SI1765292T1 - Formulacije zdravil za odvračanje od zlorab - Google Patents
Formulacije zdravil za odvračanje od zlorab Download PDFInfo
- Publication number
- SI1765292T1 SI1765292T1 SI200532186T SI200532186T SI1765292T1 SI 1765292 T1 SI1765292 T1 SI 1765292T1 SI 200532186 T SI200532186 T SI 200532186T SI 200532186 T SI200532186 T SI 200532186T SI 1765292 T1 SI1765292 T1 SI 1765292T1
- Authority
- SI
- Slovenia
- Prior art keywords
- acid
- composition
- amount
- oxycodone
- soluble
- Prior art date
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- 239000013583 drug formulation Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 claims abstract 29
- 229940079593 drug Drugs 0.000 claims abstract 10
- 239000003814 drug Substances 0.000 claims abstract 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract 8
- 239000011859 microparticle Substances 0.000 claims abstract 7
- 239000000463 material Substances 0.000 claims abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 3
- 238000009472 formulation Methods 0.000 claims abstract 2
- 235000014113 dietary fatty acids Nutrition 0.000 claims 16
- 239000000194 fatty acid Substances 0.000 claims 16
- 229930195729 fatty acid Natural products 0.000 claims 16
- 229960002085 oxycodone Drugs 0.000 claims 12
- 150000004665 fatty acids Chemical class 0.000 claims 11
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims 9
- 239000002253 acid Substances 0.000 claims 8
- 239000001993 wax Substances 0.000 claims 7
- -1 fatty acid salt Chemical class 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 235000021355 Stearic acid Nutrition 0.000 claims 3
- 239000003937 drug carrier Substances 0.000 claims 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 3
- IPCSVZSSVZVIGE-UHFFFAOYSA-N palmitic acid group Chemical group C(CCCCCCCCCCCCCCC)(=O)O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 claims 3
- 239000008117 stearic acid Substances 0.000 claims 3
- TUNFSRHWOTWDNC-UHFFFAOYSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCCC(O)=O TUNFSRHWOTWDNC-UHFFFAOYSA-N 0.000 claims 3
- TWJNQYPJQDRXPH-UHFFFAOYSA-N 2-cyanobenzohydrazide Chemical compound NNC(=O)C1=CC=CC=C1C#N TWJNQYPJQDRXPH-UHFFFAOYSA-N 0.000 claims 2
- 235000021360 Myristic acid Nutrition 0.000 claims 2
- 235000013871 bee wax Nutrition 0.000 claims 2
- 239000012166 beeswax Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- GHVNFZFCNZKVNT-UHFFFAOYSA-N decanoic acid Chemical compound CCCCCCCCCC(O)=O GHVNFZFCNZKVNT-UHFFFAOYSA-N 0.000 claims 2
- 150000004676 glycans Chemical class 0.000 claims 2
- VXZBFBRLRNDJCS-UHFFFAOYSA-N heptacosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCC(O)=O VXZBFBRLRNDJCS-UHFFFAOYSA-N 0.000 claims 2
- XMHIUKTWLZUKEX-UHFFFAOYSA-N hexacosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCC(O)=O XMHIUKTWLZUKEX-UHFFFAOYSA-N 0.000 claims 2
- FUZZWVXGSFPDMH-UHFFFAOYSA-N hexanoic acid group Chemical group C(CCCCC)(=O)O FUZZWVXGSFPDMH-UHFFFAOYSA-N 0.000 claims 2
- VKOBVWXKNCXXDE-UHFFFAOYSA-N icosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCC(O)=O VKOBVWXKNCXXDE-UHFFFAOYSA-N 0.000 claims 2
- WQEPLUUGTLDZJY-UHFFFAOYSA-N n-Pentadecanoic acid Natural products CCCCCCCCCCCCCCC(O)=O WQEPLUUGTLDZJY-UHFFFAOYSA-N 0.000 claims 2
