JP5403912B2 - 液体製剤用担体としての多孔性錠剤 - Google Patents
液体製剤用担体としての多孔性錠剤 Download PDFInfo
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- JP5403912B2 JP5403912B2 JP2007518451A JP2007518451A JP5403912B2 JP 5403912 B2 JP5403912 B2 JP 5403912B2 JP 2007518451 A JP2007518451 A JP 2007518451A JP 2007518451 A JP2007518451 A JP 2007518451A JP 5403912 B2 JP5403912 B2 JP 5403912B2
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- Prior art keywords
- oil
- tablet
- tablet according
- sorbitan
- pharmaceutically acceptable
- Prior art date
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- 239000000969 carrier Substances 0.000 title description 2
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- -1 jojoba oil Substances 0.000 claims description 60
- 239000013543 active substance Substances 0.000 claims description 56
- 239000003921 oil Substances 0.000 claims description 54
- 235000019198 oils Nutrition 0.000 claims description 54
- 238000011068 loading method Methods 0.000 claims description 50
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 38
- 239000000126 substance Substances 0.000 claims description 38
- 229920001223 polyethylene glycol Polymers 0.000 claims description 35
- 239000007788 liquid Substances 0.000 claims description 31
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- 239000000194 fatty acid Substances 0.000 claims description 17
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- 238000010521 absorption reaction Methods 0.000 claims description 12
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- 239000007909 solid dosage form Substances 0.000 claims description 10
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 9
- 125000005456 glyceride group Polymers 0.000 claims description 9
- 238000002844 melting Methods 0.000 claims description 9
- 230000008018 melting Effects 0.000 claims description 9
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- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 8
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims description 8
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- 150000004665 fatty acids Chemical class 0.000 claims description 8
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- 229920000642 polymer Polymers 0.000 claims description 8
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 7
- 235000010356 sorbitol Nutrition 0.000 claims description 7
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 6
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 6
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 6
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 6
- 229930195725 Mannitol Natural products 0.000 claims description 6
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 6
- 229930006000 Sucrose Natural products 0.000 claims description 6
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- 239000011575 calcium Substances 0.000 claims description 6
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- 235000010355 mannitol Nutrition 0.000 claims description 6
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- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 claims description 6
- 239000002904 solvent Substances 0.000 claims description 6
- 239000000600 sorbitol Substances 0.000 claims description 6
- 239000005720 sucrose Substances 0.000 claims description 6
- 235000019489 Almond oil Nutrition 0.000 claims description 5
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 5
- 235000019483 Peanut oil Nutrition 0.000 claims description 5
- HVUMOYIDDBPOLL-XWVZOOPGSA-N Sorbitan monostearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O HVUMOYIDDBPOLL-XWVZOOPGSA-N 0.000 claims description 5
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 claims description 5
