HRP20210555T1 - Orodisperzibilna tableta koja sadrži estetrol - Google Patents
Orodisperzibilna tableta koja sadrži estetrol Download PDFInfo
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- HRP20210555T1 HRP20210555T1 HRP20210555TT HRP20210555T HRP20210555T1 HR P20210555 T1 HRP20210555 T1 HR P20210555T1 HR P20210555T T HRP20210555T T HR P20210555TT HR P20210555 T HRP20210555 T HR P20210555T HR P20210555 T1 HRP20210555 T1 HR P20210555T1
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- AJIPIJNNOJSSQC-NYLIRDPKSA-N estetrol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H]([C@H](O)[C@@H]4O)O)[C@@H]4[C@@H]3CCC2=C1 AJIPIJNNOJSSQC-NYLIRDPKSA-N 0.000 title claims 11
- 229950009589 estetrol Drugs 0.000 title claims 10
- 239000002245 particle Substances 0.000 claims 25
- 238000000034 method Methods 0.000 claims 20
- 239000007788 liquid Substances 0.000 claims 9
- 239000007787 solid Substances 0.000 claims 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims 7
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 4
- 229930195725 Mannitol Natural products 0.000 claims 4
- 239000000594 mannitol Substances 0.000 claims 4
- 235000010355 mannitol Nutrition 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 4
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 3
- 229920000881 Modified starch Polymers 0.000 claims 3
- 150000001720 carbohydrates Chemical class 0.000 claims 3
- 235000014633 carbohydrates Nutrition 0.000 claims 3
- 239000008101 lactose Substances 0.000 claims 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 2
- 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 2
- 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 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- 229930006000 Sucrose Natural products 0.000 claims 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 2
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 2
- 229950008138 carmellose Drugs 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 239000008103 glucose Substances 0.000 claims 2
- 239000004615 ingredient Substances 0.000 claims 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 235000019426 modified starch Nutrition 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 235000010356 sorbitol Nutrition 0.000 claims 2
- 239000005720 sucrose Substances 0.000 claims 2
- 239000000811 xylitol Substances 0.000 claims 2
- 235000010447 xylitol Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 2
- 229960002675 xylitol Drugs 0.000 claims 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 claims 1
- 244000215068 Acacia senegal Species 0.000 claims 1
- 229920001817 Agar Polymers 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 239000004386 Erythritol Substances 0.000 claims 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 1
- 229930091371 Fructose Natural products 0.000 claims 1
- 239000005715 Fructose Substances 0.000 claims 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 229920002907 Guar gum Polymers 0.000 claims 1
- 229920000084 Gum arabic Polymers 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 239000004372 Polyvinyl alcohol Substances 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 1
- 235000010489 acacia gum Nutrition 0.000 claims 1
- 239000000205 acacia gum Substances 0.000 claims 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims 1
- 239000008272 agar Substances 0.000 claims 1
- 235000010419 agar Nutrition 0.000 claims 1
- 229940072056 alginate Drugs 0.000 claims 1
- 235000010443 alginic acid Nutrition 0.000 claims 1
- 229920000615 alginic acid Polymers 0.000 claims 1
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 239000011230 binding agent Substances 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 235000010980 cellulose Nutrition 0.000 claims 1
- 238000000748 compression moulding Methods 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 238000007907 direct compression Methods 0.000 claims 1
- 150000002016 disaccharides Chemical class 0.000 claims 1
- 235000019414 erythritol Nutrition 0.000 claims 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 1
- 229940009714 erythritol Drugs 0.000 claims 1
- 229930182830 galactose Natural products 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 239000000665 guar gum Substances 0.000 claims 1
- 235000010417 guar gum Nutrition 0.000 claims 1
- 229960002154 guar gum Drugs 0.000 claims 1
- 238000002657 hormone replacement therapy Methods 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 229960001855 mannitol Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 150000002772 monosaccharides Chemical class 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920002451 polyvinyl alcohol Polymers 0.000 claims 1
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims 1
- 239000008107 starch Substances 0.000 claims 1
- 235000019698 starch Nutrition 0.000 claims 1
- 229940032147 starch Drugs 0.000 claims 1
- 150000004043 trisaccharides Chemical class 0.000 claims 1
Classifications
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
-
- 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
- A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Zoology (AREA)
- Reproductive Health (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (26)
1. Čvrsta farmaceutska orodisperzibilna jedinica za doziranje koja ima masu između 30 i 1000 mg, navedena jedinica za doziranje sadrži najmanje 100 μg estetrolske komponente odabrane između estetrola, estera estetrola i njihovih kombinacija;
pri čemu se čvrsta jedinica za doziranje može dobiti postupkom koji obuhvaća:
• pribavljanje čestica nosača koje imaju medijalni volumni promjer od 10 μm do 400 μm;
• pribavljanje vodene tekućine koja sadrži najmanje 60 % masenog udjela vode, 1-40 % masenog udjela estetrolske komponente te opcionalno 0-40 % masenog udijela jednog ili više ostalih farmaceutski prihvatljivih sastojaka;
• miješanje 1 masenog dijela vodene tekućine sa 0.5-20 masenih dijelova čestica nosača kako bi se proizvele mokre čestice;
• uklanjanje vode iz vlažnih čestica kako bi se proizvele (dobile, radi stvaranja) napunjene čestice;
• opcionalno miješanje napunjenih čestica s jednim ili više ekscipijensa za tabletiranje; te
• formiranje napunjenih čestica ili smjese napunjenih čestica i jednog ili više ekscipijenasa za tabletiranje u čvrstu jedinicu za doziranje.
