JPWO2019234240A5 - - Google Patents

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JPWO2019234240A5
JPWO2019234240A5 JP2020568390A JP2020568390A JPWO2019234240A5 JP WO2019234240 A5 JPWO2019234240 A5 JP WO2019234240A5 JP 2020568390 A JP2020568390 A JP 2020568390A JP 2020568390 A JP2020568390 A JP 2020568390A JP WO2019234240 A5 JPWO2019234240 A5 JP WO2019234240A5
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Priority claimed from PCT/EP2019/065016 external-priority patent/WO2019234240A1/en
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疾患を治療または予防するための医薬組成物であって、医薬として有効な量のβ-ラクタム化合物またはその医薬として許容可能な塩と、プロベネシドまたはその医薬として許容可能な塩を含み、
前記β-ラクタム化合物またはその医薬として許容可能な塩と、前記プロベネシドまたはその医薬として許容可能な塩は同じ投与経路で投与される、医薬組成物。 A pharmaceutical composition for treating or preventing a disease, which comprises a pharmaceutically effective amount of a β-lactam compound or a pharmaceutically acceptable salt thereof, and probenecid or a pharmaceutically acceptable salt thereof.
A pharmaceutical composition in which the β-lactam compound or a pharmaceutically acceptable salt thereof and the probenecid or a pharmaceutically acceptable salt thereof are administered by the same route of administration. 前記β-ラクタム化合物またはその医薬として許容可能な塩と、前記プロベネシドまたはその医薬として許容可能な塩はある期間にわたって投与される、請求項1に記載の医薬組成物。 The pharmaceutical composition according to claim 1, wherein the β-lactam compound or a pharmaceutically acceptable salt thereof and the probenecid or a pharmaceutically acceptable salt thereof are administered over a certain period of time. 前記期間が約24時間よりも長く；
前記期間が、約2日間～約30日間、約3日間～約20日間、約4日間～約15日間、約5日間～約10日間、又は約6日間～約8日間であるか；あるいは前記期間が約7日間である、請求項2に記載の医薬組成物。 The period is longer than about 24 hours;
Is the period about 2 to about 30 days, about 3 to about 20 days, about 4 to about 15 days, about 5 to about 10 days, or about 6 to about 8 days; or the above. The pharmaceutical composition according to claim 2, which has a period of about 7 days. 前記医薬組成物を投与された対象のβ-ラクタム化合物の血漿中濃度が、その投与の結果として、食物を与えずにβ-ラクタム化合物とプロベネシドを投与された同等な対象（例えば、前記同等な対象は絶食している）と比較して、投与から約30分以内、または約1時間以内、または約2時間以内、または約3時間以内、または約6時間以内、または約12時間以内、または約18時間以内、または約1日以内、または約2日以内、または約3日以内、または約4日以内、または約5日以内、または約6日以内、または約7日以内は、約5％以上、または約10％以上、または約20％以上、または約30％以上、または約40％以上、または約50％以上、または約55％以上、または約60％以上、または約65％以上、または約70％以上、または約100％以上、または約150％以上、または約200％以上、または約300％以上、または約400％以上、または約500％以上大きな曲線下面積（AUC）を有する、請求項1～3のいずれか1項に記載の医薬組成物。 The plasma concentration of the β-lactam compound of the subject to which the pharmaceutical composition was administered was the equivalent subject (eg, said equivalent) to which the β-lactam compound and probenecid were administered without food as a result of the administration. Subjects are fasting), within about 30 minutes, or within 1 hour, or within approximately 2 hours, or within approximately 3 hours, or within approximately 6 hours, or within approximately 12 hours, or Within approximately 18 hours, or within approximately 1 day, or within approximately 2 days, or within approximately 3 days, or within approximately 4 days, or within approximately 5 days, or within approximately 6 days, or within approximately 7 days, approximately 5 % Or more, or about 10% or more, or about 20% or more, or about 30% or more, or about 40% or more, or about 50% or more, or about 55% or more, or about 60% or more, or about 65% or more. , Or about 70% or more, or about 100% or more, or about 150% or more, or about 200% or more, or about 300% or more, or about 400% or more, or about 500% or more large sub-curve area (AUC) The pharmaceutical composition according to any one of claims 1 to 3. 