JP2019525963A - 新規経口投与製剤 - Google Patents
新規経口投与製剤 Download PDFInfo
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- JP2019525963A JP2019525963A JP2019526350A JP2019526350A JP2019525963A JP 2019525963 A JP2019525963 A JP 2019525963A JP 2019526350 A JP2019526350 A JP 2019526350A JP 2019526350 A JP2019526350 A JP 2019526350A JP 2019525963 A JP2019525963 A JP 2019525963A
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- 239000000203 mixture Substances 0.000 claims abstract description 101
- 238000009472 formulation Methods 0.000 claims abstract description 75
- 229940112822 chewing gum Drugs 0.000 claims abstract description 42
- 235000015218 chewing gum Nutrition 0.000 claims abstract description 42
- 239000002245 particle Substances 0.000 claims abstract description 35
- 239000012669 liquid formulation Substances 0.000 claims abstract description 5
- 229930003827 cannabinoid Natural products 0.000 claims description 43
- 239000003557 cannabinoid Substances 0.000 claims description 43
- 239000003814 drug Substances 0.000 claims description 34
- 229940065144 cannabinoids Drugs 0.000 claims description 24
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 21
- CYQFCXCEBYINGO-UHFFFAOYSA-N THC Natural products C1=C(C)CCC2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3C21 CYQFCXCEBYINGO-UHFFFAOYSA-N 0.000 claims description 21
- CYQFCXCEBYINGO-IAGOWNOFSA-N delta1-THC Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@@H]21 CYQFCXCEBYINGO-IAGOWNOFSA-N 0.000 claims description 21
- 229960004242 dronabinol Drugs 0.000 claims description 18
- QHMBSVQNZZTUGM-UHFFFAOYSA-N Trans-Cannabidiol Natural products OC1=CC(CCCCC)=CC(O)=C1C1C(C(C)=C)CCC(C)=C1 QHMBSVQNZZTUGM-UHFFFAOYSA-N 0.000 claims description 16
- QHMBSVQNZZTUGM-ZWKOTPCHSA-N cannabidiol Chemical compound OC1=CC(CCCCC)=CC(O)=C1[C@H]1[C@H](C(C)=C)CCC(C)=C1 QHMBSVQNZZTUGM-ZWKOTPCHSA-N 0.000 claims description 16
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- ZTGXAWYVTLUPDT-UHFFFAOYSA-N cannabidiol Natural products OC1=CC(CCCCC)=CC(O)=C1C1C(C(C)=C)CC=C(C)C1 ZTGXAWYVTLUPDT-UHFFFAOYSA-N 0.000 claims description 16
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- JDNLPKCAXICMBW-UHFFFAOYSA-N JWH 018 Chemical compound C12=CC=CC=C2N(CCCCC)C=C1C(=O)C1=CC=CC2=CC=CC=C12 JDNLPKCAXICMBW-UHFFFAOYSA-N 0.000 claims description 4
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- RLGAYEJPGHIHIB-UHFFFAOYSA-N 1h-indol-2-yl(phenyl)methanone Chemical compound C=1C2=CC=CC=C2NC=1C(=O)C1=CC=CC=C1 RLGAYEJPGHIHIB-UHFFFAOYSA-N 0.000 claims description 3
- YNZFFALZMRAPHQ-SYYKKAFVSA-N 2-[(1r,2r,5r)-5-hydroxy-2-(3-hydroxypropyl)cyclohexyl]-5-(2-methyloctan-2-yl)phenol Chemical compound OC1=CC(C(C)(C)CCCCCC)=CC=C1[C@H]1[C@H](CCCO)CC[C@@H](O)C1 YNZFFALZMRAPHQ-SYYKKAFVSA-N 0.000 claims description 3
