JP7525903B2 - Cxcr4阻害剤の組成物ならびに調製および使用の方法 - Google Patents
Cxcr4阻害剤の組成物ならびに調製および使用の方法 Download PDFInfo
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- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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Description
関連出願の相互参照
これらのデータは、例えば細胞増殖性障害において、受容体の異常なまたは望ましくない発現によって媒介される多くの疾患および状態を処置するための、CXCR4阻害剤の重要な必要性が満たされていないことを強調している。
一態様では、本発明は、CXCR4が病変形成に関与する疾患、障害、または状態の処置、予防、および/またはそのリスクの低減に有用な化合物およびその組成物を提供する。一部の実施形態では、このような化合物には、本明細書で記載される式の化合物、または薬学的に許容されるその塩が含まれる。
2.定義
3.例示的な化合物の説明
(a)I-1、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.5%w/w未満であり、
(b)I-2、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.3%w/w未満であり、
(c)I-3、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.4%w/w未満であり、
(d)I-5、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.4%w/w未満であり、
(e)I-6、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.4%w/w未満であり、
(f)I-7、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.25%w/w未満である、X4P-001組成物またはその医薬組成物を提供する。
(a)I-1、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.02~約0.5%w/wであり、
(b)I-2、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.3%w/wであり、
(c)I-3、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.4%w/wであり、
(d)I-5、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.4%w/wであり、
(e)I-6、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.4%w/wであり、
(f)I-7、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.25%w/wである、X4P-001組成物またはその医薬組成物を提供する。
(a)I-2、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.2%w/wであり、
(b)I-3、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.2%w/wであり、
(c)I-5、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.2%w/wであり、
(d)I-6、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.4%w/wであり、
(e)I-7、または薬学的に許容されるその塩の量が、X4P-001組成物の約0.01~約0.25%w/wである、X4P-001組成物を提供する。
(a)組成物の約10~20重量%の、開示されるX4P-001組成物、
(b)組成物の約70~85重量%の、微結晶性セルロース、
(c)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(d)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を含む単位剤形を提供する。
(a)組成物の約35~75重量%の、開示されるX4P-001組成物、
(b)組成物の約5~28重量%の、微結晶性セルロース、
(c)組成物の約7~30重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約2~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.3~2.5重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.05~1.2重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.2~1.2重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を含む単位剤形を提供する。
(a)
(b)
(c)
(d)
(e)
(f)
を含むX4P-001組成物を提供し、ここで各%w/wは、X4P-001組成物中の式Iの化合物、およびI-1、I-2、I-3、I-5、I-6またはI-7から選択される1つまたは複数の化合物の全重量に対して測定される。一部の実施形態では、X4P-001組成物は、式Iの化合物、または薬学的に許容されるその塩を含み、検出可能な量の式I-4の化合物、または薬学的に許容されるその塩を含まない。
(a)
(b)
(c)
(d)
(e)
を含むX4P-001組成物を提供し、ここで各%w/wは、X4P-001組成物中の式Iの化合物、およびI-2、I-3、I-5、I-6またはI-7から選択される1つまたは複数の化合物の全重量に対して測定される。
(a)組成物の約10~20重量%の、開示されるX4P-001組成物、
(b)組成物の約70~85重量%の、微結晶性セルロース、
(c)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(d)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を含む単位剤形を提供する。
(a)組成物の約30~40重量%の、開示されるX4P-001組成物、
(b)組成物の約20~25重量%の、微結晶性セルロース、
(c)組成物の約30~35重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.1~1.0重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を含む単位剤形を提供する。
(a)組成物の約35~75重量%の、開示されるX4P-001組成物、
(b)組成物の約5~28重量%の、微結晶性セルロース、