- IHEJEKZAKSNRLY-UHFFFAOYSA-N nonacosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCCC(O)=O IHEJEKZAKSNRLY-UHFFFAOYSA-N 0.000 claims 2
- ISYWECDDZWTKFF-UHFFFAOYSA-N nonadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCCC(O)=O ISYWECDDZWTKFF-UHFFFAOYSA-N 0.000 claims 2
- FBUKVWPVBMHYJY-UHFFFAOYSA-N nonanoic acid Chemical compound CCCCCCCCC(O)=O FBUKVWPVBMHYJY-UHFFFAOYSA-N 0.000 claims 2
- UTOPWMOLSKOLTQ-UHFFFAOYSA-N octacosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCCCCC(O)=O UTOPWMOLSKOLTQ-UHFFFAOYSA-N 0.000 claims 2
- MWMPEAHGUXCSMY-UHFFFAOYSA-N pentacosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCCCCC(O)=O MWMPEAHGUXCSMY-UHFFFAOYSA-N 0.000 claims 2
- 229920001282 polysaccharide Polymers 0.000 claims 2
- 239000005017 polysaccharide Substances 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- 239000000126 substance Substances 0.000 claims 2
- SZHOJFHSIKHZHA-UHFFFAOYSA-N tridecanoic acid Chemical compound CCCCCCCCCCCCC(O)=O SZHOJFHSIKHZHA-UHFFFAOYSA-N 0.000 claims 2
- ZDPHROOEEOARMN-UHFFFAOYSA-N undecanoic acid Chemical compound CCCCCCCCCCC(O)=O ZDPHROOEEOARMN-UHFFFAOYSA-N 0.000 claims 2
- NQPDZGIKBAWPEJ-UHFFFAOYSA-N valeric acid Chemical compound CCCCC(O)=O NQPDZGIKBAWPEJ-UHFFFAOYSA-N 0.000 claims 2
- OYHQOLUKZRVURQ-NTGFUMLPSA-N (9Z,12Z)-9,10,12,13-tetratritiooctadeca-9,12-dienoic acid Chemical compound C(CCCCCCC\C(=C(/C\C(=C(/CCCCC)\[3H])\[3H])\[3H])\[3H])(=O)O OYHQOLUKZRVURQ-NTGFUMLPSA-N 0.000 claims 1
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 claims 1
- WCOXQTXVACYMLM-UHFFFAOYSA-N 2,3-bis(12-hydroxyoctadecanoyloxy)propyl 12-hydroxyoctadecanoate Chemical compound CCCCCCC(O)CCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCC(O)CCCCCC)COC(=O)CCCCCCCCCCC(O)CCCCCC WCOXQTXVACYMLM-UHFFFAOYSA-N 0.000 claims 1
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 claims 1
- AWQSAIIDOMEEOD-UHFFFAOYSA-N 5,5-Dimethyl-4-(3-oxobutyl)dihydro-2(3H)-furanone Chemical compound CC(=O)CCC1CC(=O)OC1(C)C AWQSAIIDOMEEOD-UHFFFAOYSA-N 0.000 claims 1
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 claims 1
- 239000005632 Capric acid (CAS 334-48-5) Substances 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 235000021353 Lignoceric acid Nutrition 0.000 claims 1
- CQXMAMUUWHYSIY-UHFFFAOYSA-N Lignoceric acid Natural products CCCCCCCCCCCCCCCCCCCCCCCC(=O)OCCC1=CC=C(O)C=C1 CQXMAMUUWHYSIY-UHFFFAOYSA-N 0.000 claims 1
- 239000005642 Oleic acid Substances 0.000 claims 1
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 claims 1
- 235000021314 Palmitic acid Nutrition 0.000 claims 1
- 230000002378 acidificating effect Effects 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 229940097362 cyclodextrins Drugs 0.000 claims 1
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 claims 1
- YAQXGBBDJYBXKL-UHFFFAOYSA-N iron(2+);1,10-phenanthroline;dicyanide Chemical compound [Fe+2].N#[C-].N#[C-].C1=CN=C2C3=NC=CC=C3C=CC2=C1.C1=CN=C2C3=NC=CC=C3C=CC2=C1 YAQXGBBDJYBXKL-UHFFFAOYSA-N 0.000 claims 1
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 claims 1
- 150000002632 lipids Chemical class 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 235000013310 margarine Nutrition 0.000 claims 1
