JP2008526757A - 免疫応答調節剤製剤および方法 - Google Patents
免疫応答調節剤製剤および方法 Download PDFInfo
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Abstract
Description
本出願は、米国特許仮出願第60/640873号(出願日:2004年12月30日)に対する優先権を主張するものであり、そのすべての内容が本明細書に参照により援用される。
製剤を調製するために使用した賦形剤を、以下の表1に示す。
製剤は、以下の一般的な方法を用いて調製した。緩衝剤を水と混合した。N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドを添加して、溶解するまで撹拌した。得られた溶液を追加の水および必要に応じて等張化剤と混合した。添加する等張化剤の量は、オスメット(Osmette)浸透圧計(マサチューセッツ州ナティック(Natick,MA)のプレシジョンズ・システムズ・インコーポレーテッド(Precisions Systems Inc.)製)で緩衝剤の容積モル浸透圧濃度を計算し、次いで、その差を補うのに必要な等張化剤の量を計算することにより求めた。必要に応じてpH調節剤を添加して、それぞれの製剤を所望のpHに調節した。最後に、それぞれの製剤に水を添加して、最終製剤重量に調節し、その製剤を濾過した。この方法によって調整した製剤は、表2〜表5に見ることができる。その中に沈殿物が生成した製剤は、25℃の水浴に1週間漬けておいて、平衡に達するようにしてから、濾過した。
本発明の製剤について、製剤の分解のための試験を、以下に記載の試験方法を用いて、不純物であるN−[4−(2−エチル−4−オキソ−4,5−ジヒドロ−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミド、および製剤が分解した後のその製剤における色の変化を測定することにより実施した。
N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドを含む一連の水性製剤を調製し、上述の試験方法を使用して分解についての試験を行った。表2〜5に、それぞれの製剤の組成と試験結果を示す。
本発明の製剤は、ある種のサイトカインの産生を誘発し、各種の方法での免疫応答の調節することが可能な免疫応答調節剤として有用であり、そのために、各種の障害を治療するのに有用となる。
(a)ウイルス性疾患、たとえば、下記のものによる感染から来る疾病:アデノウイルス、ヘルペスウイルス(たとえば、HSV−I、HSV−II、CMV、またはVZV)、ポックスウイルス(たとえば、オルソポックスウイルス、たとえば痘瘡もしくはワクシニア、または伝染性軟疣)、ピコルナウイルス(たとえば、ライノウイルスまたはエンテロウイルス)、オルソミクソウイルス(たとえば、インフルエンザウイルス、H5N1トリインフルエンザウイルスを含む)、パラミクソウイルス(たとえば、パラインフルエンザウイルス、流行性耳下腺炎ウイルス、麻疹ウイルス、および呼吸系発疹ウイルス(RSV))、コロナウイルス(たとえば、SARS)、パポーバウイルス(たとえば、パピローマウイルス、たとえば、性器疣贅、尋常性疣贅、または足底疣贅を引き起こすもの)、ヘパドナウイルス(たとえば、B型肝炎ウイルス)、フラビウイルス(たとえば、C型肝炎ウイルスまたはデング熱ウイルス)、または、レトロウイルス(たとえば、レンチウイルスたとえばHIV);
(b)細菌性疾患、たとえば、以下の種の細菌による感染から来る疾患:エシュリキア、エンテロバクター、サルモネラ、ブドウ球菌、赤痢菌、リステリア、アエロバクター、ヘリコバクター、クレブシェラ、プロテウス、シュードモナス、連鎖球菌、クラミジア、マイコプラズマ、肺炎球菌、ナイセリア、クロストリジウム、桿菌、コリネバクテリウム、マイコバクテリウム、カンピロバクター、ビブリオ、セラチア、プロビデンシア、クロモバクテリウム、ブルセラ、イェルシニア、ヘモフィルス、または、ボルデテラなど;
(c)その他の感染症、たとえば、クラミジア、真菌性疾患たとえば(以下のものに限定される訳ではない)カンジダ症、アスペルギルス症、ヒストプラスマ症、クリプトコッカス性髄膜炎、または、寄生虫疾患たとえば(以下のものに限定される訳ではない)マラリア、ニューモシスチスカリニ肺炎、リーシュマニア、クリプトスポリジウム症、トキソプラスマ症、およびトリパノソーマ感染;
(d)腫瘍性疾患、たとえば、上皮内新生物、子宮頸部形成異常、紫外線角化症、基底細胞癌、扁平上皮癌、腎細胞癌、カポジ肉腫、悪性黒色腫、白血病たとえば(以下のものに限定される訳ではない)、骨髄性白血病、急性リンパ性白血病、慢性リンパ性白血病、多発性骨髄腫、非ホジキンリンパ腫、皮膚T細胞リンパ腫、B細胞リンパ腫、および毛様細胞白血病、ならびにその他の癌;
(e)TH2媒介性、アトピー性疾患、たとえばアトピー性皮膚炎または湿疹、好酸球増加症、喘息、アレルギー、アレルギー性鼻炎、およびオーメン症候群;
(f)ある種の自己免疫疾患、たとえば全身性エリテマトーデス、本態性血小板血症、多発性硬化症、円板状エリテマトーデス、円形脱毛症;および
(g)創傷治癒に伴う疾患、たとえば、ケロイド生成およびその他のタイプの瘢痕化の抑制、および創傷、たとえば糖尿病性の脚潰瘍などに伴う慢性創傷の治癒の促進。
Claims (20)
- 注射に好適な水性医薬製剤であって:
前記製剤の中に完全に溶解された医薬化合物N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミド;
水;
クエン酸、酢酸、乳酸、コハク酸、および酒石酸からなる群より選択される緩衝剤;および
場合により等張度調節剤;を含み、
