DK2968121T3 - SUBLINGUAL AND BUCHAL FILM COMPOSITIONS - Google Patents
SUBLINGUAL AND BUCHAL FILM COMPOSITIONS Download PDFInfo
- Publication number
- DK2968121T3 DK2968121T3 DK14721650.1T DK14721650T DK2968121T3 DK 2968121 T3 DK2968121 T3 DK 2968121T3 DK 14721650 T DK14721650 T DK 14721650T DK 2968121 T3 DK2968121 T3 DK 2968121T3
- Authority
- DK
- Denmark
- Prior art keywords
- composition
- naloxone
- buprenorphine
- film
- acid
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims description 233
- 229960001736 buprenorphine Drugs 0.000 claims description 166
- 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 claims description 161
- 229960004127 naloxone Drugs 0.000 claims description 160
- 150000003839 salts Chemical class 0.000 claims description 111
- 229920000642 polymer Polymers 0.000 claims description 56
- 239000000872 buffer Substances 0.000 claims description 45
- 239000002738 chelating agent Substances 0.000 claims description 39
- 239000011159 matrix material Substances 0.000 claims description 38
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical group OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 27
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 24
- 208000002193 Pain Diseases 0.000 claims description 13
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 12
- 239000003963 antioxidant agent Substances 0.000 claims description 12
- 230000003647 oxidation Effects 0.000 claims description 11
- 238000007254 oxidation reaction Methods 0.000 claims description 11
- 235000018102 proteins Nutrition 0.000 claims description 10
- 102000004169 proteins and genes Human genes 0.000 claims description 10
- 108090000623 proteins and genes Proteins 0.000 claims description 10
- 229960001484 edetic acid Drugs 0.000 claims description 8
- 229920003176 water-insoluble polymer Polymers 0.000 claims description 8
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical group [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 6
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 6
- 239000002253 acid Substances 0.000 claims description 6
- 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 5
- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims description 5
- 108010054147 Hemoglobins Proteins 0.000 claims description 5
- 102000001554 Hemoglobins Human genes 0.000 claims description 5
- WHUUTDBJXJRKMK-VKHMYHEASA-N L-glutamic acid Chemical compound OC(=O)[C@@H](N)CCC(O)=O WHUUTDBJXJRKMK-VKHMYHEASA-N 0.000 claims description 5
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims description 5
- 108010076986 Phytochelatins Proteins 0.000 claims description 5
- 102000004338 Transferrin Human genes 0.000 claims description 5
- 108090000901 Transferrin Proteins 0.000 claims description 5
- 229920002988 biodegradable polymer Polymers 0.000 claims description 5
- 239000004621 biodegradable polymer Substances 0.000 claims description 5
- 229930002875 chlorophyll Natural products 0.000 claims description 5
- 235000019804 chlorophyll Nutrition 0.000 claims description 5
- 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 5
- 235000013922 glutamic acid Nutrition 0.000 claims description 5
- 239000004220 glutamic acid Substances 0.000 claims description 5
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 5
- 239000004021 humic acid Substances 0.000 claims description 5
- 229960005250 naloxone hydrochloride Drugs 0.000 claims description 5
- 102000040430 polynucleotide Human genes 0.000 claims description 5
- 108091033319 polynucleotide Proteins 0.000 claims description 5
- 229920001184 polypeptide Polymers 0.000 claims description 5
- 108090000765 processed proteins & peptides Proteins 0.000 claims description 5
- 102000004196 processed proteins & peptides Human genes 0.000 claims description 5
- 239000012581 transferrin Substances 0.000 claims description 5
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 4
- 230000003078 antioxidant effect Effects 0.000 claims description 4
- UEZVMMHDMIWARA-UHFFFAOYSA-M phosphonate Chemical compound [O-]P(=O)=O UEZVMMHDMIWARA-UHFFFAOYSA-M 0.000 claims description 4
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 3
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 3
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 3
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 3
