JP5883798B2 - プロセスおよび生成物 - Google Patents
プロセスおよび生成物 Download PDFInfo
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- JP5883798B2 JP5883798B2 JP2012542618A JP2012542618A JP5883798B2 JP 5883798 B2 JP5883798 B2 JP 5883798B2 JP 2012542618 A JP2012542618 A JP 2012542618A JP 2012542618 A JP2012542618 A JP 2012542618A JP 5883798 B2 JP5883798 B2 JP 5883798B2
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- 229960004751 varenicline Drugs 0.000 description 1
- JQSHBVHOMNKWFT-DTORHVGOSA-N varenicline Chemical compound C12=CC3=NC=CN=C3C=C2[C@H]2C[C@@H]1CNC2 JQSHBVHOMNKWFT-DTORHVGOSA-N 0.000 description 1
- 229960003726 vasopressin Drugs 0.000 description 1
- 229950005577 vesnarinone Drugs 0.000 description 1
- PJDFLNIOAUIZSL-UHFFFAOYSA-N vigabatrin Chemical compound C=CC(N)CCC(O)=O PJDFLNIOAUIZSL-UHFFFAOYSA-N 0.000 description 1
- 229960005318 vigabatrin Drugs 0.000 description 1
- 229960001255 viloxazine Drugs 0.000 description 1
- 229960004528 vincristine Drugs 0.000 description 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 description 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 description 1
- 229950006360 viqualine Drugs 0.000 description 1
- XFXANHWIBFMEOY-JKSUJKDBSA-N viqualine Chemical compound C12=CC(OC)=CC=C2N=CC=C1CCC[C@@H]1CCNC[C@@H]1C=C XFXANHWIBFMEOY-JKSUJKDBSA-N 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- HXTGXYRHXAGCFP-UHFFFAOYSA-N volinanserin Chemical compound COC1=CC=CC(C(O)C2CCN(CCC=3C=CC(F)=CC=3)CC2)=C1OC HXTGXYRHXAGCFP-UHFFFAOYSA-N 0.000 description 1
- 229960004740 voriconazole Drugs 0.000 description 1
- BCEHBSKCWLPMDN-MGPLVRAMSA-N voriconazole Chemical compound C1([C@H](C)[C@](O)(CN2N=CN=C2)C=2C(=CC(F)=CC=2)F)=NC=NC=C1F BCEHBSKCWLPMDN-MGPLVRAMSA-N 0.000 description 1
- 229960005080 warfarin Drugs 0.000 description 1
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 description 1
- 238000007704 wet chemistry method Methods 0.000 description 1
- 229940075420 xanthine Drugs 0.000 description 1
- 229960004764 zafirlukast Drugs 0.000 description 1
- 229960000523 zalcitabine Drugs 0.000 description 1
- 229960004010 zaleplon Drugs 0.000 description 1
- HUNXMJYCHXQEGX-UHFFFAOYSA-N zaleplon Chemical compound CCN(C(C)=O)C1=CC=CC(C=2N3N=CC(=C3N=CC=2)C#N)=C1 HUNXMJYCHXQEGX-UHFFFAOYSA-N 0.000 description 1
- AERLHOTUXIJQFV-RCPZPFRWSA-N zalospirone Chemical compound O=C([C@@H]1[C@@H]([C@@H]2C=C[C@H]1[C@H]1C=C[C@H]12)C1=O)N1CCCCN(CC1)CCN1C1=NC=CC=N1 AERLHOTUXIJQFV-RCPZPFRWSA-N 0.000 description 1
