JP5972261B2 - カプセル化のためのスタチン及びオメガ−3脂肪酸の医薬処方 - Google Patents
カプセル化のためのスタチン及びオメガ−3脂肪酸の医薬処方 Download PDFInfo
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- JP5972261B2 JP5972261B2 JP2013512707A JP2013512707A JP5972261B2 JP 5972261 B2 JP5972261 B2 JP 5972261B2 JP 2013512707 A JP2013512707 A JP 2013512707A JP 2013512707 A JP2013512707 A JP 2013512707A JP 5972261 B2 JP5972261 B2 JP 5972261B2
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- 239000007939 sustained release tablet Substances 0.000 description 1
- 229920001059 synthetic polymer Polymers 0.000 description 1
- 238000009492 tablet coating Methods 0.000 description 1
- 239000002700 tablet coating Substances 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 229960004559 theobromine Drugs 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000011721 thiamine Substances 0.000 description 1
- 235000019157 thiamine Nutrition 0.000 description 1
- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
- 229960002663 thioctic acid Drugs 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 239000011731 tocotrienol Substances 0.000 description 1
- 229930003802 tocotrienol Natural products 0.000 description 1
- 235000019148 tocotrienols Nutrition 0.000 description 1
- ZCIHMQAPACOQHT-ZGMPDRQDSA-N trans-isorenieratene Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/c1c(C)ccc(C)c1C)C=CC=C(/C)C=Cc2c(C)ccc(C)c2C ZCIHMQAPACOQHT-ZGMPDRQDSA-N 0.000 description 1
- KBPHJBAIARWVSC-XQIHNALSSA-N trans-lutein Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C(=CC(O)CC2(C)C)C KBPHJBAIARWVSC-XQIHNALSSA-N 0.000 description 1
- 235000001019 trigonella foenum-graecum Nutrition 0.000 description 1
- 235000013976 turmeric Nutrition 0.000 description 1
- 229910052720 vanadium Inorganic materials 0.000 description 1
- GPPXJZIENCGNKB-UHFFFAOYSA-N vanadium Chemical compound [V]#[V] GPPXJZIENCGNKB-UHFFFAOYSA-N 0.000 description 1
- UUUGYDOQQLOJQA-UHFFFAOYSA-L vanadyl sulfate Chemical compound [V+2]=O.[O-]S([O-])(=O)=O UUUGYDOQQLOJQA-UHFFFAOYSA-L 0.000 description 1
- 229940041260 vanadyl sulfate Drugs 0.000 description 1
- 229910000352 vanadyl sulfate Inorganic materials 0.000 description 1
- 235000010374 vitamin B1 Nutrition 0.000 description 1
- 239000011691 vitamin B1 Substances 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 235000009492 vitamin B5 Nutrition 0.000 description 1
- 239000011675 vitamin B5 Substances 0.000 description 1
- 235000019158 vitamin B6 Nutrition 0.000 description 1
- 239000011726 vitamin B6 Substances 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940011671 vitamin b6 Drugs 0.000 description 1
- 229940046010 vitamin k Drugs 0.000 description 1
- FJHBOVDFOQMZRV-XQIHNALSSA-N xanthophyll Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C=C(C)C(O)CC2(C)C FJHBOVDFOQMZRV-XQIHNALSSA-N 0.000 description 1
