DK2679228T3 - Terapi med et vitamin D-genopfyldningsmiddel og et vitamin D-hormonerstatningsmiddel - Google Patents
Terapi med et vitamin D-genopfyldningsmiddel og et vitamin D-hormonerstatningsmiddel Download PDFInfo
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- DK2679228T3 DK2679228T3 DK13177274.1T DK13177274T DK2679228T3 DK 2679228 T3 DK2679228 T3 DK 2679228T3 DK 13177274 T DK13177274 T DK 13177274T DK 2679228 T3 DK2679228 T3 DK 2679228T3
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Classifications
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K31/592—9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- 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
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- 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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (15)
1. Lægemiddel, som er en kombination af (i) en Vitamin D-genopfyldningsterapi, som er en forbindelse valgt blandt Vitamin D og Vitamin D-prohormoner, og (ii) en Vitamin D-hormonerstatningsterapi, som er én eller flere forbindelser valgt blandt aktive Vitamin D-hormoner og aktive Vitamin D-hormonanaloger, som er 1a-hydroxylerede Vitamin D-forbindelser, til anvendelse til behandling afen patient, hvor behandlingen er: (a) en fremgangsmåde til behandling afen patient, der har Vitamin D-mangel eller -insufficiens; og/eller (b) en fremgangsmåde til behandling af en patient, der har kronisk nyresygdom trin 3 eller trin 4.
2. Anvendelse af (i) en Vitamin D-genopfyldningsterapi, som er en forbindelse valgt blandt Vitamin D og Vitamin D-prohormoner, og (ii) en Vitamin D-hormonerstatningsterapi, som er én eller flere forbindelser valgt blandt aktive Vitamin D-hormoner og aktive Vitamin D-hormonanaloger, der er 1 α-hydroxylerede Vitamin D-forbindelser, til fremstilling af et lægemiddel til behandling afen patient, hvor behandlingen er: (a) en fremgangsmåde til behandling af en patient, der har Vitamin D-mangel eller-insufficiens; og/eller (b) en fremgangsmåde til behandling af en patient, der har kronisk nyresygdom trin 3 eller trin 4.
3. Lægemiddel til anvendelse til behandling af en patient, hvor lægemidlet er en Vitamin D-genopfyldningsterapi, der er en forbindelse valgt blandt Vitamin D og Vitamin D-prohormoner, og hvor lægemidlet er til anvendelse som en sambehandling med en Vitamin D-hormonerstatningsterapi, som er én eller flere forbindelser valgt blandt aktive Vitamin D-hormoner og aktive Vitamin D-hormonanaloger, som er 1 a-hydroxylerede Vitamin D-forbindelser, hvor behandlingen af patienten er: (a) en fremgangsmåde til behandling af en patient, der har Vitamin D-mangel eller-insufficiens; og/eller (b) en fremgangsmåde til behandling af en patient, der har kronisk nyresygdom trin 3 eller trin 4.
4. Lægemiddel til anvendelse til behandling af en patient, hvor lægemidlet er en Vitamin D-hormonerstatningsterapi, der er en forbindelse valgt blandt aktive Vitamin D-hormoner og aktive Vitamin D-hormonanaloger, der er 1 a-hydroxylerede Vitamin D-forbindelser, og hvor lægemidlet er til anvendelse som en sambehandling med en Vitamin D-genopfyldningsterapi, som er en forbindelse valgt blandt Vitamin D og Vitamin D-prohormoner, hvor behandlingen af patienten er: (a) en fremgangsmåde til behandling af en patient, der har Vitamin D-mangel eller-insufficiens; og/eller (b) en fremgangsmåde til behandling af en patient, der har kronisk nyresygdom trin 3 eller trin 4.
