JP2012514653A - ステロイド組成物 - Google Patents
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- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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Abstract
Description
ある実施形態において、本発明で提供するのは、少なくとも1つのステロイド化合物(たとえば、テストステロン、ジヒドロテストステロン、エストラジオール、又はそれらの類似体若しくはプロドラッグ)及び少なくとも1つの薬剤的に許容される担体を含む医薬組成物である。具体的な実施形態では、ステロイド化合物はステロイド性アンドロゲン(たとえば、テストステロン、ジヒドロテストステロン、又はそれらのプロドラッグ)である。いくつかの実施形態では、ステロイド化合物はアルキル化、ヒドロキシアルキル化及び/又はヒドロキシアルコイル化(alkoylated)天然ステロイド(たとえば、テストステロンアルキルエステル、ジヒドロテストステロンアルキルエステル、エストラジオールアルキルエステル等)である。ある実施形態では、テストステロンの類似体又はプロドラッグには、たとえばテストステロンのエステルが含まれる。具体的な実施形態では、テストステロンのエステルとしては、たとえばテストステロンのアルキル(たとえば、直鎖、分岐、環状、不飽和、部分飽和、完全飽和等)エステルが挙げられる。特に、テストステロンのアルキルエステルには、非限定的例を挙げると、低級アルキルエステル(たとえば、プロピオン酸テストステロン、エタン酸テストステロン、若しくはウンデカン酸テストステロンなどのテストステロンC2〜C13アルキルエステル)、又は高級アルキルエステル(たとえば、パルミチン酸テストステロンなどのテストステロンC14+アルキルエステル)が含まれる。さらなる実施形態では、テストステロンのアルキルエステルには、非限定的例を挙げると、シクロアルキルアルキルエステル(たとえば、シピオン酸テストステロン)、シクロアルキルエステル、及びアルキルシクロアルキルエステルが含まれる。さらに具体的な実施形態では、テストステロンアルキルエステルはウンデカン酸テストステロンである。いくつかの実施形態では、少なくとも1つのステロイド化合物は、(1)テストステロン低級アルキルエステル(たとえば、プロピオン酸テストステロン、エタン酸テストステロン、又はウンデカン酸テストステロン);及び(2)テストステロン高級アルキルエステル(たとえばパルミチン酸テストステロン)を含む。一般的に、本明細書で用いられる場合、ステロイド化合物を含む医薬組成物には、1以上のステロイド化合物を含む医薬組成物の開示が含まれる。
薬物動態及び薬力学
方法
担体
さらなる薬剤
投与形態
Claims (34)
- (i)治療有効量の1以上のテストステロンC2〜C13アルキルエステル;及び(ii)少なくとも1つの薬剤的に許容される担体を含む医薬組成物であって;テストステロンC2〜C13アルキルエステルの約80%以下を30分後に水性媒体中に放出する、医薬組成物。
- テストステロンC2〜C13アルキルエステルがウンデカン酸テストステロンである、請求項1記載の医薬組成物。
- 約10mg〜約1000mgのテストステロンC2〜C13アルキルエステルを含む、請求項1記載の医薬組成物。
- 前記医薬組成物の単回投与が、経口投与によって約19ng/mL以下のテストステロンの平均血漿Cmaxを提供する、請求項1記載の医薬組成物。
- 前記医薬組成物の単回投与が、経口投与によって約4.5ng/mL以下のジヒドロテストステロンの平均血漿Cmaxを提供する、請求項1記載の医薬組成物。
- 約1300ng/dL以下の定常状態でのテストステロン平均血漿Cmaxを提供する、請求項1記載の医薬組成物。
- 約200ng/dL以上の定常状態でのテストステロン平均血漿Cminを提供する、請求項1記載の医薬組成物。
- 前記医薬組成物が個体に投与されると、約500×106mL以下の(テストステロン同等用量)/(平均定常状態テストステロンCmax)比を提供する、請求項1記載の医薬組成物。
- 個体に経口投与されると、定常状態でのテストステロンの平均血漿Cmaxと定常状態でのテストステロンの平均血漿Cminとの差を約16ng/mL以下とする、請求項1記載の医薬組成物。
- 個体に経口投与されると、テストステロンC2〜C13アルキルエステルの定常状態での平均血漿Cmaxと定常状態での平均血漿Cminとの差を約275ng/mL以下とする、請求項1記載の医薬組成物。
- 医薬組成物の単回投与が、経口投与されると1時間後に約150ng/dL以下のテストステロンの平均血漿濃度を提供する、請求項1記載の医薬組成物。