- 239000008168 almond oil Substances 0.000 claims description 5
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- 235000019868 cocoa butter Nutrition 0.000 claims description 5
- 229940110456 cocoa butter Drugs 0.000 claims description 5
- 235000019864 coconut oil Nutrition 0.000 claims description 5
- 239000003240 coconut oil Substances 0.000 claims description 5
- 239000004006 olive oil Substances 0.000 claims description 5
- 235000008390 olive oil Nutrition 0.000 claims description 5
- 239000000312 peanut oil Substances 0.000 claims description 5
- 235000011076 sorbitan monostearate Nutrition 0.000 claims description 5
- 239000001587 sorbitan monostearate Substances 0.000 claims description 5
- 229940035048 sorbitan monostearate Drugs 0.000 claims description 5
- 239000003760 tallow Substances 0.000 claims description 5
- 239000008158 vegetable oil Substances 0.000 claims description 5
- 239000001993 wax Substances 0.000 claims description 5
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical class OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 claims description 4
- KHICUSAUSRBPJT-UHFFFAOYSA-N 2-(2-octadecanoyloxypropanoyloxy)propanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC(C)C(=O)OC(C)C(O)=O KHICUSAUSRBPJT-UHFFFAOYSA-N 0.000 claims description 4
- 240000002791 Brassica napus Species 0.000 claims description 4
- 235000006008 Brassica napus var napus Nutrition 0.000 claims description 4
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 4
- IJCWFDPJFXGQBN-RYNSOKOISA-N [(2R)-2-[(2R,3R,4S)-4-hydroxy-3-octadecanoyloxyoxolan-2-yl]-2-octadecanoyloxyethyl] octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OC[C@@H](OC(=O)CCCCCCCCCCCCCCCCC)[C@H]1OC[C@H](O)[C@H]1OC(=O)CCCCCCCCCCCCCCCCC IJCWFDPJFXGQBN-RYNSOKOISA-N 0.000 claims description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 4
- 235000012343 cottonseed oil Nutrition 0.000 claims description 4
- 239000002385 cottonseed oil Substances 0.000 claims description 4
- 239000006185 dispersion Substances 0.000 claims description 4
- UKMSUNONTOPOIO-UHFFFAOYSA-N docosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCC(O)=O UKMSUNONTOPOIO-UHFFFAOYSA-N 0.000 claims description 4
- 239000000839 emulsion Substances 0.000 claims description 4
- 239000008169 grapeseed oil Substances 0.000 claims description 4
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 4
- 239000004615 ingredient Substances 0.000 claims description 4
- 229960000502 poloxamer Drugs 0.000 claims description 4
- 238000002360 preparation method Methods 0.000 claims description 4
- 239000008159 sesame oil Substances 0.000 claims description 4
- 235000011803 sesame oil Nutrition 0.000 claims description 4
- 235000011078 sorbitan tristearate Nutrition 0.000 claims description 4
- 239000001589 sorbitan tristearate Substances 0.000 claims description 4
- 229960004129 sorbitan tristearate Drugs 0.000 claims description 4
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- 239000003549 soybean oil Substances 0.000 claims description 4
- 229940071209 stearoyl lactylate Drugs 0.000 claims description 4
- HLZKNKRTKFSKGZ-UHFFFAOYSA-N tetradecan-1-ol Chemical compound CCCCCCCCCCCCCCO HLZKNKRTKFSKGZ-UHFFFAOYSA-N 0.000 claims description 4
- ZORQXIQZAOLNGE-UHFFFAOYSA-N 1,1-difluorocyclohexane Chemical compound FC1(F)CCCCC1 ZORQXIQZAOLNGE-UHFFFAOYSA-N 0.000 claims description 3
- 239000000263 2,3-dihydroxypropyl (Z)-octadec-9-enoate Substances 0.000 claims description 3
- RZRNAYUHWVFMIP-GDCKJWNLSA-N 3-oleoyl-sn-glycerol Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@H](O)CO RZRNAYUHWVFMIP-GDCKJWNLSA-N 0.000 claims description 3
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims description 3
