JP2015537029A - 生物学的に活性な物質及び不規則性無機酸化物を含有する組成物 - Google Patents
生物学的に活性な物質及び不規則性無機酸化物を含有する組成物 Download PDFInfo
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- HUNXMJYCHXQEGX-UHFFFAOYSA-N zaleplon Chemical compound CCN(C(C)=O)C1=CC=CC(C=2N3N=CC(=C3N=CC=2)C#N)=C1 HUNXMJYCHXQEGX-UHFFFAOYSA-N 0.000 description 1
- 229960000607 ziprasidone Drugs 0.000 description 1
- MVWVFYHBGMAFLY-UHFFFAOYSA-N ziprasidone Chemical compound C1=CC=C2C(N3CCN(CC3)CCC3=CC=4CC(=O)NC=4C=C3Cl)=NSC2=C1 MVWVFYHBGMAFLY-UHFFFAOYSA-N 0.000 description 1
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Abstract
Description
この実施例では、以下表2に掲載するダナゾールを内包させたシリカ粉末を、過飽和条件下(すなわち、内包させたダナゾールの完全な放出が、平衡溶解度が過剰である濃度の生成と関連づけられる条件下)でFaSSIFに分散させた。2mgダナゾール投与量に相当する量の内包シリカ粉末を40mLのFaSSIFに分散させた。
この実施例では、以下表3に掲載するイトラコナゾールを内包させたシリカ粉末を、過飽和条件下(すなわち、内包させたイトラコナゾールの完全な放出が平衡溶解度が過剰である濃度の生成と関連づけられる条件下)でSGFに分散させた。2mgイトラコナゾール投与量に相当する量の内包シリカ粉末を20mLのSGFに分散させた。
この実施例では、以下表4に掲載するフェノフィブラートを内包させたシリカ粉末を、平衡濃度未満の条件下(すなわち、内包させたフェノフィブラートの完全な放出が平衡溶解度未満である濃度の生成と関連づけられる条件下)でFaSSIFに分散させた。0.8mgフェノフィブラート投与量に相当する量の内包シリカ粉末を20mlのFaSSIFに分散させた。
この実施例では、以下表5に掲載するダナゾールを内包させたシリカ粉末の混合物を、0.5% Tween 80(pH 6.5)を添加したリン酸緩衝液を含む媒質に分散させた。1mgダナゾール投与量に相当する量の内包シリカ粉末を32mlの媒質に分散させた。
Claims (67)
- 生物学的に活性な物質及び無機酸化物を含む組成物であって、前記無機酸化物が、
約2.5nm〜約15.0nmの平均細孔径を有する細孔と、
窒素ポロシメトリーにより測定したときに、約0.5cc/g以上の細孔容積を有する細孔と、
窒素吸着により測定したときに、約300m2/g以上のBET表面積と、を含む不規則性多孔質材料を含む、組成物。 - 前記平均細孔径が約2.5nm〜約10.0nmである、請求項1に記載の組成物。
- 前記平均細孔径が約3.0nm〜約10.0nmである、請求項1又は2に記載の組成物。
- 前記細孔容積が約0.6cc/g以上である、請求項1〜3のいずれか一項に記載の組成物。
- 前記細孔容積が約0.7cc/g以上である、請求項1〜4のいずれか一項に記載の組成物。
- 前記表面積が約350cm2/g以上である、請求項1〜5のいずれか一項に記載の組成物。
- 前記表面積が約400cm2/g以上である、請求項1〜6のいずれか一項に記載の組成物。
- (i)前記平均細孔径が約5.0nm〜約10.0nmであり、(ii)前記細孔容積が約0.7cc/g以上であり、かつ(iii)前記表面積が約400m2/g以上である、請求項1〜7のいずれか一項に記載の組成物。
- 前記細孔容積が約0.5cc/g超に増加するにつれて、前記表面積が、(1)細孔容積1.1cc/g超において、300m2/gに0.1cc/gの増加あたり約27m2/gを加えた合計として表される最低表面積量から、(2)細孔容積0.5cc/g超において、800m2/gに0.1cc/g増加あたり約160m2/gを加えた合計として表される最大表面積量の範囲にわたる、請求項1〜8のいずれか一項に記載の組成物。
- 前記細孔容積が約0.7cc/g超に増加するにつれて、前記表面積が、(1)細孔容積1.0cc/g超において、400m2/gに0.1cc/gの増加あたり約40m2/gを加えた合計として表される最低表面積量から、(2)細孔容積0.7cc/g超において、560m2/gに0.1cc/gの増加あたり約84m2/gを加えた合計として表される最大表面積量の範囲にわたる、請求項1〜8のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、約500m2/g以上である比表面積を更に含む、請求項1〜10のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、約600m2/g以上である比表面積を更に含む、請求項1〜11のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、不規則性多孔質材料の重量に基づき、4重量%超の強熱減量を有する、請求項1〜12のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、不規則性多孔質材料の重量に基づき、5重量%超の強熱減量を有する、請求項1〜12のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、不規則性多孔質材料の重量に基づき、6重量%超の強熱減量を有する、請求項1〜12のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、不規則性多孔質材料の重量に基づき、7重量%超の強熱減量を有する、請求項1〜12のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度又はその平衡溶解度よりも少なくとも約2倍高い、請求項1〜16のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度よりも少なくとも約2〜約10倍高い、請求項1〜16のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約0.4の細孔径分布相対スパンを有する、請求項1〜18のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約1.0の細孔径分布相対スパンを有する、請求項1〜18のいずれか一項に記載の組成物。
