Compositions and methods of treating dry eye syndrome and other traumatized non-keratinized epithelial surfaces
The present disclosure relates to a composition including non-autologous plasma or serum and a polymer; method of treating ophthalmic diseases (e.g., dry eye syndrome) or moisturizing and/or repairing non-keratinized surfaces including non-healing wounds with a composition including non-autologous plasma or serum and a polymer; and a therapeutic agent delivery device for delivery of the composition to the eye or a non-keratinized surface of a subject.
1 . An ophthalmic pharmaceutical composition formulated for topical administration and comprising plasma, a polysaccharide or derivative thereof, and an aqueous carrier,
wherein the composition is 0.25% to 2.0% (w/w) polysaccharide, wherein the polysaccharide comprises chitosan, cellulose, carboxymethylcellulose, dextrin, dextran, pectin, alginic acid, agar, agarose, carrageenan, or hyaluronic acid, or a salt or derivative thereof,
wherein the plasma is pooled from non-neonatal, allogenic plasma, and
wherein (a) or (b) is true:
(a) the polysaccharide or derivative thereof comprises a salt dissolved as an ion and counterion in the aqueous carrier, the counterion comprising a glutamate, lactate, citrate, hydrochloride, succinate, maleate, ascorbate, propionate, formate, carbonate or acetate counterion, or
(b) the polysaccharide comprises chitosan.
2 . The pharmaceutical composition of claim 1 , wherein the pH of the composition is from 3.5 to 8.0.
3 . The pharmaceutical composition of claim 1 , wherein the plasma is isolated from mammalian blood.
4 . The pharmaceutical composition of claim 3 , wherein the mammal is a human, sheep, goat, pig, horse, dog, feline, fetal, or cow.
5 . The pharmaceutical composition of claim 4 , wherein the plasma is human plasma.
6 . The pharmaceutical composition of claim 1 , wherein the plasma is exposed to one or more of a solvent, a detergent, psoralen, ultraviolet light, filtration, and gamma irradiation, prior to its incorporation into the composition.
7 . The pharmaceutical composition of claim 1 , wherein the composition is formulated as a solution, suspension, emulsion, gel, film, patch, cream or ointment.
8 . The pharmaceutical composition of claim 1 , further comprising an additive.
9 . The pharmaceutical composition of claim 8 , wherein the additive is selected from the group consisting of: chitosan, alginate, gelatin, hyaluronic acid, gellan gum, dextran, polyethylene glycol, polyethylene oxide, glucose, glucosamine, sodium chloride, polylactic acid, polylactic-co-glycolic acid, glycerol, carboxymethylcellulose, hydroxymethylcellulose, glycerin, trehalose, sodium hyaluronate, and an oil.
10 . The pharmaceutical composition of claim 8 , wherein the additive comprises one or more of glycine, ascorbic acid, alginate, gelatin, glycol chitosan, lactic acid, acetic acid, citric acid, boric acid, glutamate, and glycolate.
11 . The pharmaceutical composition of claim 1 , wherein the plasma is treated with a psoralen and exposed to ultraviolet light.
12 . The pharmaceutical composition of claim 1 , wherein the polysaccharide or derivative thereof comprises a salt dissolved as an ion and counterion in the aqueous carrier, the counterion comprising a glutamate, lactate, citrate, hydrochloride, succinate, maleate, ascorbate, propionate, formate, carbonate or acetate counterion.
13 . The pharmaceutical composition of claim 1 , wherein the polysaccharide comprises chitosan.
14 . The pharmaceutical composition of claim 13 , wherein the chitosan is hydrophobically modified.
15 . The pharmaceutical composition of claim 1 , wherein the non-neonatal plasma is not umbilical cord plasma.
16 . The pharmaceutical composition of claim 1 , wherein (a) and (b) are true.
17 . A method for treating dry eye syndrome in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of the pharmaceutical composition of claim 1 , thereby treating dry eye syndrome in the subject.
18 . The method of claim 17 , wherein treating dry eye syndrome in the subject comprises treating or ameliorating one or more symptoms associated with risk factors for temporary or chronic dry eye.
19 . The method of claim 18 , wherein the risk factors comprise skin disease on or near eyelids, gland disease in eyelids, hormone replacement therapy, refractive surgery, chemical and thermal burns, allergies, infrequent blinking, loss of sensation in cornea, immune system disorder, chronic inflammation in conjunctiva, membrane lining of eyelid, or lacrimal gland, infection, exposure to irritants, and keratitis.
20 . A method for treating an ocular epithelial surface of a subject in need thereof, the method comprising applying a therapeutically effective amount of the pharmaceutical composition of claim 1 to the ocular epithelial surface of the subject, thereby treating the ocular epithelial surface of the subject.