, Linezolid, Meropenem, Methenamine Hippurate, Metronidazole, Metronidazole, Micafungin sodium, Minocycline Hydrochloride, Minocycline, Moxifloxacin hydrochloride, Nafcillin, Nalidixic acid, Neomycin Sulfate, Nitrofurantoin, Norfloxacin, Ofloxacin, Oritavancin diphosphate, Oxacillin, Penicillin G, Penicillin G benzathine, Penicillin G Sodium, Penicillin V Potassium, Piperacillin Sodium, Polymyxin B Sulfate, Quinupristin, dalfopristin, Spectinomycin hydrochloride, Streptomycin, Sulfamethoxazole, Tedizolid Phosphate, Telavancin, Telithromycin, Tetracycline Hydrochloride, Ticarcillin disodium, Tigecycline, Tobramycin Sulfate, Tobramycin, Trimethoprim hydrochloride, tulathromycin, Vancomycin hydrochloride.

[0036] Antiviral agents may be included in the compositions of the present disclosure, where exemplary antiviral agents include acyclovir and acyclovir prodrugs, famcyclovir, zidovudine, didanosine, stavudine, lamivudine, zalcitabine, saquinavir, indinavir, ritonavir, n-docosanol, tromantadine and idoxuridine. Other suitable biologically active agents include Anthelmintics such as mebendazole, thiabendazole, niclosamide, praziquantel, pyrantel embonate and diethylcarbamazine; Cytotoxic agents such as plicamycin, cyclophosphamide, dacarbazine, fluorouracil and its prodrugs (described, for example, in International Journal of Pharmaceutics, 111, 223-233 (1994)), methotrexate, procarbazine, 6-mercaptopurine and mucophenolic acid; Anorectic and weight reducing agents including dexfenflurarnine, fenfluramine, diethylpropion, mazindol and phentermine; Agents used in hypercalcaemia such as calcitriol, dihydrotachysterol and their active derivatives or analogs; Antitussives such as ethylmorphine, dextromethorphan and pholcodine; Antiparasitic and Endectocide agents such as moxidectin, Ivermectin, Niclosamide, Praziquantel, Pyrantel, Pyrvinium, Albendazole, Flubendazole, Mebendazole, Thiabendazole