- 医薬組成物の単回投与が、経口投与されると2時間後に約500ng/dL以下のテストステロンの平均血漿濃度を提供する、請求項1記載の医薬組成物。
- 前記少なくとも1つの薬剤的に許容される担体が少なくとも1つの親水性担体を含む、請求項1記載の医薬組成物。
- 前記親水性担体が親水性トリグリセリドである、請求項13記載の医薬組成物。
- 前記親水性トリグリセリドがポリオキシル化ヒマシ油、又はポリオキシル化水素化ヒマシ油である、請求項14記載の医薬組成物。
- 前記少なくとも1つの薬剤的に許容される担体が少なくとも1つの親油性担体を含む、請求項1記載の医薬組成物。
- 前記少なくとも1つの親油性担体が、モノグリセリド、ジグリセリド、ビタミンE化合物、トリグリセリド、脂肪酸、ポリオキシル化脂肪酸、ポリオキシル化トリグリセリド、ポリオキシル化植物油、及びそれらの組み合わせからなる群から選択される、請求項1記載の医薬組成物。
- (i)治療有効量の1以上のテストステロンC2〜C13アルキルエステル;及び(ii)少なくとも1つの薬剤的に許容される担体を含む遅延放出経口製剤であって;前記遅延放出経口製剤の単回投与が、同じ量のテストステロンC2〜C13アルキルエステルを有する即時放出経口製剤の単回投与により提供されるテストステロンの平均血漿Cmaxよりも少なくとも5%低いテストステロンの血漿Cmaxを提供する、遅延放出経口製剤。
- 前記テストステロンC2〜C13アルキルエステルがウンデカン酸テストステロンである、請求項18記載の遅延放出経口製剤。
- 前記医薬組成物が約10mg〜約1000mgのテストステロンC2〜C13アルキルエステルを含む、請求項18記載の遅延放出経口製剤。
- ヒトに対して遅延放出経口製剤の用量を単回投与することによって、約500×106mL以下の(テストステロン同等用量)/(平均血漿テストステロンCmax)比を提供する、請求項18記載の遅延放出経口製剤。
- ヒトに対して遅延放出経口製剤の用量を単回投与することによって、約350×106mL以下の(テストステロン同等用量)/(平均血漿ジヒドロキシテストステロンCmax)比を提供する、請求項18記載の遅延放出経口製剤。
- 同じ量のテストステロンC2〜C13アルキルエステルを有する即時放出経口製剤によって提供される定常状態でのテストステロンC2〜C13アルキルエステルの平均血漿Cmaxよりも少なくとも50%低いテストステロンC2〜C13アルキルエステルの定常状態での平均血漿Cmaxを提供する、請求項18記載の遅延放出経口製剤。
- 前記少なくとも1つの薬剤的に許容される担体が少なくとも1つの親水性担体を含む、請求項18記載の遅延放出経口製剤。
- 前記親水性担体が親水性トリグリセリドである、請求項24記載の遅延放出経口製剤。
- 前記親水性トリグリセリドが、ポリオキシル化ヒマシ油、又はポリオキシル化水素化ヒマシ油である、請求項25記載の遅延放出経口製剤。
- 前記少なくとも1つの薬剤的に許容される担体が本質的に1以上の親油性担体からなる、請求項18記載の遅延放出経口製剤。
- 前記少なくとも1つの親油性担体が、モノグリセリド、ジグリセリド、ビタミンE化合物、トリグリセリド、脂肪酸、ポリオキシル化脂肪酸、ポリオキシル化トリグリセリド、ポリオキシル化植物油、及びそれらの組み合わせからなる群から選択される、請求項27記載の遅延放出経口製剤。
- (i)治療有効量の1以上のテストステロンアルキルエステル;及び(ii)少なくとも1つの薬剤的に許容される担体を含む医薬組成物であって、1時間後に約60%〜約90%のテストステロンアルキルエステルを水性媒体中に放出する、医薬組成物。
- (i)治療有効量の1以上のテストステロンアルキルエステル;及び(ii)少なくとも1つの薬剤的に許容される担体を含む医薬組成物であって;約50%以下のテストステロンアルキルエステルを6時間で水性媒体中に放出する、医薬組成物。
- アンドロゲン欠乏症の治療を必要とする個体におけるアンドロゲン欠乏症を治療するための医薬の製造における治療有効量の1以上のテストステロンC2〜C13アルキルエステルの使用であって、前記医薬が、30分後にテストステロンC2〜C13アルキルエステルの約90%以下を水性媒体中に放出する、使用。
- 前記医薬を食事とともに投与する、請求項31記載の使用。
- 前記医薬を1日2回又は1日1回投与する、請求項31記載の使用。
- 治療有効量のウンデカン酸テストステロンを含む医薬組成物であって、ヒト個体に投与されると、ウンデカン酸テストステロン以外のテストステロンアルキルエステルを含む以外は同じである医薬組成物をヒト個体に実質的に同様に投与することにより得られる血漿テストステロンアルキルエステル、テストステロン、又は両者の濃度と比較して、ヒト個体において、血漿テストステロンアルキルエステル、テストステロン、又は両者の濃度を増大させる、医薬組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/350,930 US11304960B2 (en) | 2009-01-08 | 2009-01-08 | Steroidal compositions |
