JP6095891B2 - 25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 - Google Patents
25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 Download PDFInfo
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- JP6095891B2 JP6095891B2 JP2011520222A JP2011520222A JP6095891B2 JP 6095891 B2 JP6095891 B2 JP 6095891B2 JP 2011520222 A JP2011520222 A JP 2011520222A JP 2011520222 A JP2011520222 A JP 2011520222A JP 6095891 B2 JP6095891 B2 JP 6095891B2
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- 239000005720 sucrose Substances 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- 210000003812 trophozoite Anatomy 0.000 description 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 1
- 238000009281 ultraviolet germicidal irradiation Methods 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 102000009310 vitamin D receptors Human genes 0.000 description 1
- 108050000156 vitamin D receptors Proteins 0.000 description 1
- 235000005282 vitamin D3 Nutrition 0.000 description 1
- 239000011647 vitamin D3 Substances 0.000 description 1
- 239000005544 vitamin D3 metabolite Substances 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 229940021056 vitamin d3 Drugs 0.000 description 1
- 208000030401 vitamin deficiency disease Diseases 0.000 description 1
- 235000019195 vitamin supplement Nutrition 0.000 description 1
- 239000000080 wetting agent Substances 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K31/593—9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
-
- 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
- A61P3/02—Nutrients, e.g. vitamins, minerals
Description
Claims (14)
- 定常状態の薬物動態にて少なくとも7日間、ヒトにおける血清レベルを30ng/mL〜200ng/mLの濃度に持続するのに十分な単回薬用量の25−ヒドロキシビタミンD3又はその一水和物と、薬学的に好適な経口担体系と、を含む経口投与用医薬組成物で
あって、前記経口投与用医薬組成物が、7日に1回の単回投与に好適であり、前記薬学的に好適な経口担体系が1以上の消化できる油を含み、かつ前記単回薬用量が25−ヒドロキシビタミンD3又はその一水和物10〜100μg/体重kgである、経口投与用医薬組成物。 - 毎週投与される前記単回薬用量が、定常状態の薬物動態にてヒトにおいて血清レベルを30ng/mL〜200ng/mLの濃度に持続するのに十分な薬用量である請求項1に記載の経口投与用医薬組成物。
- 前記濃度が、30ng/mL〜100ng/mLである請求項1に記載の経口投与用医薬組成物。
- 前記経口投与用医薬組成物の形態が、軟質ゲルカプセルである請求項1に記載の経口投与用医薬組成物。
- 前記経口担体系が、1以上の消化可能な油を含む経口担体系である請求項1に記載の経口投与用医薬組成物。
- 前記経口担体系の形態が、錠剤である請求項1に記載の経口投与用医薬組成物。
- 前記単回薬用量が、25−ヒドロキシビタミンD3又はその一水和物30〜50μg/
体重kgである請求項1に記載の経口投与用医薬組成物。 - 前記単回薬用量が、25−ヒドロキシビタミンD3又はその一水和物0.6mg〜6m
gである請求項1に記載の経口投与用医薬組成物。 - 定常状態の薬物動態にて少なくとも7日間、ヒトにおける血清レベルを30ng/mL〜200ng/mLの濃度に持続するのに十分な単回薬用量の25−ヒドロキシビタミンD3又はその一水和物と、薬学的に好適な非経口担体系と、を含む、注射剤又は点滴剤で
あり、前記単回薬用量が25−ヒドロキシビタミンD3又はその一水和物10〜100μ
g/体重kgである、非経口投与用医薬組成物。 - 毎週投与される前記単回薬用量が、定常状態の薬物動態にてヒトにおいて血清レベルを30ng/mL〜200ng/mLの濃度に持続するのに十分な単回薬用量である請求項9に記載の非経口投与用医薬組成物。
- 前記濃度が、30ng/mL〜100ng/mLである請求項9に記載の非経口投与用医薬組成物。
- 前記単回薬用量が、25−ヒドロキシビタミンD3又はその一水和物30〜50μg/
体重kgである請求項9に記載の非経口投与用医薬組成物。 - 前記単回薬用量が、25−ヒドロキシビタミンD3又はその一水和物0.6mg〜6m
gである請求項9に記載の非経口投与用医薬組成物。 - 定常状態の薬物動態にて少なくとも7日間、ヒトにおける血清レベルを30ng/mL〜200ng/mLの濃度に持続するのに十分な単回薬用量の25−ヒドロキシビタミンD2又はその一水和物と、薬学的に好適な担体系と、を含み前記単回薬用量が10〜10
0μg/体重kgである医薬組成物。
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US8322308P | 2008-07-24 | 2008-07-24 | |