2. Jedinica za doziranje prema zahtjevu 1, pri čemu jedinica za doziranje ima masu između 40 i 500 mg.
3. Jedinica za doziranje prema zahtjevu 1 ili 2, pri čemu jedinica za doziranje sadrži 0.3-100 mg estetrolske komponente.
4. Jedinica za doziranje prema bilo kojem od prethodnih zahtjeva, pri čemu je estetrolska komponenta estetrol.
5. Jedinica za doziranje prema bilo kojem od prethodnih zahtjeva, pri čemu jedinica za doziranje sadrži najmanje 20 % masenog udjela manitola.
6. Jedinica za doziranje prema bilo kojem od prethodnih zahtjeva, pri čemu jedinica za doziranje sadrži 0.1-20 % masenog udjela sredstva za raspadanje odabranog između modificiranih škrobova, umreženog polivinilpirolidona, umrežene karmeloze te njihovih kombinacija.
7. Čvrsta jedinica za doziranje prema bilo kojem od prethodnih zahtjeva za upotrebu u medicinskom liječenju, navedena upotreba uključuje sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje.
8. Čvrsta jedinica za doziranje prema bilo kojem od zahtjeva 1-6 za upotrebu u zamjenskoj hormonskoj terapiji žena, navedena upotreba obuhvaća sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje.
9. Čvrsta jedinica za doziranje za upotrebu prema zahtjevu 7 ili 8, pri čemu navedena upotreba obuhvaća primjenu jednom dnevno tijekom određenog razdoblja od najmanje 1 tjedan.
10. Postupak za žensku kontracepciju, navedeni postupak uključuje sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje prema bilo kojem od zahtjeva 1-6.
11. Postupak prema zahtjevu 10, navedeni postupak obuhvaća primjenu jednom dnevno tijekom razdoblja od najmanje 1 tjedan.
12. Postupak za pripremu čvrste jedinice za doziranje prema bilo kojem od prethodnih zahtjeva, pri čemu navedeni postupak obuhvaća korake:
• pribavljanje čestica nosača koje imaju medijalni volumni promjer od 10 μm do 400 μm;
• pribavljanje vodene tekućine koja sadrži najmanje 60 % masenog udjela vode, 1-40 % masenog udjela estetrolske komponente te opcionalno 0-40 % masenog udjela jednog ili više ostalih farmaceutski prihvatljivih sastojaka;
• miješanje 1 masenog dijela vodene tekućine sa 0.5-20 masenih dijelova čestica nosača kako bi se proizvele mokre čestice;
• uklanjanje vode iz vlažnih čestica kako bi se proizvele (dobile, radi stvaranja) napunjene čestice;
• opcionalno miješanje napunjenih čestica s jednim ili više ekscipijensa za tabletiranje; te
• formiranje napunjenih čestica ili smjese napunjenih čestica i jednog ili više ekscipijenasa za tabletiranje u čvrstu jedinicu za doziranje.
13. Postupak prema zahtjevu 12, u kojem čestice nosača sadrže najmanje 30 % masenog udjela vodotopljivih ugljikohidrata odabranih između monosaharida, disaharida, trisaharida, C4-C12šećernog alkohola te njihovih kombinacija.
