JP2021504350A - 寄生虫の寄生を治療するためのモキシデクチンを含有する組成物 - Google Patents
寄生虫の寄生を治療するためのモキシデクチンを含有する組成物 Download PDFInfo
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- JP2021504350A JP2021504350A JP2020528262A JP2020528262A JP2021504350A JP 2021504350 A JP2021504350 A JP 2021504350A JP 2020528262 A JP2020528262 A JP 2020528262A JP 2020528262 A JP2020528262 A JP 2020528262A JP 2021504350 A JP2021504350 A JP 2021504350A
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Abstract
Description
薬物とは、公認の薬局方または処方書によって認められた物質、疾患の診断、治癒、緩和、治療、または予防における使用を企図した物質、身体の構造または何らかの機能に影響を及ぼすことを企図した物質(食品以外)、医薬品の構成要素としての使用を企図した物質として定義されるが、装置または装置の構成要素、部品もしくは付属品として定義されない(生物製剤はこの定義内に含まれており、概して同じ法律および規制の対象であるが、相違点は、それらの製造プロセス、すなわち、化学プロセス対生物学的プロセスに関して存在している)。
・約3w/v%のモキシデクチン、
・約1w/v%のエチルセルロース、
・約0.05w/v%のBHT、
・約32w/v%の中鎖TG、および
・合計量1mLのベンジルアルコール。
30mg/mLのモキシデクチンについては、ピペット(ピペット容積)で次のとおりである。
・超小型犬(4kg以下):0.4mL、
・小型犬(4kg超〜10kg):1mL、
・中型犬(10kg超〜25kg):2.5mL、
・大型犬(25kg超〜40kg):4mL、
・超大型犬(40kg超〜60kg):6mL、
・極超大型犬75kg超(165ポンド超:7.5mL。
・超小型犬(4kg以下):0.5mL、
・小型犬(4kg超〜10kg):1.25mL、
・中型犬(10kg超〜25kg):3.125mL、
・大型犬(25kg超〜40kg):5mL、
・超大型犬(40kg超〜60kg):7.5mL、
・極超大型犬75kg超(165ポンド超):11.25mL。
・Demodex属:cati
・Otodectes属:cynotis
・Notoedres属:cati
・Sarcoptes属:scabiei
・Cheyletiella属:blakei、parasitovorax
・Dermanyssus属:gallinae
・Neotrombicula属:autumnalis
好ましいダニは、Otodectes属(耳ダニ)である。
・Cheyletiella属:yasguri
・Otodectes属:cyanoti
・Sarcoptes属:scabiei
・Notoedres属:cati
・Demodex属:canis
・Dermanyssus属:gallinae
・Neotrombicula属:autumnalis。
好ましいダニはOtodectes属(耳ダニ)である。
・Schistosoma属:japonicum、rodhaini
・Dirofilaria属:immitis
・Brugia属:pahangi、malayi
好ましい循環器系ワームは、Dirofilaria属(immitis:心糸状虫)である。
・Angiostrongylus属:vasorum
・Schistosoma属:japonicum、spindale、incognitum、
・Heterobilharzia属:americana
・Dirofilaria属:immitis
・Brugia属:pahangi、malayi。
好ましい循環器系ワームは、Dirofilaria属(immitis:心糸状虫)である。
・Toxoscaris属:leonina
・Toxocara属:mystax、malayensis
・Ancylostoma属:braziliense、ceylanicum、tibaeforme
・Uncinaria属:stenocephala
・Strongyloides属:stercocoralis、planiceps、felis、tumefaciens
・Diphyllobothrium属:latum、caninum
・Echinococcus属:multilocularis、oligarthrus
・Spirometra属:masoni、mansonoides、erinacei
・Taenia属:taeniaeformis
・Mesocestoides属:lineatus
・Alaria属:alata、minessotae、marcianae
・Heterophyes属:heterophyes、nocens
・Metagonimus属:yokogawai
・Apophallus属:donicum、mulhingi
・Cryptocotyle属:lingua
・Echinochasmus属:perfoliatus
・Euparyphium属:melis
・Nanophyetus属:salmincola
・Macracanthorhynchus属:hirudinaceus、catalinum
・Onicola属:campanulatus
・Trichinella属:serrata、vulpis、campanula。
・Toxocara属:canis、leonina
・Ancylostoma属:caninum、braziliense、ceylanicum
・Uncinaria属:stenocephala
・Strongyloides属:stercoralis
・Diphyllobothrium属:latum、caninum
・Echinococcus属:granulosus、quinus、orteleppi、multilocularis、vogeli
・Spirometra属:masoni、mansonoides
・Taenia属:hydatigena、multiceps、ovis、pisiformis、serialis、crassiceps
・Mesocestoides属:lineatus
・Alaria属:alata、americana、canis、michiganensis
・Heterophyes属:heterophyes、nocens
・Metagonimus属:yokogawai
・Apophallus属:donicum、mulhingi
・Cryptocotyle属:lingua
・Echinochasmus属:perfoliatus、ilocanum
・Nanophyetus属:salmincola。