そのpHが6以下であり、滅菌されている、前記製剤。 - 前記N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドが、少なくとも1mg/mlの濃度で存在する、請求項1に記載の製剤。
- 前記N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドが、少なくとも2mg/mlの濃度で存在する、請求項1に記載の製剤。
- 前記N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドが、少なくとも5mg/mlの濃度で存在する、請求項1に記載の製剤。
- 前記N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドが、少なくとも10mg/mlの濃度で存在する、請求項1に記載の製剤。
- 前記緩衝剤が、クエン酸および酢酸からなる群より選択される、請求項1〜5のいずれか一項に記載の製剤。
- 前記緩衝剤がクエン酸である、請求項6に記載の製剤。
- pHが5である、請求項1〜7のいずれか一項に記載の製剤。
- 被験者に製剤を注射することにより、医薬化合物N−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミドを送達する方法であって、ここで、前記製剤が:
前記製剤の中に完全に溶解されたN−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミド;
水;
クエン酸、酢酸、乳酸、コハク酸、および酒石酸からなる群より選択される緩衝剤;および
場合により等張度調節剤;を含み、
そのpHが6以下であり、前記製剤が滅菌されている、前記方法。 - 前記製剤が静脈内に注射される、請求項9に記載の方法。
- 前記製剤が皮下に注射される、請求項9に記載の方法。
- 前記製剤が腫瘤の中に注射される、請求項9に記載の方法。
- 疾患の治療を必要とする被験者に製剤を注射することによって、疾患を治療する方法であって、前記製剤が:
前記製剤の中に完全に溶解されたN−[4−(4−アミノ−2−エチル−1H−イミダゾ[4,5−c]キノリン−1−イル)ブチル]メタンスルホンアミド;
水;
クエン酸、酢酸、乳酸、コハク酸、および酒石酸からなる群より選択される緩衝剤;および
場合により等張度調節剤;を含み、
そのpHが6以下であり、前記製剤が滅菌されている、前記方法。 - 前記注射が皮下注射である、請求項13に記載の方法。
- 前記注射が静脈内注射である、請求項13に記載の方法。
- 前記注射が直接腫瘤の中に行われる、請求項13に記載の方法。
- 前記疾患が転移性悪性黒色腫である、請求項13に記載の方法。
- 前記製剤に、ソルビトールおよびマンニトールからなる群より選択される等張度調節剤が含まれる、請求項1〜17のいずれか一項に記載の製剤または方法。
- 前記等張度調節剤がマンニトールである、請求項18に記載の製剤または方法。
- 前記製剤が塩化ナトリウムを実質的に含まない、請求項1〜19のいずれか一項に記載の製剤または方法。
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JP2007549552A Withdrawn JP2008526752A (ja) | 2004-12-30 | 2005-12-28 | 免疫応答調節剤化合物の多経路投与 |
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EP (2) | EP1830880A4 (ja) |
JP (2) | JP2008526757A (ja) |
CN (1) | CN101443005A (ja) |
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CA (2) | CA2592573A1 (ja) |
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JP2016535775A (ja) * | 2013-11-05 | 2016-11-17 | スリーエム・イノベイティブ・プロパティーズ・カンパニー | ゴマ油ベースの注射製剤 |
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ZA200706251B (en) | 2008-11-26 |
WO2006074045A3 (en) | 2006-10-12 |
AU2005322843A1 (en) | 2006-07-13 |
EP1835915A2 (en) | 2007-09-26 |
CA2592573A1 (en) | 2006-07-13 |
EP1830880A4 (en) | 2008-03-26 |
AU2005322843B2 (en) | 2012-03-08 |
EP1835915A4 (en) | 2010-02-24 |
EP1830880A2 (en) | 2007-09-12 |
US20110021554A1 (en) | 2011-01-27 |
CN101443005A (zh) | 2009-05-27 |
US20080119508A1 (en) | 2008-05-22 |
WO2006073940A3 (en) | 2006-11-30 |
US20080207674A1 (en) | 2008-08-28 |
JP2008526752A (ja) | 2008-07-24 |
WO2006074045A2 (en) | 2006-07-13 |
WO2006073940A2 (en) | 2006-07-13 |
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CA2592575A1 (en) | 2006-07-13 |
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