(c)組成物の約7~30重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約2~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.3~2.5重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.05~1.2重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.2~1.2重量%の、ラウリル硫酸ナトリウム、
を含む医薬組成物を含む単位剤形を提供する。
4.使用、製剤、および投与
薬学的に許容される組成物
(a)組成物の約30~40重量%である、開示されるX4P-001組成物、
(b)組成物の約20~25重量%の、微結晶性セルロース、
(c)組成物の約30~35重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.1~1.0重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を提供する。
(a)組成物の約8~25重量%である、開示されるX4P-001組成物、
(b)組成物の約65~85重量%の、微結晶性セルロース、
(c)組成物の約2~10重量%の、クロスカルメロースナトリウム、
(d)組成物の約0.1~3重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.05~0.7重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を提供する。
(a)組成物の約25~45重量%である、開示されるX4P-001組成物、
(b)組成物の約10~35重量%の、微結晶性セルロース、
(c)組成物の約15~45重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約2~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.3~2.5重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.05~1.2重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.2~1.2重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を提供する。
(a)組成物の約35~75重量%である、開示されるX4P-001組成物、
(b)組成物の約5~28重量%の、微結晶性セルロース、
(c)組成物の約7~30重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約2~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.3~2.5重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.05~1.2重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.2~1.2重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を提供する。
(a)組成物の約10~30重量%の、開示されるX4P-001組成物、
(b)組成物の約60~80重量%の、微結晶性セルロース、
(c)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(d)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を含む単位剤形を提供する。
(a)組成物の約14.7重量%の、開示されるX4P-001組成物、
(b)組成物の約78.1重量%の、微結晶性セルロース、
(c)組成物の約6.0重量%の、クロスカルメロースナトリウム、
(d)組成物の約1.0重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.2重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を含む単位剤形を提供する。
(a)組成物の約10~20重量%の、開示されるX4P-001組成物、
(b)組成物の約25~40重量%の、微結晶性セルロース、
(c)組成物の約35~55重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約4~15重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.3~2重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.1~1.5重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.1~1.5重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を含む単位剤形を提供する。
(a)組成物の約12.85重量%の、開示されるX4P-001組成物、
(b)組成物の約31.92重量%の、微結晶性セルロース、
(c)組成物の約44.4重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約8.33重量%の、クロスカルメロースナトリウム、
(e)組成物の約1.38重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.42重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.7重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を含む単位剤形を提供する。
化合物および薬学的に許容される組成物の使用
細胞増殖性障害
がん
原発性免疫不全
追加の治療剤との併用投与
(実施例1)
メチルイミン不純物
スキーム1
N-ホルミル不純物
スキーム2
アルデヒド不純物
スキーム3
アセトアミド不純物
スキーム4
ベンゾイミダゾール不純物
スキーム5
(実施例6)
アミナール不純物
a LOQ(定量限界)未満の値
bX4P-001のp-ヒドロキシ安息香酸塩を出発材料として使用して製造した遊離塩基である臨床薬物物質にのみ関連する仕様
NA=不適用
ND=検出されず
NLT=以上
NMT=以下
NR=報告されず
(実施例8)
保存後に生じる不純物の同定
未知1-RRT1.14
未知2-RRT1.24
概要
HPLC条件1
カラム:Zorbax Bonus-RP、150×4.6mm、3.5μm
注入体積:100μL
検出:220nm(190~400nm)におけるUV
MS ES+ 100~700Da、ES- 100~700Da
移動相A:水中0.15%ギ酸
移動相B:MeCN中0.15%ギ酸
カラム温度:周囲
分析時間:75分
MS 調整パラメーター1
未知1 MET/CR/1448 RRT1.14[M+H]=m/z 349.2
未知2 MET/CR/1448 RRT1.24[M+H]=m/z 392.3
HPLC条件2
カラム:Zorbax SB-C8、150mm×4.6mm、3.5μm
