US2021121525A1PendingUtilityA1

Silk fibroin-containing composition and methods of use thereof

45
Assignee: UNIV GEORGETOWNPriority: Oct 20, 2017Filed: Oct 19, 2018Published: Apr 29, 2021
Est. expiryOct 20, 2037(~11.2 yrs left)· nominal 20-yr term from priority
Inventors:Morarji Peesay
A61K 38/1767A61K 9/0082A61K 31/02A61P 11/00
45
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Claims

Abstract

Provided are compositions comprising silk fibroin, perfluorocarbon (PFC), and surfactant, and methods of use thereof. The compositions can further comprise a drug, an antibody, or a vaccine. Compositions of the invention are useful in the treatment of certain lung diseases and conditions, including in particular those characterized by surfactant deficiency. Compositions of the invention are particularly useful in the treatment of respiratory distress syndrome (RDS). Also provided are methods for making the compositions, and kits comprising components of the compositions.

Claims

exact text as granted — not AI-modified
I claim: 
     
         1 . A composition comprising silk fibroin and a perfluorocarbon. 
     
     
         2 . The composition of  claim 1 , further comprising a pharmaceutically acceptable carrier. 
     
     
         3 . The composition of  claim 1  or  2 , wherein the perfluorocarbon is selected from the group consisting of perfluoro-n-butyltetrahydrofuran, perfluorodichlorooctane, perfluorobischlorobutylether, perfluorodecalin, perfluoromethyldecalin, perfluorodimethyldecalin, perfluorodimethyladamantane, perfluorooctylbromide, perfluoro-4-methyl-octahydroquinolidizine, perfluoro-N-methyl-decahydroquinoline, F-methyl-1-oxa-decalin, perfluoro-bicyclo(5.3.0)-decane, perfluorooctahydroquinolidizine, perfluoro-5,6-dihydro-5-decene, and perfluoro-4,5-dihydro-4-octene, chlorinated perfluorocarbons, and any combination thereof. 
     
     
         4 . The composition of any one of  claims 1 - 3 , wherein the perfluorocarbon is perfluorooctylbromide. 
     
     
         5 . The composition of any one of  claims 1 - 4 , wherein the ratio of silk fibroin to perfluorocarbon is about 1:4 to 1:1 (v/v). 
     
     
         6 . The composition of any one of  claims 1 - 5 , further comprising a drug, enzyme, antibody, or vaccine. 
     
     
         7 . A composition comprising silk fibroin and a surfactant. 
     
     
         8 . The composition of  claim 7 , further comprising a pharmaceutically acceptable carrier. 
     
     
         9 . The composition of  claim 7  or  8 , wherein the surfactant is selected from the group consisting of egg yolk phospholipid, polyalkyleneoxides, 1,2-dialkylglycero-3-phosphoryl cholines, 1,3-dialkylglycero-2-phosphoryl cholines, perfluorinated polyoxyethylenes, and any combination thereof. 
     
     
         10 . The composition of any one of  claims 7 - 9 , wherein the surfactant is calfactant. 
     
     
         11 . The composition of any one of  claims 7 - 10 , wherein the ratio of silk fibroin to surfactant is about 1:6 to 1:2.5 (v/v). 
     
     
         12 . The composition of any one of  claims 7 - 11 , further comprising a drug, enzyme, antibody, or vaccine. 
     
     
         13 . A composition comprising silk fibroin, a perfluorocarbon, and a surfactant. 
     
     
         14 . The composition of  claim 13 , further comprising a pharmaceutically acceptable carrier. 
     
     
         15 . The composition of  claim 13  or  14 , wherein the perfluorocarbon is selected from the group consisting of perfluoro-n-butyltetrahydrofuran, perfluorodichlorooctane, perfluorobischlorobutylether, perfluorodecalin, perfluoromethyldecalin, perfluorodimethyldecalin, perfluorodimethyladamantane, perfluorooctylbromide, perfluoro-4-methyl-octahydroquinolidizine, perfluoro-N-methyl-decahydroquinoline, F-methyl-1-oxa-decalin, perfluoro-bicyclo(5.3.0)-decane, perfluorooctahydroquinolidizine, perfluoro-5,6-dihydro-5-decene, and perfluoro-4,5-dihydro-4-octene, chlorinated perfluorocarbons, and any combination thereof. 
     
     
         16 . The composition of any one of  claims 13 - 15 , wherein the perfluorocarbon is perfluorooctylbromide. 
     
     
         17 . The composition of any one of  claims 13 - 16 , wherein the surfactant is selected from the group consisting of egg yolk phospholipid, polyalkyleneoxides, 1,2-dialkylglycero-3-phosphoryl cholines, 1,3-dialkylglycero-2-phosphoryl cholines, perfluorinated polyoxyethylenes, and any combination thereof. 
     
     
         18 . The composition of any one of  claims 13 - 17 , wherein the surfactant is calfactant. 
     
