EA034821B1 - Мягкие капсулы с кальцифедиолом - Google Patents
Мягкие капсулы с кальцифедиолом Download PDFInfo
- Publication number
- EA034821B1 EA034821B1 EA201791097A EA201791097A EA034821B1 EA 034821 B1 EA034821 B1 EA 034821B1 EA 201791097 A EA201791097 A EA 201791097A EA 201791097 A EA201791097 A EA 201791097A EA 034821 B1 EA034821 B1 EA 034821B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- soft capsule
- calciphediol
- pharmaceutical composition
- pharmaceutically acceptable
- acid
- Prior art date
Links
- 239000007901 soft capsule Substances 0.000 title claims abstract description 121
- JWUBBDSIWDLEOM-DTOXIADCSA-N calcidiol Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=C\C=C1\C[C@@H](O)CCC1=C JWUBBDSIWDLEOM-DTOXIADCSA-N 0.000 title abstract description 14
- 235000021318 Calcifediol Nutrition 0.000 title abstract description 10
- JWUBBDSIWDLEOM-UHFFFAOYSA-N 25-Hydroxycholecalciferol Natural products C1CCC2(C)C(C(CCCC(C)(C)O)C)CCC2C1=CC=C1CC(O)CCC1=C JWUBBDSIWDLEOM-UHFFFAOYSA-N 0.000 title abstract description 9
- 229960004361 calcifediol Drugs 0.000 title abstract description 8
- 239000000203 mixture Substances 0.000 claims abstract description 78
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 57
- 239000003960 organic solvent Substances 0.000 claims abstract description 31
- 108010010803 Gelatin Proteins 0.000 claims abstract description 25
- 229920000159 gelatin Polymers 0.000 claims abstract description 24
- 235000019322 gelatine Nutrition 0.000 claims abstract description 24
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 24
- 239000008273 gelatin Substances 0.000 claims abstract description 19
- 238000000034 method Methods 0.000 claims abstract description 18
- 239000001993 wax Substances 0.000 claims abstract description 16
- 206010047626 Vitamin D Deficiency Diseases 0.000 claims abstract description 11
- 238000011282 treatment Methods 0.000 claims abstract description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 95
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 63
- XEEYBQQBJWHFJM-UHFFFAOYSA-N iron Substances [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims description 35
- 239000003921 oil Substances 0.000 claims description 32
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims description 31
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 30
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 30
- -1 alkenyl alcohol Chemical compound 0.000 claims description 28
- 229920001223 polyethylene glycol Polymers 0.000 claims description 26
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 claims description 23
- 239000002202 Polyethylene glycol Substances 0.000 claims description 22
- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 claims description 21
- 150000003839 salts Chemical class 0.000 claims description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 229910052742 iron Inorganic materials 0.000 claims description 17
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims description 16
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 16
- 201000008482 osteoarthritis Diseases 0.000 claims description 16
- 201000010099 disease Diseases 0.000 claims description 14
- 239000004094 surface-active agent Substances 0.000 claims description 12
- 229940122361 Bisphosphonate Drugs 0.000 claims description 11
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 11
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 11
- 150000004663 bisphosphonates Chemical class 0.000 claims description 11
- 239000000600 sorbitol Substances 0.000 claims description 11
- 239000004014 plasticizer Substances 0.000 claims description 10
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 9
- NIQCNGHVCWTJSM-UHFFFAOYSA-N Dimethyl phthalate Chemical compound COC(=O)C1=CC=CC=C1C(=O)OC NIQCNGHVCWTJSM-UHFFFAOYSA-N 0.000 claims description 8
- ZFOZVQLOBQUTQQ-UHFFFAOYSA-N Tributyl citrate Chemical compound CCCCOC(=O)CC(O)(C(=O)OCCCC)CC(=O)OCCCC ZFOZVQLOBQUTQQ-UHFFFAOYSA-N 0.000 claims description 8
- 239000002775 capsule Substances 0.000 claims description 8
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims description 8
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 claims description 8
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims description 8
- 208000013725 Chronic Kidney Disease-Mineral and Bone disease Diseases 0.000 claims description 7
- 208000013038 Hypocalcemia Diseases 0.000 claims description 7
- 208000000038 Hypoparathyroidism Diseases 0.000 claims description 7
- 208000029663 Hypophosphatemia Diseases 0.000 claims description 7