ガードカラム:Zorbax SB-C8、12.5mm×4.6mm、5μm
注入体積:様々
検出:270nmにおけるUV
移動相:移動相A:水中0.2%TFA
移動相B:アセトニトリル中0.1%TFA
カラム温度:25℃
分析時間:55分
PTL/ST/0511、バッチ3-1、25/60 t=3カ月
PTL/DA/0175 分解試料 80℃/80%相対湿度(80/80) t=1および7日。
未知1 MET/CR/1448 RRT1.14[M+H]=m/z 349.2
未知2 MET/CR/1448 RRT1.24[M+H]=m/z 392.3
HPLC条件3
カラム:Zorbax SB-C8、150mm×4.6mm、3.5μm
ガードカラム:Zorbax SB-C8、12.5mm×4.6mm、5μm
注入体積:様々
検出:270nmにおけるUV
移動相:移動相A:水中0.2%TFA
移動相B:アセトニトリル中0.1%TFA
カラム温度:25℃
分析時間:140分
MSパラメーターは前述の調整パラメーター1に従う。
結果の考察
未知1 MET/CR/1448 RRT1.14[M+H]=m/z 349.2
未知2 MET/CR/1448 RRT1.24[M+H]=m/z 392.3
未知1 RRT1.14(アルデヒド)
(実施例9)
不純物レベルを低減および制御するためのX4P-001についての製造プロセスの改善
導入
合成経路および鍵となる中間体の説明
鍵となるプロセス変更の説明
スキーム9:バルク薬物物質において発見された不純物
プロセスバージョン3の説明ならびにプロセス1およびプロセス2の改善
NT-316の合成
AMD-2890の合成
X4P-001の合成および単離
プロセス2およびプロセス3の比較
**バッチ3-1。
結論
(実施例10)
変異原性評価
スキーム10:X4P-001のための合成プロセス2。
(実施例11)
25mg、100mg、および200mgの固体製剤
本発明は、例えば、以下の項目を提供する。
(項目1)
式I:
の化合物または薬学的に許容されるその塩、および検出可能な量の以下の化合物のうちの少なくとも1つ
または薬学的に許容されるその塩を含むX4P-001組成物であって、検出可能な量の以下の化合物
または薬学的に許容されるその塩を含まない、X4P-001組成物。
(項目2)
前記X4P-001組成物が、少なくとも検出可能な量のI-2、I-3、I-5、I-6、およびI-7のそれぞれ、または薬学的に許容されるその塩を含む、項目1に記載のX4P-001組成物。
(項目3)
I-2、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.3%w/w未満である、項目1または2に記載のX4P-001組成物。
(項目4)
I-3、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.4%w/w未満である、項目1~3のいずれか一項に記載のX4P-001組成物。
(項目5)
I-5、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.4%w/w未満である、項目1~4のいずれか一項に記載のX4P-001組成物。
(項目6)
I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.4%w/w未満である、項目1~5のいずれか一項に記載のX4P-001組成物。
(項目7)
I-7、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.25%w/w未満である、項目1~6のいずれか一項に記載のX4P-001組成物。
(項目8)
I-2、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.3%w/wである、項目3に記載のX4P-001組成物。
(項目9)
I-3、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wである、項目4に記載のX4P-001組成物。
(項目10)
I-5、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wである、項目5に記載のX4P-001組成物。
(項目11)
I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wである、項目6に記載のX4P-001組成物。
(項目12)
I-7、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.25%w/wである、項目7に記載のX4P-001組成物。
(項目13)
(a)I-2、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.3%w/w未満であり、
(b)I-3、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.4%w/w未満であり、
(c)I-5、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.4%w/w未満であり、
(d)I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.4%w/w未満であり、
(e)I-7、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.25%w/w未満である、項目1に記載のX4P-001組成物。
(項目14)
(a)I-2、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.3%w/wであり、
(b)I-3、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wであり、
(c)I-5、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wであり、
(d)I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wであり、
(e)I-7、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.25%w/wである、項目1に記載のX4P-001組成物。
(項目15)
(a)I-2、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.2%w/wであり、
(b)I-3、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.2%w/wであり、
(c)I-5、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.2%w/wであり、
(d)I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.4%w/wであり、
(e)I-7、または薬学的に許容されるその塩の量が、前記X4P-001組成物の約0.01~約0.25%w/wである、項目1に記載のX4P-001組成物。
(項目16)
前記X4P-001組成物の約0.02~約0.5%w/wの量の、以下の化合物