- MVRPPTGLVPEMPI-UHFFFAOYSA-N 2-cyclohexylphenol Chemical compound OC1=CC=CC=C1C1CCCCC1 MVRPPTGLVPEMPI-UHFFFAOYSA-N 0.000 claims description 3
- UVOLYTDXHDXWJU-UHFFFAOYSA-N Cannabichromene Chemical compound C1=CC(C)(CCC=C(C)C)OC2=CC(CCCCC)=CC(O)=C21 UVOLYTDXHDXWJU-UHFFFAOYSA-N 0.000 claims description 3
- XXGMIHXASFDFSM-UHFFFAOYSA-N Delta9-tetrahydrocannabinol Natural products CCCCCc1cc2OC(C)(C)C3CCC(=CC3c2c(O)c1O)C XXGMIHXASFDFSM-UHFFFAOYSA-N 0.000 claims description 3
- CYQFCXCEBYINGO-DLBZAZTESA-N Dronabinol Natural products C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCCCC)=CC(O)=C3[C@H]21 CYQFCXCEBYINGO-DLBZAZTESA-N 0.000 claims description 3
- YSBFLLZNALVODA-RBUKOAKNSA-N JWH-133 Chemical compound C1C(C)=CC[C@H]2C(C)(C)OC3=CC(C(C)(C)CCC)=CC=C3[C@@H]21 YSBFLLZNALVODA-RBUKOAKNSA-N 0.000 claims description 3
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- WVOLTBSCXRRQFR-DLBZAZTESA-N cannabidiolic acid Chemical compound OC1=C(C(O)=O)C(CCCCC)=CC(O)=C1[C@H]1[C@H](C(C)=C)CCC(C)=C1 WVOLTBSCXRRQFR-DLBZAZTESA-N 0.000 claims description 3
- QBEFIFWEOSUTKV-UHFFFAOYSA-N dimethylheptylpyran Chemical compound CC1(C)OC2=CC(C(C)C(C)CCCCC)=CC(O)=C2C2=C1CCC(C)C2 QBEFIFWEOSUTKV-UHFFFAOYSA-N 0.000 claims description 3
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- HQVHOQAKMCMIIM-UHFFFAOYSA-N win 55,212-2 Chemical compound C=12N3C(C)=C(C(=O)C=4C5=CC=CC=C5C=CC=4)C2=CC=CC=1OCC3CN1CCOCC1 HQVHOQAKMCMIIM-UHFFFAOYSA-N 0.000 claims description 3
- 239000000014 opioid analgesic Substances 0.000 claims description 2
- 239000001508 potassium citrate Substances 0.000 claims description 2
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims description 2
- UCONUSSAWGCZMV-HZPDHXFCSA-N Delta(9)-tetrahydrocannabinolic acid Chemical compound C([C@H]1C(C)(C)O2)CC(C)=C[C@H]1C1=C2C=C(CCCCC)C(C(O)=O)=C1O UCONUSSAWGCZMV-HZPDHXFCSA-N 0.000 claims 4
- ZROLHBHDLIHEMS-HUUCEWRRSA-N (6ar,10ar)-6,6,9-trimethyl-3-propyl-6a,7,8,10a-tetrahydrobenzo[c]chromen-1-ol Chemical compound C1=C(C)CC[C@H]2C(C)(C)OC3=CC(CCC)=CC(O)=C3[C@@H]21 ZROLHBHDLIHEMS-HUUCEWRRSA-N 0.000 claims 2
- CZXWOKHVLNYAHI-LSDHHAIUSA-N 2,4-dihydroxy-3-[(1r,6r)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-6-propylbenzoic acid Chemical compound OC1=C(C(O)=O)C(CCC)=CC(O)=C1[C@H]1[C@H](C(C)=C)CCC(C)=C1 CZXWOKHVLNYAHI-LSDHHAIUSA-N 0.000 claims 2
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- 229910052623 talc Inorganic materials 0.000 description 1
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- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 229960002044 tolmetin sodium Drugs 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
