JP2022512040A - ドンペリドンを含む製剤 - Google Patents
ドンペリドンを含む製剤 Download PDFInfo
- Publication number
- JP2022512040A JP2022512040A JP2021547549A JP2021547549A JP2022512040A JP 2022512040 A JP2022512040 A JP 2022512040A JP 2021547549 A JP2021547549 A JP 2021547549A JP 2021547549 A JP2021547549 A JP 2021547549A JP 2022512040 A JP2022512040 A JP 2022512040A
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- JP
- Japan
- Prior art keywords
- pharmaceutical
- gastroparesis
- pharmaceutical preparation
- preparation according
- ethylene oxide
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 229960001253 domperidone Drugs 0.000 title claims abstract description 47
- FGXWKSZFVQUSTL-UHFFFAOYSA-N domperidone Chemical compound C12=CC=CC=C2NC(=O)N1CCCN(CC1)CCC1N1C2=CC=C(Cl)C=C2NC1=O FGXWKSZFVQUSTL-UHFFFAOYSA-N 0.000 title claims abstract description 47
- 239000000203 mixture Substances 0.000 title abstract description 21
- 238000009472 formulation Methods 0.000 title abstract description 16
- 239000000825 pharmaceutical preparation Substances 0.000 claims abstract description 72
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims abstract description 44
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims abstract description 43
- 206010021518 Impaired gastric emptying Diseases 0.000 claims abstract description 39
- 208000001288 gastroparesis Diseases 0.000 claims abstract description 39
- 229920000642 polymer Polymers 0.000 claims abstract description 36
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 30
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 30
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical group CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims abstract description 26
- 229940075529 glyceryl stearate Drugs 0.000 claims abstract description 26
- 238000000034 method Methods 0.000 claims abstract description 23
- 150000003839 salts Chemical class 0.000 claims abstract description 22
- 125000003696 stearoyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims abstract description 20
- 125000005456 glyceride group Chemical group 0.000 claims abstract description 19
- 229920002675 Polyoxyl Polymers 0.000 claims abstract description 18
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract description 17
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- 230000008673 vomiting Effects 0.000 claims abstract description 15
- 206010028813 Nausea Diseases 0.000 claims abstract description 13
- 230000008693 nausea Effects 0.000 claims abstract description 13
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims abstract description 10
- 239000008194 pharmaceutical composition Substances 0.000 claims description 65
- 229940127557 pharmaceutical product Drugs 0.000 claims description 44
- 238000002360 preparation method Methods 0.000 claims description 17
- 239000003963 antioxidant agent Substances 0.000 claims description 15
- 235000006708 antioxidants Nutrition 0.000 claims description 15
- IZHVBANLECCAGF-UHFFFAOYSA-N 2-hydroxy-3-(octadecanoyloxy)propyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)COC(=O)CCCCCCCCCCCCCCCCC IZHVBANLECCAGF-UHFFFAOYSA-N 0.000 claims description 12
- 239000004322 Butylated hydroxytoluene Substances 0.000 claims description 8
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims description 8
- 230000003078 antioxidant effect Effects 0.000 claims description 8
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- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 6