- 239000004327 boric acid Substances 0.000 claims description 3
- 239000001630 malic acid Substances 0.000 claims description 3
- 235000011090 malic acid Nutrition 0.000 claims description 3
- 229960001889 buprenorphine hydrochloride Drugs 0.000 claims description 2
- UAIXRPCCYXNJMQ-RZIPZOSSSA-N buprenorphine hydrochlorie Chemical compound [Cl-].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)C[NH+]2CC1CC1 UAIXRPCCYXNJMQ-RZIPZOSSSA-N 0.000 claims description 2
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims description 2
- 239000001509 sodium citrate Substances 0.000 claims description 2
- 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 2
- 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 6
- JTXMVXSTHSMVQF-UHFFFAOYSA-N 2-acetyloxyethyl acetate Chemical compound CC(=O)OCCOC(C)=O JTXMVXSTHSMVQF-UHFFFAOYSA-N 0.000 claims 3
- 125000005515 organic divalent group Chemical group 0.000 claims 2
- HLWRUJAIJJEZDL-UHFFFAOYSA-M sodium;2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetate Chemical compound [Na+].OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC([O-])=O HLWRUJAIJJEZDL-UHFFFAOYSA-M 0.000 claims 2
- BDOYKFSQFYNPKF-UHFFFAOYSA-N 2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetic acid;sodium Chemical group [Na].[Na].OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O BDOYKFSQFYNPKF-UHFFFAOYSA-N 0.000 claims 1
- BDDLHHRCDSJVKV-UHFFFAOYSA-N 7028-40-2 Chemical compound CC(O)=O.CC(O)=O.CC(O)=O.CC(O)=O BDDLHHRCDSJVKV-UHFFFAOYSA-N 0.000 claims 1
- 239000002313 adhesive film Substances 0.000 claims 1
- 210000004877 mucosa Anatomy 0.000 claims 1
- 239000010408 film Substances 0.000 description 280
- RMRJXGBAOAMLHD-CTAPUXPBSA-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-CTAPUXPBSA-N 0.000 description 193
- 238000010521 absorption reaction Methods 0.000 description 134
- 239000000556 agonist Substances 0.000 description 66
- 239000005557 antagonist Substances 0.000 description 58
- 210000000214 mouth Anatomy 0.000 description 37
- 229940053209 suboxone Drugs 0.000 description 35
- -1 hydroxypropyl ethyl Chemical group 0.000 description 34
- 238000009472 formulation Methods 0.000 description 25
- 238000001727 in vivo Methods 0.000 description 25
- 230000003139 buffering effect Effects 0.000 description 24
- 229920001577 copolymer Polymers 0.000 description 23
- 239000003814 drug Substances 0.000 description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 20
- 230000003232 mucoadhesive effect Effects 0.000 description 17
- 239000002552 dosage form Substances 0.000 description 16
- 238000012360 testing method Methods 0.000 description 16
- 230000000694 effects Effects 0.000 description 14
- SFNLWIKOKQVFPB-KZCPYJDTSA-N bunavail Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C.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 SFNLWIKOKQVFPB-KZCPYJDTSA-N 0.000 description 13
- 238000011282 treatment Methods 0.000 description 13
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- 229940124597 therapeutic agent Drugs 0.000 description 12
- 239000000654 additive Substances 0.000 description 11
- 235000006708 antioxidants Nutrition 0.000 description 11
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 description 11
- 239000000126 substance Substances 0.000 description 11
- 229920003169 water-soluble polymer Polymers 0.000 description 11
- 239000003795 chemical substances by application Substances 0.000 description 10
- 239000003086 colorant Substances 0.000 description 10
- 229940079593 drug Drugs 0.000 description 10
- 239000000463 material Substances 0.000 description 10
- 229940083037 simethicone Drugs 0.000 description 10
- 239000002904 solvent Substances 0.000 description 10
- 229920000159 gelatin Polymers 0.000 description 9
- 235000019322 gelatine Nutrition 0.000 description 9
- 239000000243 solution Substances 0.000 description 9
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical class OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 8
- 108010010803 Gelatin Proteins 0.000 description 8
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 description 8
- 235000010354 butylated hydroxytoluene Nutrition 0.000 description 8
- 239000008273 gelatin Substances 0.000 description 8
- 235000011852 gelatine desserts Nutrition 0.000 description 8