- 前記無機酸化物が、異なっていて区別できる2以上のタイプの不規則性多孔質材料を含む、請求項1〜20のいずれか一項に記載の組成物。
- 前記無機酸化物が、異なっていて区別できる2以上のタイプの不規則性多孔質材料を含み、前記生物学的に活性な物質についての複合溶解速度プロファイルを形成するように、区別できるそれぞれのタイプの不規則性多孔質材料が前記生物学的に活性な物質についての1つの特有の溶解速度プロファイルを与える、請求項1〜20のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質についての前記複合溶解速度プロファイルが、いずれのタイプの不規則性多孔質材料についてのいずれの特有の溶解速度プロファイルと比較しても大きな、前記生物学的に活性な物質についての全体的な溶解速度を与える、請求項22に記載の組成物。
- 前記無機酸化物が、少なくとも1種の規則性多孔質材料を更に含む、請求項1〜20のいずれか一項に記載の組成物。
- 医薬組成物であって、
医薬的投与量の少なくとも1種の製剤成分と、
生物学的に活性な物質及び無機酸化物を含む薬剤放出組成物と、を含み、前記無機酸化物が、
約2.5nm〜約15.0nmの平均細孔径を有する細孔と、
窒素ポロシメトリーにより測定したときに、約0.5cc/g以上の細孔容積を有する細孔と、
窒素吸着により測定したときに、約300m2/g以上のBET表面積と、を含む不規則性多孔質材料を含む、医薬組成物。 - 前記平均細孔径が約2.5nm〜約10.0nmである、請求項25に記載の組成物。
- 前記平均細孔径が約3.0nm〜約10.0nmである、請求項25又は26に記載の組成物。
- 前記細孔容積が約0.6cc/g以上である、請求項25〜27のいずれか一項に記載の組成物。
- 前記細孔容積が約0.7cc/g以上である、請求項25〜28のいずれか一項に記載の組成物。
- 前記表面積が約350cm2/g以上である、請求項25〜29のいずれか一項に記載の組成物。
- 前記表面積が約400cm2/g以上である、請求項25〜30のいずれか一項に記載の組成物。
- (i)前記平均細孔径が約5.0nm〜約10.0nmであり、(ii)前記細孔容積が約0.7cc/g以上であり、かつ(iii)前記表面積が約400m2/g以上である、請求項25〜31のいずれか一項に記載の組成物。
- 前記細孔容積が約0.5cc/g超増加するにつれて、前記表面積が、(1)細孔容積1.1cc/g超において、300m2/gに0.1cc/gの増加あたり約27m2/gを加えた合計として表される最低表面積量から、(2)細孔容積0.5cc/g超において、800m2/gに0.1cc/gの増加あたり約160m2/gを加えた合計として表される最大表面積量の範囲にわたる、請求項25〜32のいずれか一項に記載の組成物。
- 前記細孔容積が約0.7cc/g超に増加するにつれて、前記表面積が、(1)細孔容積1.0cc/g超において、400m2/gに0.1cc/gの増加あたり約40m2/gを加えた合計として表される最低表面積量から、(2)細孔容積0.7cc/g超において、560m2/gに加え0.1cc/gの増加あたり約84m2/gを加えた合計として表される最大表面積量の範囲にわたる、請求項25〜33のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、約500m2/g以上の比表面積を更に含む、請求項21〜34のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、約600m2/g以上の比表面積を更に含む、請求項25〜30のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質が少なくとも1種の医薬品有効成分(API)を含む、請求項1〜36のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質がエゼチミブ(ezetimimbe)を含む、請求項1〜36のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質がタダラフィルを含む、請求項1〜36のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質がフェノフィブラートを含む、請求項1〜36のいずれか一項に記載の組成物。
- 前記無機酸化物が、異なっていて区別できる2以上のタイプの不規則性多孔質材料を含む、請求項25〜40のいずれか一項に記載の組成物。
- 前記無機酸化物が、異なっていて区別できる2以上のタイプの不規則性多孔質材料を含み、前記生物学的に活性な物質についての複合溶解速度プロファイルを形成するように、区別できるそれぞれのタイプの不規則性多孔質材料が前記生物学的に活性な物質についての1つの特有の溶解速度プロファイルを与える、請求項25〜41のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質についての前記複合溶解速度プロファイルが、いずれのタイプの不規則性多孔質材料のいずれの特有の溶解速度プロファイルと比較しても大きなる、前記生物学的に活性な物質についての全体的な溶解速度を与える、請求項42に記載の組成物。
- 前記無機酸化物が、少なくとも1種の規則性多孔質材料を更に含む、請求項25〜43のいずれか一項に記載の組成物。