- 239000004255 Butylated hydroxyanisole Substances 0.000 claims description 5
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims description 5
- 229940043253 butylated hydroxyanisole Drugs 0.000 claims description 5
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical group OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims description 5
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 4
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- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims description 4
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- QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 claims description 2
- 239000011786 L-ascorbyl-6-palmitate Substances 0.000 claims description 2
- 229930003427 Vitamin E Natural products 0.000 claims description 2
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- 235000010385 ascorbyl palmitate Nutrition 0.000 claims description 2
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 2
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- CSMWJXBSXGUPGY-UHFFFAOYSA-L sodium dithionate Chemical compound [Na+].[Na+].[O-]S(=O)(=O)S([O-])(=O)=O CSMWJXBSXGUPGY-UHFFFAOYSA-L 0.000 claims description 2
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- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims 1
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- 235000007686 potassium Nutrition 0.000 claims 1
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims 1
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- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
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- GHVNFZFCNZKVNT-UHFFFAOYSA-N decanoic acid Chemical group CCCCCCCCCC(O)=O GHVNFZFCNZKVNT-UHFFFAOYSA-N 0.000 description 4
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- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical group CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 description 4
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- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 2
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- WIKYUJGCLQQFNW-UHFFFAOYSA-N prochlorperazine Chemical compound C1CN(C)CCN1CCCN1C2=CC(Cl)=CC=C2SC2=CC=CC=C21 WIKYUJGCLQQFNW-UHFFFAOYSA-N 0.000 description 1
- 229960003111 prochlorperazine Drugs 0.000 description 1
- 239000000651 prodrug Substances 0.000 description 1
- 229940002612 prodrug Drugs 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate Nutrition 0.000 description 1
- 239000012453 solvate Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 125000000446 sulfanediyl group Chemical group *S* 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 229940095064 tartrate Drugs 0.000 description 1
- XCTYLCDETUVOIP-UHFFFAOYSA-N thiethylperazine Chemical compound C12=CC(SCC)=CC=C2SC2=CC=CC=C2N1CCCN1CCN(C)CC1 XCTYLCDETUVOIP-UHFFFAOYSA-N 0.000 description 1
- 229960004869 thiethylperazine Drugs 0.000 description 1
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Abstract
Description
ドンペリドン医薬製剤を調製し、表2~4に記載された量を用いてGMPカプセル化装置でカプセル化する。具体的には、窒素ブランケットとイエローライトの下で化合活性を行うものである。次に、2Cオーバルダイと0.040インチホールのシングルボトムショットウェッジを用いて、約38.7~51.7℃の温度でバッチをカプセル化する。カプセルは中鎖トリグリセリドとレシチンの混合物(MCT97%/レシチン3%)で手で磨かれる。
この出願の発明に関連する先行技術文献情報としては、以下のものがある(国際出願日以降国際段階で引用された文献及び他国に国内移行した際に引用された文献を含む)。
(先行技術文献)
(特許文献)
(特許文献1) 米国特許出願公開第2005/220825号明細書
(特許文献2) 米国特許出願公開第2017/298046号明細書
(特許文献3) 中国特許出願公開第102125528号明細書
Claims (35)