US12/350,930 | 2009-01-08 | ||
PCT/US2010/020538 WO2010081032A2 (en) | 2009-01-08 | 2010-01-08 | Steroidal compositions |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2014264636A Division JP2015120700A (ja) | 2009-01-08 | 2014-12-26 | ステロイド組成物 |
Publications (2)
Publication Number | Publication Date |
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JP2012514653A true JP2012514653A (ja) | 2012-06-28 |
JP5758812B2 JP5758812B2 (ja) | 2015-08-05 |
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Application Number | Title | Priority Date | Filing Date |
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JP2011545470A Expired - Fee Related JP5758812B2 (ja) | 2009-01-08 | 2010-01-08 | ステロイド組成物 |
JP2014264636A Pending JP2015120700A (ja) | 2009-01-08 | 2014-12-26 | ステロイド組成物 |
Family Applications After (1)
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JP2014264636A Pending JP2015120700A (ja) | 2009-01-08 | 2014-12-26 | ステロイド組成物 |
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US (13) | US11304960B2 (ja) |
EP (2) | EP3078368A1 (ja) |
JP (2) | JP5758812B2 (ja) |
CN (1) | CN102271665A (ja) |
AU (1) | AU2010203457C1 (ja) |
BR (1) | BRPI1007025A2 (ja) |
CA (1) | CA2744266C (ja) |
IL (1) | IL212805A0 (ja) |
MX (1) | MX2011007351A (ja) |
WO (1) | WO2010081032A2 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2019087696A1 (ja) * | 2017-11-01 | 2019-05-09 | 富士フイルム株式会社 | 経口医薬組成物 |
Families Citing this family (41)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8492369B2 (en) | 2010-04-12 | 2013-07-23 | Clarus Therapeutics Inc | Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same |
EP2985026B1 (en) | 2005-04-15 | 2022-08-03 | Clarus Therapeutics, Inc. | Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same |
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WO2019087696A1 (ja) * | 2017-11-01 | 2019-05-09 | 富士フイルム株式会社 | 経口医薬組成物 |
JPWO2019087696A1 (ja) * | 2017-11-01 | 2020-11-12 | 富士フイルム株式会社 | 経口医薬組成物 |
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