- 239000012138 yeast extract Substances 0.000 description 1
- 229940093612 zein Drugs 0.000 description 1
- 239000005019 zein Substances 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
- General Preparation And Processing Of Foods (AREA)
- Jellies, Jams, And Syrups (AREA)
Description
アトルバスタチンカルシウム(固体剤形)及びオメガ3オイル(液相)の調製
アトルバスタチンカルシウム(固体剤形)及びオメガ3オイル(液相)
アトルバスタチンカルシウム(固体剤形)及びオメガ3オイル(液相)
ロスバスタチンカルシウム(固体剤形)及びオメガ3オイル(液相)
比較安定性データ
溶解データ
140 ソフトゼラチンカプセル
Claims (28)
- スタチン化合物を含む、タブレット、カプレット、又はカプセルである少なくとも1つの予備成形固体剤形;及び、
オメガ−3脂肪酸を含む少なくとも1つの液体充填相
を含む経口投与のための多相ソフトゼラチンカプセルであって、
前記少なくとも1つの予備成形固体剤形及び前記少なくとも1つの液体充填相が、前記ソフトゼラチンカプセル中に別々に導入されており、
前記予備成形固体剤形がマイクロカプセルではない、ソフトゼラチンカプセル。 - 前記少なくとも1つの予備成形固体剤形が、医薬品グレードで完成された剤形である、請求項1に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの液体充填相が、少なくとも1つの追加の有効成分をさらに含む、請求項1又は2に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの追加の有効成分が、医薬有効成分、栄養補助食品、栄養補給食品、治療剤、機能性賦形剤、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3に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの液体充填相が、希釈油をさらに含む、請求項1〜4のいずれか一項に記載のソフトゼラチンカプセル。
- 前記希釈油が、植物油、鉱油、食用油、医薬的に許容できる油、又はそれらの混合物を含む、請求項5に記載のソフトゼラチンカプセル。
- 前記スタチン化合物が、アトルバスタチン、フルバスタチン、ロバスタチン、ピタバスタチン、プラバスタチン、ロスバスタチン、シンバスタチン、及びそれらの医薬的に許容できる塩からなる群から選択される、請求項1〜6のいずれか一項に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がアトルバスタチンカルシウムである、請求項7に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がフルバスタチンナトリウムである、請求項7に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がプラバスタチンナトリウムである、請求項7に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がロスバスタチンカルシウムである、請求項7に記載のソフトゼラチンカプセル。
- 前記予備成形固体剤形が、少なくとも1つの追加の有効成分をさらに含む、請求項1〜6のいずれか一項に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの追加の有効成分が医薬有効成分である、請求項12に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がシンバスタチンであり、前記少なくとも1つの追加の有効成分がエゼチミブである、請求項12に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がロバスタチンであり、前記少なくとも1つの追加の有効成分がナイアシンである、請求項12に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がアトルバスタチンカルシウムであり、前記少なくとも1つの追加の有効成分がアムロジピンベシル酸塩である、請求項12に記載のソフトゼラチンカプセル。
- 前記スタチン化合物がシンバスタチンであり、前記少なくとも1つの追加の有効成分がナイアシンである、請求項12に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの予備成形固体剤形が少なくとも1つの被膜を有する、請求項1〜17のいずれか一項に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの予備成形固体剤形上の前記少なくとも1つの被膜が、即時放出型被膜、保護被膜、腸溶性又は遅延放出型被膜、持続放出型被膜、バリア被膜、防湿被膜、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18に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの予備成形固体剤形上の前記少なくとも1つの被膜が、フィルム被膜、ゼラチン被膜、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18又は19に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの予備成形固体剤形上の前記少なくとも1つの被膜が、少なくとも1つの有効成分をさらに含む、請求項18〜20のいずれか一項に記載のソフトゼラチンカプセル。
- 前記有効成分が、医薬有効成分、栄養補助食品、栄養補給食品、治療剤、機能性賦形剤、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21に記載のソフトゼラチンカプセル。
- 前記液体充填相が、オメガ−3脂肪酸のトリグリセリド、エチルエステル、又は乳化処方を含む、請求項1〜22のいずれか一項に記載のソフトゼラチンカプセル。
- 前記オメガ3−脂肪酸が、エイコサペンタエン酸(EPA)、ドコサヘキサエン酸(DHA)、又はそれらの混合物を含む、請求項23に記載のソフトゼラチンカプセル。