前記疾患が、単純性尿路感染症、複雑性尿路感染症、複雑性腹腔内感染症、肺炎、中耳炎、副鼻腔炎、淋菌性尿道炎、骨盤内炎症性疾患、前立腺炎、骨感染症、関節感染症、糖尿病足病性感染症、感染性下痢である、請求項1～4のいずれか1項に記載の医薬組成物。 The diseases are simple urinary tract infection, complicated urinary tract infection, complicated intraperitoneal infection, pneumonia, middle ear inflammation, sinusitis, gonococcal urinary tract inflammation, pelvic inflammatory disease, prostatic inflammation, bone infection. , Joint infection, diabetic foot disease infection, infectious diarrhea, the pharmaceutical composition according to any one of claims 1 to 4. 前記β-ラクタム化合物が、式（I）、（Ia）、又は（Ib）の化合物：
Figure 2019234240000001
 （式中、R1は、Hであるか、場合によっては置換されたアルキルである）、
あるいはその医薬として許容可能な塩である、請求項1～5のいずれか1項に記載の医薬組成物。 The β-lactam compound is a compound of the formula (I), (Ia), or (Ib):
Figure 2019234240000001
 (In the equation, R 1 is H or, in some cases, substituted alkyl),
The pharmaceutical composition according to any one of claims 1 to 5, which is a salt acceptable as the pharmaceutically acceptable salt. 前記β-ラクタム化合物が、式（III）、（IIIa）、又は（IIIb）の化合物：
Figure 2019234240000002
 （式中、R2は、Hであるか、場合によっては置換されたアルキルである）、
あるいはその医薬として許容可能な塩であるである、請求項1～5のいずれか1項に記載の医薬組成物。 The β-lactam compound is a compound of the formula (III), (IIIa), or (IIIb):
Figure 2019234240000002
 (In the equation, R 2 is H or, in some cases, substituted alkyl),
The pharmaceutical composition according to any one of claims 1 to 5, which is a salt that is acceptable as a pharmaceutical thereof. 前記β-ラクタム化合物が、
Figure 2019234240000003
Figure 2019234240000004
 又はその医薬として許容可能な塩からな群より選択される、請求項9に記載の医薬組成物。 The β-lactam compound is
Figure 2019234240000003
Figure 2019234240000004
 The pharmaceutical composition according to claim 9, which is selected from the group consisting of salts that are acceptable as the pharmaceutically acceptable salt thereof. 前記β-ラクタム化合物またはその医薬として許容可能な塩と、前記プロベネシドまたはその医薬として許容可能な塩は合剤として投与される、請求項1～8のいずれか1項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 8, wherein the β-lactam compound or a pharmaceutically acceptable salt thereof and the probenecid or a pharmaceutically acceptable salt thereof are administered as a combination drug. 前記合剤は対象に1日に1回以上投与される、請求項9に記載の医薬組成物。 The pharmaceutical composition according to claim 9, wherein the combination drug is administered to the subject at least once a day. 前記合剤は対象に1日に1回、1日に2回、1日に3回、又は1日に4回投与される、請求項10に記載の医薬組成物。 The pharmaceutical composition according to claim 10, wherein the combination drug is administered to a subject once a day, twice a day, three times a day, or four times a day. 前記合剤が、
前記β-ラクタム化合物またはその医薬として許容可能な塩を20 mg～約5 g、または約50 mg～約2 g、または約80 mg～約1 g、または約100 mg～約900 mg、または約200 mg～約800 mg、または約300 mg～約700 mg、または約400 mg～約600 mg、または約450 mg～約550 mg、または約480 mg～約520 mgと；
前記プロベネシドまたはその医薬として許容可能な塩を20 mg～約5 g、または約50 mg～約2 g、または約80 mg～約1 g、または約100 mg～約900 mg、または約200 mg～約800 mg、または約300 mg～約700 mg、または約400 mg～約600 mg、または約450 mg～約550 mg、または約480 mg～約520 mg含む、請求項9～11のいずれか1項に記載の医薬組成物。 The combination drug
