JP2012514629A - 経口送達のための生細胞の配合物 - Google Patents
経口送達のための生細胞の配合物 Download PDFInfo
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- JP2012514629A JP2012514629A JP2011544921A JP2011544921A JP2012514629A JP 2012514629 A JP2012514629 A JP 2012514629A JP 2011544921 A JP2011544921 A JP 2011544921A JP 2011544921 A JP2011544921 A JP 2011544921A JP 2012514629 A JP2012514629 A JP 2012514629A
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- bile
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
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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
-
- 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
- A61K9/48—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
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
【選択図】なし
Description
本発明者らは、経口での細菌の送達に関するモデルとして、生きた細菌のワクチン株SLDAPD pUC18Iを使用した[13]。250mM NaClを加えたM9培地(必須アミノ酸及び栄養素を含む)において細菌を終夜成長させた後、10μlの試料を、記載([14])のように、デシケーター中、40%トレハロース及び1.5%PVPを加えたリン酸緩衝食塩水(PBS)において乾燥させた。複数の(Replicate)試料を乾燥させたままとするか又は200μlのPBS若しくは水で再水和させ、表示されるように1分間、5分間又は20分間放置した。乾燥試料若しくは回復させた試料又は対照細胞(富栄養ブロス培養液由来)をその後、表示されるように酸又は胆汁溶液又は対照緩衝液に十分に(extensively)希釈して1時間インキュベーションし、その後希釈し、寒天プレート上でプレート培養し、終夜培養後のコロニー(overnight colonies)を計数することにより試験した。細菌数を回復時及び試験時の希釈率に関して補正し、元の10μlの試料体積に対するcfu/mlとして表現した。
対照錠剤−スクロース充填剤:粉末化乾燥細菌9%/スクロース粉末91%
対照錠剤−MCC充填剤:粉末化乾燥細菌8%/微結晶性セルロース(MCC、Avicel PH101)92%
BAR錠剤−コレスチラミン:粉末化乾燥細菌8%/コレスチラミン33%/MCC充填剤58%
BAR錠剤−Dowex 1X2:粉末化乾燥細菌6%/Dowex 1X2 400メッシュ樹脂63%/MCC充填剤32%
Claims (28)
- 乾燥生細胞及び胆汁酸結合剤を含む、個体への経口投与のための固体配合物。
- 前記細胞が細菌細胞である、請求項1に記載の固体配合物。
- 前記胆汁結合剤が正に荷電したポリマーである、請求項1又は2に記載の固体配合物。
- 前記正に荷電したポリマーが陰イオン交換樹脂である、請求項3に記載の固体配合物。
- 前記陰イオン交換樹脂がコレスチラミンである、請求項4に記載の固体配合物。
- 前記生細胞を、該細胞中における二糖の細胞内レベルを増大させること、及び炭水化物安定化剤の存在下で前記細胞を乾燥させることにより乾燥させる、請求項1〜5のいずれか一項に記載の固体配合物。
- 前記二糖及び前記炭水化物安定化剤がトレハロースである、請求項6に記載の固体配合物。
- 乾燥生細菌の顆粒及び乾燥胆汁結合剤の顆粒を含むコアを含む、請求項1〜7のいずれか一項に記載の固体配合物。
- 乾燥生細菌を含むコアを含み、該コアが胆汁結合剤を含む層により囲まれる、請求項1〜7のいずれか一項に記載の固体配合物。
- 前記乾燥生細胞がリゾチーム感受性である、請求項1〜9のいずれか一項に記載の固体配合物。
- 陽イオン交換樹脂をさらに含む、請求項10に記載の固体配合物。
- 前記乾燥生細胞が異種核酸を含む、請求項1〜11のいずれか一項に記載の固体配合物。
- 前記異種核酸が外因性抗原をコードする、請求項12に記載の固体配合物。
- 前記乾燥生細胞及び前記胆汁結合剤がポリマーシェルに封入される、請求項1〜13のいずれか一項に記載の固体配合物。
- 前記ポリマーシェルがヒドロキシプロピルメチルセルロースを含む、請求項14に記載の固体配合物。
- 腸溶コーティングで覆われる、請求項1〜15のいずれか一項に記載の固体配合物。
- 生きた乾燥細菌及び胆汁結合剤を含むコア、並びに
前記コアを囲む腸溶コーティング
を含む、請求項16に記載の固体配合物。 - 前記コアが、前記腸溶コーティングでコーティングされるポリマーシェルに封入される、請求項17に記載の固体配合物。
- 経口投与のための固体配合物を製造する方法であって、
生細胞を乾燥させること、並びに
前記乾燥させた生細胞を胆汁酸結合剤、及び必要に応じて薬学的に許容される賦形剤と混和して固体配合物を製造すること
を含む、方法。 - 経口投与のための固体配合物を製造する方法であって、
生細胞を胆汁酸結合剤、並びに必要に応じて薬学的に許容される担体及び/又は上で記載される他の材料と混和して混和物を製造すること、並びに
前記混和物を乾燥させて固体配合物を製造すること
を含む、方法。 - ヒト又は動物の身体の治療処置又は予防処置における使用のための乾燥生細胞及び胆汁酸結合剤の組合せ。
- 個体の腸への生細胞の送達における使用のための、請求項1〜18のいずれか一項に記載の固体配合物。
- ヒト又は動物の身体の治療処置又は予防処置における使用のための、請求項1〜18のいずれか一項に記載の固体配合物。
- 病原体感染症、炎症性腸疾患の治療処置又は予防処置、免疫付与、免疫療法、及び腸の微生物叢の再定着化から選択される方法における使用のための乾燥生細胞及び胆汁酸結合剤の組合せ。
- 病原体感染症、炎症性腸疾患の治療処置又は予防処置、免疫付与、免疫療法、及び腸の微生物叢の再定着化から選択される方法における使用のための、請求項1〜18のいずれか一項に記載の固体配合物。
- 病原体感染症、炎症性腸疾患の治療処置又は予防処置、免疫付与、免疫療法、及び腸の微生物叢の再定着化から選択される方法であって、乾燥生細胞及び胆汁酸結合剤の組合せをそれを必要とする個体に投与することを含む、方法。
- 病原体感染症、炎症性腸疾患の治療処置又は予防処置、免疫付与、免疫療法、及び腸の微生物叢の再定着化から選択される方法であって、請求項1〜18のいずれか一項に記載の固体配合物をそれを必要とする個体に投与することを含む、方法。
- 治療法に関する乾燥生細菌細胞の有効性を増大させる方法であって、該細胞を胆汁酸結合剤と共に製剤化することを含む、方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0900350.0A GB0900350D0 (en) | 2009-01-09 | 2009-01-09 | Formulations of viable bacteria for oral delivery |
GB0900350.0 | 2009-01-09 | ||
PCT/GB2010/000035 WO2010079343A2 (en) | 2009-01-09 | 2010-01-11 | Formulations of viable cells for oral delivery |
Publications (2)
Publication Number | Publication Date |