- XZIIFPSPUDAGJM-UHFFFAOYSA-N 6-chloro-2-n,2-n-diethylpyrimidine-2,4-diamine Chemical compound CCN(CC)C1=NC(N)=CC(Cl)=N1 XZIIFPSPUDAGJM-UHFFFAOYSA-N 0.000 claims description 3
- 239000004721 Polyphenylene oxide Substances 0.000 claims description 3
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 3
- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 claims description 3
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 3
- 239000010477 apricot oil Substances 0.000 claims description 3
- 235000015278 beef Nutrition 0.000 claims description 3
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical class CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 claims description 3
- 238000012377 drug delivery Methods 0.000 claims description 3
- 239000008103 glucose Substances 0.000 claims description 3
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims description 3
- 235000019866 hydrogenated palm kernel oil Nutrition 0.000 claims description 3
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 3
- 239000004530 micro-emulsion Substances 0.000 claims description 3
- RZRNAYUHWVFMIP-UHFFFAOYSA-N monoelaidin Natural products CCCCCCCCC=CCCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-UHFFFAOYSA-N 0.000 claims description 3
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 claims description 3
- IPCSVZSSVZVIGE-UHFFFAOYSA-N palmitic acid group Chemical group C(CCCCCCCCCCCCCCC)(=O)O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 claims description 3
- 229920000058 polyacrylate Polymers 0.000 claims description 3
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- 239000001632 sodium acetate Substances 0.000 claims description 3
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- 229940035044 sorbitan monolaurate Drugs 0.000 claims description 3
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- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 claims description 3
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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 claims description 3
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- CUNWUEBNSZSNRX-RKGWDQTMSA-N (2r,3r,4r,5s)-hexane-1,2,3,4,5,6-hexol;(z)-octadec-9-enoic acid Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.CCCCCCCC\C=C/CCCCCCCC(O)=O.CCCCCCCC\C=C/CCCCCCCC(O)=O.CCCCCCCC\C=C/CCCCCCCC(O)=O CUNWUEBNSZSNRX-RKGWDQTMSA-N 0.000 claims description 2
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Classifications
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- A—HUMAN NECESSITIES
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Description
いる。この技術は、油または油様物質を含む担体組成物を微粒子物質上へ噴霧することを含む工程に基づいている。この工程の条件が、微粒子物質が比較的多い量の油または油様物質で装填されるのを可能とする。
この目的のため、最も決定的な性質は、錠剤の
i)医薬的に許容される液体製剤を十分な量吸収する能力、
ii)貯蔵中に、錠剤の表面からの液体製剤のいかなる滲出もなしに、吸収した量を維持する能力、および
iii)一旦、錠剤が試験管内溶解試験に付されたとき、および/またはヒトを含む動物のような対象に経口的に投与された場合に、活性物質を放出する能力である。
したがって、一つの観点において、本願発明は、医薬的に許容される液体製剤用の医薬担体組成物としての30容積%以上の多孔度を有する装填可能な錠剤に関する。医薬の分野で用いられる通常の錠剤は、より低い多孔度を有している。極めて多孔性の錠剤を避ける理由の一つは、そのような錠剤が包装および保管時に錠剤の正常な取り扱いを可能にする十分な強固さを有していないということである。すなわち、それらは、硬度および破砕性に関して、薬局方の必要条件を満たさないと考えられる。
多孔度は、ここでの実施例中の式1によれば、錠剤中の空隙と錠剤の総容積との容積比として定義される。
本文脈において、「不活性錠剤」の用語は、治療効果に関して不活性と通常みなされる成分を単独で含む錠剤を表すために用いられる。具体的には、そのような錠剤は、充填剤、希釈剤、結合剤、滑沢剤、グリダント(glidant)等からなる群から選択される医薬的に許容される賦形剤を含む。例えば、pH調整剤、緩衝剤、強化剤、湿潤剤、溶解剤、界面活性剤、酸化防止剤等のような添加剤を含む。
さらに、本発明による錠剤は、例えば約4%以下、約3%以下、約1%以下のような約2%以下のような、約5%以下の破砕性を有する。
一つの医薬的に許容される賦形剤は適切な性質を有することが重要であり、得られる錠剤が望ましい多孔度をも有するように、この賦形剤が十分な量で存在することが重要である。
特定の態様において、金属酸化物は、二酸化チタンもしくは二酸化ケイ素またはそれらの混合物である。
・スメクタイト型膨潤粘土、例えばベントナイト、ビーガム(veegum)、ラポナイト(laponite)。
・含水ケイ酸アルミニウムまたはアルカリ土類。ノイシリン(Neusilin)はこのグループに属し、合成重合に基づいている(メタケイ酸アルミニウムマグネシウム)。
・二酸化ケイ素は多孔性および非多孔性シリカとして細分される
・非多孔性コロイドシリカ、例えばアエロジル(ヒュームド・シリカ)
・多孔性シリカゲル、例えばシロイド、ポラシル(Porasil)、リクロソープ(Lichrosorb)
・その他、例えばゼオファーム(Zeopharm)S170、ゼオファーム6000、アエロパール300