20 mg to about 5 g, or about 50 mg to about 2 g, or about 80 mg to about 1 g, or about 100 mg to about 900 mg, or about 900 mg of the β-lactam compound or a pharmaceutically acceptable salt thereof. 200 mg to about 800 mg, or about 300 mg to about 700 mg, or about 400 mg to about 600 mg, or about 450 mg to about 550 mg, or about 480 mg to about 520 mg;
20 mg to about 5 g, or about 50 mg to about 2 g, or about 80 mg to about 1 g, or about 100 mg to about 900 mg, or about 200 mg to the pharmaceutically acceptable salt of probenecid or the like. Any one of claims 9-11, comprising about 800 mg, or about 300 mg to about 700 mg, or about 400 mg to about 600 mg, or about 450 mg to about 550 mg, or about 480 mg to about 520 mg. The pharmaceutical composition according to the section. 前記合剤が、前記β-ラクタム化合物またはその医薬として許容可能な塩を約500 mgと、前記プロベネシドまたはその医薬として許容可能な塩を約500 mg含む、請求項12に記載の医薬組成物。 The pharmaceutical composition according to claim 12, wherein the combination drug contains about 500 mg of the β-lactam compound or a pharmaceutically acceptable salt thereof and about 500 mg of the probenecid or a pharmaceutically acceptable salt thereof. 前記合剤の投与の結果として、β-ラクタム化合物の血漿中濃度が、投与から約1日以内に、約4325±3000 ng・時間/ml、または約4325±2500 ng・時間/ml、または約4325±2000 ng・時間/ml、または約4325±1500 ng・時間/ml、または約4325±1000 ng・時間/ml、または約4325±900 ng・時間/ml、または約4325±800 ng・時間/ml、または約4325±700 ng・時間/ml、または約4325±600 ng・時間/ml、または約4325±500 ng・時間/ml、または約4325±400 ng・時間/ml、または約4325±300 ng・時間/ml、または約4325±200 ng・時間/ml、または約4325±100 ng・時間/ml、または約4325±90 ng・時間/ml、または約4325±80 ng・時間/ml、または約4325±70 ng・時間/ml、または約4325±60 ng・時間/ml、または約4325±50 ng・時間/ml、または約4325±40 ng・時間/ml、または約4325±30 ng・時間/ml、または約4325±20 ng・時間/ml、または約4325±10 ng・時間/ml（例えば約4325 ng・時間/ml）の曲線下面積（AUC）を有する、請求項13に記載の医薬組成物。 As a result of administration of the mixture, the plasma concentration of β-lactam compound is about 4325 ± 3000 ng · hour / ml, or about 4325 ± 2500 ng · hour / ml, or about 1 day after administration. 4325 ± 2000 ng · hours / ml, or about 4325 ± 1500 ng · hours / ml, or about 4325 ± 1000 ng · hours / ml, or about 4325 ± 900 ng · hours / ml, or about 4325 ± 800 ng · hours / ml, or about 4325 ± 700 ng · hours / ml, or about 4325 ± 600 ng · hours / ml, or about 4325 ± 500 ng · hours / ml, or about 4325 ± 400 ng · hours / ml, or about 4325 ± 300 ng · hours / ml, or about 4325 ± 200 ng · hours / ml, or about 4325 ± 100 ng · hours / ml, or about 4325 ± 90 ng · hours / ml, or about 4325 ± 80 ng · hours / ml, or about 4325 ± 70 ng · hours / ml, or about 4325 ± 60 ng · hours / ml, or about 4325 ± 50 ng · hours / ml, or about 4325 ± 40 ng · hours / ml, or about 4325 ± Claimed to have an area under the curve (AUC) of 30 ng · hour / ml, or about 4325 ± 20 ng · hour / ml, or about 4325 ± 10 ng · hour / ml (eg, about 4325 ng · hour / ml). 13. The pharmaceutical composition according to 13. 前記合剤の投与の結果として、β-ラクタム化合物の血漿中濃度が、投与から約1日以内に、約7340±3000 ng・時間/ml、または約7340±2500 ng・時間/ml、または約7340±2000 ng・時間/ml、または約7340±1500 ng・時間/ml、または約7340±1000 ng・時間/ml、または約7340±900 ng・時間/ml、または約7340±800 ng・時間/ml、または約7340±700 ng・時間/ml、または約7340±600 ng・時間/ml、または約7340±500 ng・時間/ml、または約7340±400 ng・時間/ml、または約7340±300 ng・時間/ml、または約7340±200 ng・時間/ml、または約7340±100 ng・時間/ml、または約7340±90 ng・時間/ml、または約7340±80 ng・時間/ml、または約7340±70 ng・時間/ml、または約7340±60 ng・時間/ml、または約7340±50 ng・時間/ml、または約7340±40 ng・時間/ml、または約7340±30 ng・時間/ml、または約7340±20 ng・時間/ml、または約7340±10 ng・時間/ml（例えば約7340 ng・時間/ml）の曲線下面積（AUC）を有する、請求項13に記載の医薬組成物。 