- 208000029725 Metabolic bone disease Diseases 0.000 claims description 7
- 206010049088 Osteopenia Diseases 0.000 claims description 7
- 208000001132 Osteoporosis Diseases 0.000 claims description 7
- 238000005115 demineralization Methods 0.000 claims description 7
- 230000002328 demineralizing effect Effects 0.000 claims description 7
- 230000000705 hypocalcaemia Effects 0.000 claims description 7
- 208000005368 osteomalacia Diseases 0.000 claims description 7
- 201000006409 renal osteodystrophy Diseases 0.000 claims description 7
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- 235000021122 unsaturated fatty acids Nutrition 0.000 claims description 7
- 150000004670 unsaturated fatty acids Chemical class 0.000 claims description 7
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 claims description 5
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- 229930003779 Vitamin B12 Natural products 0.000 claims description 5
- 229930003761 Vitamin B9 Natural products 0.000 claims description 5
- 229910001424 calcium ion Inorganic materials 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- AGVAZMGAQJOSFJ-WZHZPDAFSA-M cobalt(2+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+2].N#[C-].[N-]([C@@H]1[C@H](CC(N)=O)[C@@]2(C)CCC(=O)NC[C@@H](C)OP(O)(=O)O[C@H]3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)\C2=C(C)/C([C@H](C\2(C)C)CCC(N)=O)=N/C/2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O AGVAZMGAQJOSFJ-WZHZPDAFSA-M 0.000 claims description 5
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- 235000019163 vitamin B12 Nutrition 0.000 claims description 5
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- 239000011727 vitamin B9 Substances 0.000 claims description 5
- ZNOVTXRBGFNYRX-STQMWFEESA-N (6S)-5-methyltetrahydrofolic acid Chemical compound C([C@@H]1N(C=2C(=O)N=C(N)NC=2NC1)C)NC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 ZNOVTXRBGFNYRX-STQMWFEESA-N 0.000 claims description 4
- PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims description 4
- FBSAITBEAPNWJG-UHFFFAOYSA-N dimethyl phthalate Natural products CC(=O)OC1=CC=CC=C1OC(C)=O FBSAITBEAPNWJG-UHFFFAOYSA-N 0.000 claims description 4
- 229960001826 dimethylphthalate Drugs 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 4
- 239000001087 glyceryl triacetate Substances 0.000 claims description 4
- 235000013773 glyceryl triacetate Nutrition 0.000 claims description 4
- 235000007635 levomefolic acid Nutrition 0.000 claims description 4
- 239000011578 levomefolic acid Substances 0.000 claims description 4
- 229960003208 levomefolic acid Drugs 0.000 claims description 4
- 229960002622 triacetin Drugs 0.000 claims description 4
- 235000019445 benzyl alcohol Nutrition 0.000 claims description 3
- 239000003086 colorant Substances 0.000 claims description 3
- 230000002265 prevention Effects 0.000 claims description 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract description 7
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- 238000002360 preparation method Methods 0.000 description 19
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- ZAKOWWREFLAJOT-CEFNRUSXSA-N D-alpha-tocopherylacetate Chemical compound CC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-CEFNRUSXSA-N 0.000 description 11
- 239000002253 acid Substances 0.000 description 11
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- YZXBAPSDXZZRGB-DOFZRALJSA-N arachidonic acid Chemical compound CCCCC\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O YZXBAPSDXZZRGB-DOFZRALJSA-N 0.000 description 8
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- OGSPWJRAVKPPFI-UHFFFAOYSA-N Alendronic Acid Chemical compound NCCCC(O)(P(O)(O)=O)P(O)(O)=O OGSPWJRAVKPPFI-UHFFFAOYSA-N 0.000 description 6
- MPBVHIBUJCELCL-UHFFFAOYSA-N Ibandronate Chemical compound CCCCCN(C)CCC(O)(P(O)(O)=O)P(O)(O)=O MPBVHIBUJCELCL-UHFFFAOYSA-N 0.000 description 6
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- 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
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
- A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
-
- 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
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
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- Orthopedic Medicine & Surgery (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15382042.8A EP3053598A1 (en) | 2015-02-06 | 2015-02-06 | Calcifediol soft capsules |
| PCT/EP2016/052458 WO2016124724A1 (en) | 2015-02-06 | 2016-02-05 | Calcifediol soft capsules |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA201791097A1 EA201791097A1 (ru) | 2017-08-31 |