[0037] The compositions of the present disclosure may include: an expectorant such as carbolcysteine, bromihexine, emetine, quanifesin, ipecacuanha and saponins; Decongestants such as phenylephrine, phenylpropanolamine and pseudoephedrine; Bronchospasm relaxants such as ephedrine, fenoterol, orciprenaline, rimiterol, salbutamol, sodium cromoglycate, cromoglycic acid and its prodrugs (described, for example, in International Journal of Pharmaceutics 7, 63-75 (1980)), terbutaline, ipratropium bromide, salmeterol and theophylline and theophylline derivatives; Antihistamines such as meclozine, cyclizine, chlorcyclizine, hydroxyzine, brompheniramine, chlorpheniramine, clemastine, cyproheptadine, dexchlorpheniramine, diphenhydramine, diphenylamine, doxylamine, mebhydrolin, pheniramine, tripolidine, azatadine, diphenylpyraline, methdilazine, terfenadine, astemizole, loratidine and cetirizine; Local anaesthetics such as benzocaine, bupivacaine, amethocaine, lignocaine, lidocaine, cocaine,cinchocaine, dibucaine, mepivacaine, prilocaine, etidocaine, veratridine (specific c-fiber blocker) and procaine; Stratum comeum lipids, such as ceramides, cholesterol and free fatty acids, for improved skin barrier repair [Man, et al. J. Invest. Dermatol., 106(5), 1096, (1996)]; Neuromuscular blocking agents such as suxamethonium, alcuronium, pancuronium, atracurium, gallamine, tubocurarine and vecuronium; sclerocing agents or sclerosants may be a surfactant or it may be selected from the group consisting of ethanol, dimethyl sulfoxide, sucrose, sodium chloride, dextrose, glycerin, minocycline, tetracycline, doxycycline, polidocanol, sodium tetradecyl sulfate, sodium morrhuate, and sotradecol. an angiogenesis inhibitor; a 5-lipoxygenase inhibitor or antagonist; a chemokine receptor antagonist; a cell cycle inhibitor; a taxane; an antimicrotubule agent; paclitaxel; an analogue or derivative of paclitaxel; a vinca alkaloid; camptothecin or an analogue or derivative thereof; a podophyllotoxin, wherein the podophyllotoxin may be an etoposide or an analogue or derivative thereof; an anthracycline, wherein the anthracycline may be doxorubicin or an analogue or derivative thereof or the anthracycline may be mitoxantrone or an analogue or derivative thereof; a platinum compound; a nitrosourea; a nitroimidazole; a folic acid antagonist; a cytidine analogue; a pyrimidine analogue; a fluoropyrimidine analogue; a purine analogue; a nitrogen mustard or an analogue or derivative thereof; a hydroxyurea; a mytomicin or an analogue or derivative thereof; an alkyl sulfonate; a benzamide or an analogue or derivative thereof; a nicotinamide or an analogue or derivative thereof; a halogenated sugar or an analogue or derivative thereof; a DNA alkylating agent; an antimicrotubule agent; a topoisomerase inhibitor; a DNA cleaving agent; an antimetabolite; a nucleotide interconversion inhibitor; a hydroorotate dehydrogenase inhibitor; a DNA intercalation agent; an RNA synthesis inhibitor; a pyrimidine synthesis inhibitor; a cyclin dependent protein kinase inhibitor; an epidermal growth factor kinase inhibitor; an elastase inhibitor; a factor Xa inhibitor; a famesyltransferase inhibitor; a fibrinogen antagonist; a guanylate cyclase stimulant; a heat shock protein 90 antagonist; which may be a geldanamycin or an analogue or derivative thereof; a guanylate cyclase stimulant; a HMGCoA reductase inhibitor, which may be simvastatin or an analogue or derivative thereof; an IKK2 inhibitor; an IL-1 antagonist; an ICE antagonist; an IRAK antagonist; an IL-4 agonist; an immunomodulatory agent; sirolimus or an analogue or derivative thereof; everolimus or an analogue or derivative thereof; tacrolimus or an analogue or derivative thereof; bioImus or an analogue or derivative thereof; tresperimus or an analogue or derivative thereof; auranofin or an analogue or derivative thereof; 27-0-demethylrapamycin or an analogue or derivative thereof; gusperimus or an analogue or derivative thereof; pimecrolimus or an analogue or derivative thereof; ABT-578 or an analogue or derivative thereof; an inosine monophosphate dehydrogenase (1MPDH) inhibitor, which may be mycophenolic acid or ananalogue or derivative thereof or l-.alpha.-25 dihydroxy vitamin D.sub.3 or an analogue or derivative thereof; a leukotriene inhibitor; an MCP- 1 antagonist; an MMP inhibitor; an NF kappa B inhibitor, which may be Bay 11-7082; an NO antagonist; a p38 MAP kinase inhibitor, which may be SB 202190; a phosphodiesterase inhibitor; a TGF-.beta. inhibitor; a thromboxane A2 antagonist; a TNF-. alpha, antagonist; a TACE inhibitor; a tyrosine kinase inhibitor; vitronectin inhibitor; a fibroblast growth factor inhibitor; a protein kinase inhibitor; a PDGF receptor kinase inhibitor; an endothelial growth factor receptor kinase inhibitor; a retinoic acid receptor antagonist; a platelet derived growth factor receptor kinase inhibitor; a fibrinogen antagonist; an antimycotic agent; sulconizole; a bisphosphonate; a phospholipase Al inhibitor; a histamine H1 / H2 / H3 receptor antagonist; a macrolide antibiotic; a GPIIb / IIIa receptor antagonist; an endothelin receptor antagonist; a peroxisome proliferator-activated receptor agonist; an estrogen receptor agent; a somastostatin analogue; a neurokinin 1 antagonist; a neurokinin 3 antagonist; a VLA-4 