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 description 8
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 description 7
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 7
- 229920002472 Starch Polymers 0.000 description 7
- 235000019698 starch Nutrition 0.000 description 7
- 239000004322 Butylated hydroxytoluene Substances 0.000 description 6
- 229940095259 butylated hydroxytoluene Drugs 0.000 description 6
- 235000015165 citric acid Nutrition 0.000 description 6
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- 150000001875 compounds Chemical class 0.000 description 6
- 235000003599 food sweetener Nutrition 0.000 description 6
- 230000008569 process Effects 0.000 description 6
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 6
- 239000004094 surface-active agent Substances 0.000 description 6
- 239000003765 sweetening agent Substances 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 239000001856 Ethyl cellulose Substances 0.000 description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 5
- 235000010489 acacia gum Nutrition 0.000 description 5
- 239000004480 active ingredient Substances 0.000 description 5
- 229940056146 buprenorphine / naloxone Drugs 0.000 description 5
- 229920002678 cellulose Polymers 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 5
- 150000002148 esters Chemical class 0.000 description 5
- 235000019325 ethyl cellulose Nutrition 0.000 description 5
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- WTEVQBCEXWBHNA-JXMROGBWSA-N geranial Chemical compound CC(C)=CCC\C(C)=C\C=O WTEVQBCEXWBHNA-JXMROGBWSA-N 0.000 description 5
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 5
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 5
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 5
- 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 description 5
- 238000002844 melting Methods 0.000 description 5
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- 239000004031 partial agonist Substances 0.000 description 5
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- 230000001225 therapeutic effect Effects 0.000 description 5
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 4
- 235000005979 Citrus limon Nutrition 0.000 description 4
- 244000131522 Citrus pyriformis Species 0.000 description 4
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- 239000002202 Polyethylene glycol Substances 0.000 description 4
- 229920002125 Sokalan® Polymers 0.000 description 4
- 235000010323 ascorbic acid Nutrition 0.000 description 4
- 229960005070 ascorbic acid Drugs 0.000 description 4
- 239000011668 ascorbic acid Substances 0.000 description 4
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- 235000020971 citrus fruits Nutrition 0.000 description 4
- 239000003925 fat Substances 0.000 description 4
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- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 4
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 4
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- 230000000670 limiting effect Effects 0.000 description 4
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 description 4
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- 239000003381 stabilizer Substances 0.000 description 4
- 208000024891 symptom Diseases 0.000 description 4
- MYRTYDVEIRVNKP-UHFFFAOYSA-N 1,2-Divinylbenzene Chemical class C=CC1=CC=CC=C1C=C MYRTYDVEIRVNKP-UHFFFAOYSA-N 0.000 description 3
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 3
- 241000167854 Bourreria succulenta Species 0.000 description 3
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 3
- 235000008733 Citrus aurantifolia Nutrition 0.000 description 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 3
- 229920002907 Guar gum Polymers 0.000 description 3
- 229920000084 Gum arabic Polymers 0.000 description 3
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 3
- 229920000954 Polyglycolide Polymers 0.000 description 3
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- 240000006909 Tilia x europaea Species 0.000 description 3
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- CXMXRPHRNRROMY-UHFFFAOYSA-N sebacic acid Chemical compound OC(=O)CCCCCCCCC(O)=O CXMXRPHRNRROMY-UHFFFAOYSA-N 0.000 description 3
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- 239000011734 sodium Substances 0.000 description 3