- 前記無機酸化物が酸化ケイ素を含む、請求項25〜44のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度又はその平衡溶解度よりも少なくとも約2倍高い、請求項25〜45のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度よりも少なくとも約2〜約10倍高い、請求項25〜45のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約0.4の細孔径分布相対スパンを有する、請求項25〜45のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約1.0の細孔径分布相対スパンを有する、請求項25〜45のいずれか一項に記載の組成物。
- 請求項1〜49のいずれか一項に記載の組成物の使用方法であって、
前記生物学的に活性な物質を患者に送達するよう前記組成物を前記患者に投与することを含む、使用方法。 - 請求項1〜49のいずれか一項に記載の組成物の製造方法であって、
前記生物学的に活性な物質を前記無機酸化物に組み込むことを含む、製造方法。 - 生物学的に活性な物質及び無機酸化物を含む組成物であって、前記無機酸化物は不規則性多孔質材料を含み、細孔容積が約0.5cc/g超に増加するにつれて、前記表面積が、(1)細孔容積1.1cc/g超において、300m2/gに0.1cc/gの増加あたり約27m2/gを加えた合計として表される最低表面積量から(2)細孔容積0.5cc/g超において、800m2/gに0.1cc/gの増加あたり約160m2/gを加えた合計として表される最大表面積量の範囲にわたる、組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度又はその平衡溶解度よりも少なくとも約2倍高い、請求項52に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度よりも少なくとも約2〜約10倍高い、請求項52又は53に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約0.4の細孔径分布相対スパンを有する、請求項52〜54のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約1.0の細孔径分布相対スパンを有する、請求項52〜55のいずれか一項に記載の組成物。
- 生物学的に活性な物質及び無機酸化物を含む組成物であって、前記無機酸化物が、異なっていて区別できる2以上のタイプの不規則性多孔質材料を含み、前記生物学的に活性な物質についての複合溶解速度プロファイルを形成するように、区別できるそれぞれのタイプの不規則性多孔質材料が前記生物学的に活性な物質についての1つの特有の溶解速度プロファイルを与える、組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度又はその平衡溶解度よりも少なくとも約2倍高い、請求項57に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度よりも少なくとも約2〜約10倍高い、請求項57又は58のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約0.4の細孔径分布相対スパンを有する、請求項57〜59のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約1.0の細孔径分布相対スパンを有する、請求項57〜60のいずれか一項に記載の組成物。
- 生物学的に活性な物質及び無機酸化物を含む組成物であって、前記無機酸化物が、異なっていて区別できる2以上のタイプの多孔質材料を含み、第1の多孔質材料が少なくとも1つのタイプの不規則性多孔質材料を含み、第2の多孔質材料が少なくとも1つのタイプの規則性多孔質材料を含む、組成物。
- 前記生物学的に活性な物質についての複合溶解速度プロファイルを形成するように、前記第1及び第2の多孔質材料のそれぞれが、前記生物学的に活性な物質についての1つの特有の溶解速度プロファイルを与える、請求項62に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度又はその平衡溶解度よりも少なくとも約2倍高い、請求項62又は63のいずれか一項に記載の組成物。
- 前記生物学的に活性な物質の試験管内溶解速度が、結晶形態の生物学的に活性な物質の溶解速度よりも少なくとも約2〜約10倍高い、請求項62〜64のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約0.4の細孔径分布相対スパンを有する、請求項62〜65のいずれか一項に記載の組成物。
- 前記不規則性多孔質材料が、少なくとも約1.0の細孔径分布相対スパンを有する、請求項62〜66のいずれか一項に記載の組成物。
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ES2821528T3 (es) | 2021-04-26 |
EP2919903A4 (en) | 2016-08-10 |
PL2919903T3 (pl) | 2020-12-14 |
HUE051406T2 (hu) | 2021-03-01 |
JP7373309B2 (ja) | 2023-11-02 |
JP2022000430A (ja) | 2022-01-04 |
JP2023139172A (ja) | 2023-10-03 |
KR20150084053A (ko) | 2015-07-21 |
EP2919903A1 (en) | 2015-09-23 |
US10835495B2 (en) | 2020-11-17 |
EP2919903B1 (en) | 2020-07-22 |
HK1216240A1 (zh) | 2016-10-28 |
JP2019194218A (ja) | 2019-11-07 |
WO2014078435A1 (en) | 2014-05-22 |
KR102237799B1 (ko) | 2021-04-08 |
CN113842362A (zh) | 2021-12-28 |
CN105050708A (zh) | 2015-11-11 |
US20160303048A1 (en) | 2016-10-20 |
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