- 229950005255 zalospirone Drugs 0.000 description 1
- ARAIBEBZBOPLMB-UFGQHTETSA-N zanamivir Chemical compound CC(=O)N[C@@H]1[C@@H](N=C(N)N)C=C(C(O)=O)O[C@H]1[C@H](O)[C@H](O)CO ARAIBEBZBOPLMB-UFGQHTETSA-N 0.000 description 1
- 229960001028 zanamivir Drugs 0.000 description 1
- REZGGXNDEMKIQB-UHFFFAOYSA-N zaprinast Chemical compound CCCOC1=CC=CC=C1C1=NC(=O)C2=NNNC2=N1 REZGGXNDEMKIQB-UHFFFAOYSA-N 0.000 description 1
- 229950005371 zaprinast Drugs 0.000 description 1
- HJMQDJPMQIHLPB-UHFFFAOYSA-N zardaverine Chemical compound C1=C(OC(F)F)C(OC)=CC(C2=NNC(=O)C=C2)=C1 HJMQDJPMQIHLPB-UHFFFAOYSA-N 0.000 description 1
- 229950001080 zardaverine Drugs 0.000 description 1
- 229960002555 zidovudine Drugs 0.000 description 1
- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 description 1
- MWLSOWXNZPKENC-SSDOTTSWSA-N zileuton Chemical compound C1=CC=C2SC([C@H](N(O)C(N)=O)C)=CC2=C1 MWLSOWXNZPKENC-SSDOTTSWSA-N 0.000 description 1
- 229960005332 zileuton Drugs 0.000 description 1
- 229960002791 zimeldine Drugs 0.000 description 1
- OYPPVKRFBIWMSX-SXGWCWSVSA-N zimeldine Chemical compound C=1C=CN=CC=1C(=C/CN(C)C)\C1=CC=C(Br)C=C1 OYPPVKRFBIWMSX-SXGWCWSVSA-N 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- 229960000607 ziprasidone Drugs 0.000 description 1
- MVWVFYHBGMAFLY-UHFFFAOYSA-N ziprasidone Chemical compound C1=CC=C2C(N3CCN(CC3)CCC3=CC=4CC(=O)NC=4C=C3Cl)=NSC2=C1 MVWVFYHBGMAFLY-UHFFFAOYSA-N 0.000 description 1
- 229960004276 zoledronic acid Drugs 0.000 description 1
- XRASPMIURGNCCH-UHFFFAOYSA-N zoledronic acid Chemical compound OP(=O)(O)C(P(O)(O)=O)(O)CN1C=CN=C1 XRASPMIURGNCCH-UHFFFAOYSA-N 0.000 description 1
- 229960001360 zolmitriptan Drugs 0.000 description 1
- UTAZCRNOSWWEFR-ZDUSSCGKSA-N zolmitriptan Chemical compound C=1[C]2C(CCN(C)C)=CN=C2C=CC=1C[C@H]1COC(=O)N1 UTAZCRNOSWWEFR-ZDUSSCGKSA-N 0.000 description 1
- 229960002911 zonisamide Drugs 0.000 description 1
- UBQNRHZMVUUOMG-UHFFFAOYSA-N zonisamide Chemical compound C1=CC=C2C(CS(=O)(=O)N)=NOC2=C1 UBQNRHZMVUUOMG-UHFFFAOYSA-N 0.000 description 1
- 229960004496 zotepine Drugs 0.000 description 1
- HDOZVRUNCMBHFH-UHFFFAOYSA-N zotepine Chemical compound CN(C)CCOC1=CC2=CC=CC=C2SC2=CC=C(Cl)C=C12 HDOZVRUNCMBHFH-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
http://www.fei.com/uploadedFiles/Documents/Content/ particle_morphology.pdf.
