Elastomeric matrices based on plasticized PVOH compositions and uses thereof
Provided herein is an elastomeric matrix which includes poly(vinyl alcohol) (PVOH), at least two plasticizers none of which is water, and water. The combined mass ratio of plasticizers to PVOH is at least 2:1; and the combined mass content of PVOH and plasticizers is at least 70% by weight of the total weight of the matrix excluding water.
1 . An ophthalmic device comprising an elastomeric matrix that comprises:
poly(vinyl alcohol) (PVOH),
at least one plasticizer which is not water, and
water,
wherein:
a mass ratio of said plasticizer to said PVOH is at least 2:1; and
a combined mass content of said PVOH and said plasticizer is at least 70-50% wt of the total weight of the matrix excluding said water.
2 . The ophthalmic device of claim 1 , wherein said at least one plasticizer comprises at least two plasticizers, none of which is water.
3 . The ophthalmic device of claim 1 , wherein the elastomeric matrix is characterized by substantially isotropic swelling and shrinking, wherein swelling and shrinking are such that dimensional changes measured along three mutually orthogonal principal dimensions of the matrix differ from one another by no more than ±20%,
and wherein the dimensional changes are determined by comparing the dimensions of the matrix along each of the three mutually orthogonal principal dimensions in the matrix dry form prior to use to the dimensions of the matrix along each of the three mutually orthogonal principal dimensions while immersed in simulated tear fluid comprising an aqueous solution containing 0.67% sodium chloride, 0.2% sodium bicarbonate, and 0.008% calcium chloride.
4 . The ophthalmic device of claim 1 , wherein the elastomeric matrix is characterized by swelling by less than 50% by volume under wet conditions, wherein the volumetric swelling is determined by comparing a volume of the matrix in dry form prior to use to a volume of the matrix while immersed in a simulated tear fluid comprising an aqueous solution containing 0.67% sodium chloride, 0.2% sodium bicarbonate, and 0.008% calcium chloride.
5 . The ophthalmic device of claim 3 , wherein the elastomeric matrix is characterized by swelling by less than 50% by volume under wet conditions, wherein the volumetric swelling is determined by comparing a volume of the matrix in dry form prior to use to a volume of the matrix while immersed in the simulated tear fluid.
6 . The ophthalmic device of claim 1 , wherein said PVOH is characterized by a degree of hydrolysis of more than 90%.
7 . The ophthalmic device of claim 2 , wherein two of said at least two plasticizers are a polyol and a saccharide.
8 . The ophthalmic device of claim 1 , wherein said plasticizer or at least one of said plasticizers comprises at least two hydrogen bond forming functional groups.
9 . The ophthalmic device of claim 1 , wherein said plasticizer or at least one of said plasticizers is characterized by a molar mass of less than 1,000 g/mol.
10 . The ophthalmic device of claim 1 , wherein, when comprising more than one plasticizer, at least one of said plasticizers is an oligomer characterized by a molar mass of more than 1,000 g/mol.
11 . The ophthalmic device of claim 1 , wherein, when comprising more than one plasticizer, at least one of said plasticizers is characterized by a viscosity of at least 1000 cp, and at least one other of said plasticizers is characterized by a viscosity of less than 200 cp.
12 . The ophthalmic device of claim 1 , wherein said water constitutes less than 50% wt of the total mass content of said elastomeric matrix.
13 . The ophthalmic device of claim 1 , wherein said elastomeric matrix is essentially devoid of covalent crosslinking.
14 . The ophthalmic device of claim 1 , further comprising a pharmaceutically active agent.
15 . The ophthalmic device of claim 1 , configured to be positioned on a surface of an eye.
16 . The ophthalmic device of claim 15 , wherein said surface is at least partially underneath at least one of the upper and lower eyelids and outside a cornea of the eye.
17 . The ophthalmic device of claim 1 , configured to deliver at least one pharmaceutically active agent to an eye for an extended period of time.
18 . The ophthalmic device of claim 1 , wherein the combined mass content of the PVOH and the plasticizer is at least 70% wt of the total weight of the matrix excluding the water.
19 . The ophthalmic device of claim 14 , wherein the pharmaceutically active agent is selected from the group consisting of a prostaglandin analog, a prostamide, a carbonic anhydrase inhibitor, a beta-adrenergic antagonist, a corticosteroid, a non-steroidal anti-inflammatory drug, an antihistamine, an antibiotic, an anti-infective agent, and a small-molecule integrin antagonist, and combinations thereof.
20 . The ophthalmic device of claim 14 , wherein the pharmaceutically active agent is selected from the group consisting of bimatoprost, travoprost, latanoprost, tafluprost, dorzolamide, cyclosporine, lifitegrast, loteprednol, fluoromethalone, ketorolac, olopatadine, doxycycline, tetracycline, azithromycin and combinations thereof.