AU2014227693B2 - Sublingual and buccal film compositions - Google Patents
Sublingual and buccal film compositions Download PDFInfo
- Publication number
- AU2014227693B2 AU2014227693B2 AU2014227693A AU2014227693A AU2014227693B2 AU 2014227693 B2 AU2014227693 B2 AU 2014227693B2 AU 2014227693 A AU2014227693 A AU 2014227693A AU 2014227693 A AU2014227693 A AU 2014227693A AU 2014227693 B2 AU2014227693 B2 AU 2014227693B2
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- AU
- Australia
- Prior art keywords
- composition
- pharmaceutically acceptable
- naloxone
- acceptable salt
- acid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000000203 mixture Substances 0.000 title claims description 274
- 229940002226 buccal film Drugs 0.000 title description 2
- 238000000034 method Methods 0.000 claims abstract description 19
- 238000011282 treatment Methods 0.000 claims abstract description 16
- 208000002193 Pain Diseases 0.000 claims abstract description 15
- 238000010521 absorption reaction Methods 0.000 claims description 139
- 229960004127 naloxone Drugs 0.000 claims description 92
- 229960001736 buprenorphine Drugs 0.000 claims description 88
- 150000003839 salts Chemical class 0.000 claims description 82
- 229920000642 polymer Polymers 0.000 claims description 64
- 239000011159 matrix material Substances 0.000 claims description 52
- 239000000872 buffer Substances 0.000 claims description 51
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 39
- 210000000214 mouth Anatomy 0.000 claims description 39
- -1 poly(lactic acid) Polymers 0.000 claims description 39
- 239000002738 chelating agent Substances 0.000 claims description 38
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 35
- 230000003139 buffering effect Effects 0.000 claims description 27
- 229920001577 copolymer Polymers 0.000 claims description 27
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 21
- 239000003963 antioxidant agent Substances 0.000 claims description 20
- 235000006708 antioxidants Nutrition 0.000 claims description 20
- 230000003078 antioxidant effect Effects 0.000 claims description 12
- 229920000159 gelatin Polymers 0.000 claims description 11
- 235000019322 gelatine Nutrition 0.000 claims description 11
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 11
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 11
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 11
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 11
- 108010010803 Gelatin Proteins 0.000 claims description 10
- 239000008273 gelatin Substances 0.000 claims description 10
- 235000011852 gelatine desserts Nutrition 0.000 claims description 10
- 229920002472 Starch Polymers 0.000 claims description 9
- 235000010489 acacia gum Nutrition 0.000 claims description 9
- 239000001488 sodium phosphate Substances 0.000 claims description 9
- 235000019698 starch Nutrition 0.000 claims description 9
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 8
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 8
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 8
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 8
- 230000008569 process Effects 0.000 claims description 8
- 229920002678 cellulose Polymers 0.000 claims description 7
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 7
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 7
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 7
- 239000008107 starch Substances 0.000 claims description 7
- KDYFGRWQOYBRFD-UHFFFAOYSA-N succinic acid Chemical compound OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 7
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims description 6
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims description 6
- 229920002125 Sokalan® Polymers 0.000 claims description 6
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 6
- 239000001913 cellulose Substances 0.000 claims description 6
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 6
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 6
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 5
- 229920002907 Guar gum Polymers 0.000 claims description 5
- 229920000084 Gum arabic Polymers 0.000 claims description 5
