JP7033848B2 - 免疫グロブリンg調製物の皮内投与 - Google Patents
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Description
ID経路は、IgGの自己投与を可能にするための新規な方法を提供することができる。したがって、いくつかの実施形態において、本開示は、IgG調製物をID経路により投与するための方法を提供する。いくつかの実施形態において、本方法は、IgG調製物のID経路による自己投与を提供する。いくつかの実施形態において、本方法は、SC経路と比較して、IgGの優れた血漿薬物動態プロフィールを提供する。いくつかの実施形態において、本方法は、SC経路と比較して、より速いTmaxを有する、IgGの優れた血漿薬物動態プロフィールを提供する。
a)大量のIgG調製物を、針を含むID送達装置に添加する工程、
b)装置を皮膚送達部位にあてがう工程、
c)装置を使用して、針を真皮侵入させる工程、
d)大量のIgG調製物を皮膚送達部位において送達する工程、及び
e)送達装置を除去する工程。
いくつかの実施形態において、組成物は、IgG調製物である。いくつかの実施形態において、組成物はIgG溶液である。いくつかの実施形態において、IgGの濃度は約15%から約30%(w/v)の間であり得る。いくつかの実施形態において、濃度は約7%~約14%である。いくつかの実施形態において、濃度は約23%~約30%である。いくつかの実施形態において、濃度は、約5%、6%、7%、8%、9%、10%、11%、12%、13%、14%、15%、16%、17%、18%、19%、20%、21%、22%、23%、24%、25%、26%、27%、28%、29%、又は30%(w/v)である。いくつかの実施形態において、濃度は約30%又はそれ以上である。
IgG調製物の、IV、SC、及びID経由によるブタへの投与
若い家畜用ブタ(20~25kg)に、IgG(20mg/kg)をIV(n=4)、SC(n=4)、及びID(n=3)経路により投与した。イムノアッセイによるヒト特異的IgGの測定のために、静脈血試料を、IgG投与後2分目、30分目、及び60分目、3時間目及び6時間目、その後、10日間、毎日、採取した。
IgG調製物pHの送達部位への影響
IgG調製物pHの送達部位への影響を評価するために、2mLのGamunex(登録商標)及びIGSC 20% IgG製剤(Grifols Therapeuctics Inc.社、USA)どちらもpH4.0、並びにIGIM-S/D(Grifols Therapeuctics Inc.社、USA)pH6.5を若い家畜用ブタに投与した。
小児処置
本開示による方法は、原発性免疫不全症を有する小児患者を処置するために用いることができる。患者の体重は、約25kgである。そのような患者についての典型的な用量範囲は、約4週間にわたって、約300~約800mg/kg体重である。この用量は、約2mL又は約4mLの濃縮されたIgG調製物の1回のID投与で本方法を用いて達成することができる。濃縮されたIgG調製物は、約16.5%又は約20%(w/v)のIgGの濃度を有する。
Claims (16)
- それを必要としている対象における免疫不全症の処置に使用するための、IgGを含む組成物であって、針を含む除去可能な皮内(ID)送達装置を使用してID経路により投与され、前記組成物のpHが4.5から8.0までであり、及び、前記組成物が15%~30%(w/v)のIgG濃度を有する、組成物。
- 前記組成物のpHが6.5である、請求項1に記載の組成物。
- 前記組成物の体積が、皮膚送達部位あたり最高10mLまでである、請求項1に記載の組成物。
- 前記組成物の体積が、皮膚送達部位あたり2mLから8mLの間である、請求項3に記載の組成物。
- 前記組成物の体積が、皮膚送達部位あたり4mLから6mLの間である、請求項3に記載の組成物。
- 1つ又は複数の追加の血漿タンパク質を含む、請求項1に記載の組成物。
- 前記対象が小児患者である、請求項1に記載の組成物。
- 前記対象が非小児患者である、請求項1に記載の組成物。
- それを必要としている対象における疾患の処置のための、IgGを含む組成物であって、
前記組成物が、針を含む除去可能な皮内(ID)送達装置を使用してID経路により投与され、
前記組成物のpHが4.5から8.0までであり、及び、前記組成物におけるIgGの濃度が15%~30%(w/v)である、組成物。 - pHが6.5である、請求項9に記載の組成物。
- 前記対象が小児患者である、請求項9に記載の組成物。
- 前記対象が非小児患者である、請求項9に記載の組成物。
- 前記疾患が免疫不全症である、請求項9に記載の組成物。
- 前記免疫不全症が、原発性免疫不全症、続発性免疫不全症、又は後天性免疫不全症のうちの1つである、請求項13に記載の組成物。
- IgG分子全体、IgGの治療に有効な断片、又はそれらの組合せを含む、請求項9に記載の組成物。
- 1つ又は複数の追加の血漿タンパク質を含む、請求項9に記載の組成物。
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US201662292075P | 2016-02-05 | 2016-02-05 | |
US62/292,075 | 2016-02-05 |
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JP2017137297A JP2017137297A (ja) | 2017-08-10 |
