HRP20210668T1 - Orodisperzibilna tableta koja sadrži estetrol - Google Patents
Orodisperzibilna tableta koja sadrži estetrol Download PDFInfo
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- HRP20210668T1 HRP20210668T1 HRP20210668TT HRP20210668T HRP20210668T1 HR P20210668 T1 HRP20210668 T1 HR P20210668T1 HR P20210668T T HRP20210668T T HR P20210668TT HR P20210668 T HRP20210668 T HR P20210668T HR P20210668 T1 HRP20210668 T1 HR P20210668T1
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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 29
- 238000000034 method Methods 0.000 claims 23
- 239000007788 liquid Substances 0.000 claims 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 9
- 239000007787 solid Substances 0.000 claims 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims 7
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 6
- 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 5
- 229930195725 Mannitol Natural products 0.000 claims 5
- 229920002678 cellulose Polymers 0.000 claims 5
- 239000001913 cellulose Substances 0.000 claims 5
- 235000010980 cellulose Nutrition 0.000 claims 5
- 239000000594 mannitol Substances 0.000 claims 5
- 235000010355 mannitol Nutrition 0.000 claims 5
- 239000003960 organic solvent Substances 0.000 claims 5
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-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 4
- 239000011230 binding agent Substances 0.000 claims 4
- 150000001720 carbohydrates Chemical class 0.000 claims 4
- 235000014633 carbohydrates Nutrition 0.000 claims 4
- 239000008101 lactose Substances 0.000 claims 4
- 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 3
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 3
- 239000001856 Ethyl cellulose Substances 0.000 claims 3
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 3
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 3
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 3
- 229920001249 ethyl cellulose Polymers 0.000 claims 3
- 235000019325 ethyl cellulose Nutrition 0.000 claims 3
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 3
- 239000000811 xylitol Substances 0.000 claims 3
- 235000010447 xylitol Nutrition 0.000 claims 3
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 3
- 229960002675 xylitol Drugs 0.000 claims 3
- 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 2
- 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 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
- 239000004386 Erythritol Substances 0.000 claims 2
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 2
- 229930091371 Fructose Natural products 0.000 claims 2
- 239000005715 Fructose Substances 0.000 claims 2
- 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 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
- 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 2
- 229920000881 Modified starch Polymers 0.000 claims 2
- 239000002202 Polyethylene glycol Substances 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
- 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 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
- 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 2
- 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 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
- 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 2
- 230000015572 biosynthetic process Effects 0.000 claims 2
- 229950008138 carmellose Drugs 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 235000019414 erythritol Nutrition 0.000 claims 2
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 2
- 229940009714 erythritol Drugs 0.000 claims 2
- 229930182830 galactose Natural products 0.000 claims 2
- 239000008103 glucose Substances 0.000 claims 2
- 239000004615 ingredient Substances 0.000 claims 2
- 239000000845 maltitol Substances 0.000 claims 2
- 235000010449 maltitol Nutrition 0.000 claims 2
- 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 2
- 229940035436 maltitol Drugs 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 235000019426 modified starch Nutrition 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 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
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 claims 1
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229920002472 Starch Polymers 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
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 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
- 239000012530 fluid Substances 0.000 claims 1
- 238000002657 hormone replacement therapy Methods 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 229920003063 hydroxymethyl cellulose Polymers 0.000 claims 1
- 229940031574 hydroxymethyl cellulose Drugs 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 239000000905 isomalt Substances 0.000 claims 1
- 235000010439 isomalt Nutrition 0.000 claims 1
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 1
- 229960001375 lactose Drugs 0.000 claims 1
- 229960001855 mannitol Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 235000010981 methylcellulose Nutrition 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
- 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
-
- 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
- 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
- A61K9/20—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61P5/30—Oestrogens
Claims (34)
1. Čvrsta farmaceuatska 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 prosječno ponderiranu veličinu čestice od 10 μm do 400 μm;
• pribavljanje tekućine za punjenje koja sadrži najmanje 50 % masenog udjela organskog otapala odabranog između metanola, etanola, izopropanola, acetona te njihovih kombinacija; 1-50 % masenog udjela estetrolske komponente, te opcionalno 0-49 % masenog udijela jednog ili više ostalih farmaceutski prihvatljivih sastojaka;
• miješanje 1 masenog dijela tekućine za punjenje sa 0.5-20 masenih dijelova čestica nosača kako bi se proizvele mokre čestice;
• uklanjanje organskog otapala iz mokrih čestica kako bi se proizvele 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 30-99.9 % vodotopljivih ugljikohidrata odabranih između maltoze, fruktoze, saharoze, laktoze, glukoze, galaktoze, trehaloze, ksilitola, sorbitola, eritritola, maltitola, manitola, izomalta te njihovih kombinacija.
6. Jedinica za doziranje prema zahtjevu 5, pri čemu jedinica za doziranje sadrži najmanje 20 % masenog udjela manitola.
7. Jedinica za doziranje prema bilo kojem od prethodnih zahtjeva, pri čemu jedinica za doziranje sadrži 0.1-20 % masenog udjela veziva odabranog između derivata celuloze, polietilen glikola te njihovih kombinacija.
