JP2010248231A - 長時間放出性の口腔生物接着性錠剤 - Google Patents
長時間放出性の口腔生物接着性錠剤 Download PDFInfo
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- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
【解決手段】活性成分は、代謝から、水分、酵素、pH作用による分解から保護され、制御速度で生物学的利用性を発揮する。活性成分は、製造時に水分から保護され、さらに重要なことに、患者が錠剤を緩やかな制御速度で利用する後まで水分から保護される。この漸進的水和機能によりフラクションである活性成分の部分のみが吸収に利用され、投与後長時間保護される生体接着性錠剤。
【選択図】なし
Description
ヒドロキシプロピルメチルセルロース15000(=HPMC15000)をトウモロコシデンプンおよびラクトースと混合し、次いで水分に非感受性の活性成分の場合、活性物質を加える。混合物をヒドロキシプロピルメチルセルロース5(=HPMC5)の水溶液で湿らせ、次いで練る/顆粒とする。
タルク、二酸化ケイ素、ステアリン酸マグネシウム、および水分感受性の活性物質の場合、活性成分を加える。このすべてを、口径サイズ500μmのふるい器でふるい、次いでフリーフォール混合器に移す。
錠剤用混合物を回転式打錠器で錠剤とする。この打錠器は上側に9mm平面、下側に曲面(r=9mm)、両斜面縁のパンチを有しているものである。錠剤を取り出し、包装する。
下記は、ヒトにおける完全な生理的置換のための製剤(製剤8、バッチ#00029906)の例である。
テストステロン 30.000mg 24.0%
HPMC 26.250mg 21.0%
トウモロコシデンプン 22.500mg 18.0%
ラクトース一水和物 30.125mg 24.1%
シリカ 1.250mg 1.0%
ポリカルボフィル(Noveon) 3.125mg 2.5%
カルボマー974P 9.375mg 7.5%
タルク 1.500mg 1.2%
ステアリン酸マグネシウム 0.875mg 0.7%
Claims (22)
- 徐放性の漸進性水和生物接着錠剤であって、下記:
有効量の活性成分、
約5ないし約50重量%のセルロース、
約0.5ないし約25重量%のデンプン、
約1ないし約50重量%のラクトース、
約0.5ないし約10重量%の水不溶性架橋ポリカルボン酸ポリマー、
約1ないし約75重量%の水溶性ポリマー、
を含む錠剤。 - 該錠剤が少量で約50重量%の活性成分を含む、請求項1の錠剤。
- 約1重量%のシリカをさらに含む、請求項2の錠剤。
- 約0.5ないし約2重量%のタルクをさらに含む、請求項3の錠剤。
- 約0.5ないし約1重量%のステアリン酸マグネシウムをさらに含む、請求項3の錠剤。
- 該活性成分が、糖タンパク質、タンパク質、性ホルモン、抗ホルモン、硝酸エステル、ベータ−アゴニスト、ベータ−アンタゴニスト、オピオイド、オピオイド−アンタゴニスト、抗うつ剤、HMG−CoAレダクターゼ阻害剤、抗ヒスタミン剤、ACE阻害剤、プロスタグランジン、および水分、酵素、pHにより代謝または分解される他の活性成分よりなる群から選ばれる、請求項1または5の錠剤。
- 該デンプンが約2ないし約10重量%で、該ラクトースが約8ないし約16重量%で、水不溶性ポリマーが約25ないし約35重量%で存在し、該活性成分を患者の膣腔を経て血流に送達されるのに該錠剤が適している、請求項5の錠剤。
- 該デンプンが約14ないし約24重量%で、該ラクトースが約17ないし約27重量%で、水不溶性ポリマーが約5ないし約20重量%で存在し、該活性成分を患者の口腔を経て血流に送達されるのに該錠剤が適している、請求項5の錠剤。
- 徐放性の漸進性水和生物接着錠剤であって、下記:
有効量の活性成分、
約2ないし約30重量%の結合剤、
約5ないし約40重量%のラクトース、
約1ないし約3重量%の水不溶性架橋ポリカルボン酸ポリマー、
約5ないし約50重量%の水溶性ポリマー、
を含む錠剤。 - 約0.2ないし2重量%のシリカをさらに含む、請求項9の錠剤。
- 約0.5ないし約2重量%のタルクをさらに含む、請求項10の口腔錠剤。
- 約0.5ないし約2重量%のステアリン酸マグネシウムをさらに含む、請求項11の錠剤。
- 該活性成分が、テストステロンであり、該テストステロンが約1ないし約30重量%の量で存在している、請求項11の口腔錠剤。
- 該デンプンが約2ないし約10重量%で、該ラクトースが約8ないし約16重量%で、該水不溶性ポリマーが約25ないし約35重量%で存在し、該活性成分を患者の膣腔を経て血流に送達されるのに該錠剤が適している、請求項13の錠剤。
- 該デンプンが約15ないし約24重量%で、該ラクトースが約17ないし約27重量%で、水不溶性ポリマーが約5ないし約20重量%で存在し、該活性成分を患者の口腔を経て血流に送達されるのに該錠剤が適している、請求項13の錠剤。
- 活性成分をヒトに送達する方法であって、漸進性水和生物接着錠剤よる活性成分の徐放性投与を含む方法。