antagonist; an osteoclast inhibitor; a DNA topoisomerase ATP hydrolyzing inhibitor; an angiotensin I converting enzyme inhibitor; an angiotensin II antagonist; an enkephalinase inhibitor; a peroxisome proliferator-activated receptor gamma agonist insulin sensitizer; a protein kinase C inhibitor; a ROCK (rho-associated kinase) inhibitor; a CXCR3 inhibitor; Itk inhibitor; a cytosolic phospholipase A.sub.2-.alpha. inhibitor; a PPAR agonist; an immunosuppressant; an Erb inhibitor; an apoptosis agonist; a lipocortin agonist; a VCAM-1 antagonist; a collagen antagonist; an .alpha. -2 integrin antagonist; a TNF-. alpha, inhibitor; a nitric oxide inhibitor; and a cathepsin inhibitor, anti-fibrin and fibrinolytic agents, including plasmin, streptokinase, single chain urokinase, urokinase, t-PA (tissue type plasminogen activator), aminocaproic acid; anti-platelet agents including, aspirin, prostacyclins (and analogues); glycoprotein Ilb / IIIa agents including monoclonal antibodies, peptides (e.g. ReoPro, Cilastagel, eptifibatide, tirofiban, ticlopidine, Vapiprost, dipyridamole, forskolin, angiopeptin, argatroban), thromboxane inhibitors; antithrombin and anti-coagulant agents, including dextan, heparin, LMW heparin (Enoxaparin, Dalteparin), hirudin, recombinant hirudin, anti-thrombin, synthetic antithrombins, thrombin inhibitors, Warfarin (and other coumarins); anti-mitotic, antiproliferative and cytostatic agents, including vincristine, vinblastine, paclitaxel, methotrexate, cisplatin, fluorouracil, rapamycin, azathioprine, cyclophosphamide, mycophenolic acid, corticosteroids, colchicine, nitroprusside; antiangiogenic and angiostatic agents, including paclitaxel, angiostatin and endostatin; genetic materials and oligonucleotides; ACE inhibitors (e.g. Cilazapril, Lisinopril, Captopril); growth factor (e.g. VEGF, FGF) antagonists; antioxidants and vitamins (e.g. Probucol, Tocopherol); calcium channel blockers (e.g. nifedipine); fish oil (omega 3-fatty acid); phosphodiesterase inhibitors (e.g. dipyridamole); nitric acid donor (e.g. Molsidomine); somatostatin analogues (e.g.angiopeptin); immunosuppressives and anti-inflammatory agents (e.g. prednisolone, glucocorticoid and dexamethasone); antimicrobials (e.g. rifampin, minocycline, rifamycin) and radionuclides, including alpha, beta and gamma emitting isotopes (e.g. Re-188, Re-186, 1-125, Y- 90); COX-2 inhibitors such as Celecoxib and Vioxx; kinase inhibitors, such as epidermal growth factor kinase inhibitor, tyrosine kinase inhibitors, MAP kinase inhibitors protein transferase inhibitors, Resten-NG, Smoking cessation agents such as nicotine, bupropion and ibogaine; Insecticides and other pesticides which are suitable for local application; Dermatological agents, such as vitamins A, C, Bl, B2, B6, B 12, B 12. alpha.., and E, vitamin E acetate and vitamin E sorbate; Allergens for desensitisation such as house, dust or mite allergens; Nutritional agents and neutraceuticals, such as vitamins, essential amino acids and fats; Macromolecular pharmacologically active agents such as proteins, enzymes, peptides, polysaccharides (such as cellulose, amylose, dextran, chitin), nucleic acids, cells, tissues, and the like; Bone mending biochemicals such as calcium carbonate, calcium phosphate, tricalcium phosphate, hydroxyapetite or bone morphogenic protein (BMP); Angiogenic growth factors such as Vascular Endothelial Growth Factor (VEGF) and epidermal growth factor (EFG), cytokines interleukins, fibroblasts and cytotaxic chemicals; and Keratolytics such as the alpha-hydroxy acids, glycolic acid and salicylic acid; and DNA, RNA or other oligonucleotides. Vaccines that contain Hendra virus (HeV) G glycoprotein and / or Nipah virus G glycoprotein, Lutenising Hormone Releasing Hormone (LHRH) peptide, LHRH-diphtheria toxoid conjugate, porcine circovirus type 2 (PCV2) antigen, a porcine reproductive and respiratory syndrome virus antigen, Mycoplasma hyopneumoniae protein antigen. Proteins or protein fragments, for example ORFI Torque teno virus protein, or other TTV proteins or fragments, antigens against Aeromonas salmonicida, antigens against Vibrio anguillarum, and antigens against V. salmonicida. Growth factors include but are not limited to Vascular Endothelial Growth Factor (VEGF) and epidermal growth factor (EFG), Growth Differentiation Factors (GDFs), Fibroblast Growth Factors ( FGF-1 through FGF-23), Osteoprotegerin, Cartilage Derived Morphogenic Proteins (CDMPs, which can be a foundation for soft or hard tissue), Lim Mineralization Proteins (LMPs), Interleukins (IL-1 through IL-13), Insulin- like Growth Factor- 1, Connective Tissue Growth Factor (CTGF), platelet derived growth factor (PDGF), nerve growth factors, neutrophins Brain-derived neurotrophic factor (BDNF), Nerve growth factor (NGF), Neurotrophin-3 (NT-3), Neurotrophin-4 (NT-4)], Transforming growth factors (TGF-a, TGF-P), Tumor necrosis factor (TNF). Growth factor Agonists or antagonists as well as antibodies against these growth factors. Biologically active agents that can be used to treat macular degeneration include but are not limited to bevacizumab and ranibizumab.Biologically active agents can include ansamycin antibiotic. Ansamycin antibiotics can include but are not limited to rifampicin, geldanamycin, rifabutin, rifaximin, and rifamycin S.