     
         19 . The composition of any one of  claims 13 - 18 , wherein the ratio of silk fibroin to perfluorocarbon is about 1:4 to 1:1 (v/v). 
     
     
         20 . The composition of any one of  claims 13 - 19 , wherein the ratio of silk fibroin to surfactant is about 1:6 to 1:2.5 (v/v). 
     
     
         21 . The composition of any one of  claims 13 - 20 , further comprising a drug, enzyme, antibody, or vaccine. 
     
     
         22 . A method of making the composition of  claim 1 , comprising placing the silk fibroin and the perfluorocarbon in an aqueous medium. 
     
     
         23 . A method of making the composition of  claim 7 , comprising placing the silk fibroin and the surfactant in an aqueous medium. 
     
     
         24 . A method of making the composition of  claim 13 , comprising placing the silk fibroin, the perfluorocarbon, and the surfactant in an aqueous medium. 
     
     
         25 . A method of treating a lung disease or lung condition, comprising administering a therapeutically effective amount of the composition of  claim 1  to an airway of a subject in need thereof. 
     
     
         26 . The method of  claim 25 , wherein the subject is a human. 
     
     
         27 . The method of  claim 26 , wherein the subject is a preterm infant or an infant. 
     
     
         28 . The method of any one of  claims 25 - 27 , wherein the lung disease or lung condition is selected from the group consisting of respiratory failure, surfactant deficiency, respiratory distress syndrome (RDS), adult respiratory distress syndrome (ARDS), meconium aspiration syndrome, hyaline membrane disease, pneumonia, cystic fibrosis, idiopathic pulmonary fibrosis, atelectasis, and any combination thereof. 
     
     
         29 . The method of  claim 28 , wherein the lung disease or lung condition is respiratory distress syndrome (RDS). 
     
     
         30 . The method of any one of  claims 25 - 29 , wherein the administering comprises liquid ventilation. 
     
     
         31 . The method of  claim 30 , wherein the liquid ventilation is total liquid ventilation. 
     
     
         32 . The method of  claim 30 , wherein the liquid ventilation is partial liquid ventilation. 
     
     
         33 . A method of treating a lung disease or lung condition, comprising administering a therapeutically effective amount of the composition of  claim 7  to an airway of a subject in need thereof. 
     
     
         34 . The method of  claim 33 , wherein the subject is a human. 
     
     
         35 . The method of  claim 34 , wherein the subject is a preterm infant or an infant. 
     
     
         36 . The method of any one of  claims 33 - 35 , wherein the lung disease or lung condition is selected from the group consisting of respiratory failure, surfactant deficiency, respiratory distress syndrome (RDS), adult respiratory distress syndrome (ARDS), meconium aspiration syndrome, hyaline membrane disease, pneumonia, cystic fibrosis, idiopathic pulmonary fibrosis, atelectasis, and any combination thereof. 
     
     
         37 . The method of  claim 36 , wherein the lung disease or lung condition is respiratory distress syndrome (RDS). 
     
     
         38 . The method of any one of  claims 33 - 37 , wherein the administering comprises liquid ventilation. 
     
     
         39 . The method of  claim 38 , wherein the liquid ventilation is total liquid ventilation. 
     
     
         40 . The method of  claim 38 , wherein the liquid ventilation is partial liquid ventilation. 
     
     
         41 . A method of treating a lung disease or lung condition, comprising administering a therapeutically effective amount of the composition of  claim 13  to an airway of a subject in need thereof. 
     
     
         42 . The method of  claim 41 , wherein the subject is a human. 
     
     
         43 . The method of  claim 42 , wherein the subject is a preterm infant or an infant. 
     
     
         44 . The method of any one of  claims 41 - 43 , wherein the lung disease or lung condition is selected from the group consisting of respiratory failure, surfactant deficiency, respiratory distress syndrome (RDS), adult respiratory distress syndrome (ARDS), meconium aspiration syndrome, hyaline membrane disease, pneumonia, cystic fibrosis, idiopathic pulmonary fibrosis, atelectasis, and any combination thereof. 
     
     
         45 . The method of  claim 44 , wherein the lung disease or lung condition is respiratory distress syndrome (RDS). 
     
     
         46 . The method of any one of  claims 41 - 45 , wherein the administering comprises liquid ventilation. 
     
     
         47 . The method of  claim 46 , wherein the liquid ventilation is total liquid ventilation. 
     
     
         48 . The method of  claim 46 , wherein the liquid ventilation is partial liquid ventilation. 
     
     
         49 . A kit comprising silk fibroin in a first container and a perfluorocarbon in a second container. 
     
     
         50 . A kit comprising silk fibroin in a first container and a surfactant in a second container. 
     
     
         51 . A kit comprising silk fibroin in a first container, a perfluorocarbon in a second container, and a surfactant in a third container.

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