- 生物接着錠剤が水不溶性・水膨潤性架橋ポリカルボン酸ポリマー、水溶性ポリマー、テストステロンを含む、請求項16の方法。
- 虚血またはアルツハイマー病を治療または予防する方法であって、患者に医療的に有効量のテストステロンを徐放性の漸進性水和錠剤によって投与することを含む方法。
- 生物接着錠剤が、水不溶性架橋ポリカルボン酸ポリマー、水溶性ポリマー、テストステロンを含む口腔錠である、請求項18の方法。
- 生物接着錠剤が、水不溶性架橋ポリカルボン酸ポリマー、水溶性ポリマー、テストステロンを含む膣用錠である、請求項18の方法。
- 活性成分を患者の血流に送達して健康状態を処置するための徐放性の漸進性生物接着錠剤であって、医療的に有効量の活性成分、水不溶性架橋ポリカルボン酸ポリマー、水溶性ポリマーを含む錠剤。
- 活性成分を患者の血流に送達して健康状態を処置するための徐放性の漸進性生物接着錠剤の製造のために、活性成分を水不溶性架橋ポリカルボン酸ポリマーおよび水溶性ポリマーとともに使用すること。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US9784398P | 1998-08-25 | 1998-08-25 | |
US09/379,310 US6248358B1 (en) | 1998-08-25 | 1999-08-23 | Bioadhesive progressive hydration tablets and methods of making and using the same |
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JP2000565858A Division JP5411398B2 (ja) | 1998-08-25 | 1999-08-24 | 長時間放出性の口腔生物接着性錠剤 |
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JP2010248231A true JP2010248231A (ja) | 2010-11-04 |
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JP2000565858A Expired - Fee Related JP5411398B2 (ja) | 1998-08-25 | 1999-08-24 | 長時間放出性の口腔生物接着性錠剤 |
JP2010151682A Pending JP2010248231A (ja) | 1998-08-25 | 2010-07-02 | 長時間放出性の口腔生物接着性錠剤 |
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JP2000565858A Expired - Fee Related JP5411398B2 (ja) | 1998-08-25 | 1999-08-24 | 長時間放出性の口腔生物接着性錠剤 |
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Country | Link |
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US (1) | US6248358B1 (ja) |
EP (1) | EP1105104B1 (ja) |
JP (2) | JP5411398B2 (ja) |
KR (1) | KR100716702B1 (ja) |
CN (2) | CN1879608A (ja) |
AR (1) | AR036972A1 (ja) |
AT (1) | ATE306253T1 (ja) |
AU (1) | AU754880B2 (ja) |
BR (1) | BR9913239B1 (ja) |
CA (1) | CA2341375C (ja) |
DE (1) | DE69927694T2 (ja) |
DK (1) | DK1105104T3 (ja) |
ES (1) | ES2251220T3 (ja) |
HK (1) | HK1034895A1 (ja) |
HU (1) | HU226591B1 (ja) |
IL (1) | IL141445A (ja) |
MA (1) | MA24964A1 (ja) |
MX (1) | MXPA01002007A (ja) |
MY (2) | MY125919A (ja) |
NO (1) | NO331255B1 (ja) |
NZ (1) | NZ509963A (ja) |
PE (1) | PE20001036A1 (ja) |
RU (1) | RU2227022C2 (ja) |
UA (1) | UA78967C2 (ja) |
WO (1) | WO2000010536A1 (ja) |
ZA (1) | ZA995445B (ja) |
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