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JP2012514629A true JP2012514629A (ja) | 2012-06-28 |
JP5779762B2 JP5779762B2 (ja) | 2015-09-16 |
Family
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Application Number | Title | Priority Date | Filing Date |
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JP2011544921A Active JP5779762B2 (ja) | 2009-01-09 | 2010-01-11 | 経口送達のための生細胞の配合物 |
Country Status (13)
Country | Link |
---|---|
US (1) | US10016467B2 (ja) |
EP (1) | EP2384190B1 (ja) |
JP (1) | JP5779762B2 (ja) |
CN (2) | CN102341100A (ja) |
AU (1) | AU2010204159B2 (ja) |
DK (1) | DK2384190T3 (ja) |
ES (1) | ES2640979T3 (ja) |
GB (1) | GB0900350D0 (ja) |
HK (1) | HK1220134A1 (ja) |
HU (1) | HUE034713T2 (ja) |
PL (1) | PL2384190T3 (ja) |
PT (1) | PT2384190T (ja) |
WO (1) | WO2010079343A2 (ja) |
Families Citing this family (7)
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JP6724379B2 (ja) * | 2016-01-20 | 2020-07-15 | 住友ゴム工業株式会社 | 空気入りタイヤ |
US10220003B2 (en) * | 2016-03-09 | 2019-03-05 | Incube Labs, Llc | Methods and articles for delivering viable cells into solid tissue |
EP3746091A4 (en) * | 2018-01-30 | 2021-10-06 | Pharmascience Inc. | CHOLESTYRAMINE FORMULATIONS AND METHODS OF USE |
JP7348299B2 (ja) | 2018-10-30 | 2023-09-20 | バイタボーラス インク. | 治療用哺乳動物細胞の経口送達 |
US10973908B1 (en) | 2020-05-14 | 2021-04-13 | David Gordon Bermudes | Expression of SARS-CoV-2 spike protein receptor binding domain in attenuated salmonella as a vaccine |
EP4124342A1 (en) | 2021-07-28 | 2023-02-01 | Prokarium Limited | Cancer therapy with live attenuated bacteria |
WO2023105076A1 (en) | 2021-12-09 | 2023-06-15 | Prokarium Limited | Combination cancer therapy |
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JP2004250338A (ja) * | 2003-02-18 | 2004-09-09 | Sunstar Inc | 有用生菌製剤 |
WO2008114889A1 (ja) * | 2007-03-19 | 2008-09-25 | Morishita Jintan Co., Ltd. | 経口ワクチン |
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2010
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- 2010-01-11 DK DK10700756.9T patent/DK2384190T3/en active
- 2010-01-11 WO PCT/GB2010/000035 patent/WO2010079343A2/en active Application Filing
- 2010-01-11 JP JP2011544921A patent/JP5779762B2/ja active Active
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- 2010-01-11 EP EP10700756.9A patent/EP2384190B1/en active Active
- 2010-01-11 CN CN2010800104104A patent/CN102341100A/zh active Pending
- 2010-01-11 CN CN201610034562.7A patent/CN105663171B/zh active Active
- 2010-01-11 PL PL10700756T patent/PL2384190T3/pl unknown
- 2010-01-11 ES ES10700756.9T patent/ES2640979T3/es active Active
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2016
- 2016-07-14 HK HK16108256.4A patent/HK1220134A1/zh unknown
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Also Published As
Publication number | Publication date |
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EP2384190B1 (en) | 2017-07-26 |
HUE034713T2 (en) | 2018-02-28 |
US20120027811A1 (en) | 2012-02-02 |
HK1220134A1 (zh) | 2017-04-28 |
AU2010204159A1 (en) | 2011-09-01 |
WO2010079343A2 (en) | 2010-07-15 |
PL2384190T3 (pl) | 2018-01-31 |
PT2384190T (pt) | 2017-10-03 |
AU2010204159B2 (en) | 2015-09-03 |
EP2384190A2 (en) | 2011-11-09 |
CN102341100A (zh) | 2012-02-01 |
ES2640979T3 (es) | 2017-11-07 |
JP5779762B2 (ja) | 2015-09-16 |
CN105663171A (zh) | 2016-06-15 |
US10016467B2 (en) | 2018-07-10 |
CN105663171B (zh) | 2020-09-22 |
DK2384190T3 (en) | 2017-10-16 |
GB0900350D0 (en) | 2009-02-11 |
WO2010079343A3 (en) | 2010-09-02 |
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