- 少なくとも1つの被膜を有する、請求項1〜24のいずれか一項に記載のソフトゼラチンカプセル。
- 前記ソフトゼラチンカプセル上の前記少なくとも1つの被膜が、即時放出型被膜、保護被膜、腸溶性又は遅延放出型被膜、持続放出型被膜、バリア被膜、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25に記載のソフトゼラチンカプセル。
- 前記ソフトゼラチンカプセル上の前記少なくとも1つの被膜が、少なくとも1つの有効成分をさらに含む、請求項25又は26に記載のソフトゼラチンカプセル。
- 前記少なくとも1つの有効成分が、医薬有効成分、栄養補助食品、栄養補給食品、治療剤、機能性賦形剤、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に記載のソフトゼラチンカプセル。
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CA2,706,270 | 2010-06-03 | ||
CA2706270A CA2706270C (en) | 2010-06-03 | 2010-06-03 | Pharmaceutical formulations of statins and omega-3 fatty acids for encapsulation |
PCT/CA2011/000650 WO2011150505A1 (en) | 2010-06-03 | 2011-06-03 | Pharmaceutical formulations of statins and omega-3 fatty acids for encapsulation |
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JP2016093142A Division JP2016138143A (ja) | 2010-06-03 | 2016-05-06 | カプセル化のためのスタチン及びオメガ−3脂肪酸の医薬処方 |
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JP2013527205A JP2013527205A (ja) | 2013-06-27 |
JP5972261B2 true JP5972261B2 (ja) | 2016-08-17 |
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JP2013512707A Active JP5972261B2 (ja) | 2010-06-03 | 2011-06-03 | カプセル化のためのスタチン及びオメガ−3脂肪酸の医薬処方 |
JP2016093142A Pending JP2016138143A (ja) | 2010-06-03 | 2016-05-06 | カプセル化のためのスタチン及びオメガ−3脂肪酸の医薬処方 |
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US (2) | US11975108B2 (ja) |
EP (2) | EP2575787B1 (ja) |
JP (2) | JP5972261B2 (ja) |
AU (1) | AU2011261117B2 (ja) |
CA (1) | CA2706270C (ja) |
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ES (1) | ES2807498T3 (ja) |
HU (1) | HUE050830T2 (ja) |
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PL (1) | PL2575787T3 (ja) |
PT (1) | PT2575787T (ja) |
WO (1) | WO2011150505A1 (ja) |
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WO2017171484A1 (ko) * | 2016-03-31 | 2017-10-05 | 한미약품 주식회사 | 오메가-3 지방산 또는 이의 에스테르, 및 하이드록시메틸글루타릴 코엔자임에이 환원효소 억제제를 포함하는 경구용 복합 제제 |
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EP2575787B1 (en) | 2020-05-27 |
HUE050830T2 (hu) | 2021-01-28 |
EP2575787A4 (en) | 2013-11-27 |
JP2016138143A (ja) | 2016-08-04 |
US20230233472A1 (en) | 2023-07-27 |
MX2019013095A (es) | 2020-01-30 |
AU2011261117A1 (en) | 2012-12-13 |
AU2011261117B2 (en) | 2015-08-13 |
CA2706270A1 (en) | 2011-12-03 |
EP3581173A1 (en) | 2019-12-18 |
DK2575787T3 (da) | 2020-08-03 |
CA2706270C (en) | 2020-01-07 |
WO2011150505A1 (en) | 2011-12-08 |
MX369477B (es) | 2019-11-08 |
PT2575787T (pt) | 2020-07-28 |
US11975108B2 (en) | 2024-05-07 |
MX2012013933A (es) | 2013-02-11 |
PL2575787T3 (pl) | 2020-11-02 |
EP2575787A1 (en) | 2013-04-10 |
US20130115281A1 (en) | 2013-05-09 |
JP2013527205A (ja) | 2013-06-27 |
EP3581173B1 (en) | 2024-08-28 |
ES2807498T3 (es) | 2021-02-23 |
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