で見ることができる。
プロピオン、カルバマゼピン、カロキサゾン、セリクラミン、コチニン、フェゾラミン、フルペンチキソール、イダゾキサン、キタンセリン(kitanserin)、レボプロチリン、リチウム塩、マプロチリン、メジホキサミン、メチルフェニデート、メトラリンドール(metralindole)、ミナプリン、ネファゾドン、ニソキセチン、ノミフェンシン、オキサフロザン、オキシトリプタン、フェニヒドラジン(phenyhydrazine)、ロリプラム、ロキシンドール、シブトラミン、テニロキサジン、チアネプチン、トフェナシン、トラザドン(trazadone)、トリプトファン、ビロキサジン、およびザロスピロンを含む他の抗うつ薬。
実験において、用いた有効成分はコハク酸スマトリプタンであった。以下に列挙する通り、有効成分の異なる処置を、異なる物理特性に対して比較した。
ジェット製粉したコハク酸スマトリプタン
本実施例は、ジェット製粉したコハク酸スマトリプタンの無秩序/無結晶の含量を試験した。
ブレンドCSS090120RPAのジェット製粉を、バッチサイズ100gに対して、AS50スパイラルジェットミル(Hosokawa)、コハク酸スマトリプタン(Natco)、供給速度(第1の通過)3.2g/分、供給速度(第2の通過)4g/分、圧縮空気供給、ベンチュリ5バール、粉砕3バールを用いて行った。
ふくらみ率(Table 1(表1))
円状率(Table 1(表1))
DVS(Table 2および3(表2および3))
ACI(Table 2(表2))
表面積(Table 4(表4))
粒子サイズ(Table 1(表1))
MCBによって処理加工されるジェット製粉したコハク酸スマトリプタン
方法
ジェット製粉、ふくらみ率、円状率、DVS、ACI、表面積、粒子サイズ、および円相当径を全て、実施例1.1における通りに行った。実施例1.1と同じジェット製粉したバッチを用いた。
ふくらみ率(Table 1(表1))
円状率(Table 1(表1))
DVS(Table 2および3(表2および3))
ACI(Table 2(表2))
表面積(Table 4(表4))
粒子サイズ(Table 1(表1))
高湿度でのコハク酸スマトリプタンのジェット製粉およびMCB処理加工
ジェット製粉、ふくらみ率、円状率、DVS、ACI、表面積、粒子サイズ、円相当径を実施例1同様に行った。実施例1.1と同じジェット製粉したバッチを用いた。
ふくらみ率(Table 1(表1))
円状率(Table 1(表1))
DVS(Table 2および3(表2および3))
ACI(Table 2(表2))
表面積(Table 4(表4))
粒子サイズ(Table 1(表1))
低湿度でジェット製粉およびMCB処理加工したコハク酸スマトリプタン
ブレンドCSS080828RPAのジェット製粉を、AS 50スパイラルジェットミル(Hosokawa)、コハク酸スマトリプタン(Natco)、供給速度(第1の通過)3g/分、供給速度(第2の通過)3g/分、圧縮空気供給、ベンチュリ5バール、粉砕3バールを用いて行った。バッチサイズ80g。
DVS(Table 2(表2))を参照されたい
ACI(Table 2(表2))を参照されたい
表面積4.28m2/g
粒子サイズd0.1μm=0.761、d0.5μm=1.787、d0.9μm = 3.692
DVS分析は、ジェット製粉技術の結果として、表面の無秩序な(非結晶の)構造の形成を指摘している。高湿度(82%RH)および乾燥(10%RH)両方の条件下において、圧縮およびせん断を伴うプロセスによって処理加工した場合、同じ出発材料の非晶質含量は、ジェット製粉よりも処理加工後に非結晶生成物の少ない生成物がもたらされる。この生成物は、とりわけ、ジェット製粉した生成物よりも、より高いレベルの送達される用量および微粒子分画を実証した。圧縮力およびせん断力によって生成される本発明の生成物は、処理後、同じジェット製粉した生成物よりも大きな円状率およびふくらみ率を有する。圧縮力およびせん断力によって生成される本発明の生成物は、例えば、送達される用量によって評価して、ジェット製粉した生成物のプロファイルが高度に変動性である期間において、T=0カ月からT=1カ月まで、変動性の低いプロファイルを有する。このように、本発明のプロセスは、ジェット製粉した生成物と比べて増強された特性を有する有効成分を提供する。
Claims (14)
- 薬学上有効な単一または複数の成分を、担体粒子および添加剤の非存在下で圧縮力およびせん断力にかける工程を含む、有効成分を処理加工する方法であって、
前記有効成分が処理加工の前に微粒子化され、
前記有効成分の非晶質含量が、微粒子化された有効な出発材料に関して低減され、
前記担体粒子は水ではなく、前記添加剤は水ではない、方法。 - 前記有効な単一または複数の成分が単独で圧縮力およびせん断力にかけられる、請求項1に記載の方法。
- 前記有効成分が圧縮およびせん断の間に調整される、請求項1または2に記載の方法。
- 前記有効成分が、相対湿度を経時的に70%に上昇させることによって調整される、請求項3に記載の方法。
- 前記有効成分が、少なくとも30℃の、または、少なくとも50℃の、最低の温度で調整される、請求項1から4のいずれか一項に記載の方法。
- 前記有効成分がメカノフュージョンプロセスにかけられる、請求項1から5のいずれか一項に記載の方法。