14. Postupak prema zahtjevu 13, u kojem čestice nosača sadrže najmanje 50 % masenog udjela vodotopljivih ugljikohidrata.
15. Postupak prema zahtjevu 13 ili 14, u kojem se vodotopljivi ugljikohidrati odabiru između maltoze, fruktoze, saharoze, laktoze, glukoze, galaktoze, trehaloze, ksilitola, sorbitola, eritritola, maltitola, manitola te njihovih kombinacija.
16. Postupak prema bilo kojem od zahtjeva 13-15, u kojem čestice nosača sadrže najmanje 20 % masenog udjela manitola.
17. Postupak prema bilo kojem od zahtjeva 13-16, u kojem čestice nosača sadrže najmanje 10 % masenog udjela laktoze.
18. Postupak prema bilo kojem od zahtjeva 13-17, u kojem vodena tekućina sadrži disperzirani estetrol koji ima medijalni volumni promjer manji od 50 μm.
19. Postupak prema bilo kojem od zahtjeva 13-18, u kojem vodena tekućina sadrži 1.5-30 % masenog udjela estetrolske komponente.
20. Postupak prema bilo kojem od zahtjeva 13-19, u kojem vodena tekućina sadrži 0.5-40 % masenog udjela veziva odabranog između derivata celuloze, preželatiniziranog škroba, polivinil alkohola, polivinilpirolidona, agara, želatina, guar guma, arapske gume, alginata, polietilen glikola, glukoze, saharoze, sorbitola te njihovih kombinacija.
21. Postupak prema bilo kojem od zahtjeva 13-20, u kojem se vlažne čestice proizvode kombiniranjem vodene tekućine i čestica nosača u granulatoru s visokim smicanjem, granulatoru s niskim smicanjem ili u granulatoru s fluidnim ležajem.
22. Postupak prema bilo kojem od zahtjeva 13-21, u kojem se vlažne čestice pripremaju miješanjem vodene tekućine s česticama nosača u masenom omjeru koji je u rasponu od 1:0.8 do 1:12.
23. Postupak prema bilo kojem od zahtjeva 13-22, u kojem napunjene čestice imaju medijalni volumni promjer u rasponu od 100-4000 μm.
24. Postupak prema bilo kojem od zahtjeva 13-23, u kojem ekscipijensi za tabletiranje sadrže 0-15 % od masenog udjela jedinice za doziranje za sredstvo za raspadanje odabranog između modificiranih škrobova, umreženog polivinil pirolidona, umrežene karmeloze te njihovih kombinacija.
25. Postupak prema bilo kojem od zahtjeva 13-24, u kojem jedan ili više ekscipijenasa za tabletiranje sadrže najmanje 30% masenog udjela eksipijenasa za tabletiranje odabranog između laktoze, manitola, ksilitola, mikrokristalne celuloze, škroba, kroskarmeloze natrija, polivinil pirolidona te njihovih kombinacija.
26. Postupak prema bilo kojem od zahtjeva 13-25, u kojem je čvrsta jedinica za doziranje formirana izravnim komprimiranjem ili kompresijskim prešanjem.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15172755 | 2015-06-18 | ||
| PCT/EP2016/064181 WO2016203044A1 (en) | 2015-06-18 | 2016-06-20 | Orodispersible tablet containing estetrol |
| EP16733352.5A EP3310346B1 (en) | 2015-06-18 | 2016-06-20 | Orodispersible tablet containing estetrol |
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| Publication Number | Publication Date |
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| HRP20210555TT HRP20210555T1 (hr) | 2015-06-18 | 2021-04-07 | Orodisperzibilna tableta koja sadrži estetrol |
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| EP (1) | EP3310346B1 (hr) |
| JP (1) | JP6813150B2 (hr) |
| CN (1) | CN107750157B (hr) |
| CA (1) | CA2988362C (hr) |
| CY (1) | CY1124052T1 (hr) |
| DK (1) | DK3310346T3 (hr) |
| ES (1) | ES2877476T3 (hr) |