製造容器内で、以下に示す組成によるモキシデクチン溶液を調製した。撹拌の下で、一部のベンジルアルコール、ブチルヒドロキシルトルエン(BHT)、炭酸プロピレンおよびモキシデクチンを添加した。次に、容積をベンジルアルコールで合計量にした。
製造容器内で、以下に示す組成によるモキシデクチン溶液を調製した。攪拌の下で、一部のイソプロピルアルコール、BHT、ジプロピレングリコールモノメチルエーテル(DPGME)およびモキシデクチンを添加した。次に、容積をイソプロピルアルコールで合計量にした。
実施例1と同じプロセスを使用した。
実施例2と同じプロセスを使用した。
製造容器内に、以下に示す組成によるモキシデクチン溶液を調製した。撹拌の下で、一部のベンジルアルコール、ブチルヒドロキシルトルエン、炭酸プロピレン、ポリビニルピロリドンおよびモキシデクチンを添加した。次に、容積をベンジルアルコールで合計量にした。
製造容器内で、以下に示す組成によるモキシデクチン溶液を調製した。撹拌の下で、一部のイソプロピルアルコール、ブチルヒドロキシルトルエン、DPGME、ポリビニルピロリドンおよびモキシデクチンを添加した。次に、イソプロピルアルコールで容積を合計量にした。
製造容器内で、以下に示す組成によるモキシデクチン溶液が調製された。撹拌の下で、一部のベンジルアルコール、ブチルヒドロキシルトルエン(BHT)、中鎖トリグリセリドおよびエチルセルロースを添加した。溶液が均質になったとき、モキシデクチンを添加した。次に、容積をベンジルアルコールで合計量にした。
製造容器内で、以下に示す組成によるモキシデクチン溶液を調製した。撹拌の下で、一部のベンジルアルコール、ブチルヒドロキシルトルエン(BHT)、中鎖トリグリセリド、PEG−35ひまし油、およびモキシデクチンを添加した。次に、容積はベンジルアルコールで合計量にした。
製造容器内で、以下に示す組成によるモキシデクチン溶液を調製した。撹拌の下で、一部のベンジルアルコール、ブチルヒドロキシルトルエン(BHT)、中鎖トリグリセリドおよびエチルセルロースを添加した。溶液が均質になったとき、モキシデクチンを添加した。次に、容積をベンジルアルコールで合計量にした。
製造容器内で、以下に示す組成によるモキシデクチン溶液を調製した。撹拌の下で、一部のベンジルアルコール、ブチルヒドロキシルトルエン(BHT)、中鎖トリグリセリドおよびエチルセルロースを添加した。溶液が均質になったとき、モキシデクチンおよびPEG−35ひまし油を添加した。次に、容積をベンジルアルコールで合計量にした。
製剤1の試料を、3mg/kgのモキシデクチン用量でビーグル犬3匹に投与した。薬物動態情報を、0.17mg/kgの用量で投与する注射可能な製品Proheart 6(登録商標)と比較した。平均血漿情報は、腸内ワームの根絶に適した5ng/mlを上回る最大濃度(Cmax)と、6か月間の心糸状虫予防を可能にするProheart(登録商標)6と類似のまたはそれを上回る血漿持続性を呈する。
独特な局所適用の後、モキシデクチンに感受性のあるほとんどの内部寄生虫を標的にすることができる。
実施例7〜10に説明する局所製剤A106、A73、A107およびA108をイヌで検査した。ビーグル犬8匹からなる群を、各製剤の単回用量(0.1ml/kg)で処置し、薬物動態用に血液を採取した。局所製剤は十分に許容された。吸収は迅速で、持続し、有意であった。Proheartと類似の持続的な血中濃度(実施例1および図1)が、処置後210日を超えて観察された。
Claims (16)
- 非ヒト哺乳動物における寄生虫の寄生を予防および/または治療する上での使用のための、モキシデクチンまたはその塩を含む動物用組成物または薬学的組成物であって、3〜9か月ごとに局所投与されることを特徴とする、動物用組成物または薬学的組成物。
- 非ヒト哺乳動物における寄生虫の寄生を予防および/または治療する上での使用のための、モキシデクチンまたはその塩を唯一の有効成分として含む動物用組成物または薬学的組成物であって、3〜9か月ごとに局所投与されることを特徴とする、動物用組成物または薬学的組成物。
- モキシデクチンが、1〜4w/v%で構成された濃度を有する、請求項1または2に記載の使用のための、動物用組成物または薬学的組成物。
- 前記非ヒト哺乳動物がイヌなどのペットである、請求項1〜3のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記寄生虫の寄生が線虫によって生じる、請求項1〜4のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記線虫がdirofilaria immitisである、請求項5に記載の使用のための、動物用組成物または薬学的組成物。
- 前記寄生虫の寄生が耳ダニによって生じる、請求項1〜6のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物が3〜6か月ごとに投与される、請求項1〜7のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物が9か月ごとに投与される、請求項1〜8のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物の局所投与がラインオン投与である、請求項1〜9のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物の局所投与がスポットオン投与である、請求項1〜10のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物が、酸化防止剤としてブチルヒドロキシトルエンをさらに含む、請求項1〜11のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物が、ベンジルアルコール、イソプロピルアルコール、中鎖トリグリセリド、炭酸プロピレン、ジプロピレングリコールモノメチルエーテル、およびこれらの混合物のうちで選択される溶剤をさらに含む、請求項1〜12のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 前記組成物が、
・約3w/v%のモキシデクチンと、
・約1w/v%のエチルセルロースと、
・約0.05w/v%のBHTと、
・約32w/v%の中鎖TGと、
・合計量を1mLにするベンジルアルコールと、を含む、請求項1〜13のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。 - 前記モキシデクチンが、約1.5mg/kg体重〜3.5mg/kg体重、好ましくは約3.0mg/kg体重で含まれる量で投与される、請求項1〜14のいずれか一項に記載の使用のための、動物用組成物または薬学的組成物。
- 非ヒト哺乳動物における寄生虫の寄生の治療および/または予防の方法であって、3〜9か月ごとに前記非ヒト哺乳動物に、モキシデクチンまたはその塩を含む動物用組成物または薬学的組成物を局所投与することを含む、方法。
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