CPC A61K 9/0012 (2013.01) [A61K 9/10 (2013.01); A61K 9/5026 (2013.01); A61K 9/5138 (2013.01); A61K 31/56 (2013.01); A61K 47/32 (2013.01); A61K 38/00 (2013.01)] | 19 Claims |
1. A method of delivering an ophthalmic formulation across a mucosal barrier of the eye comprising:
topically administering the ophthalmic formulation to the eye, wherein the ophthalmic formulation comprises:
(a) a plurality of mucus-penetrating coated particles, wherein each of the coated particles comprises:
(i) a core particle comprising a pharmaceutical agent or a salt thereof, wherein the pharmaceutical agent constitutes at least about 80 wt % of the core particle; and
(ii) a mucus penetration-enhancing coating comprising a surface-altering agent surrounding the core particle, wherein the surface-altering agent comprises a poly(vinyl alcohol) (PVA) polymer having pendant hydroxyl groups on the backbone of the PVA polymer, the PVA polymer having a molecular weight of at least about 1 kDa and less than or equal to about 1000 kDa, wherein the hydrolysis level of the PVA polymer is at least about 30% and less than about 95%, and
(b) one or more pharmaceutically acceptable excipients or carriers;
wherein the coated particles have an increased mobility in human mucus relative to uncoated particles; and
wherein the coated particles have an average size of less than 1 μm.
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