US61/083,223 | 2008-07-24 | ||
PCT/US2009/051664 WO2010011906A1 (en) | 2008-07-24 | 2009-07-24 | Once-a-week administration of 25-hydroxy vitamin d3 to sustain elevated steady-state pharmacokinetic blood concentration |
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JP2016230604A Division JP6375353B2 (ja) | 2008-07-24 | 2016-11-28 | 25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 |
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JP2016230604A Expired - Fee Related JP6375353B2 (ja) | 2008-07-24 | 2016-11-28 | 25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 |
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US (4) | US8759328B2 (ja) |
EP (1) | EP2321273B1 (ja) |
JP (2) | JP6095891B2 (ja) |
AU (1) | AU2009273889B2 (ja) |
CA (1) | CA2731382C (ja) |
DK (1) | DK2321273T3 (ja) |
ES (1) | ES2525180T3 (ja) |
HR (1) | HRP20150093T1 (ja) |
PL (1) | PL2321273T3 (ja) |
PT (1) | PT2321273E (ja) |
SI (1) | SI2321273T1 (ja) |
SM (1) | SMT201500020B (ja) |
WO (1) | WO2010011906A1 (ja) |
Cited By (1)
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JP2017061545A (ja) * | 2008-07-24 | 2017-03-30 | ウイスコンシン アラムナイ リサーチ ファウンデーシヨンWisconsin Alumni Research Foundation | 25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 |
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CA2882048C (en) | 2006-02-03 | 2020-03-24 | Proventiv Therapeutics, Llc | Treating vitamin d insufficiency and deficiency with 25-hydroxyvitamin d2 and 25-hydroxyvitamin d3 |
ES2497494T3 (es) | 2006-06-21 | 2014-09-23 | Opko Renal, Llc | Método de tratamiento y prevención del hiperparatiroidismo secundario |
WO2009047644A2 (en) | 2007-04-25 | 2009-04-16 | Cytochroma Inc. | Method of treating vitamin d insufficiency and deficiency |
KR20190028822A (ko) | 2007-04-25 | 2019-03-19 | 사이토크로마 인코포레이티드 | 비타민 d 화합물과 밀랍성 담체를 포함하는 경구 조절성 방출 조성물 |
WO2008134523A1 (en) | 2007-04-25 | 2008-11-06 | Proventiv Therapeutics, Llc | Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease |
WO2008134518A2 (en) | 2007-04-25 | 2008-11-06 | Cytochroma Inc. | Methods and compounds for vitamin d therapy |
US8962239B2 (en) | 2008-04-02 | 2015-02-24 | Opko Renal, Llc | Methods useful for vitamin D deficiency and related disorders |
PT2552484T (pt) | 2010-03-29 | 2020-04-03 | Opko Ireland Global Holdings Ltd | Métodos e composições para redução dos níveis de parafróides |
US10055727B2 (en) | 2012-11-05 | 2018-08-21 | Mfoundry, Inc. | Cloud-based systems and methods for providing consumer financial data |
KR101847947B1 (ko) | 2013-03-15 | 2018-05-28 | 옵코 아이피 홀딩스 Ⅱ 인코포레이티드 | 안정화되고 변형된 비타민 d 방출 제형 |
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EP3193925A2 (en) | 2014-08-07 | 2017-07-26 | OPKO Ireland Global Holdings, Ltd. | Adjunctive therapy with 25-hydroxyvitamin d |
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CN108383767B (zh) * | 2018-02-06 | 2020-03-24 | 山东海能生物工程有限公司 | 25-羟基胆钙化醇一水合物晶体及其制备方法以及使用其的微乳液 |