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- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 3
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- 235000010265 sodium sulphite Nutrition 0.000 description 3
- 229920001285 xanthan gum Polymers 0.000 description 3
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- 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 description 2
- SPSPIUSUWPLVKD-UHFFFAOYSA-N 2,3-dibutyl-6-methylphenol Chemical compound CCCCC1=CC=C(C)C(O)=C1CCCC SPSPIUSUWPLVKD-UHFFFAOYSA-N 0.000 description 2
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- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-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
- 229920003170 water-soluble synthetic polymer Polymers 0.000 description 1
- 235000021119 whey protein Nutrition 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 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
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- 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
-
- 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
-
- 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
-
- 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)
- Physiology (AREA)
- Nutrition Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Addiction (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (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 (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US13/842,543 US20140271788A1 (en) | 2013-03-15 | 2013-03-15 | Sublingual and buccal film compositions |
| 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 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2968121T3 true DK2968121T3 (en) | 2019-02-04 |
Family
ID=51528033
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK14721650.1T DK2968121T3 (en) | 2013-03-15 | 2014-03-14 | SUBLINGUAL AND BUCHAL FILM COMPOSITIONS |
Country Status (15)
Families Citing this family (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20140271788A1 (en) * | 2013-03-15 | 2014-09-18 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| WO2016071767A1 (en) | 2014-11-07 | 2016-05-12 | Indivior Uk Limited | Buprenorphine dosing regimens |
| US20160175296A1 (en) * | 2014-12-23 | 2016-06-23 | Arx, Llc | Method of producing uniform buprenorphine-containing formulations |
| JPWO2016163403A1 (ja) * | 2015-04-07 | 2018-02-01 | ニプロ株式会社 | 経口フィルム製剤 |
| DK3411031T3 (da) | 2016-02-04 | 2024-10-21 | Cindome Pharma Inc | Deutererede domperidonpræparater og fremgangsmåder til terapi af lidelser |
| 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 |
| IL266537B2 (en) | 2016-11-15 | 2023-12-01 | Klaria Pharma Holding Ab | Pharmaceutical formulation |
| MX2019007923A (es) | 2016-12-31 | 2019-09-10 | Bioxcel Therapeutics Inc | Uso de dexmedetomidina sublingual para el tratamiento de la agitacion. |
| 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 |
| US12478612B2 (en) | 2017-06-30 | 2025-11-25 | Cindome Pharma, Inc. | Deuterated domperidone compositions, methods, and preparation |
| KR20240125702A (ko) | 2017-06-30 | 2024-08-19 | 신돔 파마, 인크. | 중수소화 돔페리돈 조성물, 방법, 및 제조 |
| 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 |
| JPWO2019240212A1 (ja) | 2018-06-14 | 2021-06-24 | 株式会社カネカ | 薬学的活性成分を含む製剤 |
| PT3813802T (pt) | 2018-06-27 | 2025-01-15 | Arx Llc | Formulações de películas contendo dexmedetomidina e métodos de produção das mesmas |
| WO2020006073A1 (en) * | 2018-06-28 | 2020-01-02 | 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 |
| KR20220049526A (ko) | 2019-07-19 | 2022-04-21 | 바이오엑셀 테라퓨틱스 인코포레이티드 | 비-진정성 덱스메데토미딘 치료 양생법 |
| US11806320B2 (en) * | 2020-02-19 | 2023-11-07 | Endo Ventures Limited | Isoproterenol compositions and methods |
| US11806334B1 (en) | 2023-01-12 | 2023-11-07 | Bioxcel Therapeutics, Inc. | Non-sedating dexmedetomidine treatment regimens |
| WO2025147530A1 (en) * | 2024-01-05 | 2025-07-10 | Taho Pharmaceuticals Ltd. | Naloxone buccal film product and uses thereof |
Family Cites Families (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| EP0782445B1 (en) | 1994-09-19 | 2002-03-13 | Dupont Pharmaceuticals Company | Combination of an opioid antagonist and a selective serotonin reuptake inhibitor for treatment of alcoholism and alcohol dependence |