- 229920000954 Polyglycolide Polymers 0.000 claims description 5
- 239000000205 acacia gum Substances 0.000 claims description 5
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 5
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 5
- 238000005266 casting Methods 0.000 claims description 5
- 235000010417 guar gum Nutrition 0.000 claims description 5
- 239000000665 guar gum Substances 0.000 claims description 5
- 229960002154 guar gum Drugs 0.000 claims description 5
- 229920000591 gum Polymers 0.000 claims description 5
- 239000004584 polyacrylic acid Substances 0.000 claims description 5
- 229920001285 xanthan gum Polymers 0.000 claims description 5
- 235000010493 xanthan gum Nutrition 0.000 claims description 5
- 239000000230 xanthan gum Substances 0.000 claims description 5
- 229940082509 xanthan gum Drugs 0.000 claims description 5
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 4
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 4
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 4
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 4
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 4
- 239000004373 Pullulan Substances 0.000 claims description 4
- 229920001218 Pullulan Polymers 0.000 claims description 4
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 4
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 4
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 4
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 4
- 239000004327 boric acid Substances 0.000 claims description 4
- 235000010338 boric acid Nutrition 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 4
- 239000001630 malic acid Substances 0.000 claims description 4
- 235000011090 malic acid Nutrition 0.000 claims description 4
- 235000019423 pullulan Nutrition 0.000 claims description 4
- 235000010413 sodium alginate Nutrition 0.000 claims description 4
- 239000000661 sodium alginate Substances 0.000 claims description 4
- 229940005550 sodium alginate Drugs 0.000 claims description 4
- 239000001509 sodium citrate Substances 0.000 claims description 4
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 4
- 239000004471 Glycine Substances 0.000 claims description 3
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims description 3
- 239000001744 Sodium fumarate Substances 0.000 claims description 3
- 229910021538 borax Inorganic materials 0.000 claims description 3
- KYQODXQIAJFKPH-UHFFFAOYSA-N diazanium;2-[2-[bis(carboxymethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [NH4+].[NH4+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O KYQODXQIAJFKPH-UHFFFAOYSA-N 0.000 claims description 3
- WPUMTJGUQUYPIV-JIZZDEOASA-L disodium (S)-malate Chemical compound [Na+].[Na+].[O-]C(=O)[C@@H](O)CC([O-])=O WPUMTJGUQUYPIV-JIZZDEOASA-L 0.000 claims description 3
- MSJMDZAOKORVFC-SEPHDYHBSA-L disodium fumarate Chemical compound [Na+].[Na+].[O-]C(=O)\C=C\C([O-])=O MSJMDZAOKORVFC-SEPHDYHBSA-L 0.000 claims description 3
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 3
- 229910000397 disodium phosphate Inorganic materials 0.000 claims description 3
- 235000019800 disodium phosphate Nutrition 0.000 claims description 3
- 239000001530 fumaric acid Substances 0.000 claims description 3
- 229910000403 monosodium phosphate Inorganic materials 0.000 claims description 3
- 235000019799 monosodium phosphate Nutrition 0.000 claims description 3
- 230000003232 mucoadhesive effect Effects 0.000 claims description 3
- 235000019265 sodium DL-malate Nutrition 0.000 claims description 3
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims description 3
- 229940005573 sodium fumarate Drugs 0.000 claims description 3
- 235000019294 sodium fumarate Nutrition 0.000 claims description 3
- 239000001394 sodium malate Substances 0.000 claims description 3
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 3
- 235000011008 sodium phosphates Nutrition 0.000 claims description 3
- 235000010339 sodium tetraborate Nutrition 0.000 claims description 3
- WUWHFEHKUQVYLF-UHFFFAOYSA-M sodium;2-aminoacetate Chemical compound [Na+].NCC([O-])=O WUWHFEHKUQVYLF-UHFFFAOYSA-M 0.000 claims description 3