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WO2022224001A1 (en) * | 2021-04-22 | 2022-10-27 | Faes Farma, S.A. | Universal dosage regime of 25-hydroxy vitamin d3 |
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US3607888A (en) * | 1969-08-07 | 1971-09-21 | Wisconsin Alumni Res Found | 25-hydroxytachysterol3 25-hydroxydihydrotachysterol3 and methods for preparing same |
CA2144728C (en) * | 1992-09-15 | 2005-04-26 | Susan Thys-Jacobs | Method of treating premenstrual syndrome symptomatology with vitamin d or vitamin d and calcium |
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WO2003086415A1 (en) * | 2002-04-05 | 2003-10-23 | Merck & Co., Inc. | Method for inhibiting bone resorption with an alendronate and vitamin d formulation |
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CA2882048C (en) * | 2006-02-03 | 2020-03-24 | Proventiv Therapeutics, Llc | Treating vitamin d insufficiency and deficiency with 25-hydroxyvitamin d2 and 25-hydroxyvitamin d3 |
ES2497494T3 (es) * | 2006-06-21 | 2014-09-23 | Opko Renal, Llc | Método de tratamiento y prevención del hiperparatiroidismo secundario |
WO2008134518A2 (en) * | 2007-04-25 | 2008-11-06 | Cytochroma Inc. | Methods and compounds for vitamin d therapy |
KR20190028822A (ko) * | 2007-04-25 | 2019-03-19 | 사이토크로마 인코포레이티드 | 비타민 d 화합물과 밀랍성 담체를 포함하는 경구 조절성 방출 조성물 |
WO2009047644A2 (en) * | 2007-04-25 | 2009-04-16 | Cytochroma Inc. | Method of treating vitamin d insufficiency and deficiency |
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JP6095891B2 (ja) * | 2008-07-24 | 2017-03-15 | ウイスコンシン アラムナイ リサーチ ファウンデーシヨンWisconsin Alumni Research Foundation | 25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 |
PT2552484T (pt) * | 2010-03-29 | 2020-04-03 | Opko Ireland Global Holdings Ltd | Métodos e composições para redução dos níveis de parafróides |
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Cited By (1)
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JP2017061545A (ja) * | 2008-07-24 | 2017-03-30 | ウイスコンシン アラムナイ リサーチ ファウンデーシヨンWisconsin Alumni Research Foundation | 25−ヒドロキシビタミンd3を含む経口剤形、及び、その経口剤形を週1回ヒトに投与することを含む方法 |
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US20110105444A1 (en) | 2011-05-05 |
US20200281947A1 (en) | 2020-09-10 |
PT2321273E (pt) | 2014-12-29 |
ES2525180T3 (es) | 2014-12-18 |
HRP20150093T1 (hr) | 2015-03-27 |
EP2321273A4 (en) | 2011-11-30 |
SI2321273T1 (sl) | 2015-03-31 |
CA2731382C (en) | 2020-04-28 |
EP2321273B1 (en) | 2014-11-19 |
US20140100203A1 (en) | 2014-04-10 |
US20150374722A1 (en) | 2015-12-31 |
AU2009273889B2 (en) | 2013-01-31 |
US8759328B2 (en) | 2014-06-24 |
WO2010011906A1 (en) | 2010-01-28 |
CA2731382A1 (en) | 2010-01-28 |
SMT201500020B (it) | 2015-03-05 |
DK2321273T3 (en) | 2015-02-16 |
EP2321273A1 (en) | 2011-05-18 |
JP6375353B2 (ja) | 2018-08-15 |
JP2011529081A (ja) | 2011-12-01 |
JP2017061545A (ja) | 2017-03-30 |
AU2009273889A1 (en) | 2010-01-28 |
PL2321273T3 (pl) | 2015-05-29 |
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