- 239000003264 margarine Substances 0.000 claims 1
- 239000004200 microcrystalline wax Substances 0.000 claims 1
- 235000019808 microcrystalline wax Nutrition 0.000 claims 1
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims 1
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims 1
- 150000007524 organic acids Chemical class 0.000 claims 1
- 235000005985 organic acids Nutrition 0.000 claims 1
- 239000012188 paraffin wax Substances 0.000 claims 1
- 150000003904 phospholipids Chemical class 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- QZZGJDVWLFXDLK-UHFFFAOYSA-N tetracosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCCCC(O)=O QZZGJDVWLFXDLK-UHFFFAOYSA-N 0.000 claims 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 239000011247 coating layer Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 230000001010 compromised effect Effects 0.000 abstract 1
- 210000001035 gastrointestinal tract Anatomy 0.000 abstract 1
- 229940005483 opioid analgesics Drugs 0.000 abstract 1
- 239000003960 organic solvent Substances 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 239000003799 water insoluble solvent Substances 0.000 abstract 1
Classifications
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- 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
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Claims (20)
- Formulacije zdravil za odvračanje od zlorab Patentni zahtevki1. Farmacevtski sestavek za odvračanje od zlorab za oralno uporabo, ki vsebuje mikrodelce, kjer mikrodelci vsebujejo: (a) terapevtsko učinkovito količino farmacevtsko sprejemljivega sredstva; (b) eno ali več maščobnih kislin, izbranih iz skupine, ki vsebujejo C5 do C30 monovalentne maščobne kisline, C8 do C40 divalentne maščobne kisline in njihove mešanice; in (c) farmacevtsko sprejemljiv nosilec, kije voskasta snov, kjer omenjeno farmacevtsko sprejemljivo sredstvo (a) vsebuje sol organske maščobne kisline oksikodona; in je omenjena ena ali več organskih kislin prisotna v količini, ki znaša od dva do petnajstkrat molame količine oksikodona.
- 2. Sestavek po zahtevku 1, kjer je ena ali več maščobnih kislin prisotna v količini, ki znaša od dva do približno desetkrat molame količine oksikodona.
- 3. Sestavek po zahtevku 1, kjer je C5 do C30 monovalentna maščobna kislina izbrana iz skupine, ki vsebuje pentanojsko kislino, heksanojsko (kapronsko) kislino, heptanojsko kislino, oktanojsko (kaprilično) kislino, nonanojsko kislino, dekanojsko (kaprinsko) kislino, undekanojsko kislino, dodekanojsko (lavrinsko) kislino, tridekanojsko kislino, tetradekanojsko (miristinsko) kislino, pentadekanojsko kislino, heksadekanojsko (palmitinsko) kislino, heptadekanojsko (margarinsko) kislino, oktadekanojsko (stearinsko) kislino, nonadekanojsko kislino, eikozanojsko (arašidno) kislino, heneikozanojsko kislino, dokozanojsko (behenojsko) kislino, trikozanojsko kislino, tetrakozanojsko (lignocerinsko) kislino, pentakozanojsko kislino, heksakozanojsko kislino, heptakozanojsko » » w w m m m 9 w w 9 « t · · kislino, oktakozanojsko kislino, nonakozanojsko kislino, linolno kislino, oleinsko kislino in njihove mešanice.