ター(Calstar)、ジ-カフォス、オルト燐酸二カルシウム、ジ-タブ(Di-TAB)、エムコンプレス、燐酸のカルシウム塩(1:1)二水和物、二級燐酸カルシウム、フジクリン(Fujiclin)SGからなる群から選択され得る。
、キシリトール、マンニトール(例えばマンノゲム(Mannogem)(エス・ピー・アイ ファーマ)のようなもの)、マルチトール、イノシトール、マンニトール(例えばペアリトール(Pealitol)SP100)からなる群から選択される糖アルコールであり、そして/またはその賦形剤は、蔗糖、ブドウ糖、果糖、ソルボース、キシロース、乳糖、デキストラン、デキストラン誘導体、サイクロデキストリンを含む単糖、二糖または多糖類からなる群から選択される糖であり得る。
装填可能な錠剤は、勿論、錠剤の製造に通常用いられているようなその他の医薬的に許容される賦形剤も含み得る。
な異なる使用を考慮してなされる。好適な使用のためのその他の医薬的に許容される賦形剤は、例えば酸性化剤、アルカリ化剤、保存剤、抗酸化剤、緩衝剤、キレート剤、着色剤、錯化剤、乳化剤および/または溶解剤、香味料および香料、保水剤、甘味剤、湿潤剤等である。
剤、懸濁化剤、吸収促進剤、放出変更剤等である。
本発明による錠剤に用いられる好適な賦形剤は、例えば、リポシン社(Lipocine,Inc.)名のWO00/50007に開示されているような両親媒性界面活性剤のような界面活性剤である。
i) 例えばポリエチレングリコールのラウリン酸、オレイン酸、ステアリン酸、ミリスチン酸、リシノール酸とのモノもしくジエステルのようなポリエチレングリコールモノもしくはジ脂肪酸エステルまたはそれらの混合物のようなポリエトキシ化脂肪酸であり、そのポリエチレングリコールは、PEG4、PEG5、PEG6、PEG7、PEG8、PEG9、PEG10、PEG12、PEG15、PEG20、PEG25、PEG30、PEG32、PEG40、PEG45、PEG50、PEG55、PEG100、PEG200、PEG400、PEG600、PEG800、PEG1000、PEG2000、PEG3000、PEG4000、PEG5000、PEG6000、PEG7000、PEG8000、PEG9000、PEG1000、PEG10,000、PEG15,000、PEG20,000、PEG35,000から選択され得る、
iii)グリセリン、プロピレングリコール、エチレングリコール、PEGまたはソルビトールと、例えば水素添加ひまし油、アーモンド油、パーム核油、ひまし油、杏仁油、オリーブ油、落花生油、水素添加パーム核油等の植物油とのエステル、
iv)例えばポリグリセロールステアレート、ポリグリセロールオレエート、ポリグリセロールリシノレート、ポリグリセロールリノレートのようなポリグリセリン化脂肪酸、
vi)例えばグリセリルモノオレエート、グリセリルジオレエート、グリセリルモノおよび/またはジオレエート、グリセリルカプリレート、グリセリルカプレートなどのようなモノおよびジグリセリド;
vii)ステロールおよびステロール誘導体;
viii)上記の種々の分子量をもつPEGのエステルおよび種々のツイーン(登録商標)シリーズのようなポリエチレングリコールソルビタン脂肪酸エステル(PEGソルビタン脂肪酸エステル);
x)例えば蔗糖モノパルミテートおよび蔗糖モノラウレートのような糖エステル;
xi)例えばトリトン(Triton)(登録商標)XまたはNシリーズのようなポリエチレングリコールアルキルフェノール;
xiv)例えばオレエート、イソプロピルミリステート、イソプロピルパルミテート等のような低級アルコール脂肪酸エステル;
xv)例えば脂肪酸塩、胆汁酸塩、燐脂質、燐酸エステル、カルボキシレート、スルフェート、スルホネート等のような陽イオン性、陰イオン性および両イオン性界面活性剤を含むイオン性界面活性剤。
上記の錠剤は、医薬的に許容される液体製剤を、例えば約25重量%以上、約30重量%以上のような、約20重量%以上(装填時の固形投与形態の総重量に基づく)の濃度で装填できるように設計される。したがって、もう一つの観点において、本発明はそのような錠剤に関するものである。
好ましい観点において、医薬的に許容される液体製剤は、例えば約50重量%以上または約60重量%以上のような、約40重量%以上(装填時の固形投与形態の総重量に基づく)の濃度で存在する。
体製剤が加熱または冷却され得るので、それほど重要ではない。
そのような油または油様物質は、水、植物油、水素添加植物油および動物油からなる群から選択され得る。
ルを用いることができる。
ロイルラクチレートカルシウム、モノおよびジグリセリドのジアセチル酒石酸エステル等のような、溶媒または半固形状の賦形剤を含み得る。
典型的には、錠剤中の医薬的に許容される液体製剤の濃度は、例えば約10重量%以上、約15重量%以上、約20重量%以上、約25重量%以上、約30重量%以上、約35重量%以上、約40重量%以上、約45重量%以上、約50重量%以上、約60重量%以上または約70重量%以上のような、約5重量%以上である。
さらに、錠剤は、活性物質を実質的に即座に、または変更された方法で放出するように設計することができる。即座に放出するように設計された錠剤は、典型的に、ヨーロッパ薬局方に従って試験されたとき、最長でも15分の崩壊時間を有するが、膜被覆の錠剤は最長でも30分の崩壊時間を有し得る。放出の変更された錠剤にとって、活性物質の放出は重要である。
上記のように、好ましい態様は、一以上の治療的、予防的および/または診断的に活性な物質を装填された錠剤である。
本発明者は、親油性製剤を装填された錠剤の崩壊は、脂質環境下での崩壊剤の膨張性の減少により、親水性の超崩壊剤の添加では改善されないことを見出した。この場合は、発泡効果に基づいて、異なる崩壊の原理が適用されるかもしれない。錠剤の崩壊は、二酸化炭素の内部放出によって改善される。発泡性錠剤製剤は、金属炭酸塩と酸源との組み合わせに基づいている。金属炭酸塩は、重炭酸ナトリウム、炭酸ナトリウム、重炭酸カリウム、炭酸カリウム、炭酸カルシウム、およびセスキ炭酸ナトリウムのようなものである。酸源は、クエン酸、クエン酸二水素ナトリム、クエン酸水素二ナトリウム、酒石酸、リンゴ酸、フマル酸、燐酸二水素ナトリウム、亜硫酸ナトリウム塩である。錠剤が酸性の胃液に溶解して金属炭酸塩と反応するとき、生体内において発泡効果が得られるので、酸成分は錠剤製剤において除外され得るかもしれない。
錠剤は、例えば即座のまたは変更された放出のための膜コーティング、腸溶性コーティング、変更された放出のコーティング、保護コーティング、付着防止コーティング等でも被覆され得る。
酸酢酸セルロース、フタール酸ポリ酢酸ビニル、フタール酸ヒドロキシプロピルメチルセルロース、ポリビニルアルコール、カルボキシメチルセルロースナトリウム、酢酸セルロース、フタール酸酢酸セルロース、ゼラチン、メタクリル酸共重合体、ポリエチレングリコール、シェラック、蔗糖、二酸化チタン、カルナウバ蝋、微結晶性蝋、ゼインである。
可塑剤およびその他の成分を被覆材料中に添加し得る。同一または異なった活性物質も被覆材料中へ添加し得る。
本発明による脂質装填錠剤の疎水性表面は、水性または有機溶媒の中で用いられる被覆ポリマーの付着を防止し得るであろう。代替として、通常の被覆設備を使用して、溶融形態で噴霧し、錠剤表面で固化する親油性の異なった溶融可能な脂質を用いる溶融被覆が好適である。有用な溶融被覆物質は、ポリグリコール化グリセリド(ゲルシア50/02、ゲルシア62/05、ゲルシア53/10)、ポリグリセリールパルミトステアレート、グリセリルベヘネート(コンプリトール(Compritol)888ATO)、グリセリールステアレート(プレシロール(Precirol)WL)、グリセリルパルミトステアレート(プレシロールATO5)、ポリグリコール化不飽和グリセリド(ラブラフィル(Labrafil)M1944)のようなものである。
本文脈において、治療的および/または予防的に活性な物質は、例えばヒトのような哺乳類のような動物に対して作用を有する生物的および/または生理的に活性なあらゆる物質を含む。この用語は、薬剤物質、ホルモン、遺伝子または遺伝子配列、抗原を含む物質(antigen-comprising material)、蛋白質、ペプチド、例えばビタミン、ミネラルのような栄養素、脂質および炭水化物ならびにそれらの混合物を含む。このように、該用語は、動物または人間に影響を及ぼす疾患または障害の治療および/または予防に、または動物またはヒトのいかなる生理的状態の調整に有用である物質を含む。該用語は、有効量で投与されたときに、生細胞または生物に効果を有する生物学的に活性な物質をも含む。
抗炎症剤(例えばイブプロフェン、インドメタシン、ナプロキセン、ナロフィンのような)、