| 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 |
| DE19602959A1 (de) | 1995-12-20 | 1997-07-31 | Nycomed Arzneimittel Gmbh | Neue Morphinderivate, Verfahren zu deren Herstellung und deren Verwendung |
| DK0914097T3 (da) | 1996-03-12 | 2002-04-29 | Alza Corp | Sammensætning og doseringsform omfattende opioid antagonist |
| WO1998035679A1 (de) | 1997-02-14 | 1998-08-20 | Gödecke Aktiengesellschaft | Stabilisierung von naloxonhydrochlorid |
| ES2217563T3 (es) | 1997-07-11 | 2004-11-01 | Toray Industries, Inc. | Compuestos medicinales estables que contienen derivados de 4,5-epoximorfinado. |
| 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 |
| 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 |
| US20140271788A1 (en) * | 2013-03-15 | 2014-09-18 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| US7357891B2 (en) | 2001-10-12 | 2008-04-15 | Monosol Rx, Llc | Process for making an ingestible film |
| US7666337B2 (en) | 2002-04-11 | 2010-02-23 | Monosol Rx, Llc | Polyethylene oxide-based films and drug delivery systems made therefrom |
| US20110033542A1 (en) * | 2009-08-07 | 2011-02-10 | Monosol Rx, Llc | Sublingual and buccal film compositions |
| 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 |
| WO2005117838A1 (en) * | 2004-06-02 | 2005-12-15 | Galephar M/F | Stable oral pharmaceutical compositions of buprenorphine and derivatives |
| US20060046962A1 (en) * | 2004-08-25 | 2006-03-02 | Aegis Therapeutics Llc | Absorption enhancers for drug administration |
| US7666442B2 (en) * | 2004-08-31 | 2010-02-23 | Tracie Martyn International, Llc | Topical compositions comprising benfotiamine and pyridoxamine |
| JP2007304673A (ja) | 2006-05-09 | 2007-11-22 | Kyocera Mita Corp | 監視装置及び監視システム並びに監視プログラム |
| US8475832B2 (en) * | 2009-08-07 | 2013-07-02 | Rb Pharmaceuticals Limited | Sublingual and buccal film compositions |
-
2013
- 2013-03-15 US US13/842,543 patent/US20140271788A1/en not_active Abandoned
-
2014
- 2014-03-04 US US14/196,082 patent/US9511033B2/en active Active
- 2014-03-14 CA CA2906773A patent/CA2906773C/en active Active
- 2014-03-14 EP EP14721650.1A patent/EP2968121B1/en active Active
- 2014-03-14 JP JP2016502836A patent/JP6448096B2/ja active Active
- 2014-03-14 WO PCT/US2014/028568 patent/WO2014144241A1/en not_active Ceased
- 2014-03-14 RU RU2015143647A patent/RU2015143647A/ru not_active Application Discontinuation
- 2014-03-14 MY MYPI2015703198A patent/MY181159A/en unknown
- 2014-03-14 BR BR112015023725A patent/BR112015023725A2/pt not_active Application Discontinuation
- 2014-03-14 MX MX2015013184A patent/MX2015013184A/es unknown
- 2014-03-14 CN CN201480027179.8A patent/CN105491997B/zh active Active
- 2014-03-14 DK DK14721650.1T patent/DK2968121T3/en active
- 2014-03-14 AU AU2014227693A patent/AU2014227693B2/en active Active
- 2014-03-14 KR KR1020157028424A patent/KR20160029730A/ko not_active Withdrawn
-
2015
- 2015-09-10 IL IL241441A patent/IL241441B/en active IP Right Grant
- 2015-10-14 ZA ZA2015/07685A patent/ZA201507685B/en unknown
-
2016
- 2016-12-05 US US15/369,101 patent/US20170296482A1/en not_active Abandoned
-
2018
- 2018-10-09 US US16/155,100 patent/US20190038570A1/en not_active Abandoned
- 2018-11-30 JP JP2018225191A patent/JP2019048882A/ja not_active Abandoned
-
2019
- 2019-12-06 US US16/705,422 patent/US20200315984A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| US20140271789A1 (en) | 2014-09-18 |
| MX2015013184A (es) | 2016-04-07 |
| IL241441A0 (en) | 2015-11-30 |
| AU2014227693B2 (en) | 2018-06-21 |
| US20170296482A1 (en) | 2017-10-19 |
| KR20160029730A (ko) | 2016-03-15 |
| WO2014144241A1 (en) | 2014-09-18 |
| ZA201507685B (en) | 2017-06-28 |
| US9511033B2 (en) | 2016-12-06 |
| US20200315984A1 (en) | 2020-10-08 |
| CA2906773A1 (en) | 2014-09-18 |
| JP2019048882A (ja) | 2019-03-28 |
| JP6448096B2 (ja) | 2019-01-09 |
| AU2014227693A1 (en) | 2015-10-29 |
| IL241441B (en) | 2019-07-31 |
| CA2906773C (en) | 2023-12-12 |
| RU2015143647A (ru) | 2017-04-21 |
| MY181159A (en) | 2020-12-19 |
| EP2968121A1 (en) | 2016-01-20 |
| EP2968121B1 (en) | 2018-12-19 |
| CN105491997B (zh) | 2019-12-17 |
| JP2016513736A (ja) | 2016-05-16 |
| US20190038570A1 (en) | 2019-02-07 |
| BR112015023725A2 (pt) | 2017-07-18 |
| CN105491997A (zh) | 2016-04-13 |
| US20140271788A1 (en) | 2014-09-18 |
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