- KZQSXALQTHVPDQ-UHFFFAOYSA-M sodium;butanedioate;hydron Chemical compound [Na+].OC(=O)CCC([O-])=O KZQSXALQTHVPDQ-UHFFFAOYSA-M 0.000 claims description 3
- 239000001384 succinic acid Substances 0.000 claims description 3
- JZBRFIUYUGTUGG-UHFFFAOYSA-J tetrapotassium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [K+].[K+].[K+].[K+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O JZBRFIUYUGTUGG-UHFFFAOYSA-J 0.000 claims description 3
- UEUXEKPTXMALOB-UHFFFAOYSA-J tetrasodium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound [Na+].[Na+].[Na+].[Na+].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O UEUXEKPTXMALOB-UHFFFAOYSA-J 0.000 claims description 3
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims description 3
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 3
- QJZYHAIUNVAGQP-UHFFFAOYSA-N 3-nitrobicyclo[2.2.1]hept-5-ene-2,3-dicarboxylic acid Chemical compound C1C2C=CC1C(C(=O)O)C2(C(O)=O)[N+]([O-])=O QJZYHAIUNVAGQP-UHFFFAOYSA-N 0.000 claims description 2
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims description 2
- 102000001554 Hemoglobins Human genes 0.000 claims description 2
- 108010054147 Hemoglobins Proteins 0.000 claims description 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 2
- 108010076986 Phytochelatins Proteins 0.000 claims description 2
- 102000004338 Transferrin Human genes 0.000 claims description 2
- 108090000901 Transferrin Proteins 0.000 claims description 2
- 229930002875 chlorophyll Natural products 0.000 claims description 2
- 235000019804 chlorophyll Nutrition 0.000 claims description 2
- ATNHDLDRLWWWCB-AENOIHSZSA-M chlorophyll a Chemical compound C1([C@@H](C(=O)OC)C(=O)C2=C3C)=C2N2C3=CC(C(CC)=C3C)=[N+]4C3=CC3=C(C=C)C(C)=C5N3[Mg-2]42[N+]2=C1[C@@H](CCC(=O)OC\C=C(/C)CCC[C@H](C)CCC[C@H](C)CCCC(C)C)[C@H](C)C2=C5 ATNHDLDRLWWWCB-AENOIHSZSA-M 0.000 claims description 2
- 235000013922 glutamic acid Nutrition 0.000 claims description 2
- 239000004220 glutamic acid Substances 0.000 claims description 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 2
- 239000004021 humic acid Substances 0.000 claims description 2
- 102000040430 polynucleotide Human genes 0.000 claims description 2
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- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 claims 18
- RMRJXGBAOAMLHD-IHFGGWKQSA-N buprenorphine Chemical compound C([C@]12[C@H]3OC=4C(O)=CC=C(C2=4)C[C@@H]2[C@]11CC[C@]3([C@H](C1)[C@](C)(O)C(C)(C)C)OC)CN2CC1CC1 RMRJXGBAOAMLHD-IHFGGWKQSA-N 0.000 claims 10
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- LESFYQKBUCDEQP-UHFFFAOYSA-N tetraazanium;2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate Chemical compound N.N.N.N.OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O LESFYQKBUCDEQP-UHFFFAOYSA-N 0.000 claims 2
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 claims 2
- QBYMCVQZZZQPHE-UHFFFAOYSA-N 2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetic acid;calcium Chemical compound [Ca].OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O QBYMCVQZZZQPHE-UHFFFAOYSA-N 0.000 claims 1
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- SHWNNYZBHZIQQV-UHFFFAOYSA-J EDTA monocalcium diisodium salt Chemical compound [Na+].[Na+].[Ca+2].[O-]C(=O)CN(CC([O-])=O)CCN(CC([O-])=O)CC([O-])=O SHWNNYZBHZIQQV-UHFFFAOYSA-J 0.000 claims 1
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- RGPDIGOSVORSAK-STHHAXOLSA-N naloxone hydrochloride Chemical compound Cl.O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C RGPDIGOSVORSAK-STHHAXOLSA-N 0.000 description 72
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- GGCSSNBKKAUURC-UHFFFAOYSA-N sufentanil Chemical compound C1CN(CCC=2SC=CC=2)CCC1(COC)N(C(=O)CC)C1=CC=CC=C1 GGCSSNBKKAUURC-UHFFFAOYSA-N 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 229920001897 terpolymer Polymers 0.000 description 1
- ISXSCDLOGDJUNJ-UHFFFAOYSA-N tert-butyl prop-2-enoate Chemical compound CC(C)(C)OC(=O)C=C ISXSCDLOGDJUNJ-UHFFFAOYSA-N 0.000 description 1
- 239000004408 titanium dioxide Substances 0.000 description 1
- 229960004380 tramadol Drugs 0.000 description 1
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 description 1