[0038] In an aspect, an active agent is a protein, where that term includes peptides and polypeptides, sugar-modified protein such as glycoprotein, as well as functional descriptions of protein classes such as antigen, enzyme, immunoglobulin and antibody. A composition may include a special delivery vehicle for the active agent, such as a virus or modified virus, where the active agent, such as a protein or polynucleotide, is contained within or expressed by the special delivery vehicle.

[0039] In an aspect, an active agent is a PD-L1 inhibitor. A PD-L1 inhibitor can include but is not limited to Atezolizumab, Avelumab, Durvalumab, LY3300054 (Eli Lilly and Company), and monoclonal antibodies or monoclonal antibody conjugates that act as a PD-L1 inhibitor

[0040] In an aspect, an active agent is a PD-1 inhibitor A PD-1 inhibitor can include but is not limited to pembrolizumab, Nivolumab, Cemiplimab and monoclonal antibodies or monoclonal antibody conjugates that act as a PD-1 inhibitors.

[0041] In an aspect, an active agent is a CTLA-4 inhibitor. A CTLA-4 inhibitor can include but is not limited to Ipilimumab, AGEN1884 and monoclonal antibodies or monoclonal antibody conjugates that act as a CTLA-4 inhibitor.

[0042] In an aspect, an active agent is a compound that is used to treat non-muscle invasive bladder cancer. The compounds that can be used include but are not limited to non-live immunologically active Bacillus Calmette- Guerin (BCG) subcomponents that include BCG cell wall and various BCG proteins and antigens, an IL-2 fusion protein such as ALT-801 (Aitor Bioscience), Oportuzumab monatox (Sesen Bio), sunitinib (Pfizer), enzalutamide, ethacrynic acid, Imiquimod and tamoxifen, ALT-803 (Aitor Bioscience), and Lenalidomide.

[0043] In an aspect, an active agent is an antibody drug conjugate. The antibody drug conjugate can include but is not limited to trastuzumab emtansine, Sacituzumab govitecan, Enfortumab vedotin, ASG-15ME, Gemtuzumab ozogamicin, Brentuximab vedotin, Trastuzumab emtansine, and Inotuzumab ozogamicin.