- 医薬製剤であって、
(i)ドンペリドンまたはその薬学的に許容される塩、ステアリン酸グリセリル、および中鎖トリグリセリド、または
(ii)ドンペリドンまたはその薬学的に許容される塩、ステアロイルポリオキシルグリセリド、非イオン性ポリ(エチレンオキシド)ポリマー、および中鎖トリグリセリド、または
iii)ドンペリドンまたはその薬学的に許容される塩、非イオン性ポリ(エチレンオキシド)ポリマー、およびポリエチレングリコール
を含む、医薬製剤。 - 請求項1に記載の医薬製剤において、ドンペリドンまたはその薬学的に許容される塩と、ステアリン酸グリセリルと、および中鎖トリグリセリドとを含む、医薬製剤。
- 請求項1または2に記載の医薬製剤において、前記ステアリン酸グリセリルが、パルミトステアリン酸グリセリル、ジステアリン酸グリセロール、ジステアリン酸グリセリル、またはそれらの組み合わせである、医薬製剤。
- 請求項1~3のいずれか1項に記載の医薬製剤において、前記製剤の重量に基づいて、約2~約20%(w/w)、好ましくは約5~約15%(w/w)、より好ましくは約10%(w/w)の前記ステアリン酸グリセリルを含む、医薬製剤。
- 請求項1~4のいずれか1項に記載の医薬製剤において、前記製剤の重量に基づいて、約70~約90%(w/w)、または好ましくは約80~約85%(w/w)の前記中鎖トリグリセリドを含む、医薬製剤。
- 請求項1~5のいずれか1項に記載の医薬製剤において、前記ステアリン酸グリセリルがPrecirol(商標登録)ATO 5である、医薬製剤。
- 請求項1記載の医薬製剤において、ドンペリドンまたはその薬学的に許容される塩と、ステアロイルポリオキシルグリセリドと、非イオン性ポリ(エチレンオキシド)ポリマーと、および中鎖トリグリセリドとを含む、医薬製剤。
- 請求項7記載の医薬製剤において、前記製剤の重量に基づいて、約3~約15%(w/w)、好ましくは約5~約10%(w/w)、より好ましくは約7%(w/w)の前記ステアロイルポリオキシルグリセリドを含む、医薬製剤。
- 請求項7または8記載の医薬製剤において、前記製剤の重量に基づいて、約5~約40%(w/w)、好ましくは約12~約25%(w/w)、またはより好ましくは約19%(w/w)の前記非イオン性ポリ(エチレンオキシド)ポリマーを含む、医薬製剤。
- 請求項7~9のいずれか1項に記載の医薬製剤において、前記製剤の重量に基づいて、約40~約80%(w/w)、好ましくは約50~68%(w/w)、またはより好ましくは約64%(w/w)の中鎖トリグリセリドを含む、医薬製剤。
- 請求項7~10のいずれか1項に記載の医薬製剤において、前記ステアロイルポリオキシルグリセリドがGelucire(商標登録)50/13である、医薬製剤。
- 請求項7~11のいずれか1項に記載の医薬製剤において、前記非イオン性ポリ(エチレンオキシド)ポリマーが、ポリエチレンオキシド303である、医薬製剤。
- 請求項1記載の医薬製剤において、ドンペリドンまたはその薬学的に許容される塩と、非イオン性ポリ(エチレンオキシド)ポリマーと、およびポリエチレングリコールとを含む、医薬製剤。
- 請求項13記載の医薬製剤において、前記製剤の重量に基づいて、約5~約30%(w/w)、好ましくは約10~約20%(w/w)、またはより好ましくは約15%(w/w)の前記非イオン性ポリ(エチレンオキシド)ポリマーを含む、医薬製剤。
- 請求項13記載の医薬製剤であって、前記製剤の重量に基づいて、約70~約90%(w/w)、好ましくは約70~約80%(w/w)、またはより好ましくは約75%(w/w)のポリエチレングリコールを含む、医薬製剤。
- 請求項13~15のいずれか1項に記載の医薬製剤において、前記非イオン性ポリ(エチレンオキシド)ポリマーが、約400,000~約8,000,000のMwを有する、医薬製剤。
- 請求項13~16のいずれか1項に記載の医薬製剤において、前記非イオン性ポリ(エチレンオキシド)ポリマーが、約7,000,000のMwを有する、医薬製剤。
- 請求項13~17のいずれか1項に記載の医薬製剤において、前記ポリエチレングリコールが、約300~約1000のMwを有する、医薬製剤。
- 請求項13~18のいずれか1項に記載の医薬製剤において、前記ポリエチレングリコールが約400のMwを有する、医薬製剤。
- 請求項1~19の請求項のいずれか1項に記載の医薬製剤であって、さらに抗酸化剤を含む、医薬製剤。
- 請求項20記載の医薬製剤において、前記抗酸化剤が、アスコルビン酸、パルミチン酸アスコルビル、ブチル化ヒドロキシアニソール、ブチル化ヒドロキシトルエン、没食子酸プロピル、メタ重亜硫酸カリウム、メタ重亜硫酸ナトリウム、チオ硫酸ナトリウム、またはビタミンEであり、または好ましくはブチル化ヒドロキシアニソールまたはブチル化ヒドロキシトルエンである、医薬製剤。
- 請求項1~21の請求項のいずれか1項に記載の医薬製剤において、前記製剤の重量に基づいて、約1~約20%(w/w)、好ましくは約5~約12%(w/w)、またはより好ましくは約10%(w/w)の前記ドンペリドンを含む、医薬製剤。
- 請求項1~22の請求項のいずれか1項に記載の医薬製剤において、約1~約50mgのドンペリドンを含む、医薬製剤。
- 患者における胃不全麻痺、胃不全麻痺とは別の吐き気、胃不全麻痺とは別の嘔吐、胃不全麻痺に伴う吐き気、胃不全麻痺に伴う嘔吐、胃食道逆流症、授乳不全、またはそれらの組み合わせである障害を治療する方法であって、請求項1~23のいずれか1項に記載の製剤を患者に投与する工程を含む、方法。
- 請求項24に記載の方法において、前記投与が、経口、経皮、非経口、またはそれらの組み合わせである、方法。
- 請求項24または25に記載の方法において、前記投与が経口である、方法。
- 請求項24~26のいずれか1項に記載の方法において、前記製剤が、錠剤、カプセル、ソフトジェル、懸濁液、液体、またはそれらの組み合わせの形態である、方法。
- 請求項24~27のいずれか1項に記載の方法において、前記障害が胃不全麻痺である、方法。
- 請求項24~27のいずれか1項に記載の方法において、前記疾患が胃食道逆流症である、方法。
- 請求項24~27のいずれか1項に記載の方法において、前記障害が授乳不足である、方法。
- 胃不全麻痺、胃不全麻痺とは別の吐き気、胃不全麻痺とは別の嘔吐、胃不全麻痺に伴う吐き気、胃不全麻痺に伴う嘔吐、胃食道逆流症、授乳不全、またはそれらの組み合わせである障害を、それを必要とする対象において治療するための、請求項1~23のいずれか1項に記載の製剤。
- 請求項31に記載の製剤において、前記製剤が、錠剤、カプセル、ソフトジェル、懸濁液、液体、またはそれらの組み合わせの形態である、製剤。
- 請求項31または32に記載の方法において、前記疾患が胃不全麻痺である、方法。
- 請求項31または32に記載の方法において、前記疾患が胃食道逆流症である、方法。
- 請求項31または32に記載の方法において、前記障害が不十分な授乳である、方法。
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SG11202103295VA (en) | 2021-05-28 |
ES2869197T3 (es) | 2021-10-25 |
CN112969460A (zh) | 2021-06-15 |
IL282576B (en) | 2022-05-01 |
AU2019368098A1 (en) | 2021-05-06 |
WO2020086950A1 (en) | 2020-04-30 |
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US20220110927A1 (en) | 2022-04-14 |
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