| EA034821B1 true EA034821B1 (ru) | 2020-03-25 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201791097A EA034821B1 (ru) | 2015-02-06 | 2016-02-05 | Мягкие капсулы с кальцифедиолом |
Country Status (32)
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3053598A1 (en) | 2015-02-06 | 2016-08-10 | Faes Farma, S.A. | Calcifediol soft capsules |
| CN108542908A (zh) * | 2018-06-08 | 2018-09-18 | 唐飞 | 25-羟基维生素d3在制备治疗或预防肝性骨病药物中的应用 |
| EP3843706A1 (en) | 2018-08-31 | 2021-07-07 | OPKO Ireland Global Holdings, Ltd. | Vitamin d pediatric dosage forms, methods of making and using |
| CN109662953B (zh) * | 2019-02-18 | 2022-05-10 | 威海金思力生物科技股份有限公司 | 一种维生素d软胶囊及其制作方法 |
| WO2021011538A1 (en) * | 2019-07-15 | 2021-01-21 | R.P. Scherer Technologies, Llc | Capsule dosage forms, methods of preparation and methods of use thereof |
| CN114269348A (zh) * | 2019-08-22 | 2022-04-01 | 工业技术和生物技术公司 | 用于治疗和预防癌症的激素d(维生素d)及其衍生物 |
| CN113559079B (zh) * | 2020-04-28 | 2023-10-20 | 江苏恒瑞医药股份有限公司 | 一种软胶囊及其制备方法和用途 |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
| LT4243797T (lt) | 2020-11-16 | 2026-06-10 | Orcosa Inc. | Greitos infuzijos platforma ir kompozicijos, skirtos žmonių terapiniam gydymui |
| WO2022224001A1 (en) | 2021-04-22 | 2022-10-27 | Faes Farma, S.A. | Universal dosage regime of 25-hydroxy vitamin d3 |
| CN114159402A (zh) * | 2021-12-21 | 2022-03-11 | 湖州展望天明药业有限公司 | 一种不透明植物胶囊及其制备方法 |
| CN116350598A (zh) * | 2021-12-28 | 2023-06-30 | 人福普克药业（武汉）有限公司 | 一种用于维生素d类药物的成膜组合物及其药物制剂和制备方法 |
| CN114712505B (zh) * | 2022-03-10 | 2023-09-05 | 南方医科大学南方医院 | 维生素d受体激动剂在制备预防和/或治疗炎症性骨丢失的药物中的应用 |
| AU2023397554B2 (en) | 2022-12-14 | 2026-01-29 | R.P. Scherer Technologies, Llc | Softgel capsules and a method for preparing the softgel capsules |
| CN116270520A (zh) * | 2023-03-03 | 2023-06-23 | 正大制药（青岛）有限公司 | 一种维生素d胶囊型滴剂及其制备方法 |
| CN121466026B (zh) * | 2026-01-12 | 2026-07-24 | 厦门紫旭医药科技有限公司 | 一种双层软胶膜及其制备方法和应用与大装量胶囊 |
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| EP1208843A1 (en) * | 1999-08-31 | 2002-05-29 | Chugai Seiyaku Kabushiki Kaisha | Soft capsules |
| WO2007092755A2 (en) * | 2006-02-03 | 2007-08-16 | Proventiv Therapeutics, Llc | Treating vitamin d insufficiency and deficiency with 25-hydroxyvitamin d2 and 25-hydroxyvitamin d3 |
| WO2008097646A1 (en) * | 2007-02-09 | 2008-08-14 | Schering Corporation | Methods to treat and/or prevent mucositis |
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| EP3053598A1 (en) | 2015-02-06 | 2016-08-10 | Faes Farma, S.A. | Calcifediol soft capsules |
-
2015
- 2015-02-06 EP EP15382042.8A patent/EP3053598A1/en not_active Withdrawn
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2016
- 2016-02-05 MY MYPI2021001039A patent/MY199862A/en unknown
- 2016-02-05 AU AU2016214336A patent/AU2016214336B2/en active Active
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- 2016-02-05 RS RS20230331A patent/RS64166B1/sr unknown
- 2016-02-05 FI FIEP16702960.2T patent/FI3204047T4/fi active
- 2016-02-05 SM SM20200278T patent/SMT202000278T1/it unknown
- 2016-02-05 EP EP16702960.2A patent/EP3204047B2/en active Active
- 2016-02-05 MD MDE20170056T patent/MD3204047T2/ro unknown
- 2016-02-05 DK DK16702960.2T patent/DK3204047T3/da active
- 2016-02-05 KR KR1020177012947A patent/KR101971384B1/ko not_active Ceased
- 2016-02-05 HU HUE16702960A patent/HUE050133T2/hu unknown
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- 2016-02-05 EP EP20163569.5A patent/EP3689380B1/en not_active Revoked
- 2016-02-05 LT LTEP16702960.2T patent/LT3204047T/lt unknown
- 2016-02-05 EA EA201791097A patent/EA034821B1/ru unknown
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- 2016-02-05 BR BR112017010657-4A patent/BR112017010657B1/pt active IP Right Grant
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- 2016-02-05 CN CN202110038958.XA patent/CN112843014A/zh active Pending
- 2016-02-05 CN CN201680004162.XA patent/CN106999441B/zh active Active
- 2016-02-05 WO PCT/EP2016/052458 patent/WO2016124724A1/en not_active Ceased
- 2016-02-05 DK DK20163569.5T patent/DK3689380T3/da active
- 2016-02-05 ES ES20163569T patent/ES2941385T3/es active Active
-
2017
- 2017-05-05 CO CONC2017/0004545A patent/CO2017004545A2/es unknown
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1208843A1 (en) * | 1999-08-31 | 2002-05-29 | Chugai Seiyaku Kabushiki Kaisha | Soft capsules |
| WO2007092755A2 (en) * | 2006-02-03 | 2007-08-16 | Proventiv Therapeutics, Llc | Treating vitamin d insufficiency and deficiency with 25-hydroxyvitamin d2 and 25-hydroxyvitamin d3 |
| WO2008097646A1 (en) * | 2007-02-09 | 2008-08-14 | Schering Corporation | Methods to treat and/or prevent mucositis |
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