US2019209496A1PendingUtilityA1

Formulations for the treatment of ocular surface diseases and related methods

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Assignee: WANG MINGWUPriority: Nov 14, 2016Filed: Mar 19, 2019Published: Jul 11, 2019
Est. expiryNov 14, 2036(~10.3 yrs left)· nominal 20-yr term from priority
Inventors:Mingwu WangCindy Wang
A61P 27/04A61P 27/02A61K 47/34A61K 31/137A61K 47/42A61K 9/0048A61K 47/38A61K 9/08A61K 47/02A61K 47/32A61P 27/10
42
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Claims

Abstract

Formulations for treating ocular surface diseases, such as dry eye disease, and related methods are disclosed. The formulations include and effective amount of ambroxol or a chemical derivative thereof (for example, bromhexine) that may be dispersed in a carrier and may optionally include a biocompatible polymer to provide extended release properties.

Claims

exact text as granted — not AI-modified
1 . A method of treating an ocular surface affected by dry eye disease or a symptom thereof, the method comprising topically administering to the ocular surface an effective amount of a formulation comprising ambroxol and/or a salt form of ambroxol. 
     
     
         2 . The method of  claim 1 , wherein said formulation comprises ambroxol and/or a salt form of ambroxol in a carrier, said carrier being suitable for topical application to the eye and selected from the group consisting of one or more of a solution, gel, drop, ointment, suspension, microemulsion, nanoparticulate dispersion, liposome, lotion, and paste. 
     
     
         3 . The method of  claim 1 , wherein the ambroxol and/or salt form of ambroxol is present in the formulation in a weight percent of between 0.001% and 20% based on total weight or total volume of the formulation. 
     
     
         4 . The method of  claim 1 , wherein the formulation is administered to the subject using a device that provides continuous application of the formulation. 
     
     
         5 . The method of  claim 2 , wherein the formulation is administered to the subject at least once a day for a period of at least five days. 
     
     
         6 . The method of  claim 2 , wherein the formulation is administered to the subject using a device that provides continuous application of the formulation. 
     
     
         7 . The method of  claim 1 , wherein the ambroxol and/or salt form of ambroxol is present in the formulation in a weight percent of between 0.02% and 10% based on total weight or total volume of the formulation. 
     
     
         8 . The method of  claim 1 , wherein the ambroxol and/or a salt form of ambroxol is present in the formulation in a weight percent of between 0.5 and 5% based on total weight or total volume of the formulation. 
     
     
         9 . The method of  claim 2 , wherein the formulation further comprises a biocompatible polymer dissolved in the carrier or ambroxol impregnated within a biocompatible polymer. 
     
     
         10 . The method of  claim 9 , wherein the biocompatible polymer is poly-2-hydroxyethylmethacrylate (p-HEMA hydrogels), poly(lactic-co-glycolic) acid (PLGA). polycaprolactone (PCL), hydroxypropyl cellulose, Anecortave acetate (AnA) gelatin, and/or collagen. 
     
     
         11 . The method of  claim 1 , wherein the formulation further comprises at least one additive, wherein the additive is a demulcent, preservative, emollient, ionic species, pH-adjusting agents, and other additives. 
     
     
         12 . The method of  claim 2 , wherein the formulation further comprises at least one additive, wherein the additive is a demulcent, preservative, emollient, ionic species, pH-adjusting agents, and other additives. 
     
     
         13 . The method of  claim 2 , wherein the ambroxol and/or a salt form of ambroxol is present in a weight percent of between 0.001 and 2% based on total weight or total volume of the formulation. 
     
     
         14 . The method of  claim 1 , wherein the symptom thereof comprises unclear vision, inflammation, itching, dryness, burning, and/or light sensitivity. 
     
     
         15 . A method of treating dry eye disease or a symptom thereof, the method comprising topically administering to an ocular surface an effective amount of a formulation comprising a chemical derivative of ambroxol, the chemical derivative of ambroxol being selected from the group consisting of one or more of bromhexine or a salt of bromhexine. 
     
     
         16 . The method of  claim 15 , wherein said formulation comprises said chemical derivative of ambroxol in a carrier, said carrier being suitable for topical application to the eye and selected from the group consisting of one or more of a solution, gel, drop, ointment, suspension, microemulsion, nanoparticulate dispersion, liposome, lotion, and paste. 
     
     
         17 . The method of  claim 15 , wherein the chemical derivative of ambroxol is present in the formulation in a weight percent of between 0.001% and 20% based on total weight or total volume of the formulation. 
     
     
         18 . The method of  claim 15 , wherein the formulation is administered to the subject using a device that provides continuous application of the formulation. 
     
     
         19 . The method of  claim 15 , wherein the formulation is administered to the subject at least once a day for a period of at least five days. 
     
     
         20 . The method of  claim 16 , wherein the formulation is administered to the subject using a device that provides continuous application of the formulation. 
     
     
         21 . The method of  claim 15 , wherein the chemical derivative of ambroxol is present in the formulation in a weight percent of between 0.02% and 10% based on total weight or total volume of the formulation. 
     
     
         22 . The method of  claim 15 , wherein the chemical derivative of ambroxol is present in the formulation in a weight percent of between 0.5 and 5% based on total weight or total volume of the formulation. 
     
     
         23 . The method of  claim 16 , wherein the formulation further comprises a biocompatible polymer dissolved in the carrier or the chemical derivative of ambroxol impregnated within a biocompatible polymer. 
     
     
         24 . The method of  claim 23 , wherein the biocompatible polymer is poly-2-hydroxyethylmethacrylate (p-HEMA hydrogels), poly(lactic-co-glycolic) acid (PLGA). polycaprolactone (PCL), hydroxypropyl cellulose, Anecortave acetate (AnA) gelatin, and/or collagen. 
     
     
         25 . The method of  claim 15 , wherein the formulation further comprises at least one additive, wherein the additive is a demulcent, preservative, emollient, ionic species, pH-adjusting agents, and other additives. 
     
     
         26 . The method of  claim 16 , wherein the formulation further comprises at least one additive, wherein the additive is a demulcent, preservative, emollient, ionic species, pH-adjusting agents, and other additives. 
     
     
         27 . The method of  claim 15 , wherein the chemical derivative of ambroxol is present in a weight percent of between 0.001 and 2% based on total weight or total volume of the formulation. 
     
     
         28 . The method of  claim 15 , wherein the symptom thereof comprises unclear vision, inflammation, itching, dryness, burning, and/or light sensitivity. 
     
     
         29 . A composition comprising chemical derivative of ambroxol, selected from the group consisting of one or more of bromhexine or a salt of bromhexine, in a weight percent of between 0.001% and 2% based on total weight or total volume of the formulation and a carrier suitable for topical application to the eye. 
     
     
         30 . The composition of  claim 29 , wherein said carrier comprises buffered saline. 
     
     
         31 . A composition comprising ambroxol and/or a salt form of ambroxol, in a weight percent of between 0.001% and 2% based on total weight or total volume of the formulation, and a carrier suitable for topical application to the eye. 
     
     
         32 . The composition of  claim 31 , wherein said carrier comprises buffered saline.

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