もしくはその異性体形態、または薬学的に許容されるその塩を必要に応じてさらに含む、項目13~15のいずれか一項に記載のX4P-001組成物。
(項目17)
項目1~16のいずれか一項に記載のX4P-001組成物、および薬学的に許容される賦形剤、アジュバント、担体、またはビヒクルを含む、医薬組成物。
(項目18)
前記薬学的に許容されるアジュバントが、少なくとも1つの希釈剤、崩壊剤、滑沢剤、および流動助剤を含む、項目17に記載の医薬組成物。
(項目19)
(a)組成物の約10~20重量%の、項目1~16のいずれか一項に記載のX4P-001組成物、
(b)組成物の約70~85重量%の、微結晶性セルロース、
(c)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(d)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を含む単位剤形。
(項目20)
(a)組成物の約10~20重量%の、項目1~16のいずれか一項に記載のX4P-001組成物、
(b)組成物の約70~85重量%の、微結晶性セルロース、
(c)組成物の約5~10重量%の、クロスカルメロースナトリウム、
(d)組成物の約0.5~2重量%の、フマル酸ステアリルナトリウム、および
(e)組成物の約0.1~1.0重量%の、コロイド状二酸化ケイ素
を含む医薬組成物を含む単位剤形。
(項目21)
(a)組成物の約35~75重量%の、項目1~16のいずれか一項に記載のX4P-001組成物、
(b)組成物の約5~28重量%の、微結晶性セルロース、
(c)組成物の約7~30重量%の、リン酸水素カルシウム二水和物、
(d)組成物の約2~10重量%の、クロスカルメロースナトリウム、
(e)組成物の約0.3~2.5重量%の、フマル酸ステアリルナトリウム、
(f)組成物の約0.05~1.2重量%の、コロイド状二酸化ケイ素、および
(g)組成物の約0.2~1.2重量%の、ラウリル硫酸ナトリウム
を含む医薬組成物を含む単位剤形。
(項目22)
CXCR4と関連する疾患、障害、または状態を処置することを必要とする対象におけるCXCR4と関連する疾患、障害、または状態を処置する方法であって、前記対象に、有効量の項目1~16のいずれか一項に記載のX4P-001組成物を投与するステップを含む、方法。
(項目23)
前記疾患、障害、または状態が、腎細胞癌(RCC)もしくは腎臓がん;肝細胞癌(HCC)もしくは肝芽腫もしくは肝臓がん;黒色腫;乳がん;結腸直腸癌もしくは結腸直腸がん;結腸がん;直腸がん;肛門がん;非小細胞肺がん(NSCLC);小細胞肺がん(SCLC);卵巣上皮がん;卵巣癌;卵管がん;乳頭状漿液性嚢胞腺癌もしくは子宮乳頭状漿液性癌(UPSC);前立腺がん;精巣がん;胆嚢がん;肝臓胆管癌;軟部組織および骨滑膜肉腫;横紋筋肉腫;骨肉腫;軟骨肉腫;ユーイング肉腫;未分化甲状腺がん;副腎皮質癌;膵臓がん;膵管癌;膵臓腺癌;胃腸管/胃(GIST)がん;リンパ腫;頭頸部扁平上皮癌(SCCHN);唾液腺がん;神経膠腫もしくは脳がん;神経線維腫症1型関連悪性末梢神経鞘腫(MPNST);ワルデンストレームマクログロブリン血症;または髄芽腫から選択されるがんである、項目22に記載の方法。
(項目24)
前記疾患、障害、または状態が、進行性腎細胞癌、腎明細胞癌(ccRCC)、乳頭状腎癌、転移性黒色腫、またはワルデンストレームマクログロブリン血症から選択されるがんである、項目22に記載の方法。
(項目25)
前記疾患、障害、または状態が、原発性免疫不全である、項目22に記載の方法。
(項目26)
前記疾患、障害、または状態が、疣贅、低ガンマグロブリン血症、感染症、骨髄性細胞貯留(WHIM)症候群、重症先天性好中球減少症(SCN)、GATA2欠損症(Mono MAC症候群)、特発性CD4+Tリンパ球減少症(ICL)、またはウィスコット-アルドリッチ症候群から選択される、項目22に記載の方法。
(項目27)
前記疾患、障害、または状態が、WHIM症候群である、項目22に記載の方法。
(項目28)
前記疾患、障害、または状態が、SCNである、項目22に記載の方法。
Claims (19)
- I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の0.01~0.4%w/wである、請求項1に記載のX4P-001組成物。
- I-6、または薬学的に許容されるその塩の量が、前記X4P-001組成物の0.01~0.3%w/wである、請求項1に記載のX4P-001組成物。
- I-6の量が、前記X4P-001組成物の0.01~0.2%w/wである、請求項1に記載のX4P-001組成物。
- 前記組成物が以下の化合物
または薬学的に許容されるその塩を含む、請求項1~4のいずれか一項に記載のX4P-001組成物。 - 前記組成物が以下の化合物
または薬学的に許容されるその塩を含む、請求項1~5のいずれか一項に記載のX4P-001組成物。 - 前記組成物が以下の化合物
または薬学的に許容されるその塩を含む、請求項1~6のいずれか一項に記載のX4P-001組成物。 - 前記組成物が以下の化合物
または薬学的に許容されるその塩を含む、請求項6に記載のX4P-001組成物。 - 前記X4P-001組成物がI-2またはI-5、または薬学的に許容されるその塩を含まない、請求項8に記載のX4P-001組成物。
- I-2、または薬学的に許容されるその塩の量が、前記X4P-001組成物の0.01~0.3%w/wである、請求項5に記載のX4P-001組成物。
- I-3、または薬学的に許容されるその塩の量が、前記X4P-001組成物の0.01~0.4%w/wである、請求項6または8に記載のX4P-001組成物。
- I-5、または薬学的に許容されるその塩の量が、前記X4P-001組成物の0.01~0.4%w/wである、請求項7に記載のX4P-001組成物。
- I-7、または薬学的に許容されるその塩の量が、前記X4P-001組成物の0.01~0.25%w/wである、請求項12に記載のX4P-001組成物。
- 存在するI-6および任意の追加の不純物の総重量が、前記X4P-001組成物の0.8%w/w以下を含む、請求項1~13のいずれか一項に記載のX4P-001組成物。
- 前記X4P-001組成物が、以下の化合物
または薬学的に許容されるその塩を含まない、請求項1~14のいずれか一項に記載のX4P-001組成物。 - 式Iの化合物が遊離塩基として前記X4P-001組成物中に存在する、請求項1~15のいずれか一項に記載のX4P-001組成物。
- 3.0%以下の全不純物が存在する、請求項1~16のいずれか一項に記載のX4P-001組成物。
- 式Iの化合物のR鏡像体過剰率(%ee)が97.0%以上である、請求項1~17のいずれか一項に記載のX4P-001組成物。
- 請求項1~18のいずれか一項に記載のX4P-001組成物、および薬学的に許容されるアジュバント、担体、またはビヒクルを含む、医薬組成物。
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US11672793B2 (en) | 2023-06-13 |
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