8. Jedinica za doziranje prema zahtjevu 7, pri čemu je vezivo derivat celuloze.
9. Jedinica za doziranje prema zahtjevu 7 ili 8, pri čemu su derivati celuloze odabrani između hidroksipropil celuloze, hidroksietil celuloze, hidroksimetil celuloze, hidroksipropilmetil celuloze, metil celuloze, etil celuloze, karboksimetil celuloze te njihovih kombinacija.
10. Jedinica za doziranje prema zahtjevu 9, pri čemu je derivat celuloze etilceluloza.
11. 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.
12. 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.
13. Čvrsta jedinica za doziranje prema bilo kojem od zahtjeva 1-11 za upotrebu u zamjenskoj hormonskoj terapiji žena, navedena upotreba obuhvaća sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje.
14. Čvrsta jedinica za doziranje za upotrebu prema zahtjevu 12 ili 13, pri čemu navedena upotreba obuhvaća primjenu jednom dnevno tijekom razdoblja od najmanje 1 tjedan.
15. Postupak za žensku kontracepciju, navedeni postupak uključuje sublingvalnu, bukalnu ili sublabijalnu primjenu jedinice za doziranje prema bilo kojem od zahtjeva 1-11.
16. Postupak prema zahtjevu 15, navedeni postupak obuhvaća primjenu jednom dnevno tijekom razdoblja od najmanje 1 tjedan.
17. Postupak za pripremu čvrste jedinice za doziranje prema bilo kojem od prethodnih zahtjeva, pri čemu navedeni postupak obuhvaća korake:
• pribavljanje čestica nosača koje imaju prosječno ponderiranu veličinu čestice od 10 μm do 400 μm;
• pribavljanje tekućine za punjenje koja sadrži najmanje 50 % masenog udjela organskog otapala odabranog između metanola, etanola, izopropanola, acetona te njihovih kombinacija; 1-50 % masenog udjela estetrolske komponente, te 0-49 % masenog udijela jednog ili više ostalih farmaceutski prihvatljivih sastojaka;
• miješanje 1 masenog dijela tekućine za punjenje sa 0.5-20 masenih dijelova čestica nosača kako bi se proizvele mokre čestice;
• uklanjanje organskog otapala iz mokrih čestica kako bi se proizvele 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.
18. Postupak prema zahtjevu 17, u kojem čestice nosača sadrže najmanje 30 % masenog udjela vodotopljivih ugljikohidrata odabranih između monosaharida, disaharida, trisaharida, C4-C12 šećernog alkohola te njihovih kombinacija.
19. Postupak prema zahtjevu 18, u kojem čestice nosača sadrže najmanje 50 % masenog udjela vodotopljivih ugljikohidrata.
20. Postupak prema zahtjevu 18 ili 19, u kojem su vodotopljivi ugljikohidrati odabrani između maltoze, fruktoze, saharoze, laktoze, glukoze, galaktoze, trehaloze, ksilitola, sorbitola, eritritola, maltitola, manitola te njihovih kombinacija.
21. Postupak prema bilo kojem od zahtjeva 17-20, u kojem čestice nosača sadrže najmanje 20 % masenog udjela manitola.
22. Postupak prema bilo kojem od zahtjeva 17-21, u kojem čestice nosača sadrže najmanje 10 % masenog udjela laktoze.
23. Postupak prema bilo kojem od zahtjeva 17-22, u kojem se više od 90 % masenog udjela estetrolske komponente u tekućini za punjenje otopi kada se tekućina za punjenje pomiješa sa česticama nosača.
24. Postupak prema bilo kojem od zahtjeva 17-23, u kojem tekućina za punjenje sadrži 2-40 % masenog udjela estetrolske komponente.
25. Postupak prema bilo kojem od zahtjeva 17-24, u kojem tekućina za punjenje sadrži 0.5-40 % masenog udjela veziva odabranog između derivata celuloze, polietilen glikola te njihovih kombinacija.
26. Postupak prema zahtjevu 25, u kojem je vezivo etil celuloza.
27. Postupak prema bilo kojem od zahtjeva 17-26, u kojem se mokre čestice proizvode kombiniranjem tekućine za punjenje i čestica nosača u granulatoru s visokim smicanjem, granulatoru s niskim smicanjem ili u granulatoru s fluidnim ležajem.
28. Postupak prema bilo kojem od zahtjeva 17-27, u kojem se organsko otapalo uklanja iz mokrih čestica u granulatoru s fluidnim ležajem.
29. Postupak prema bilo kojem od zahtjeva 17-28, u kojem tekućina za punjenje sadrži najmanje 60 % masenog udjela etanola.
30. Postupak prema bilo kojem od zahtjeva 17-29, u kojem se mokre čestice pripremaju miješanjem tekućine za punjenje sa česticama nosača u masenom omjeru koji je u rasponu od 1:0.8 do 1:12.
31. Postupak prema bilo kojem od zahtjeva 17-30, u kojem napunjene čestice imaju medijalni volumni promjer u rasponu od 100-4000 μm.