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- 229940116362 tragacanth Drugs 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
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 229940078499 tricalcium phosphate Drugs 0.000 description 1
- 229910000391 tricalcium phosphate Inorganic materials 0.000 description 1
- 235000019731 tricalcium phosphate Nutrition 0.000 description 1
- 229960003500 triclosan Drugs 0.000 description 1
- IRYJRGCIQBGHIV-UHFFFAOYSA-N trimethadione Chemical compound CN1C(=O)OC(C)(C)C1=O IRYJRGCIQBGHIV-UHFFFAOYSA-N 0.000 description 1
- 229960004453 trimethadione Drugs 0.000 description 1
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- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 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
- 229940038773 trisodium citrate Drugs 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
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- 239000003071 vasodilator agent Substances 0.000 description 1
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- 229920006163 vinyl copolymer Polymers 0.000 description 1
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Abstract
Description
・トリクロサン、塩化セチルピリジニウム、臭化ドミフェン、第4級アンモニウム塩、亜鉛化合物、サンギナリン、フッ化物、アレキシジン、クロルヘキシジン、オクトニジン、EDTAなどの抗菌剤;
・アスピリン、アセトアミノフェン、イブプロフェン、ケトプロフェン、ジフルニサル、フェノプロフェンカルシウム、ナプロキセン、トルメチンナトリウム、インドメタシンなどの非ステロイド系抗炎症薬;
・ベンゾナテート、エジシル酸カラミフェン、メントール、臭化水素酸デキストロメトルファン、塩酸クロフェジアノールなどの鎮咳薬;
・塩酸プソイドエフェドリン、フェニレフリン、フェニルプロパノールアミン、硫酸プソイドエフェドリンなどのうっ血除去薬;
・マレイン酸ブロムフェニラミン、マレイン酸クロルフェニラミン、マレイン酸カルビノキサミン、フマル酸クレマスチン、マレイン酸デキスクロルフェニラミン、塩酸ジフェンヒドラミン、塩酸ジフェニルピラリン、マレイン酸アザタジン、クエン酸ジフェンヒドラミン、コハク酸ドキシラミン、塩酸プロメタジン、マレイン酸ピリラミン、クエン酸トリペレンナミン、塩酸トリプロリジン、アクリバスチン、ロラタジン、ブロムフェニラミン、デキスブロムフェニラミン、セチリジン、レボセチリジンなどの抗ヒスタミン薬;
・グアイフェネシン、トコン、ヨウ化カリウム、テルピンなどの去痰薬;
・ロペラミドなどの止瀉薬;
・ファモチジン、ラニチジンなどのH2拮抗薬;
・オメプラゾール、ランソプラゾールなどのプロトンポンプ阻害剤;
・脂肪族アルコール、バルビツール酸塩などの非選択的CNS抑制薬;
・カフェイン、ニコチン、ニコチンポラクリレクス、ニコチンとアルカリ剤との組み合わせ、ストリキニーネ、ピクロトキシン、ペンチレンテトラゾールなどの非選択的CNS刺激薬;
・フェニルヒダントイン、フェノバルビタール、プリミドン、カルバマゼピン、エトスクシミド、メトスクシミド、フェンスクシミド、トリメタジオン、ジアゼパム、ベンゾジアゼピン、フェナセミド、フェネツリッド、アセタゾラミド、スルチアム、臭化物などのCNS機能を選択的に調節する薬物;
・レボドパ、アマンタジンなどの抗パーキンソン病薬;
・サリチル酸塩、フェニルブタゾン、インドメタシン、フェナセチンなどの鎮痛解熱薬;
・クロルプロマジン、メトトリメプラジン、ハロペリドール、クロザピン、レセルピン、イミプラミン、トラニルシプロミン、フェネルジン、MC−4受容体拮抗薬、リチウムなどの向精神薬;
・睡眠剤、鎮静剤、抗てんかん剤、覚醒剤;
・ビタミンおよび無機物;
・アミノ酸およびペプチド;
・クエン酸シルデナフィル;
・PPY(3−36);デカペプチド;KSL−W(酢酸塩)、フルオル(fluor);
・メトホルミン、メトホルミンHCl、グリブリド、インスリン分泌促進剤、インスリン刺激剤、脂質代謝剤、糖質代謝剤、インスリン、スタチン類のようなコレステロール低下剤、エキセナチド、GLP−1などの抗糖尿病薬;
・アルフェンタニル、アリルプロジン、アルファプロジン、アニレリジン、ベンジルモルヒネ、ベジトラミド、ブプレノルフィン、ブトルファノール、クロニタゼン、コデイン、コカイン、シクラゾシン、デソモルヒネ、デキストロモラミド、デゾシン、ジアンプロミド、ジヒドロコデイン、ジヒドロモルヒネ、ジメノキサドール、ジメフェプタノール、ジメチルチアムブテン、ジオキサフェチルブチラート、ジピパノン、エプタゾシン、エトヘプタジン、エチルメチルチアムブテン、エチルモルヒネ、エトニタジン、フェンタニル、ヘロイン、ヒドロコドン、ヒドロモルホン、ヒドロキシペチジン、イソメタドン、ケトベミドン、レバロルファン、レボルファノール、レボフェナシルモルファン、ロフェンタニル、メペリジン、メプタジノール、メタゾシン、メサドン、メトポン、モルヒネ、ジアモルヒネ、ミロピン、ナルブフィン、ナルセイン、ニコモルヒネ、ノルレボルファノール、ノルメタドン、ナロルフィン、ノルモルヒネ、ノルピパノン、アヘン、オキシコドン、オキシモルフォン、パパベレタム、ペンタゾシン、フェナドキソン、フェノモルヒネ、フェナゾシン、フェノペリジン、ピミノジン、ピリトラミド、プロフェプタジン、プロメドール、プロペリジン、プロピラム、プロポキシフェン、スフェンタニル、トラマドール、チリジン、μ作動薬/拮抗薬の混合物、μ作動薬の組み合わせ、前記薬剤の任意の混合物などのオピオイド鎮痛薬であって、遊離塩基、薬学的に許容される塩の形、または薬学的に許容される錯体の形でありうるオピオイド鎮痛薬;ならびに