5. Anvendelse af en forbindelse til fremstilling af et lægemiddel til behandling af en patient, hvor forbindelsen er (i) en Vitamin D-genopfyldningsterapi, som er en forbindelse valgt blandt Vitamin D og Vitamin D-prohormoner, og hvor forbindelsen er til anvendelse som en sambehandling med en Vitamin D-hormonerstatningsterapi, som er én eller flere forbindelser valgt blandt aktive Vitamin D-hormoner og aktive Vitamin D-hormonanaloger, som er 1 a-hydroxylerede Vitamin D-forbindelser, eller (ii) en Vitamin D-hormonerstatningsterapi, der er én eller flere forbindelser valgt blandt aktive Vitamin D-hormoner og aktive Vitamin D-hormonanaloger, som er 1 α-hydroxylerede Vitamin D-forbindelser, og hvor forbindelsen er til anvendelse som en sambehandling med en Vitamin D-genopfyldningsterapi, der er en forbindelse valgt blandt Vitamin D og Vitamin D-prohormoner, og hvor behandlingen af patienten er: (a) en fremgangsmåde til behandling af en patient, der har Vitamin D-mangel eller -insufficiens; og/eller (b) en fremgangsmåde til behandling af en patient, der har kronisk nyresygdom trin 3 eller trin 4.
6. Lægemiddel eller anvendelse ifølge et hvilket som helst af kravene 3 til 5, hvor sam-behandlingen involverer: (i) administration af forbindelserne med forskellige adskilte intervaller, men overlappende i et tidsrum med periodisk administration af forbindelserne; eller (ii) samtidig administration af forbindelserne; eller (iii) administration af én af forbindelserne efterfulgt af administration af den anden forbindelse.
7. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, hvor Vitamin D-genopfyldningsterapien: (a) er en forbindelse valgt blandt ergocalciferol, cholecalciferol, 25-hydroxy-vitamin D2 og 25-hydroxyvitamin D3; eller (b) er en 25-hydroxyvitamin D-forbindelse; eller (c) er en 25-hydroxyvitamin D-forbindelse, der hovedsagelig omfatter 25-hydroxyvitamin D3.
8. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, hvor Vitamin D-hormonerstatningsterapien er: (a) et aktivt Vitamin D-hormon; eller (b) en forbindelse valgt blandt 1,25-dihydroxyvitamin D2, 1,25-dihydroxyvitamin D3 og 1,25-dihydroxyvitamin D4.
9. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, hvor lægemidlet omfatter et middel til kontrolleret frigivelse af én eller begge forbindelser til Vitamin D-genopfyldning og forbindelsen til Vitamin D-hormonerstatning.
10. Lægemiddel eller anvendelse ifølge krav 9, hvor midlet til kontrolleret frigivelse: (a) styrer frigivelseshastigheden af forbindelsen fra doseringsformen for at reducere den maksimale serumkoncentration af forbindelsen i et dosisinterval (Cmax) sammenlignet med Cmax for en ækvivalent mængde af forbindelsen, som administreres ved bolus IV-injektion og/eller en oral doseringsform med øjeblikkelig frigivelse, og/eller (b) styrer frigivelseshastigheden af forbindelsen fra doseringsformen for at forøge tiden for plasmakoncentrationen af forbindelsen til at nå sit maksimum i et dosisinterval efter administration (Tmax) sammenlignet med Tmaxfor en ækvivalent mængde af forbindelsen, som administreres ved bolus IV-injektion og/eller en oral doseringsform med øjeblikkelig frigivelse, og/eller (c) styrer frigivelseshastigheden af forbindelsen fra doseringsformen for at reducere forholdet mellem den maksimale serumkoncentration inden for 24 timer efter administration af forbindelsen og koncentrationen 24 timer efter administration (Crnax24timer/C24timer) i sammenligning med Crnax24timer/C24timer for en ækvivalent mængde af forbindelsen, som administreres ved bolus IV-injektion og/eller en oral doseringsform med øjeblikkelig frigivelse.
11. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, der yderligere omfatter: (i) et phosphatbindemiddel; og/eller (ii) et calcimimetisk middel.
12. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, hvor behandlingen er: (a) en fremgangsmåde til behandling af forhøjede blodniveauer af intakt para-thyroidhormon (iPTH) hos en human patient samtidig med (i) forøgelse eller opretholdelse af serumkalciumniveauer, (ii) opretholdelse af serumphosphornive-auer, (iii) forøgelse eller opretholdelse af serum 25-hydroxyvitamin D og (iv) forøgelse eller opretholdelse af serum 1,25-dihydroxyvitamin D-niveauer i den humane patient; og/eller (b) en fremgangsmåde, hvor suprafysiologiske niveauer af 25-hydroxyvitamin D formindskes eller elimineres.
13. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, hvor behandlingen er: (a) en fremgangsmåde til forøgelse eller opretholdelse af blodkoncentrationer af både 25-hydroxyvitamin D og 1,25-dihydroxyvitamin D i en human patient, hvor blodkoncentrationerne af 25-hydroxyvitamin D øges til og opretholdes ved eller over 30 ng/ml, og blodkoncentrationer af 1,25-dihydroxyvitamin D øges til eller opretholdes inden for en patients normale historiske fysiologiske område for 1,25-dihydroxyvitamin D; og/eller (b) en fremgangsmåde til samtidig nedsættelse eller opretholdelse af plasma-iPTH-niveauer, forøgelse eller opretholdelse af serumkalciumniveauer, opretholdelse af serumphosphorniveauer, forøgelse eller opretholdelse af serum 25-hydroxyvitamin D og forøgelse eller opretholdelse af serum 1,25-dihydroxy-vitamin D-niveauer i en human patient; og/eller c) en fremgangsmåde til reduktion af risikoen for oversuppression af plasma-iPTH-niveauer hos en patient, der gennemgår behandling for forhøjede niveauer af plasma-iPTH, hvor forbindelsen til Vitamin D-genopfyldning og forbindelsen til Vitamin D-hormonerstatning administreres i mængder, der er tilstrækkelige til at formindske forhøjede plasma-iPTH-niveauer, samtidig med at der undgås en abnormt lav knogleomsætningshastighed; eller (d) en fremgangsmåde til opretholdelse i patientens blod af koncentrationer af 25-hydroxyvitamin D ved eller over 30 ng/ml og blodkoncentrationer af 1,25-dihydroxyvitamin D i patienten i niveauer inden for patientens normale historiske fysiologiske område, mens forhøjede blodniveauer af iPTH sænkes uden at forårsage væsentligt øget risiko for hypercalcæmi, hyperphosphatæmi eller oversuppression af plasma iPTH.
14. Lægemiddel eller anvendelse ifølge krav 13, hvor behandlingen er en fremgangsmåde til reduktion af risikoen for oversuppression af plasma-iPTH-niveauer hos en patient, der gennemgår behandling for forhøjede niveauer af plasma-iPTH, hvor forbindelsen til Vitamin D-genopfyldning og forbindelsen til Vitamin D-hormonerstatning administreres i mængder, der er tilstrækkelige til at nedsætte forhøjede plasma-iPTH-niveauer, samtidig med at der undgås en abnormt lav knogleomsætningshastighed.
15. Lægemiddel eller anvendelse ifølge et hvilket som helst af de foregående krav, hvor Vitamin D-genopfyldningsterapien og/eller Vitamin D-hormonerstatningsterapien administreres oralt.