[0044] In an aspect, an active agent is a small molecule protein kinase inhibitor. The small molecule protein kinase inhibitor can include but is not limited to abenaciclib, acalabrutini, afatinib, alectinib, axitinib, baricitinib, binimetinib, bosutinib, brigatinib, cabozantinib, ceritinib, cobimetinib, crisotinib, dabrafenib, dacomitinib, dasatinib, encorafenib, erdafitinib, erlotinib, everolimus, fostamatinib, gefitinib, gilteritinib, ibrutinib, imatinib, lapatinib, larotrectinib, lenvatinib, lorlatinib, midostaurin, neratinib, netarsudil, nilotinib, nintedanib, osimertinib,palbociclib, Pazopanib, Ponatinib, Regorafenib, Ribociclib, Ruxolitinib, Sirolimus, Sorafenib, Sunitinib, Temsirolimus, Tofacitinib, Trametinib, Vandetanib, and Vemurafenib.EXAMPLESExample 1PLGA electrospun matrix with hydrating compound

[0045] PLGA (10:90 lactide:glycolide) is dissolved in hexafluoroisopropanol (HFIP) to produce a solution of about 10% polymer. Polyethylene glycol 400 is added to the polymer solution at 0.5% and is allowed to dissolve. The resultant solution transferred to a syringe with a blunt needle and the syringe is then placed in a syringe pump. This is repeats so that there is an array of 8 syringes. The polymer solution is then electrospun onto a rotating collector drum at a flow rate of about 0.2 ml / min. After a sufficiently thick electrospun material is obtained, the electrospinning process is terminated, the collector is stopped and the electrospun material is removed from the collector. The electrospun material is dried under vacuum at room temperature for 24 hours. The process is repeated using polyethylene glycol 400, polyethylene glycol 1000, polyethylene glycol 1500, polyethylene glycol 3350 and polyethylene glycol 8000.Example 2Two fiber population electrospun matrix with hydrating compound

[0046] A PLGA (10:90 lactide: glycolide) is dissolved in hexafluoroisopropanol (HFIP) to produce a solution of about 10% polymer. A polydioxanone (PDO) polymer dissolved in hexafluoroisopropanol (HFIP) to produce a solution of about 10% polymer. Polyethylene glycol 400 is added to the both the PLGA solution and the PDO solution at concentration of about 0.5% (w / v). The resultant solutions are transferred to separate syringes with a blunt needle and the syringe is then placed in a syringe pump such that 4 syringes of each polymer solution are prepared. The syringes are placed in a linear array such that the two different polymer solutions alternate in the array. The polymer solutions are then electrospun onto a rotating collector drum at a flow rate of about 0.2 ml / min. After a sufficiently thick electrospun material is obtained, the electrospinning process is terminated, the collector is stopped and the electrospun material is removed from the collector. The electrospun material is dried under vacuum at room temperature for 24 hours. The process is repeated using polyethylene glycol 400, polyethylene glycol 1000, polyethylene glycol 1500, polyethylene glycol 3350 and polyethylene glycol 8000.Example 3Two fiber population electrospun matrix with hydrating compound - 2

[0047] A triaxial polymer (US 6,462,169) is dissolved in hexafluoroisopropanol (HFIP) to produce a solution of about 10% polymer. A polydioxanone (PDO) polymer dissolved in hexafluoroisopropanol (HFIP) to produce a solution of about 10% polymer. Polyethylene glycol 400 is added to the both the triaxial polymer solution and the PDO solution at concentration of about 0.5%. The resultant solutions are transferred to separate syringes with a blunt needle and the syringe is then placed in a syringe pump such that 4 syringes of each polymer solution are prepared. The syringes are placed in a linear array such that the two different polymer solutions alternate in the array. The polymer solutions are then electrospun onto a rotating collector drum at a flow rate of about 0.2 ml / min. After a sufficiently thick electrospun material is obtained, the electrospinning process is terminated, the collector is stopped and the electrospun material is removed from the collector. The electrospun material is dried under vacuum at room temperature for 24 hours. The process is repeated using polyethylene glycol 400, polyethylene glycol 1000, polyethylene glycol 1500, polyethylene glycol 3350 and polyethylene glycol 8000.Example 4 Electrospun matrix with hydrating compound - dip coated