As a result of administration of the mixture, the plasma concentration of β-lactam compound is about 7340 ± 3000 ng · hour / ml, or about 7340 ± 2500 ng · hour / ml, or about 1 day after administration. 7340 ± 2000 ng · hours / ml, or about 7340 ± 1500 ng · hours / ml, or about 7340 ± 1000 ng · hours / ml, or about 7340 ± 900 ng · hours / ml, or about 7340 ± 800 ng · hours / ml, or about 7340 ± 700 ng · hours / ml, or about 7340 ± 600 ng · hours / ml, or about 7340 ± 500 ng · hours / ml, or about 7340 ± 400 ng · hours / ml, or about 7340 ± 300 ng · hours / ml, or about 7340 ± 200 ng · hours / ml, or about 7340 ± 100 ng · hours / ml, or about 7340 ± 90 ng · hours / ml, or about 7340 ± 80 ng · hours / ml, or about 7340 ± 70 ng · hours / ml, or about 7340 ± 60 ng · hours / ml, or about 7340 ± 50 ng · hours / ml, or about 7340 ± 40 ng · hours / ml, or about 7340 ± Claimed to have an area under the curve (AUC) of 30 ng · hour / ml, or about 7340 ± 20 ng · hour / ml, or about 7340 ± 10 ng · hour / ml (eg about 7340 ng · hour / ml). 13. The pharmaceutical composition according to 13. 前記合剤は、約1日間、または約2日間、または約3日間、または約4日間、または約5日間、または約6日間、または約7日間、または約14日間、または約21日間、または約28日間にわたって、1日に1回、または1日に2回、または1日に3回、または1日に4回、対象に投与される、請求項9～15のいずれか1項に記載の医薬組成物。 The combination may be used for about 1 day, or about 2 days, or about 3 days, or about 4 days, or about 5 days, or about 6 days, or about 7 days, or about 14 days, or about 21 days, or 13. Pharmaceutical composition. 前記合剤は経口合剤である、請求項9～16のいずれか1項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 9 to 16, wherein the combination is an oral combination. 前記合剤は錠剤である、請求項17に記載の医薬組成物。 The pharmaceutical composition according to claim 17, wherein the combination drug is a tablet. 前記β-ラクタム化合物またはその医薬として許容可能な塩と、前記プロベネシドまたはその医薬として許容可能な塩は同時に投与される、請求項1～8のいずれか1項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 8, wherein the β-lactam compound or a pharmaceutically acceptable salt thereof and the probenecid or a pharmaceutically acceptable salt thereof are administered at the same time. 前記β-ラクタム化合物またはその医薬として許容可能な塩は、1日に1回以上、約20 mg～約5 g、または約50 mg～約2 g、または約80 mg～約1 g、または約100 mg～約900 mg、または約200 mg～約800 mg、または約300 mg～約700 mg、または約400 mg～約600 mg、または約450 mg～約550 mg、または約480 mg～約520 mgの範囲の1日用量で、
好ましくは約500 mgの1日用量で投与される、請求項19に記載の医薬組成物。 The β-lactam compound or a pharmaceutically acceptable salt thereof is at least once a day, about 20 mg to about 5 g, or about 50 mg to about 2 g, or about 80 mg to about 1 g, or about. 100 mg to about 900 mg, or about 200 mg to about 800 mg, or about 300 mg to about 700 mg, or about 400 mg to about 600 mg, or about 450 mg to about 550 mg, or about 480 mg to about 520 With daily doses in the range of mg
19. The pharmaceutical composition of claim 19, preferably administered at a daily dose of about 500 mg. 前記β-ラクタム化合物またはその医薬として許容可能な塩を、1日に1回以上、約50 mg～約10 g、または約100 mg～約5 g、または約200 mg～約3 g、または約400 mg～約2 g、または約600 mg～約1.5 g、または約800 mg～約1.2 g、または約900 mg～約1.1 gの範囲の1日用量で、
好ましくは約1 gの1日用量で投与される、請求項19に記載の医薬組成物。 The β-lactam compound or a pharmaceutically acceptable salt thereof at least once a day, about 50 mg to about 10 g, or about 100 mg to about 5 g, or about 200 mg to about 3 g, or about. With daily doses ranging from 400 mg to about 2 g, or about 600 mg to about 1.5 g, or about 800 mg to about 1.2 g, or about 900 mg to about 1.1 g.