32. Postupak prema bilo kojem od zahtjeva 17-31, u kojem ekscipijensi za tabletiranje sadrže 0-15 % masenog udjela jedinice za doziranje sredstva za raspadanje odabranog između modificiranih škrobova, umreženog polivinil pirolidona, umrežene karmeloze te njihovih kombinacija.
33. Postupak prema bilo kojem od zahtjeva 17-32, u kojem jedan ili više ekscipijenasa za tabletiranje sadrže najmanje 30% masenog udjela jedinice za doziranje eksipijensa odabranog između laktoze, manitola, ksilitola, mikrokristalne celuloze, škroba, kroskarmeloze natrija, polivinil pirolidona te njihovih kombinacija.
34. Postupak prema bilo kojem od zahtjeva 17-33, u kojem je čvrsta jedinica za doziranje formirana izravnim komprimiranjem ili kompresijskim prešanjem.
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| EP15172751 | 2015-06-18 | ||
| PCT/EP2016/064071 WO2016203009A1 (en) | 2015-06-18 | 2016-06-17 | Orodispersible tablet containing estetrol |
| EP16729601.1A EP3310345B1 (en) | 2015-06-18 | 2016-06-17 | Orodispersible tablet containing estetrol |
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| HRP20240121T8 (hr) | 2015-06-23 | 2024-05-10 | Laboratorios Leon Farma Sa | Kontracepcija na bazi drospirenona za pacijenticu s viškom tjelesne težine |
| CA3041016C (en) | 2016-10-28 | 2023-09-05 | Estetra Sprl | Method for the management of dysmenorrhea and menstrual pain |
| KR20220144885A (ko) | 2016-08-05 | 2022-10-27 | 에스테트라, 소시에떼 아 레스폰서빌리떼 리미떼 | 월경통 및 생리통의 관리방법 |
| US20200046729A1 (en) | 2016-08-05 | 2020-02-13 | Estetra Sprl | Methods using combined oral contraceptive compositions with reduced cardiovascular effects |
| UA126746C2 (uk) | 2018-02-07 | 2023-01-18 | Естетра Спрл | Композиція контрацептива зі зниженими ефектами щодо серцево-судинної системи |
-
2016
- 2016-06-17 ES ES16729601T patent/ES2877186T3/es active Active
- 2016-06-17 LT LTEP16729601.1T patent/LT3310345T/lt unknown
- 2016-06-17 SI SI201631167T patent/SI3310345T1/sl unknown
- 2016-06-17 JP JP2017564396A patent/JP6866561B2/ja active Active
- 2016-06-17 MA MA44205A patent/MA44205B1/fr unknown
- 2016-06-17 CA CA2988485A patent/CA2988485A1/en not_active Abandoned
- 2016-06-17 MD MDE20180402T patent/MD3310345T2/ro unknown
- 2016-06-17 PL PL16729601T patent/PL3310345T3/pl unknown
- 2016-06-17 EP EP16729601.1A patent/EP3310345B1/en active Active
- 2016-06-17 RS RS20210512A patent/RS61812B1/sr unknown
- 2016-06-17 HU HUE16729601A patent/HUE054589T2/hu unknown
- 2016-06-17 CN CN201680035673.8A patent/CN107810001A/zh active Pending
- 2016-06-17 PT PT167296011T patent/PT3310345T/pt unknown
- 2016-06-17 DK DK16729601.1T patent/DK3310345T3/da active
- 2016-06-17 WO PCT/EP2016/064071 patent/WO2016203009A1/en active Application Filing
- 2016-06-17 US US15/737,233 patent/US10894014B2/en active Active
-
2021
- 2021-04-26 HR HRP20210668TT patent/HRP20210668T1/hr unknown
- 2021-05-05 CY CY20211100379T patent/CY1124104T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PT3310345T (pt) | 2021-05-28 |
| PL3310345T3 (pl) | 2021-10-18 |
| LT3310345T (lt) | 2021-06-25 |
| CY1124104T1 (el) | 2022-05-27 |
| RS61812B1 (sr) | 2021-06-30 |
| EP3310345A1 (en) | 2018-04-25 |
| SI3310345T1 (sl) | 2021-05-31 |
| ES2877186T3 (es) | 2021-11-16 |
| CA2988485A1 (en) | 2016-12-22 |
| US10894014B2 (en) | 2021-01-19 |
| EP3310345B1 (en) | 2021-03-31 |
| MA44205A (fr) | 2018-04-25 |
| CN107810001A (zh) | 2018-03-16 |
| JP2018517718A (ja) | 2018-07-05 |
| WO2016203009A1 (en) | 2016-12-22 |
| HUE054589T2 (hu) | 2021-09-28 |
| DK3310345T3 (da) | 2021-05-25 |
| MA44205B1 (fr) | 2021-04-30 |
| MD3310345T2 (ro) | 2021-07-31 |
| JP6866561B2 (ja) | 2021-04-28 |
| US20180185271A1 (en) | 2018-07-05 |
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