JP5934312B2 - 薬物送達組成物 - Google Patents
薬物送達組成物 Download PDFInfo
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- JP5934312B2 JP5934312B2 JP2014182031A JP2014182031A JP5934312B2 JP 5934312 B2 JP5934312 B2 JP 5934312B2 JP 2014182031 A JP2014182031 A JP 2014182031A JP 2014182031 A JP2014182031 A JP 2014182031A JP 5934312 B2 JP5934312 B2 JP 5934312B2
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- 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
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- 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
- A61K31/4353—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 ortho- or peri-condensed with heterocyclic ring systems
- A61K31/436—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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
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- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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Description
本出願は米国特許法119条(e)項に基づき米国仮出願No.61/168040、2009年4月9日の利益を主張し、その開示は、引用により全体として本明細書に取り込まれる。
実施例1
本発明による中性の化合物の典型的な薬物送達組成物は以下を含み:
実施例2は可溶化剤を含む薬物送達組成物と、可溶化剤を含まない薬物送達組成物と、及び可溶化剤、又は、半透性被膜のないナノ微粒子型の薬物の投与処方との間の比較である。
実施例3は本発明の薬物送達組成物の医薬タクロリムス処方対ナノ微粒子タクロリムス処方の薬物動態比較を示す。
実施例4は、例えば、商業的に利用可能である速放性のクロザピン錠剤等のクロザピン対照処方と比較した際の弱塩基性の化合物、クロザピン、及び、pH調節剤を含む典型的な薬物送達組成物を用いた液体環境での溶解薬物量を示す。
本発明の薬物送達組成物をサポートするための診断処方モデルシステムが確立された。このモデルシステムは、半透性膜と、医薬粒子と、可溶化剤とを包含した。前記モデルシステムは、本発明の薬物送達組成物をサポートするのに必要とされるかもしれない、広くさまざまな処方変数及び異なるインビトロ放出調節実験に対処する柔軟性を提供するために多数の特徴を伴って設計された。
本実施例では、塩基性薬物、カルベジロール、及び、適切な弱酸性のpH調節剤を含む実施例5によるモデルシステムが検討された。図6は溶解時間に対するmlあたりの溶解mg量のプロフィールプロットを示す。
本実施例では、弱酸性薬物であるボリノスタット及び弱塩基pH調節剤を利用する実施例5による代替システムが検討された。図7は溶解時間に対するmlあたりの溶解mg量の溶解プロフィールプロットを示す。
110: 不活性物質
120: 溶解剤層
130: ナノ微粒子クロザピン層
135: 溶解中のクロザピン粒子
140: 半透性被膜
142: 細孔
210: 液体
220: 溶解剤で溶解されたクロザピン
225: 矢印で示されている浸透圧で促進された対流及び/又は受動拡散のクロザピンの流れ
Claims (8)
- 複数のビーズを有する多粒子の組成物であって、
該それぞれのビーズは、不活性物質と、可溶化剤と、半透性被膜と、医薬粒子とを含み、
前記可溶化剤は、陰イオン性界面活性剤層の形態で前記不活性物質の周りに配置され、
前記医薬粒子は、前記界面活性剤及び前記半透性被膜との間に配置され、2μm又はそれ未満の有効平均粒径を有し、医薬粒子の表面に表面安定化剤が吸着されていることを特徴とする、組成物。 - 複数のビーズを有する多粒子の組成物であって、
該それぞれのビーズは、コアと、医薬粒子層と、半透性被膜と、可溶化剤とを含み、
前記コアはビーズ中心にあり、
可溶化剤は前記コアから放射状に外側にpH調節剤層の形態であり、
前記医薬粒子層は、前記可溶化剤層から放射状に外側にあり、2μm又はそれ未満の有効平均粒径を有し、医薬粒子の表面に表面安定化剤が吸着されており、
前記半透性被膜はもっとも外側の層にあり、
前記pH調節剤は、アジピン酸と、アスコルビン酸と、クエン酸と、フマル酸と、没食子酸と、グルタル酸と、乳酸と、リンゴ酸と、マレイン酸と、コハク酸と、酒石酸と、これらの混合物及び組み合わせとからなる群から選択される弱酸であることを特徴とする、組成物。 - 前記コアは、不活性物質か、前記可溶化剤か、結合剤若しくは担体と混合した可溶化剤の組み合わせか、医薬粒子か又は結合剤若しくは担体と混合した医薬粒子の組み合わせかで形成されることを特徴とする、請求項2に記載の組成物。