[0048] PLGA polymer (50:50 lactide:glycolide) is dissolved in hexafluoroisopropanol (HFIP) to produce a solution of about 10% polymer. The resultant solution transferred to a syringe with a blunt needle and the syringe is then placed in a syringe pump. This is repeats so that there is an array of 8 syringes. The polymer solution is then electrospun onto a rotating collector drum at a flow rate of about 0.2 ml / min. After a sufficiently thick electrospun material is obtained, the electrospinning process is terminated, the collector is stopped and the electrospun material is removed from the collector. The electrospun material is then fully immersed into a solution of polyethylene glycol 400 dissolved in methanol at 0.5% (w / v). After about 10 seconds, the electrospun material is removed from the solution and the excess solution is allowed to drip from the material. The electrospun material is dried under vacuum at room temperature for 24 hours. The process is repeated using polyethylene glycol 1000, glycerol, and polysorbate 20.Example 5 Control polymer preparation

[0049] Control polymers are prepared in a similar manner to that described in Examples 1 to 4 with the exception that no hydrating compound was used.Example 6 Hydration test

[0050] A 1 inch by 1 inch sample is cut from each of the electrospun materials prepared in Examples 1 to 5. 100 L of deionized water is added to the center of each piece of the samples. The time is recorded from the point of addition of the water to when the water is fully absorbed into the electrospun material. For all the electrospun materials that comprises the hydrating compound, the water is absorbed into the material in less than 2 seconds. The time for the water to be absorbed by all the control electrospun samples is greater than 30 seconds with some samples taking over 1 minute to absorb all the water.Example 7 Areal density

[0051] A 2 inch by 2 inch sample is cut from each of the electrospun materials prepared in Examples 1 to 4. The samples are dried under vacuum for 24 hours. The exact weight, length and width of each samples is measured and the areal density is calculated. Each sample is immersed in 50 mL methanol for 1 minute. The samples are removed and dried for 24 hours under vacuum. The exact weight, length and width of each sample is measured and the areal density is calculated. The difference in areal density of each sample of the electrospun matrix that comprises the hydrating compound and the electrospun material in which the hydrating compound is leeched out, is less than about 5%.Example 8 Average pore length

[0052] A 2 inch by 2 inch sample is cut from each of the electrospun materials prepared in Examples 1 to 4. The samples are dried under vacuum for 24 hours. A sample of these materials are then prepared for scanning electron microscopy and an image of the surface is taken. The pore length is measured for 10 pores and the average pore length is calculated. Another set of 2 inch by 2 inch samples are each sample is immersed in 50 mL methanol for 1 minute. The samples are removed and dried for 24 hours under vacuum. A sample of these materials are then prepared for scanning electron microscopy and an image of the surface is taken. The pore length is measured for 10 pores and the average pore length is calculated. The difference in average pore length of each sample of the electrospun matrix that comprises the hydrating compound and the electrospun material in which the hydrating compound is leeched out, is less than about 10%.DEFINITIONS

[0053] As used herein, nomenclature for compounds, including organic compounds, can be given using common names, IUPAC, IUBMB, or CAS recommendations for nomenclature. When one or more stereochemical features are present, Cahn-Ingold-Prelog rules for stereochemistry can be employed to designate stereochemical priority, EIZ specification, and the like. One of skill in the art can readily ascertain the structure of a compound if given a name, either by systemic reduction of the compound structure using naming conventions, or by commercially available software, such as CHEMDRAW™ (Cambridgesoft Corporation, U.S.A.).

[0054] As used in the specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a functional group," "an alkyl," or "a residue" includes mixtures of two or more such functional groups, alkyls, or residues, and the like.