抗パーキンソン病剤(例えばブロモクリプチン、ビペリジン、ベンツヘキソール、ベンツトロピン等のような)、
抗欝剤(例えばイミプラミン、ノルトリプチリン、プリチプチリン等のような)、
抗生物質(例えばクリンダマイシン、エリスロマイシン、フシジン酸、ゲンタマイシン、ムピロシン、アンフォマイシン、ネオマイシン、メトロニダゾール、スルファメチゾール、バシトラシン、フラマイセチン、ポリミキシンB,アクチノマイシン等のような)、
抗菌剤(例えばメトロニダゾール、テトラサイクリン、オキシテトラサイクリン、ペニシリン等のような)、
制吐剤(例えばメトクロプラミド、ドロペリドール、ハロペリドール、プロメタジン等のような)、
抗偏頭痛剤(例えばジヒドロエルゴタミン、エルゴタミン、ピゾフィリン等のような)、冠血管、大脳および末梢血管拡張剤(例えばニフェジピン、ジルチアゼム等のような)、抗狭心症剤(例えばグリセリルナイトレート、イソソルビッドジナイトレート、モルシドミン、ベラパミル等のような)、
ホルモン剤(例えばエストラジオール、エストロン、エストリオール、ポリエストラジオール、ポリエストリオール、ジエネストロール、ジエチルスチルベストロール、プロゲステロン、ジヒドロプロゲステロン、サイプロステロン、ダナゾール、テストステロン等のような)、
避妊薬(例えばエチニルエストラジオール、リネストレノール、エチノジオール、ノレシステロン、メストラノール、ノルゲストレル、レボノルゲストレル、デソデストレル、メドロキシプロゲステロン等のような)、
利尿剤(例えばヒドロクロロチアジド、フルナリジン、ミノキシジル等のような)、
降圧剤(例えばプロパノロール、メトプロロール、クロニジン、ピンドロール等のような)、
ステロイド剤(例えばエストラジオール、プロゲステロン、ノレシンドロン、レボノルゲストレル、エチノジオール、レボノルゲストロール、ノルゲスチメート、ゲスタニン、デソゲストレル、3-ケトン-デソゲステレル、デメゲストン、プロメトエステロール、テストステロン、スピロノラクトンおよびそれらのエステル等のような)、
オピオイド(例えばモルヒネ、ブプレノルフィン、オキシモルフォン、ヒドロモルフォン、コデイン、トラマドール等のような)、
プロスタグランジン(例えばPGA、PGB、PGEまたはPGFシリーズのメンバー(例えばミノプロストール、ジノプロストン、カルボプロスト、エネプロスチル等のような)のような)、
を含む。
心血管薬
ゾコール(Zocor)(登録商標)、リピトール(Lipitor)(登録商標)、プレバコール(Prevachol)(登録商標)、メバロチン(Mevalotin)(登録商標)、メバコール(Mevacor)(登録商標)、レスコール(Lescol)(登録商標)、トリコール(TriCor)(登録商標)、ノルバスク(Norvasc)(登録商標)、コザール(Cozaar)およびハイザール(Hyzaar)(登録商標)、プリニビル(Prinivil)およびプリンザイド(Prinzide)(登録商標)、ジオバン(Diovan)(登録商標)/コ-ジオバン(Co-Diovan)(登録商標)、ゼストリル(Zestril)(登録商標)、バソテック(Vasotech)(登録商標)およびバセレチック(Vaseretic)(登録商標)、ロテンシン(Lotensin)(登録商標)/シバセン(Cibacen)(登録商標)およびロトレル(Lotrel)(登録商標)、アダラート(Adalat)(登録商標)、トプロール(Toprol)XL(登録商標)/セロケン(Seloken)(登録商標)、トリテイス(Tritace)(登録商標)/デリックス(Delix)(登録商標)、アキュプリル(Accupril)(登録商標)およびアキュレチック(Accuretic)(登録商標)、アバプロ(Avapro)(登録商標)およびアバリド(Avalide)(登録商標)、プレンジル(Plendil)(登録商標)、モノプリル(Monopril)(登録商標)、ブロプレス(Blopress)(登録商標)、アタカンド(Atacand)(登録商標)、テノルミン(Tenormin)(登録商標)、アバプロ(Avapro)(登録商標)/アプロベル(Aprovel)(登録商標)、コレグ(Coreg)(登録商標)、アルテェイス(Altace)(登録商標)、カポテン(Capoten)(登録商標)、プラビックス(Plavix)(登録商標)、ロベノックス(Lovenox)(登録商標)/クレキサン(Clexane)(登録商標)、フラキシパリン(Fraxiparine)(登録商標)、レオプロ(ReoPro)(登録商標)、パナルジン(Panaldine)(登録商標)、コルダロン(Cordarone)(登録商標)
パキシル(Paxil)/セロクサット(Seroxat)(登録商標)、ゾロトフト(Zolotoft)(登録商標)、プロザック(Prozac)(登録商標)、プロザックウィークリー(Prozac Weekly)(登録商標)およびサラフェム(Sarafem)(登録商標)、イフェクソール(Effexor)(登録商標)、ウエルブトリン(Wellbutrin)(登録商標)、セレクサ(Celexa)(登録商標)、レメロン(Remeron)(登録商標)、セルゾン(Serzone)(登録商標)、ザイプレキサ(Zyprexa)(登録商標)、リスパーダル(Risperdal)(登録商標)、セロクエル(Seroquel)(登録商標)、クロザリル(Clozaril)(登録商標)/レポネックス(Leponex)(登録商標)、ニューロンチン(Neurontin)(登録商標)、デパクトウク(Depaktoke)(登録商標)、ラミクタル(Lamictal)(登録商標)、トパマックス(Topamax)(登録商標)、テグレトール(Tegretol)(登録商標)、イミトレックス(Imitrex)(登録商標)/イミグラン(Imigran)(登録商標)、ゾミグ(Zomig)(登録商標)、マクサルト(Maxalt)(登録商標)、アンビエン(Ambien)(登録商標)、スチルノックス(Stilnox)(登録商標)、ウルタン(Ultane)(登録商標)/セボラン(Sevorane)(登録商標)、ジプリバン(Diprivan)(登録商標)、ブスパール(BuSpar)(登録商標)、キサナックス(Xanax)(登録商標)、アリセプト(Aricept)(登録商標)、メマンチン(Memantine)(登録商標)、アデラール(Adderall)(登録商標)、ダイストニア(Dystonia)(登録商標)、ボトックス(Botox)(登録商標)
オーグメンチン(Augmentin)(登録商標)、シプロ(Cipro)(登録商標)/シプロベイ(Ciprobay)(登録商標)、ジスロマックス(Zithromax)(登録商標)、バイアキシン(Biaxin)(登録商標)、レバクイン(Levaquin)(登録商標)およびフロキシン(Floxin)(登録商標)、ロセフィン(Rocephin)(登録商標)、プリマキシン(Primaxin)(登録商標)、セフチン(Ceftin)(登録商標)/ジンナット(Zinnat)(登録商標)、クラビット(Cravit)(登録商標)、ゾシン(Zosyn)(登録商標)/タゾシン(Tazocin)(登録商標)、セフジル(Cefzil)(登録商標)、テクイン(Tequin)(登録商標)、トータッツ(Tortaz)(登録商標)/フォータム(Fortum)(登録商標)、コムビビアー(Combivir)(登録商標)、ゼリット(Zerit)(登録商標)、バルトレックス(Valtrex)(登録商標)、エピビール(Epivir)(登録商標)、ゾビラクス(Zovirax)(登録商標)、クリキシバン(Crixivan)(登録商標)、ビラセプト(Viracept)(登録商標)、ビラミュン(Viramune)(登録商標)、カレトラ(Kaletra)(登録商標)、ジフルカン(Diflucan)(登録商標)、ラミシル(Lamisil)(登録商標)、スポラノクス(Sporanox)(登録商標)
クラリチンアレグラ(ClaritinAllegra)(登録商標)、テルファスト(Telfast)(登録商標)、ジールテック(Zyrtec)(登録商標)、フロネイス(Flonase)(登録商標)/フリキソネイス(Flixonase)(登録商標)、アトロベント(Atrovent)(登録商標)、ナソネックス(Nasonex)(登録商標)、リノコート(Rhinocort)(登録商標)、アレシオン(Alesion)(登録商標)、シングレアー(Singulair)(登録商標)、フロベント(Flovent)(登録商標)/フリクソタイド(Flixotide)(登録商標)、アドベアー(Advair)(登録商標)/セレタイド(Seretide)(登録商標)、セレベント(Serevent)(登録商標)、プルミコート(Pulmicort)(登録商標)、べントリン(Ventoline)(登録商標)、コムビベント(Combivent)(登録商標)、シナギス(Synagis)(登録商標)、ムコソルバン(Mucosolvan)(登録商標)