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| EP07840277.3A EP2037936B1 (en) | 2006-06-21 | 2007-06-21 | Method of treating and preventing secondary hyperparathyroidism |
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| DK2679228T3 true DK2679228T3 (da) | 2018-06-06 |
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| DK13177274.1T DK2679228T3 (da) | 2006-06-21 | 2007-06-21 | Terapi med et vitamin D-genopfyldningsmiddel og et vitamin D-hormonerstatningsmiddel |
| DK07840277.3T DK2037936T3 (da) | 2006-06-21 | 2007-06-21 | Fremgangsmåde til behandling og forebyggelse af sekundær hyperparathyroidisme |
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| SI3095447T1 (sl) | 2006-02-03 | 2022-02-28 | Opko Renal, Llc | Zdravljenje pomanjkanja vitamina D s 25-hidroksivitaminom D2 in 25-hidroksivitaminom D3 |
| HUE037309T2 (hu) | 2006-06-21 | 2018-08-28 | Opko Ireland Global Holdings Ltd | Terápia D-vitamin telítési szer alkalmazásával és D-vitamin hormon helyettesítõ szer |
| PL2148661T3 (pl) | 2007-04-25 | 2013-07-31 | Cytochroma Inc | Doustne kompozycje o kontrolowanym uwalnianiu zawierające związek będący witaminą D i woskowy nośnik |
| US8592401B2 (en) | 2007-04-25 | 2013-11-26 | Proventiv Therapeutics, Llc | Methods and compounds for vitamin D therapy |
| PT3335712T (pt) | 2007-04-25 | 2025-10-23 | Opko Renal Llc | Método de tratamento e prevenção seguro e eficaz do hiperparatiroidismo secundário na doença renal crónica |
| DK2148684T3 (da) | 2007-04-25 | 2013-04-22 | Cytochroma Inc | Fremgangsmåde til behandling af vitamin D-insufficiens og -deficiens |
| CN102046812A (zh) | 2008-04-02 | 2011-05-04 | 赛特克罗公司 | 用于维生素d缺乏症和相关障碍的方法、组合物、用途和试剂盒 |
| WO2010011906A1 (en) * | 2008-07-24 | 2010-01-28 | Wisconsin Alumni Research Foundation | Once-a-week administration of 25-hydroxy vitamin d3 to sustain elevated steady-state pharmacokinetic blood concentration |
| PT2552484T (pt) | 2010-03-29 | 2020-04-03 | Opko Ireland Global Holdings Ltd | Métodos e composições para redução dos níveis de parafróides |
| EP2819749A4 (en) * | 2012-03-01 | 2016-03-02 | Univ Columbia | BIOMARKERS FOR AUTISM AND USES THEREOF |
| KR101847947B1 (ko) | 2013-03-15 | 2018-05-28 | 옵코 아이피 홀딩스 Ⅱ 인코포레이티드 | 안정화되고 변형된 비타민 ｄ 방출 제형 |
| US10220047B2 (en) | 2014-08-07 | 2019-03-05 | Opko Ireland Global Holdings, Ltd. | Adjunctive therapy with 25-hydroxyvitamin D and articles therefor |
| MY198547A (en) | 2016-03-28 | 2023-09-04 | Opko Ireland Global Holdings Ltd | Methods of vitamin d treatment |
| MX2020010338A (es) | 2018-04-03 | 2020-11-13 | Opko Ireland Global Holdings Ltd | Uso de calcifediol en pacientes de cirugia bariatrica. |
| EP3920938A1 (en) | 2019-02-06 | 2021-12-15 | EirGen Pharma Ltd. | Method of controlling progression of hyperparathyroidism with calcifediol, and compositions for use therein |
| JP7408094B2 (ja) * | 2020-04-27 | 2024-01-05 | キョーラク株式会社 | 構造体 |
| EP4157231A1 (en) * | 2020-05-31 | 2023-04-05 | EirGen Pharma Ltd. | Hard capsule dosage form and uses thereof |
| KR102666469B1 (ko) | 2023-05-04 | 2024-05-17 | 주식회사 아리바이오 | 텔로머라제 활성화제와 나노 입자를 포함하는 약물 전달용 조성물 및 이를 포함하는 탈모 예방, 개선 또는 치료용 조성물 |
| WO2025094144A1 (en) | 2023-11-02 | 2025-05-08 | Eirgen Pharma Ltd. | Controlling loss of kidney function |
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| WO1998008517A2 (en) * | 1996-08-26 | 1998-03-05 | Takeda Chemical Industries, Ltd. | Pharmaceutical composition containing osteogenesis-promoting substance and a polyethylene glycol |
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