[0055] References in the specification and concluding claims to parts by weight of a particular element or component in a composition denotes the weight relationship between the element or component and any other elements or components in the composition or article for which a part by weight is expressed. Thus, in a compound containing 2 parts by weight of component X and 5 parts by weight component Y, X and Y are present at a weight ratio of 2:5, and are present in such ratio regardless of whether additional components are contained in the compound.

[0056] A weight percent (wt. %) of a component, unless specifically stated to the contrary, is based on the total weight of the formulation or composition in which the component is included. A mole percent (mole % or %(molar)) of a component, unless specifically stated to the contrary, is based on the total moles of all monomers used to manufacture the composition in which the component is included.

[0057] As used herein, when a compound is referred to as a monomer or a compound, it is understood that this is not interpreted as one molecule or one compound. For example, two monomers generally refers to two different monomers, and not two molecules.

[0058] As used herein, the terms "optional" or "optionally" means that the subsequently described event or circumstance can or cannot occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0059] As used herein, the terms "about," "approximate," and "at or about" mean that the amount or value in question can be the exact value designated or a value that provides equivalent results or effects as recited in the claims or taught herein. That is, it is understood that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversionT1factors, rounding off, measurement error and the like, and other factors known to those of skill in the art such that equivalent results or effects are obtained. In general, an amount, size, formulation, parameter or other quantity or characteristic is "about," "approximate," or "at or about" whether or not expressly stated to be such. It is understood that where "about," "approximate," or "at or about" is used before a quantitative value, the parameter also includes the specific quantitative value itself, unless specifically stated otherwise.

[0060] As used herein, the terms "comprises," "comprising," "includes," "including," "containing," "characterized by," "has," "having" or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0061] The transitional phrase "consisting of excludes any element, step, or ingredient not specified in the claim, closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith. When the phrase "consists of appears in a clause of the body of a claim, rather than immediately following the preamble, it limits only the element set forth in that clause; other elements are not excluded from the claim as a whole.

[0062] The transitional phrase "consisting essentially of limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s) of the claimed invention. A 'consisting essentially of claim occupies a middle ground between closed claims that are written in a 'consisting of format and fully open claims that are drafted in a 'comprising' format. Optional additives as defined herein, at a level that is appropriate for such additives, and minor impurities are not excluded from a composition by the term "consisting essentially of.

[0063] When a composition, a process, a structure, or a portion of a composition, a process, or a structure, is described herein using an open-ended term such as "comprising," unless otherwise stated the description also includes an embodiment that "consists essentially of or "consists of the elements of the composition, the process, the structure, or the portion of the composition, the process, or the structure.

[0064] The articles "a" and "an" may be employed in connection with various elements and components of compositions, processes or structures described herein. This is merely for convenience and to give a general sense of the compositions, processes or structures. Such a description includes "one or at least one" of the elements or components. Moreover, as used herein, the singular articles also include a description of a plurality of elements or components, unless it is apparent from a specific context that the plural is excluded.

[0065] The term "about" means that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error and the like, and other factors known to those of skill in the art. In general, an amount, size, formulation, parameter or other quantity or characteristic is "about" or "approximate" whether or not expressly stated to be such.

[0066] The term "or", as used herein, is inclusive; that is, the phrase "A or B" means "A, B, or both A and B". More specifically, a condition "A or B" is satisfied by any one of the following: A is true (or present) and B is false (or not present); A is false (or not present) and B is true (or present); or both A and B are true (or present). Exclusive "or" is designated herein by terms such as "either A or B" and "one of A or B", for example.

[0067] In addition, the ranges set forth herein include their endpoints unless expressly stated otherwise. Further, when an amount, concentration, or other value or parameter is given as a range, one or more preferred ranges or a list of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether such pairs are separately disclosed. The scope of the invention is not limited to the specific values recited when defining a range.

[0068] When materials, methods, or machinery are described herein with the term "known to those of skill in the art", "conventional" or a synonymous word or phrase, the term signifies that materials, methods, and machinery that are conventional at the time of filing the present application are encompassed by this description. Also encompassed are materials, methods, and machinery that are not presently conventional, but that will have become recognized in the art as suitable for a similar purpose.|0069| Unless stated otherwise, all percentages, parts, ratios, and like amounts, are defined by weight.