プリロセック(Prilosec)(登録商標)/ロセック(Losec)(登録商標)、プレバシド(Prevacid)(登録商標)、ガスター(Gaster)(登録商標)、タケプロン(Takepron)(登録商標)、ザンタック(Zantac)(登録商標)、パントゾール(Pantozol)、ネキシム(Nexium)、プロトニクス(Protonix)(登録商標)、アシフェックス(Aciphex)(登録商標)/パリエト(Pariet)(登録商標)、ペプシド(Pepcid)(登録商標)、アキシド(Axid)(登録商標)、ゾトン(Zoton)(登録商標)、ゾフラン(Zofran)(登録商標)
タキソール(Taxol)(登録商標)、タキソテーレ(Taxotere)(登録商標)、ノルバデックス(Nolvadex)(登録商標)、ヘルセプチン(Herceptin)、エレンス(Ellence)(登録商標)/ファーモルビシン(Pharmorubicin)(登録商標)、ルプロン(Lupron)(登録商標)、ゾラデックス(Zoladex)(登録商標)、ロイプリン(Leuplin)(登録商標)、カソデックス(Casodex)(登録商標)、イントロン(Intron)A(登録商標)、ペグ-イントロン(Peg-Intron)(登録商標)およびレバートロン(Rebertron)(登録商標)、リツキサン(Rituxan)(登録商標)、ゲムザール(Gemzar)(登録商標)、パラプラチン(Paraplatin)(登録商標)、カンプトサール(Camptosar)(登録商標)
セレブレックス(Celebrex)(登録商標)、ビオックス(Vioxx)(登録商標)、エンブレル(Enbrel)(登録商標)、レミケイド(Remicade)(登録商標)、ボルタレン(Voltaren)(登録商標)、モビック(Mobic)(登録商標)
ドラゲシック(Duragesic)(登録商標)
ウルトラム(Ultram)(登録商標)およびウルトルセット(Ultrcet)(登録商標)
プロクリット(Procrit)(登録商標)/エプレックス(Eprex)(登録商標)、エポゲン(Epogen)(登録商標)、エポギン(Epogin)(登録商標)、ネオレコーモン(NeoRecormon)(登録商標)、
ニューポゲン(Neupogen)(登録商標)、ノボセブン(NovoSeven)(登録商標)
グルコファージ(Glucophage)(登録商標)、ヒュムリン アバンジア(Humulin Avandia)(登録商標)、ヒューマログ(Humalog)(登録商標)、アクトス(Actos)(登録商標)、アマリール(Amaryl)(登録商標)、グルコバンス(Glucovance)(登録商標)、グルコファージ(Glucophage)XR(登録商標)、グルコトロール(Glucotrol)XL(登録商標)、プレコース(Precose)(登録商標)/グルコベイ(Glucobay)(登録商標)
フォサマックス(Fosamax)(登録商標)、エビスタ(Evista)(登録商標)、ミアカルシン(Miacalcin)(登録商標)、アクトネル(Actonel)(登録商標)、アレディア(Aredia)(登録商標)
ハーナル(Harnal)(登録商標)、プロスカー(Proscar)(登録商標)、カーデュラ(Cardura)(登録商標)、フロマックス(Flomax)(登録商標)、デトロール(Detrol)(登録商標)
プレマリン(Premarin)(登録商標)、プレムフェイス(Premphase)(登録商標)およびプレムプロ(prempro)(登録商標)、エストラダーム(Estraderm)(登録商標)、シンスロイド(Synthroid)(登録商標)
ネオラール(Neoral)(登録商標)/サンディムン(Sandimmun)(登録商標)、セルセプト(CellCept)、ラパミュン(Rapamune)(登録商標)、タクロリムス(例えばプログラフ(登録商標))、メドロール(Medrol)(登録商標)
アボネックス(Avonex)(登録商標)、ベータセロン(Betaseron)(登録商標)/ベータフェロン(Betaferon)(登録商標)、レビフ(Rebif)(登録商標)、コパクソン(Copaxone)(登録商標)
プレブナール(Prevnar)(登録商標)、エンゲリクス(Engerix)-B(登録商標)、インファンリクス(Infanrix)(登録商標)、ガミミュン(Gamimune)N(登録商標)
バイアグラ(登録商標)
造影剤
ロパミロン(Iopamiron)(登録商標)、オムニペイキュ(Omnipaque)(登録商標)、マグネビスト(Magnevist)(登録商標)
眼科用薬
キサラタン(Xalatan)(登録商標)、トルソプト(Trusopt)(登録商標)およびコソプト(Cosopt)(登録商標)
アキュタン(Accutane)(登録商標)/ロアキュタン(Roaccutan)(登録商標)、クレオシン(Cleocin)(登録商標)
成長障害治療用薬
ゲノトロピン(Genotropin)(登録商標)、ヒュマトロープ(Humatrope)(登録商標)
不妊症用薬
ゴナール(Gonal)-F(登録商標)、フォリスチム(Follistim)(ピュレゴン(Puregon)(登録商標)
セレザイム(Cerezyme)(登録商標)
肥満治療薬
キセンシャル(Xencial)(登録商標)
先端巨大症薬
サンドスタチン(Sandostatin)(登録商標)
避妊薬
デポ-プロベラ(Depo-Provera)(登録商標)
本発明は、次の工程:
i)任意に一以上の治療的、予防的および/または診断的に活性な物質を含む特許請求の範囲1〜32のいずれか一つに記載されているような装填可能な錠剤を製造すること、
ii)工程i)で得られた装填可能な錠剤に、任意に一以上の治療的、予防的および/または診断的に活性な物質を含む特許請求の範囲33〜59のいずれか一つに記載されているような医薬的に許容される液体製剤を、その医薬的に許容される液体製剤が装填可能な錠剤に飽和するのに十分な時間で装填すること
を含む錠剤の製造法にも関連する。
本発明は次の非限定的な実施例でさらに説明される。
装填可能な錠剤の製造とその性質
6種の錠剤組成物が、油吸収物質、アエロパール300(二酸化ケイ素、デグッサ社(Degussa))、ノイシリンUS2(メタケイ酸アルミニウムマグネシウム、フジ化学社(Fuji Chemical Industry))、アビセル(結晶性セルロース、FMC社)およびフジカリンSG(二塩基性燐酸カルシウム無水物、フジ化学社)を基に製造された。
ノイシリンUS2 99%
ステアリン酸マグネシウム 1%
組成物2
アビセルPH102 99%
ステアリン酸マグネシウム 1%
アエロパール300 80%
PEG6000 19%
ステアリン酸マグネシウム 1%
組成物4
アエロパール300 55%
アビセルPH101 44%
ステアリン酸マグネシウム 1%
アビセルPH102 99%
ステアリン酸マグネシウム 1%
組成物6
フジカリン 99%
ステアリン酸マグネシウム 1%
組成物5の錠剤を、10%溶解シムバスタチンを有するイムウィトール(Imwitor)308、サソール(Sasol)(グリセリールモノカプリレート)で装填した。油の装填は、40℃に対応するイムウィトールの融点(融点35℃)を超える温度で遂行された。
表1.ノイシリンUS2を含有する錠剤の油吸収能(組成物1)
表2.油の装填前および後における錠剤硬度(組成物1)
装填前の錠剤の多孔度は、錠剤の密度ρtおよび成分の「真密度(true density)」ρsを基に計算される。錠剤の多孔度εは式1により算出される。
表4.アビセルを有する錠剤の油吸収能(組成物2)
表5.油装填前および後の錠剤の硬度(組成物2)
表7.アエロパール/PEG6000を有する錠剤の油吸収能(組成物3)
表8.油装填前および後の錠剤の硬度(組成物3)
表10.アエロパール/アビセルを有する錠剤の油吸収能(組成物4)
表13.イムウィトール308中のシムバスタチン10%溶液を装填されたアビセルを有する錠剤の油吸収能(組成物5)
表17.コーン油を装填されたフジカリンを有する錠剤の油吸収能(組成物6)
多孔性錠剤は、薬物を液体の形態または液体担体中に溶解もしくは分散した形態で含む、油、エマルジョン、マイクロエマルジョンおよび温度上昇で溶ける半固体のような油状製剤のための担体として使用することができる。油は慣用の被覆技術(ドラム、多孔容器