19. The pharmaceutical composition of claim 19, preferably administered at a daily dose of about 1 g. 前記β-ラクタム化合物またはその医薬として許容可能な塩は1日に2回投与される、請求項1～8及び19～21のいずれか1項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 8 and 19 to 21, wherein the β-lactam compound or a pharmaceutically acceptable salt thereof is administered twice a day. 前記プロベネシドまたはその医薬として許容可能な塩は、1日に1回以上、約20 mg～約5 g、または約50 mg～約2 g、または約80 mg～約1 g、または約100 mg～約900 mg、または約200 mg～約800 mg、または約300 mg～約700 mg、または約400 mg～約600 mg、または約450 mg～約550 mg、または約480 mg～約520 mgの範囲の1日用量で、
好ましくは約500 mgの1日用量で投与される、請求項1～8及び19～22のいずれか1項に記載の医薬組成物。 The probenecid or a pharmaceutically acceptable salt thereof is at least once a day, about 20 mg to about 5 g, or about 50 mg to about 2 g, or about 80 mg to about 1 g, or about 100 mg to. Range of about 900 mg, or about 200 mg to about 800 mg, or about 300 mg to about 700 mg, or about 400 mg to about 600 mg, or about 450 mg to about 550 mg, or about 480 mg to about 520 mg With a daily dose of
The pharmaceutical composition according to any one of claims 1 to 8 and 19 to 22, preferably administered at a daily dose of about 500 mg. 前記プロベネシドまたはその医薬として許容可能な塩は、1日に1回以上、約50 mg～約10 g、または約100 mg～約5 g、または約200 mg～約3 g、または約400 mg～約2 g、または約600 mg～約1.5 g、または約800 mg～約1.2 g、または約900 mg～約1.1 gの範囲の1日用量で、
好ましくは約1 gの1日用量で投与される、請求項1～8及び19～22のいずれか1項に記載の医薬組成物。 The probenecid or a pharmaceutically acceptable salt thereof is at least once a day, about 50 mg to about 10 g, or about 100 mg to about 5 g, or about 200 mg to about 3 g, or about 400 mg to. At daily doses ranging from about 2 g, or about 600 mg to about 1.5 g, or about 800 mg to about 1.2 g, or about 900 mg to about 1.1 g,
The pharmaceutical composition according to any one of claims 1 to 8 and 19 to 22, preferably administered at a daily dose of about 1 g. 前記プロベネシドまたはその医薬として許容可能な塩は1日に2回投与される、請求項1～8及び19～24のいずれか1項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 8 and 19 to 24, wherein the probenecid or a pharmaceutically acceptable salt thereof is administered twice a day. 前記医薬組成物の投与対象は、投与前の約1時間以内、または約2時間以内、または約3時間以内、または約6時間以内、または約12時間以内、または約24時間以内、または約2日間以内、または約5日間以内、または約10日間以内に絶食させない、請求項1～25のいずれか1項に記載の医薬組成物。 The subject to which the pharmaceutical composition is administered is within about 1 hour, or within about 2 hours, or within about 3 hours, or within about 6 hours, or within about 12 hours, or within about 24 hours, or about 2 before administration. The pharmaceutical composition according to any one of claims 1 to 25, which is not fasted within a day, about 5 days, or within about 10 days. 前記医薬組成物の投与対象は、投与前に食事させる、請求項26に記載の医薬組成物。 The pharmaceutical composition according to claim 26, wherein the subject of administration of the pharmaceutical composition is to be fed before administration. 前記医薬組成物の投与対象は、投与前に絶食させる、請求項1～25のいずれか1項に記載の医薬組成物。 The pharmaceutical composition according to any one of claims 1 to 25, wherein the subject of administration of the pharmaceutical composition is fasted before administration. 前記医薬組成物の投与対象は、投与前の約1時間以内、または約2時間以内、または約3時間以内、または約6時間以内、または約12時間以内、または約24時間以内、または約2日間以内、または約5日間以内、または約10日間以内に絶食させる、請求項28に記載の医薬組成物。 The subject to which the pharmaceutical composition is administered is within about 1 hour, or within about 2 hours, or within about 3 hours, or within about 6 hours, or within about 12 hours, or within about 24 hours, or about 2 before administration. 28. The pharmaceutical composition according to claim 28, which is fasted within a day, or within about 5 days, or within about 10 days.
JP2020568390A 2018-06-07 2019-06-07 Combination of β-lactam compound and probenecid and its use Pending JP2021525787A (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862682116P 2018-06-07 2018-06-07
US62/682,116 2018-06-07
US201962804970P 2019-02-13 2019-02-13
US62/804,970 2019-02-13
PCT/EP2019/065016 WO2019234240A1 (en) 2018-06-07 2019-06-07 Combinations of beta-lactam compounds and probenecid and uses thereof

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