[0070] All patents, patent applications and references included herein are specifically incorporated by reference in their entireties.EXEMPLARY ASPECTS

[0071] In view of the described compositions, devices, systems, and methods, herein below are described certain more particularly described aspects of the inventions. The particularly recited aspects should not, however, be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein or that the “particular” aspects aresomehow limited in some way other than the inherent meaning of the language and formulas literally used therein.

[0072] Example 1: An electrospun material comprising two fiber populations and a hydrating compound wherein (a) the electrospun material is in a non-woven form, (b) the fiber populations comprise hydrolytically degradable polymers that are not soluble in water, (c) the two fiber populations have a different chemical composition, (d) a one inch by one inch sample of the electrospun material absorbs 100 pL water in less than five seconds.

[0073] Example 2: An electrospun material of any example herein, particularly example 1, wherein the hydrating compound comprises less than 5% of the electrospun material.

[0074] Example 3: An electrospun material of any example herein, particularly example 1, wherein one fiber population comprises a polymer that comprises residues of glycolide.

[0075] Example 4: An electrospun material of any example herein, particularly example 1, wherein one fiber population comprises polydioxanone.

[0076] Example 5: An electrospun material of any example herein, particularly example 1, wherein one fiber population comprises a polymer that comprises residues of trimethylene carbonate.

[0077] Example 6: An electrospun material of any example herein, particularly example 1 wherein one fiber population comprises a polymer that comprises residues of glycolide and lactide.

[0078] Example 7: An electrospun material of any example herein, particularly example 1, wherein the hydrating compound is polyethylene glycol.

[0079] Example 8: An electrospun material of any example herein, particularly example 1, wherein the hydrating compound is polyethylene glycol that has a molecular weight of less than 2000.

[0080] Example 9: An electrospun material of any example herein, particularly example 1, wherein the electrospun material further comprises a biologically active agent.

[0081] Example 10: A medical device comprising the electrospun material of any example herein, particularly example 1 , wherein the medical device is sterile and has an endotoxin level of less than 20 EU per device.

[0082] It should be understood, of course, that the foregoing relates only to preferred embodiments of the present disclosure and that numerous modifications or alterations may be made therein without departing from the spirit and the scope of the disclosure as set forth in this disclosure.

[0083] The present disclosure is further illustrated by the examples contained herein, which are not to be construed in any way as imposing limitations upon the scope thereof. On the contrary, itis to be clearly understood that resort may be had to various other embodiments, modifications, and equivalents thereof which, after reading the description herein, may suggest themselves to those skilled in the art without departing from the spirit of the present disclosure and / or the scope of the appended claims.

Claims

CLAIMSWhat is claimed:

1. An electrospun material comprising two fiber populations and a hydrating compound wherein(a) the electrospun material is in a non-woven form,(b) the fiber populations comprise hydrolytically degradable polymers that are not soluble in water,(c) the two fiber populations have a different chemical composition,(d) a one inch by one inch sample of the electrospun material absorbs 100 pL water in less than five seconds.

2. An electrospun material of Claim 1 wherein the hydrating compound comprises less than 5% of the electrospun material.

3. An electrospun material of Claim 1 wherein one fiber population comprises a polymer that comprises residues of glycolide.

4. An electrospun material of Claim 1 wherein one fiber population comprises polydioxanone.

5. An electrospun material of Claim 1 wherein one fiber population comprises a polymer that comprises residues of trimethylene carbonate.

6. An electrospun material of Claim 1 wherein one fiber population comprises a polymer that comprises residues of glycolide and lactide.

7. An electrospun material of Claim 1 wherein the hydrating compound is polyethylene glycol.

8. An electrospun material of Claim 1 wherein the hydrating compound is polyethylene glycol that has a molecular weight of less than 2000.

9. An electrospun material of Claim 1 wherein the electrospun material further comprises a biologically active agent.

10. A medical device comprising the electrospun material of Claim 1 wherein the medical device is sterile and has an endotoxin level of less than 20 EU per device.