または流動床)でもって錠剤に塗布され得る。油の供給速度は、錠剤コア中への油の吸収速度と平衡になるように調整すべきである。
油吸収能は錠剤コアの多孔度によって決定される。油は錠剤の空隙をほぼ飽和にまで満たす。
実施例2
コア錠剤の明細
ノイシリンUS2 93mg
ステアリン酸マグネシウム 1mg
平均錠剤硬度:52N
錠剤の直径:8mm(複合カップ状)
錠剤は単一打ち抜き錠剤機ジアフ(Diaf)TM20上で圧縮された。
0.95%濃度でタクロリムスをポリエチレングリコール400に溶解し、これを被覆容器の中で大気温度にて、ノイシリンUS2コア錠剤上に噴霧した。53重量%の媒質の装填に相当する200mgの装填された錠剤重量に対応する、装填された1mg錠剤の組成が表1に示される。
平均錠剤硬度:52N
コア錠剤の明細
ノイシリンUS2 198mg
ステアリン酸マグネシウム 2mg
平均錠剤硬度:42N
錠剤の直径:10mm(複合カップ状)
錠剤は単一打ち抜き錠剤機ジアフTM20上で圧縮された。
40℃で溶融したイムウィトール308(グリセリールモノカプリレート)中に10%
濃度でアトールバスタチンを溶解し、被覆容器中で35℃に加熱されたノイシリンUS2コア錠剤上に噴霧した。装填後、媒質を固形化するために、装填された錠剤を冷蔵庫の中で冷却した。
50重量%の媒質の装填に相当する400mgの装填された錠剤重量に対応する、装填された20mg錠剤の組成が表2に示される。
平均錠剤硬度:48N
コア錠剤の明細
ノイシリンUS2 351mg
ステアリン酸マグネシウム 2mg
平均錠剤硬度:60N
錠剤形状:長楕円状錠剤 9x19mm
錠剤は単一打ち抜き錠剤機ジアフTM20上で圧縮された。
80℃の温度で、ポリエチレングリコール6000とポロキサマー188の溶融した混合物(70:30)中に35%濃度でフェノフィブレートを溶解し、被覆容器中で70℃の温度に加熱されたノイシリンUS2コア錠剤上に噴霧した。錠剤は装填後、被覆容器の中で、PEGとポリキサマーの融点(60℃)以下の温度に冷却した。
54重量%の媒質の装填に相当する装填された767mg錠剤重量に対応する、装填された145mg錠剤の組成が表3に示される。
平均錠剤硬度:57N
コア錠剤の明細
ノイシリンUS2 84mg
ステアリン酸マグネシウム 1mg
平均錠剤硬度:42N
錠剤直径:7mm(複合カップ状)
錠剤は単一打ち抜き錠剤機ジアフTM20上で圧縮された。
被覆容器中で、10%濃度でシムバスタチンを、ノイシリンUS2核上の(MCT)ビスコレオ(Viscoleo)中に溶解した。54重量%の媒質の装填に相当する装填された錠剤重量185mgに対応する、装填された10mg錠剤の組成が表4に示される。
ビスコレオ(中鎖グリセリド)のノイシリン錠剤への装填
打錠工程
ノイシリン錠剤は、単一打ち抜き製錠機ジアフTM20上で圧縮された。
装填前の錠剤の性質
錠剤直径:9mm
錠剤形状:複合カップ状
錠剤重量:134mg
錠剤重量変動Srel:1.6%
錠剤硬度:51N(硬度試験機シュロイニーガーM8上で測定)
50g錠剤に、実験室規模の流動床フェースト(Phast)FB100の中で、頂点噴霧を備えた被覆モジュールを用いてビスコレオを装填した。
噴霧空気流速:時間当たり1m3
流動空気流速:時間当たり40m3
液体供給速度:2.5g 分
錠剤の飽和までの被覆時間:30分
増加重量:67.5g ビスコレオ
錠剤重量:305mg(56重量%装填)
錠剤硬度:51N
錠剤重量変動Srel:5.1%
流動床のような慣用の被覆設備は、短い加工時間で液体製剤を多孔性錠剤に装填するのに適している。錠剤は、錠剤表面への噴霧によって塗布される液体を素早く吸収する。錠剤の硬度は、液体の装填では影響されない。重量の変動は、活性物質が取り込まれたときに投薬量変動に関連する許容できる限度内である1.6%〜5.2%に増加する。
Claims (31)
- 錠剤が多孔性賦与賦形剤としてケイ酸アルミニウムを少なくとも60重量%以上の濃度で含み、30容積%以上の多孔度を有し、20N以上の硬度を有する、医薬的に許容される液体製剤を装填するための、医薬的担体組成物としての錠剤。
- ケイ酸アルミニウムがメタケイ酸アルミニウムマグネシウムである、請求項1に記載の錠剤。
- 多孔性賦与賦形剤が70重量%以上の濃度で存在する、請求項1または2に記載の錠剤。
- 多孔性賦与賦形剤が80重量%以上の濃度で存在する、請求項1または2に記載の錠剤。
- 多孔性賦与賦形剤が95重量%以上の濃度で存在する、請求項1または2に記載の錠剤。
- コーン油の重量ベースでの最大吸収量を
で算出したときに、最低でも20重量%(装填時の固形投与形態の総重量に基づく)のコーン油で錠剤を装填する結果となる、請求項1〜5のいずれか一つに記載の錠剤。 - 25N以上の硬度を有する、請求項1〜6のいずれか一つに記載の錠剤。
- 5%以下の破砕性を有する、請求項1〜7のいずれか一つに記載の錠剤。
- 治療的に不活性である、請求項1〜8のいずれか一つに記載の錠剤。
- 医薬的に許容される液体製剤が20重量%以上(装填時の固形投与形態の総重量に基づく)の濃度で装填される、請求項1〜9のいずれか一つに記載の錠剤。
- 医薬的に許容される液体製剤が40重量%以上(装填時の固形投与形態の総重量に基づく)の濃度で存在する、請求項10に記載の錠剤。
- 錠剤に装填される際の医薬的に許容される液体製剤が、150℃の温度で、最大でも600mPa秒の粘度を有する、請求項10または11に記載の錠剤。
- 医薬的に許容される液体製剤が、最低でも0℃および最高でも250℃の融点を有する、請求項10〜12のいずれか一つに記載の錠剤。
- 医薬的に許容される液体製剤が5℃以上の融点を有する、請求項13に記載の錠剤。
- 医薬的に許容される液体製剤が、油または油様物質を含む、請求項10〜14のいずれか一つに記載の錠剤。
- 医薬的に許容される液体製剤が医薬的に許容される溶媒を含む、請求項10〜14のいずれか一つに記載の錠剤。
- 油または油様物質が植物油、水素添加植物油および動物油からなる群から選択される、請求項15に記載の錠剤。
- 油または油様物質が、杏子油、アーモンド油、アボカド油、ひまし油、ココナツ脂、カカオ脂、コーン油、綿実油、ブドウ種子油、ホホバ油、亜麻仁油、トウモロコシ油、オリーブ油、ヤシ油、落花生油、パセリ油、ケシ種子油、セイヨウアブラナ種子油、胡麻油、大豆油、ヒマワリ油、アザミ種子油、クルミ油、小麦胚芽油、牛脂、豚脂、トール油、鯨油、およびそれらの混合物からなる群から選択される、請求項17に記載の錠剤。
- 油または油様物質が、ポリエーテルグリコール;ポリオキシエチレン;ポリオキシプロピレン;ポロキサマーおよびそれらの混合物からなる群から選択される親水性の油または油様物質であるか、あるいはキシリトール、ソルビトール、酒石酸ナトリウムカリウム、蔗糖三ベヘネート、ブドウ糖、ラムノース、ラクチトール、ベヘン酸、ヒドロキノンモノメチルエーテル、酢酸ナトリウム、フマル酸エチル、ミリスチン酸、クエン酸、PEG−32グリセリルパルミトステアレート、麦芽糖、マンニトールおよびそれらの混合物からなる群から選択される、請求項17に記載の錠剤。
- 油または油様物質が、直鎖状飽和炭化水素、ソルビタンエステル、パラフィン;油脂;高級脂肪酸、高級アルコール、グリセリルモノステアレート、グリセリルモノオレエート、水素添加獣脂、ミリスチルアルコール、ステアリルアルコール、置換および/または非置換の不飽和モノグリセリド、置換および/または非置換の不飽和ジグリセリド、置換および/または非置換のトリグリセリド、黄色蜜蝋、白色蜜蝋、カルナウバ蝋、ひまし蝋、木蝋、アセチル化モノグリセリドから選択される低融点の蝋;NVPポリマー、PVPポリマー、アクリルポリマー、またはそれらの混合物からなる群から選択される、請求項17に記載の錠剤。
- 油または油様物質が400〜35,000の範囲の平均分子量を有するポリエチレングリコールである、請求項17に記載の錠剤。
- 油または油様物質が2,000〜7,000,000の分子量を有するポリエチレンオキシドである、請求項17に記載の錠剤。
- 油または油様物質がポロキサマーである、請求項17に記載の錠剤。
- 油または油様物質が、ソルビタンジイソステアレート、ソルビタンジオレエート、ソルビタンモノラウレート、ソルビタンモノイソステアレート、ソルビタンモノオレエート、ソルビタンモノパルミテート、ソルビタンモノステアレート、ソルビタンセスキイソステアレート、ソルビタンセスキオレエート、ソルビタンセスキステアレート、ソルビタントリイソステアレート、ソルビタントリオレエート、ソルビタントリステアレートまたはそれらの混合物から選択されるソルビタンエステルである、請求項17に記載の錠剤。