- 4. Sestavek po zahtevku 3, kjer je C5 do C30 monovalentna maščobna kislina mešanica palmitinsko kisline in stearinske kisline.
- 5. Sestavek po zahtevku 3, kjer je C5 do C30 monovalentna maščobna kislina miristinska kislina.
- 6. Sestavek po zahtevku 3, kjer je C5 do C30 monovalentna maščobna kislina stearinska kislina.
- 7. Sestavek po zahtevku 1, kjer je nosilec (c) prisoten v količini, ki znaša od 0,25 do osem krat teže količine oksikodona.
- 8. Sestavek po zahtevku 7, kjer je nosilec (c) prisoten v količini, ki znaša od dva do šest krat teže količine oksikodona.
- 9. Sestavek po zahtevku 1, kjer je vosek izbran iz skupine, ki vsebuje kamauba vosek, čebelji vosek, mikrokristalni vosek in njihove zmesi, ali je vosek Glycowax®, ricinusov vosek, parafin ali kandelilski vosek.
- 10. Sestavek po zahtevku 9, kjer je vosek čebelji vosek.
- 11. Sestavek po zahtevku 9, kjer je vosek kamauba vosek.
- 12. Sestavek po zahtevku 1, kjer je farmacevtsko aktivno sredstvo vključeno v množico posameznih mikrodelcev, ki vsebujejo material, ki je počasi topen v vodi ali v vodi ni topen.
- 13. Sestavek po zahtevku 12, kjer mikrodelci nadalje vsebujejo material izbran iz skupine, ki vsebuje naravno v vodi netopne proteine, naravno v vodi netopne polisaharide, naravno v vodi netopne lipide in fosfolipide, premrežene vodotopne * » » * » * » v ▼ « v * · « v proteine, premrežene vodotopne polisaharide, premrežene vodotopne ciklodekstrine in njihove kombinacije.
- 14. Sestavek po zahtevku 12, kjer so posamezni mikrodelci oplaščeni z eno ali več neodvisnimi plastmi, kjer ena izmed plasti ni topna v vodi.
- 15. Sestavek po zahtevku 14, kjer vsaj ena plast ni topna v alkoholu.
- 16. Sestavek po zahtevku 14, kjer sestavek ni popolnoma topen in, kjer zdravilo ni popolnoma sproščeno v eni raztopini topila.
- 17. Sestavek po zahtevku 1, ki je v obliki tablete ali kapsule.
- 18. Sestavek po zahtevku 5, kjer je miristinska kislina prisotna v količini, ki znaša od 6,9 do 15 krat, prednostno med 6,9 in 10 krat molame količine oksikodona.
- 19. Postopek izdelave farmacevtskega sestavka po zahtevku 1, kjer postopek obsega: - mešanje terapevtsko učinkovite količine oksikodona z eno ali več maščobnih kislin in farmacevtsko sprejemljivim nosilcem, kije voskasta snov, da dobimo mešanico; kjer količina ene ali več maščobnih kislin znaša od dva do petnajst krat molame količine oksikodona; kjer nastane sol maščobne kisline oksikodona; in kjer je sol maščobne kisline oksikodona dispergirana v mešanici.
- 20. Postopek po zahtevku 19, kjer postopek obsega: - mešanje terapevtsko učinkovite količine oksikodona z eno ali več maščobnih kislin, da nastane sol maščobne kisline oksikodona; in - dispergiranje ali raztapljanje soli maščobne kisline oksikodona v farmacevtsko sprejemljivem nosilci. DlUKič DUŠAN
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- 2005-06-10 US US11/149,867 patent/US7771707B2/en active Active
- 2005-06-10 EP EP17188009.9A patent/EP3326617A1/en not_active Withdrawn
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- 2005-06-10 WO PCT/US2005/020588 patent/WO2005123039A1/en active Application Filing
- 2005-06-10 ES ES05759527.4T patent/ES2653568T3/es active Active
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