| HK (1) | HK1254649A1 (hr) |
| HR (1) | HRP20210555T1 (hr) |
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| LT (1) | LT3310346T (hr) |
| MA (1) | MA44206B1 (hr) |
| MD (1) | MD3310346T2 (hr) |
| PL (1) | PL3310346T3 (hr) |
| PT (1) | PT3310346T (hr) |
| RS (1) | RS61777B1 (hr) |
| SI (1) | SI3310346T1 (hr) |
| WO (1) | WO2016203044A1 (hr) |
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| KR101994805B1 (ko) | 2011-06-01 | 2019-07-01 | 에스테트라 에스.피.알.엘. | 에스테트롤 중간체의 제조 방법 |
| CN103619867B (zh) | 2011-06-01 | 2015-12-23 | 埃斯特拉公司 | 用于产生雌四醇中间体的方法 |
| EP2383279A1 (en) | 2011-07-19 | 2011-11-02 | Pantarhei Bioscience B.V. | Process for the preparation of estetrol |
| EP3701944B1 (en) | 2015-06-18 | 2021-12-08 | Estetra SRL | Orodispersible dosage unit containing an estetrol component |
| MD3310345T2 (ro) | 2015-06-18 | 2021-07-31 | Estetra Sprl | Comprimată orodispersabilă ce conține estetrol |
| MD3310346T2 (ro) | 2015-06-18 | 2021-06-30 | Estetra Sprl | Comprimată orodispersabilă ce conține estetrol |
| NO3106148T3 (hr) | 2015-06-18 | 2018-08-11 | ||
| CA3178291A1 (en) | 2016-08-05 | 2018-04-12 | Estetra Srl | Method for the management of dysmenorrhea and menstrual pain |
| TWI801561B (zh) | 2018-04-19 | 2023-05-11 | 比利時商依思特拉私人有限責任公司 | 化合物及其用於緩解絕經相關症狀的用途 |
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| HU231240B1 (hu) | 2019-09-03 | 2022-04-28 | Richter Gedeon Nyrt. | Ipari eljárás nagytisztaságú ösztetrol hatóanyag előállítására |
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2016
- 2016-06-20 MD MDE20180408T patent/MD3310346T2/ro unknown
- 2016-06-20 WO PCT/EP2016/064181 patent/WO2016203044A1/en active Application Filing
- 2016-06-20 JP JP2017563337A patent/JP6813150B2/ja active Active
- 2016-06-20 MA MA44206A patent/MA44206B1/fr unknown
- 2016-06-20 EP EP16733352.5A patent/EP3310346B1/en active Active
- 2016-06-20 PT PT167333525T patent/PT3310346T/pt unknown
- 2016-06-20 SI SI201631150T patent/SI3310346T1/sl unknown
- 2016-06-20 DK DK16733352.5T patent/DK3310346T3/da active
- 2016-06-20 ES ES16733352T patent/ES2877476T3/es active Active
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- 2016-06-20 LT LTEP16733352.5T patent/LT3310346T/lt unknown
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- 2016-06-20 HU HUE16733352A patent/HUE054551T2/hu unknown
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- 2021-04-21 CY CY20211100348T patent/CY1124052T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US10888518B2 (en) | 2021-01-12 |
| HK1254649A1 (zh) | 2019-07-26 |
| MA44206B1 (fr) | 2021-04-30 |
| DK3310346T3 (da) | 2021-05-25 |
| JP2018517715A (ja) | 2018-07-05 |
| JP6813150B2 (ja) | 2021-01-13 |
| RS61777B1 (sr) | 2021-06-30 |
| HUE054551T2 (hu) | 2021-09-28 |
| ES2877476T3 (es) | 2021-11-16 |
| PL3310346T3 (pl) | 2021-10-25 |
| CN107750157A (zh) | 2018-03-02 |
| CA2988362C (en) | 2022-07-19 |
| WO2016203044A1 (en) | 2016-12-22 |
| SI3310346T1 (sl) | 2021-07-30 |
| MD3310346T2 (ro) | 2021-06-30 |
| EP3310346B1 (en) | 2021-03-24 |
| EP3310346A1 (en) | 2018-04-25 |
| PT3310346T (pt) | 2021-04-22 |
| CA2988362A1 (en) | 2016-12-22 |
| CN107750157B (zh) | 2021-07-13 |
| MA44206A (fr) | 2018-04-25 |
| CY1124052T1 (el) | 2022-05-27 |
| US20180153801A1 (en) | 2018-06-07 |
| LT3310346T (lt) | 2021-06-10 |
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