- ILJSQTXMGCGYMG-UHFFFAOYSA-N triacetic acid Chemical compound CC(=O)CC(=O)CC(O)=O ILJSQTXMGCGYMG-UHFFFAOYSA-N 0.000 description 1
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- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 235000019871 vegetable fat Nutrition 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 235000012431 wafers Nutrition 0.000 description 1
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- 239000000811 xylitol Substances 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical class OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/7007—Drug-containing films, membranes or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Emergency Medicine (AREA)
- Nutrition Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Physiology (AREA)
- Biomedical Technology (AREA)
- Addiction (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| US13/842,543 | 2013-03-15 | ||
| US13/842,543 US20140271788A1 (en) | 2013-03-15 | 2013-03-15 | Sublingual and buccal film compositions |
| US14/196,082 | 2014-03-04 | ||
| US14/196,082 US9511033B2 (en) | 2013-03-15 | 2014-03-04 | Sublingual and buccal film compositions |
| PCT/US2014/028568 WO2014144241A1 (en) | 2013-03-15 | 2014-03-14 | Sublingual and buccal film compositions |
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| AU2014227693A1 AU2014227693A1 (en) | 2015-10-29 |
| AU2014227693B2 true AU2014227693B2 (en) | 2018-06-21 |
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| AU2014227693A Active AU2014227693B2 (en) | 2013-03-15 | 2014-03-14 | Sublingual and buccal film compositions |
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|---|---|
| US (5) | US20140271788A1 (enExample) |
| EP (1) | EP2968121B1 (enExample) |
| JP (2) | JP6448096B2 (enExample) |
| KR (1) | KR20160029730A (enExample) |
| CN (1) | CN105491997B (enExample) |
| AU (1) | AU2014227693B2 (enExample) |
| BR (1) | BR112015023725A2 (enExample) |
| CA (1) | CA2906773C (enExample) |
| DK (1) | DK2968121T3 (enExample) |
| IL (1) | IL241441B (enExample) |
| MX (1) | MX2015013184A (enExample) |
| MY (1) | MY181159A (enExample) |
| RU (1) | RU2015143647A (enExample) |
| WO (1) | WO2014144241A1 (enExample) |
| ZA (1) | ZA201507685B (enExample) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10792246B2 (en) | 2018-06-27 | 2020-10-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140271788A1 (en) * | 2013-03-15 | 2014-09-18 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| AU2015341490C1 (en) | 2014-11-07 | 2021-03-11 | Indivior Uk Limited | Buprenorphine dosing regimens |
| US20160175296A1 (en) * | 2014-12-23 | 2016-06-23 | Arx, Llc | Method of producing uniform buprenorphine-containing formulations |
| EP3281625B1 (en) * | 2015-04-07 | 2020-02-26 | Nipro Corporation | Oral film preparation |
| KR102851614B1 (ko) | 2016-02-04 | 2025-08-29 | 신돔 파마, 인크. | 장애 치료를 위한 중수소화된 돔페리돈 조성물 및 방법 |
| US11738036B2 (en) | 2016-05-28 | 2023-08-29 | Rajiv Gandhi Centre For Biotechnology, An Autonomous Institute Under The Department Of Biotechnology, Government Of India | Uttroside B and derivatives thereof as therapeutics for hepatocellular carcinoma |
| JP2020500220A (ja) | 2016-11-15 | 2020-01-09 | クラリア ファーマ ホールディング エービー | 医薬製剤 |
| GB201709141D0 (en) | 2017-06-08 | 2017-07-26 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| US10646484B2 (en) | 2017-06-16 | 2020-05-12 | Indivior Uk Limited | Methods to treat opioid use disorder |
| KR20240125702A (ko) | 2017-06-30 | 2024-08-19 | 신돔 파마, 인크. | 중수소화 돔페리돈 조성물, 방법, 및 제조 |
| US12478612B2 (en) | 2017-06-30 | 2025-11-25 | Cindome Pharma, Inc. | Deuterated domperidone compositions, methods, and preparation |
| EP3473246A1 (en) | 2017-10-19 | 2019-04-24 | Capsugel Belgium NV | Immediate release abuse deterrent formulations |
| GB201808462D0 (en) | 2018-05-23 | 2018-07-11 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| WO2019240212A1 (ja) * | 2018-06-14 | 2019-12-19 | 株式会社カネカ | 薬学的活性成分を含む製剤 |
| US11648197B2 (en) * | 2018-06-28 | 2023-05-16 | Arx, Llc | Dispensing method for producing dissolvable unit dose film constructs |
| GB201819978D0 (en) * | 2018-12-11 | 2019-01-23 | Univ Strathclyde | Oral thin films |