・カンナビノイドやその誘導体、テルペン類、パクリタキセル(商標)、植物由来のビタミン、植物由来のタンパク質(大豆、レンズ豆)などの、植物材料由来の医薬品。
実施例2 オピエート系製剤(オピエート+THC+カンナビノイド)の調製
[表3]経口液剤の成分
Claims (15)
- 経口投与可能なチューインガム製剤であって、薬学的に許容されるガム基剤と、大きさが約50〜約2000μmである医薬品粒子とを含有し、該医薬品粒子を約0.5〜30重量%含有する製剤。
- 前記医薬品がオピオイド鎮痛薬である、請求項1のチューインガム製剤。
- 前記医薬品が植物材料から得られる、請求項1のチューインガム製剤。
- 前記医薬品が、カンナビノイド、カンナビノイド誘導体およびテルペンからなる群から選択される、請求項3のチューインガム製剤。
- 前記医薬品が、カンナビジオール(CBD)、カンナビジオール酸(CBDA)、カンナビノール(CBN)、カンナビゲロール(CBG)、カンナビゲロール酸(CBGA)、カンナビジバリン(CBDV)、カンナビジバリン酸(CBDVA)、カンナビノバリン(CBNV)、カンナビゲロバリン(CBGV)、カンナビクロメン(CBC)、ナフトイルインドール、フェニルアセチルインドール、ベンゾイルインドール、シクロヘキシルフェノール、デルタ−9−テトラヒドロカンナビノール(THCまたはドロナビノール)、デルタ−8−テトラヒドロカンナビノール(D8−THC)、テトラヒドロカンナビノール酸(THCA)、テトラヒドロカンナビバリン(THCV)、テトラヒドロカンナビバリン酸(THCVA)、ナビロン、リモナバン(SR141716)、JWH−018、JWH−073、CP−55940、ジメチルヘプチルピラン、HU−210、HU−331、SR144528、WIN55,212−2、JWH−133、レボナントラドール、およびAM−2201からなる群から選択される、請求項3のチューインガム製剤。
- 前記医薬品が、CBD、THC、またはその組み合わせである、請求項5のチューインガム製剤。
- 前記医薬品粒子の少なくとも75重量%の大きさが、300〜750μmの範囲にある、請求項1のチューインガム製剤。
- 前記ガム基剤が、5〜80重量%のエラストマー、5〜80重量%の可塑剤、0〜40重量%のワックス、5〜35重量%の軟化剤、および0〜50重量%の賦形剤を含有する、請求項1のチューインガム製剤。
- さらに緩衝剤を、製剤の0.1%〜10重量%含有する、請求項1のチューインガム製剤。
- 前記緩衝剤が、炭酸ナトリウム、炭酸水素ナトリウム、炭酸カリウム、炭酸水素カリウム、リン酸二カリウム、クエン酸カリウム、およびこれらの任意の組み合わせからなる群から選択される、請求項9のチューインガム製剤。
- 水、アルコールおよび/またはプロピレングリコールを約60〜99重量%の範囲で含有し、かつ医薬品含有粒子を約1〜40重量%の範囲で含有する、水性液体製剤。
- 前記医薬品が、カンナビノイド、カンナビノイド誘導体およびテルペンからなる群から選択される、請求項11の製剤。
- 前記医薬品が、カンナビジオール(CBD)、カンナビジオール酸(CBDA)、カンナビノール(CBN)、カンナビゲロール(CBG)、カンナビゲロール酸(CBGA)、カンナビジバリン(CBDV)、カンナビジバリン酸(CBDVA)、カンナビノバリン(CBNV)、カンナビゲロバリン(CBGV)、カンナビクロメン(CBC)、ナフトイルインドール、フェニルアセチルインドール、ベンゾイルインドール、シクロヘキシルフェノール、デルタ−9−テトラヒドロカンナビノール(THCまたはドロナビノール)、デルタ−8−テトラヒドロカンナビノール(D8−THC)、テトラヒドロカンナビノール酸(THCA)、テトラヒドロカンナビバリン(THCV)、テトラヒドロカンナビバリン酸(THCVA)、ナビロン、リモナバン(SR141716)、JWH−018、JWH−073、CP−55940、ジメチルヘプチルピラン、HU−210、HU−331、SR144528、WIN55,212−2、JWH−133、レボナントラドール、およびAM−2201からなる群から選択される、請求項12の製剤。
- 前記医薬品が、CBD、THC、またはその組み合わせである、請求項13の製剤。
- 前記医薬品粒子の少なくとも75重量%の大きさが、300〜750μmの範囲にある、請求項11の製剤。
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CL2019000209A1 (es) | 2019-09-27 |
IL264484A (en) | 2019-02-28 |
JP7050777B2 (ja) | 2022-04-08 |
ZA202001037B (en) | 2020-07-29 |
WO2018018152A1 (en) | 2018-02-01 |
US9833408B1 (en) | 2017-12-05 |
EP4353221A3 (en) | 2024-07-10 |
BR122020007418B1 (pt) | 2021-11-03 |
US10456357B2 (en) | 2019-10-29 |
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JP2022088537A (ja) | 2022-06-14 |
AU2017301239B2 (en) | 2020-10-08 |
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