- 前記微粒子化が衝撃製粉またはジェット製粉による、請求項1から6のいずれか一項に記載の方法。
- 有効材料が、圧縮およびせん断の後に、別の有効成分、または賦形剤もしくは添加剤などの別の材料と合わせられ、あるいはさらに処理加工される、請求項1から7のいずれか一項に記載の有効成分を処理加工する方法。
- 前記有効成分が、処理加工された後にレセプタクルまたは送達装置内に包装される、請求項1から8のいずれか一項に記載の方法。
- 前記方法によって生成された有効成分が、6カ月の期間にわたって25/60の貯蔵条件下で安定であり、名目上の用量のFPF(微粒子分画)のパーセント値における差が最初のFPFパーセント値の±20%を超えない、請求項1から9のいずれか一項に記載の方法。
- 名目上の用量のFPFのパーセント値における差が15%を超えない、請求項10に記載の方法。
- 名目上の用量のFPFのパーセント値における差が10%を超えない、請求項11に記載の方法。
- 名目上の用量のFPFのパーセント値における差が7%を超えない、請求項12に記載の方法。
- 名目上の用量のFPFのパーセント値における差が5%を超えない、請求項13に記載の方法。
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GBGB0921481.8A GB0921481D0 (en) | 2009-12-08 | 2009-12-08 | Process and product |
PCT/GB2010/052053 WO2011070361A1 (en) | 2009-12-08 | 2010-12-08 | Process and product |
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US9757395B2 (en) | 2012-12-20 | 2017-09-12 | Otitopic Inc. | Dry powder inhaler and methods of use |
US9757529B2 (en) | 2012-12-20 | 2017-09-12 | Otitopic Inc. | Dry powder inhaler and methods of use |
EP2991634A1 (en) | 2013-04-30 | 2016-03-09 | Otitopic Inc. | Dry powder formulations and methods of use |
US20160235667A1 (en) * | 2013-10-02 | 2016-08-18 | Vectura Limited | Method and apparatus for making compositions for pulmonary administration |
TWI590837B (zh) | 2014-03-25 | 2017-07-11 | 林信湧 | 一種用於治療心臟病之吸入式醫藥組成物及其備製方法 |
EP3474831A1 (en) | 2016-06-23 | 2019-05-01 | Corium International, Inc. | Adhesive matrix with hydrophilic and hydrophobic domains and a therapeutic agent |
KR102424270B1 (ko) | 2016-07-27 | 2022-07-25 | 코리움, 인크. | 경구 전달과 생물학적으로 동등한 약물동역학을 가진 경피 전달 시스템 |
SG11201900712SA (en) | 2016-07-27 | 2019-02-27 | Corium Int Inc | Memantine transdermal delivery systems |
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GB0409703D0 (en) * | 2004-04-30 | 2004-06-02 | Vectura Ltd | Pharmaceutical compositions |
EP1951197A4 (en) | 2005-11-10 | 2011-12-21 | Alphapharm Pty Ltd | METHOD OF CHECKING THE PARTICLE SIZE |
GB0613161D0 (en) * | 2006-06-30 | 2006-08-09 | Novartis Ag | Organic Compounds |
CA2728808A1 (en) * | 2008-02-01 | 2009-08-06 | Vectura Limited | Pulmonary formulations of triptans |
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CN102811709A (zh) | 2012-12-05 |
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GB0921481D0 (en) | 2010-01-20 |
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