| JP7287032B2 (ja) | 2019-03-20 | 2023-06-06 | 株式会社リコー | シート、シート積層体、医薬品、シートの製造方法、及びシート積層体の製造方法 |
| US11806320B2 (en) * | 2020-02-19 | 2023-11-07 | Endo Ventures Limited | Isoproterenol compositions and methods |
| WO2025147530A1 (en) * | 2024-01-05 | 2025-07-10 | Taho Pharmaceuticals Ltd. | Naloxone buccal film product and uses thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2005117838A1 (en) * | 2004-06-02 | 2005-12-15 | Galephar M/F | Stable oral pharmaceutical compositions of buprenorphine and derivatives |
| US20110033541A1 (en) * | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| US20110033542A1 (en) * | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
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| US3493657A (en) | 1961-03-14 | 1970-02-03 | Mozes Juda Lewenstein | Therapeutic compositions of n-allyl-14-hydroxy - dihydronormorphinane and morphine |
| US4457933A (en) | 1980-01-24 | 1984-07-03 | Bristol-Myers Company | Prevention of analgesic abuse |
| US4366159A (en) | 1981-09-08 | 1982-12-28 | Michael Richard Magruder | Nalbuphine-narcotic analgesic composition and method of producing analgesia |
| GB8332556D0 (en) | 1983-12-06 | 1984-01-11 | Reckitt & Colmann Prod Ltd | Analgesic compositions |
| US5225417A (en) | 1992-01-21 | 1993-07-06 | G. D. Searle & Co. | Opioid agonist compounds |
| US5223507A (en) | 1992-01-21 | 1993-06-29 | G. D. Searle & Co. | Method of using opioid compounds as delta opioid selective agonist analgesics |
| GB9202464D0 (en) | 1992-02-05 | 1992-03-18 | Danbiosyst Uk | Composition for nasal administration |
| ATE214276T1 (de) | 1994-09-19 | 2002-03-15 | Du Pont Pharm Co | Zusammensetzungen von opioid antagonisten mit selektiven serotonin-aufnahme inhibitoren, zur behandlung von alkoholismus und alkohoabhängigkeit |
| US5866154A (en) * | 1994-10-07 | 1999-02-02 | The Dupont Merck Pharmaceutical Company | Stabilized naloxone formulations |
| AT403162B (de) | 1995-10-11 | 1997-11-25 | Nycomed Austria Gmbh | Neue kristallform von morphin-6-glucuronid |
| DE19602969A1 (de) | 1995-12-20 | 1997-07-31 | Nycomed Arzneimittel Gmbh | Neue Morphinderivate, Verfahren zu deren Herstellung und deren Verwendung |
| PT914097E (pt) | 1996-03-12 | 2002-06-28 | Alza Corp | Composicao e forma de dosagem compreendendo antagonista de opioide |
| WO1998035679A1 (de) | 1997-02-14 | 1998-08-20 | Gödecke Aktiengesellschaft | Stabilisierung von naloxonhydrochlorid |
| KR100514963B1 (ko) | 1997-07-11 | 2005-09-15 | 도레이 가부시끼가이샤 | 4,5-에폭시모르피난 유도체를 함유하는 안정한 의약품 조성물 |
| ATE210983T1 (de) | 1997-11-03 | 2002-01-15 | Stada Arzneimittel Ag | Stabilisiertes kombinationsarzneimittel enthaltend naloxone und ein opiatanalgetikum |
| IT1302682B1 (it) | 1998-10-16 | 2000-09-29 | Formenti Farmaceutici Spa | Composizioni farmaceutiche orali contenenti buprenorfina |
| US20140271788A1 (en) * | 2013-03-15 | 2014-09-18 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| US7666337B2 (en) | 2002-04-11 | 2010-02-23 | Monosol Rx, Llc | Polyethylene oxide-based films and drug delivery systems made therefrom |
| US7357891B2 (en) | 2001-10-12 | 2008-04-15 | Monosol Rx, Llc | Process for making an ingestible film |
| US7425292B2 (en) | 2001-10-12 | 2008-09-16 | Monosol Rx, Llc | Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom |
| US8017150B2 (en) | 2002-04-11 | 2011-09-13 | Monosol Rx, Llc | Polyethylene oxide-based films and drug delivery systems made therefrom |
| CA2530843A1 (en) * | 2003-07-01 | 2005-01-20 | Todd Maibach | Film comprising therapeutic agents |
| US20060046962A1 (en) * | 2004-08-25 | 2006-03-02 | Aegis Therapeutics Llc | Absorption enhancers for drug administration |
| WO2006026713A2 (en) * | 2004-08-31 | 2006-03-09 | Tracie Martyn International, Llc | Topical benfotiamine and pyridoxamine compositions |
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-
2013
- 2013-03-15 US US13/842,543 patent/US20140271788A1/en not_active Abandoned
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2014
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- 2014-03-14 BR BR112015023725A patent/BR112015023725A2/pt not_active Application Discontinuation
- 2014-03-14 MY MYPI2015703198A patent/MY181159A/en unknown