- 油または油様物質が、プロピレングリコール、ポリグリコシル化グリセリド、カカオ脂、カルナウバ蝋を含む植物起源の複合脂肪物質、アーモンド油、ココナツ油、コーン油、綿実油、胡麻油、大豆油、オリーブ油、ひまし油、パーム核油、落花生油、セイヨウアブラナ油、ブドウ種子油を含む植物油、水素添加落花生油、水素添加パーム核油、水素添加綿実油、水素添加大豆油、水素添加ひまし油、水素添加ココナツ油を含む水素添加植物油;蜜蝋、ラノリンを含む動物起源の天然脂肪物質、セチル、ステアリル、ラウリック、ミリスチック、パルミチック、ステアリック脂肪族アルコールを含む脂肪族アルコール;グリセロールステアレート、グリコールステアレート、エチルオレエート、イソプロピルミリステートを含むエステル;エステル交換された液体の半合成グリセリド;ステアラミドエタノール、脂肪ココナツ酸のジエタノールアミドを含むアミドまたは脂肪酸アルコールアミド、モノおよびジグリセリドの酢酸エステル、モノおよびジグリセリドのクエン酸エステル、モノおよびジグリセリドの乳酸エステル、モノおよびジグリセリド、脂肪酸のポリグリセリンエステル、ポリグリセロールポリリシノレエート、脂肪酸のプロピレングリコールエステル、ソルビタンモノステアレート、ソルビタントリステアレート、ステアロイルラクチレートナトリウム、ステアロイルラクチレートカルシウム、モノおよびジグリドのジアセチル酒石酸エステルから選択される溶媒または半固形状の賦形剤である、請求項17に記載の錠剤。
- 医薬的に許容される液体製剤が、エマルジョン、マイクロエマルジョン、自己マイクロエマルジョン化薬物送達システム(SMEDDS)または懸濁液を含む分散液である、請求項10〜25のいずれか一つに記載の錠剤。
- 錠剤中の医薬的に許容される液体製剤の濃度が5重量%以上である、請求項10〜26のいずれか一つに記載の錠剤。
- 一以上の治療的、予防的および/または診断的に活性な物質をさらに含む、請求項10〜27のいずれか一つに記載の錠剤。
- 活性物質が医薬的に許容される液体製剤に分散している、請求項28に記載の錠剤。
- 活性物質が少なくとも部分的に医薬的に許容される液体製剤に溶解している、請求項28に記載の錠剤。
- 活性物質が少なくとも部分的に非晶質の形態で存在する、請求項28に記載の錠剤。
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TW222585B (ja) * | 1992-09-11 | 1994-04-21 | Hoechst Ag | |
JP2700141B2 (ja) * | 1993-09-17 | 1998-01-19 | 富士化学工業株式会社 | リン酸水素カルシウム及びその製法並びにそれを用いた賦形剤 |
ATE306250T1 (de) * | 1998-12-23 | 2005-10-15 | Alza Corp | Dosierungsformen, die poröse partikel enthalten |
US6399591B1 (en) * | 2000-01-19 | 2002-06-04 | Yung-Shin Pharmaceutical Ind. Co., Ltd. | Chargeable pharmaceutical tablets |
US20050147666A1 (en) * | 2002-03-06 | 2005-07-07 | Kyowa Hakko Kogyo Co., Ltd. | Tablets quickly disintegrating in oral cavity |
EP1771243A1 (en) * | 2004-06-28 | 2007-04-11 | H.Lundbeck A/S | Porous article for delivering chemical substances |
WO2007076874A1 (en) * | 2006-01-05 | 2007-07-12 | Lifecycle Pharma A/S | Disintegrating loadable tablets |
US20110244031A1 (en) * | 2010-03-31 | 2011-10-06 | Lifecycle Pharma A/S | Porous tablets as carriers for liquid formulations |
-
2005
- 2005-06-27 EP EP20050753603 patent/EP1765297A2/en not_active Withdrawn
- 2005-06-27 CN CN2005800249102A patent/CN101001613B/zh active Active
- 2005-06-27 JP JP2007518451A patent/JP5403912B2/ja active Active
- 2005-06-27 KR KR1020077000836A patent/KR101352299B1/ko active IP Right Grant
- 2005-06-27 AU AU2005256322A patent/AU2005256322C1/en active Active
- 2005-06-27 WO PCT/DK2005/000436 patent/WO2006000229A2/en active Application Filing
- 2005-06-27 CA CA2572180A patent/CA2572180C/en active Active
- 2005-06-27 MX MXPA06014894A patent/MXPA06014894A/es active IP Right Grant
- 2005-06-27 BR BRPI0512660-6A patent/BRPI0512660A/pt not_active IP Right Cessation
- 2005-06-27 CN CNA2005800217775A patent/CN1976751A/zh active Pending
- 2005-06-27 EA EA200700173A patent/EA013632B1/ru not_active IP Right Cessation
- 2005-06-27 US US11/631,180 patent/US20090181083A1/en not_active Abandoned
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2015
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Also Published As
Publication number | Publication date |
---|---|
EA200700173A1 (ru) | 2007-04-27 |
CN1976751A (zh) | 2007-06-06 |
US20150164812A1 (en) | 2015-06-18 |
AU2005256322A1 (en) | 2006-01-05 |
CN101001613A (zh) | 2007-07-18 |
BRPI0512660A (pt) | 2008-04-01 |
CN101001613B (zh) | 2010-09-29 |
MXPA06014894A (es) | 2007-03-21 |
JP2008504308A (ja) | 2008-02-14 |
EP1765297A2 (en) | 2007-03-28 |
WO2006000229A2 (en) | 2006-01-05 |
KR20070035033A (ko) | 2007-03-29 |
AU2005256322B2 (en) | 2011-03-03 |
CA2572180C (en) | 2014-05-20 |
US20090181083A1 (en) | 2009-07-16 |
WO2006000229A3 (en) | 2006-08-24 |
CA2572180A1 (en) | 2006-01-05 |
KR101352299B1 (ko) | 2014-02-17 |
EA013632B1 (ru) | 2010-06-30 |
AU2005256322C1 (en) | 2011-07-07 |
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