JP7033848B2 true JP7033848B2 (ja) | 2022-03-11 |
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US (2) | US20170226191A1 (ja) |
EP (1) | EP3202393B1 (ja) |
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JP2014514345A (ja) | 2011-05-02 | 2014-06-19 | イミューノメディクス、インコーポレイテッド | 少容量投与用のアロタイプ選択抗体の限外濾過濃縮 |
WO2014143909A1 (en) | 2013-03-15 | 2014-09-18 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
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US7754208B2 (en) | 2001-01-17 | 2010-07-13 | Trubion Pharmaceuticals, Inc. | Binding domain-immunoglobulin fusion proteins |
US20050180952A1 (en) * | 2003-08-26 | 2005-08-18 | Pettis Ronald J. | Methods for intradermal delivery of therapeutics agents |
CN103897063B (zh) | 2007-06-01 | 2017-04-12 | 马里兰大学巴尔的摩分校 | 免疫球蛋白恒定区Fc受体结合剂 |
TWI532498B (zh) * | 2008-03-17 | 2016-05-11 | 巴克斯特保健公司 | 供免疫球蛋白及玻尿酸酶之皮下投藥之用的組合及方法 |
WO2016161423A1 (en) | 2015-04-02 | 2016-10-06 | Kieu Hoang | Process of cloning and further purification to make a recombinant intravenous immunoglobulin |
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WO2005086773A3 (en) | 2004-03-08 | 2007-01-25 | Becton Dickinson Co | A method for delivering therapeutic proteins to the intradermal compartment |
JP2014514345A (ja) | 2011-05-02 | 2014-06-19 | イミューノメディクス、インコーポレイテッド | 少容量投与用のアロタイプ選択抗体の限外濾過濃縮 |
WO2014143909A1 (en) | 2013-03-15 | 2014-09-18 | Bayer Healthcare Llc | Anti-prolactin receptor antibody formulations |
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IL249795B (en) | 2020-01-30 |
KR20170093704A (ko) | 2017-08-16 |
MX2017000268A (es) | 2018-07-04 |
IL249795A0 (en) | 2017-03-30 |
CA2953543A1 (en) | 2017-08-05 |
MY198746A (en) | 2023-09-22 |
UY37061A (es) | 2017-03-31 |
EP3202393B1 (en) | 2022-08-31 |
TW201728338A (zh) | 2017-08-16 |
EP3202393A1 (en) | 2017-08-09 |
RU2762499C2 (ru) | 2021-12-21 |
JP2017137297A (ja) | 2017-08-10 |
US12091444B2 (en) | 2024-09-17 |
TWI791425B (zh) | 2023-02-11 |
CN107041953A (zh) | 2017-08-15 |
ES2929631T3 (es) | 2022-11-30 |
AU2017200007B2 (en) | 2023-07-06 |
AR107295A1 (es) | 2018-04-18 |
PL3202393T3 (pl) | 2022-12-19 |
AU2017200007A1 (en) | 2017-08-24 |
US20200199201A1 (en) | 2020-06-25 |
RU2017100665A3 (ja) | 2020-05-20 |
US20170226191A1 (en) | 2017-08-10 |
SG10201700022QA (en) | 2017-09-28 |
CL2017000016A1 (es) | 2017-06-16 |
RU2017100665A (ru) | 2018-07-16 |
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