- 前記半透性被膜は、使用環境において不溶性のポリマーと、前記使用環境において溶解性の細孔形成添加剤とを含む微多孔制御被膜であることを特徴とする、請求項1又は2に記載の組成物。
- 前記細孔形成添加剤が、HPMCと、PVPとからなる群から選択されることを特徴とする、請求項4に記載の組成物。
- 前記医薬は、37℃の水において、10mg/mLを超えない溶解度を有することを特徴とする、請求項1又は2に記載の組成物。
- 前記表面安定化剤は、ヒドロキシプロピルメチルセルロース(HPMC)と、スルホコハク酸ジオクチルナトリウム(DOSS)と、ラウリル硫酸ナトリウム(SLS)と、ヒドロキシプロピルセルロースと、ポリビニルピロリドンと、デオキシコール酸ナトリウムと、レシチンと、アルブミンと、リゾチームと、ゼラチンと、マクロゴール15ヒドロキシステアリン酸と、チロキサポールと、ポリエトキシル化ヒマシ油とからなる群から選択されることを特徴とする、請求項1又は2に記載の組成物。
- 前記可溶化剤は、使用環境への前記医薬の送達前に、前記組成物内の前記医薬粒子を溶解するのに十分な種類と量が存在することを特徴とする、請求項1又は2に記載の組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US16804009P | 2009-04-09 | 2009-04-09 | |
US61/168,040 | 2009-04-09 |
Related Parent Applications (1)
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JP2012504860A Division JP2012523427A (ja) | 2009-04-09 | 2010-04-08 | 薬物送達組成物 |
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JP2016092931A Division JP2016138136A (ja) | 2009-04-09 | 2016-05-06 | 薬物送達組成物 |
Publications (2)
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JP2015007111A JP2015007111A (ja) | 2015-01-15 |
JP5934312B2 true JP5934312B2 (ja) | 2016-06-15 |
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Application Number | Title | Priority Date | Filing Date |
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JP2012504864A Withdrawn JP2012523428A (ja) | 2009-04-09 | 2010-04-08 | 放出制御クロザピン組成物 |
JP2012504860A Pending JP2012523427A (ja) | 2009-04-09 | 2010-04-08 | 薬物送達組成物 |
JP2014182031A Expired - Fee Related JP5934312B2 (ja) | 2009-04-09 | 2014-09-08 | 薬物送達組成物 |
JP2016092931A Withdrawn JP2016138136A (ja) | 2009-04-09 | 2016-05-06 | 薬物送達組成物 |
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JP2012504864A Withdrawn JP2012523428A (ja) | 2009-04-09 | 2010-04-08 | 放出制御クロザピン組成物 |
JP2012504860A Pending JP2012523427A (ja) | 2009-04-09 | 2010-04-08 | 薬物送達組成物 |
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JP2016092931A Withdrawn JP2016138136A (ja) | 2009-04-09 | 2016-05-06 | 薬物送達組成物 |
Country Status (15)
Country | Link |
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US (3) | US20100260858A1 (ja) |
EP (2) | EP2416782A1 (ja) |
JP (4) | JP2012523428A (ja) |
KR (1) | KR20120022895A (ja) |
CN (2) | CN102448447A (ja) |
AU (2) | AU2010234339B2 (ja) |
BR (2) | BRPI1010301A2 (ja) |
CA (2) | CA2758258A1 (ja) |
IL (1) | IL215608A0 (ja) |
MX (2) | MX2011010620A (ja) |
NZ (1) | NZ595691A (ja) |
RU (3) | RU2011145278A (ja) |
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