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- 2014-03-14 CA CA2906773A patent/CA2906773C/en active Active
- 2014-03-14 AU AU2014227693A patent/AU2014227693B2/en active Active
- 2014-03-14 DK DK14721650.1T patent/DK2968121T3/en active
- 2014-03-14 KR KR1020157028424A patent/KR20160029730A/ko not_active Withdrawn
- 2014-03-14 EP EP14721650.1A patent/EP2968121B1/en active Active
- 2014-03-14 CN CN201480027179.8A patent/CN105491997B/zh active Active
- 2014-03-14 MX MX2015013184A patent/MX2015013184A/es unknown
- 2014-03-14 RU RU2015143647A patent/RU2015143647A/ru not_active Application Discontinuation
- 2014-03-14 WO PCT/US2014/028568 patent/WO2014144241A1/en not_active Ceased
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2015
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2018
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- 2018-11-30 JP JP2018225191A patent/JP2019048882A/ja not_active Abandoned
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2019
- 2019-12-06 US US16/705,422 patent/US20200315984A1/en not_active Abandoned
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005117838A1 (en) * | 2004-06-02 | 2005-12-15 | Galephar M/F | Stable oral pharmaceutical compositions of buprenorphine and derivatives |
| US20110033541A1 (en) * | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| US20110033542A1 (en) * | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
Cited By (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11786508B2 (en) | 2016-12-31 | 2023-10-17 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11931340B2 (en) | 2016-12-31 | 2024-03-19 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11839604B2 (en) | 2016-12-31 | 2023-12-12 | Bioxcel Therapeutics, Inc. | Use of sublingual dexmedetomidine for the treatment of agitation |
| US11559484B2 (en) | 2018-06-27 | 2023-01-24 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11517524B2 (en) | 2018-06-27 | 2022-12-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11806429B2 (en) | 2018-06-27 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US10792246B2 (en) | 2018-06-27 | 2020-10-06 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11497711B2 (en) | 2018-06-27 | 2022-11-15 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11478422B2 (en) | 2018-06-27 | 2022-10-25 | Bioxcel Therapeutics, Inc. | Film formulations containing dexmedetomidine and methods of producing them |
| US11998529B2 (en) | 2019-07-19 | 2024-06-04 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11890272B2 (en) | 2019-07-19 | 2024-02-06 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US12109196B2 (en) | 2019-07-19 | 2024-10-08 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US12090140B2 (en) | 2023-01-12 | 2024-09-17 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US11998528B1 (en) | 2023-01-12 | 2024-06-04 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US12138247B2 (en) | 2023-01-12 | 2024-11-12 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| US12364683B2 (en) | 2023-01-12 | 2025-07-22 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
Also Published As
| Publication number | Publication date |
|---|---|
| RU2015143647A (ru) | 2017-04-21 |
| IL241441B (en) | 2019-07-31 |
| EP2968121A1 (en) | 2016-01-20 |
| US20140271788A1 (en) | 2014-09-18 |
| JP6448096B2 (ja) | 2019-01-09 |
| CN105491997A (zh) | 2016-04-13 |
| IL241441A0 (en) | 2015-11-30 |
| WO2014144241A1 (en) | 2014-09-18 |
| KR20160029730A (ko) | 2016-03-15 |
| CA2906773C (en) | 2023-12-12 |
| US20200315984A1 (en) | 2020-10-08 |
| AU2014227693A1 (en) | 2015-10-29 |
| US9511033B2 (en) | 2016-12-06 |
| CN105491997B (zh) | 2019-12-17 |
| MY181159A (en) | 2020-12-19 |
| BR112015023725A2 (pt) | 2017-07-18 |
| DK2968121T3 (en) | 2019-02-04 |
| MX2015013184A (es) | 2016-04-07 |
| ZA201507685B (en) | 2017-06-28 |
| EP2968121B1 (en) | 2018-12-19 |
| US20170296482A1 (en) | 2017-10-19 |
| US20140271789A1 (en) | 2014-09-18 |
| JP2019048882A (ja) | 2019-03-28 |
| CA2906773A1 (en) | 2014-09-18 |
| US20190038570A1 (en) | 2019-02-07 |
| JP2016513736A (ja) | 2016-05-16 |
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