JP2018502168A5 - - Google Patents
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- Publication number
- JP2018502168A5 JP2018502168A5 JP2017556787A JP2017556787A JP2018502168A5 JP 2018502168 A5 JP2018502168 A5 JP 2018502168A5 JP 2017556787 A JP2017556787 A JP 2017556787A JP 2017556787 A JP2017556787 A JP 2017556787A JP 2018502168 A5 JP2018502168 A5 JP 2018502168A5
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- oral dosage
- solid oral
- dose
- fingolimod
- 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.)
- Pending
Links
- 239000007787 solid Substances 0.000 claims 11
- 239000006186 oral dosage form Substances 0.000 claims 10
- KKGQTZUTZRNORY-UHFFFAOYSA-N Fingolimod Chemical compound CCCCCCCCC1=CC=C(CCC(N)(CO)CO)C=C1 KKGQTZUTZRNORY-UHFFFAOYSA-N 0.000 claims 5
- 229960000556 fingolimod Drugs 0.000 claims 5
- 239000003826 tablet Substances 0.000 claims 4
- 230000035533 AUC Effects 0.000 claims 2
- 230000035839 C max Effects 0.000 claims 2
- 230000037098 T max Effects 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 235000020937 fasting conditions Nutrition 0.000 claims 2
- 210000002381 Plasma Anatomy 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 239000006191 orally-disintegrating tablet Substances 0.000 claims 1
- 239000000546 pharmaceutic aid Substances 0.000 claims 1
- 230000036470 plasma concentration Effects 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
Claims (8)
- ０．１ｍｇ〜１ｍｇのフィンゴリモドラウリル硫酸塩および少なくとも１つの薬学的に許容される賦形剤を含む固体経口剤形であって、絶食条件下で健康な成人に前記固体経口剤形を単回用量投与した後の最大のフィンゴリモド濃度（Ｔ ｍａｘ ）までの時間は約１０〜約３５時間であり、用量調整された最大のフィンゴリモド濃度（Ｃ ｍａｘ／用量 ）は、約０．５５〜約１．５ｎｇ／ｍｌ／ｍｇであり、用量調整された血漿濃度−時間曲線下面積（ＡＵＣ ０−∞／用量 ）は、約１２５〜約２７５ｎｇ・ｈｒ／ｍｌ／ｍｇである、固体経口剤形。
- 絶食条件下で健康な成人に前記固体剤形を単回用量投与した後の最大のフィンゴリモド濃度（Ｔｍａｘ）までの時間は約１２〜約３０時間であり、用量調整された最大のフィンゴリモド濃度（Ｃｍａｘ／用量）は約０．６０〜約１．２５ｎｇ／ｍｌ／ｍｇであり、用量調整された血漿濃度−時間曲線下面積（ＡＵＣ０−∞／用量）は約１５０〜約２５０ｎｇ・ｈｒ／ｍｌ／ｍｇである、請求項１に記載の固体経口剤形。
- 約０．５ｍｇのフィンゴリモドを含む、請求項１に記載の固体経口剤形。
- 前記固体経口剤形は、錠剤である、請求項１に記載の固体経口剤形。
- 前記錠剤は、ＵＳＰ崩壊装置を用いて試験した場合１．５分未満で崩壊する、請求項４に記載の固体経口剤形。
- 前記錠剤は、口腔内崩壊錠剤または口腔内溶解錠剤である、請求項４に記載の固体経口剤形。
- 薬剤を必要とする対象の病気の治療のための前記薬剤の製造における請求項１〜６のいずれか１項における固体経口剤形の使用。
- 前記病気は、多発性硬化症である、請求項７に記載の使用。
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562105603P | 2015-01-20 | 2015-01-20 | |
| US62/105,603 | 2015-01-20 | ||
| US201562216100P | 2015-09-09 | 2015-09-09 | |
| US62/216,100 | 2015-09-09 | ||
| PCT/US2016/013938 WO2016118515A1 (en) | 2015-01-20 | 2016-01-19 | Stable solid fingolimod dosage forms |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2018502168A JP2018502168A (ja) | 2018-01-25 |
| JP2018502168A5 true JP2018502168A5 (ja) | 2019-02-28 |
Family
ID=56417652
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017556787A Pending JP2018502168A (ja) | 2015-01-20 | 2016-01-19 | 安定な固体フィンゴリモド剤形 |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US20230149302A1 (ja) |
| EP (1) | EP3247341A4 (ja) |
| JP (1) | JP2018502168A (ja) |
| CN (1) | CN107530301A (ja) |
| AU (1) | AU2016209466A1 (ja) |
| CA (1) | CA2974375A1 (ja) |
| TW (1) | TW201642842A (ja) |
| WO (1) | WO2016118515A1 (ja) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP7503420B2 (ja) | 2020-05-18 | 2024-06-20 | 東和薬品株式会社 | フィンゴリモドを含む医薬組成物とその製造方法及び安定化方法 |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110005320A (ko) * | 2003-04-08 | 2011-01-17 | 노파르티스 아게 | Ｓ1ｐ 수용체 아고니스트 및 당 알콜을 포함하는 고형 제약 조성물 |
| EP1923058A1 (en) * | 2006-09-26 | 2008-05-21 | Novartis AG | Coated pharmaceutical composition comprising an S1P agonist or modulator |
| CA2953372C (en) * | 2006-09-26 | 2020-06-23 | Novartis Ag | Pharmaceutical composition comprising an s1p receptor modulator |
| EP1923055A1 (en) * | 2006-09-26 | 2008-05-21 | Novartis AG | Freeze-dried pharmaceutical composition comprising an S1P agonist or modulator |
| EP2465492B1 (en) * | 2007-10-12 | 2015-07-01 | Novartis AG | Compositions comprising sphingosine I phosphate (sip) receptor modulators |
| EP2560619A2 (en) * | 2010-04-22 | 2013-02-27 | Ratiopharm GmbH | A method of preparing an oral dosage form comprising fingolimod |
| AR085749A1 (es) * | 2011-04-01 | 2013-10-23 | Novartis Ag | Formulaciones |
| EP2609912A1 (en) * | 2011-12-30 | 2013-07-03 | Deva Holding Anonim Sirketi | Pharmaceutical combination of fingolimod and nabiximols |
| US20140199382A1 (en) * | 2013-01-11 | 2014-07-17 | Cadila Healthcare Limited | Stable pharmaceutical compositions of an s1p receptor agonist |
| US9925138B2 (en) * | 2015-01-20 | 2018-03-27 | Handa Pharmaceuticals, Llc | Stable solid fingolimod dosage forms |
-
2016
- 2016-01-19 CA CA2974375A patent/CA2974375A1/en not_active Abandoned
- 2016-01-19 CN CN201680006946.6A patent/CN107530301A/zh active Pending
- 2016-01-19 EP EP16740597.6A patent/EP3247341A4/en not_active Withdrawn
- 2016-01-19 AU AU2016209466A patent/AU2016209466A1/en not_active Abandoned
- 2016-01-19 WO PCT/US2016/013938 patent/WO2016118515A1/en active Application Filing
- 2016-01-19 JP JP2017556787A patent/JP2018502168A/ja active Pending
- 2016-01-20 TW TW105101755A patent/TW201642842A/zh unknown
-
2022
- 2022-12-30 US US18/091,481 patent/US20230149302A1/en not_active Abandoned
-
2023
- 2023-09-08 US US18/243,735 patent/US20240050365A1/en active Pending
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