HRP20110113T1 - Kapecitabin tablete za djecu - Google Patents
Kapecitabin tablete za djecu Download PDFInfo
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- HRP20110113T1 HRP20110113T1 HR20110113T HRP20110113T HRP20110113T1 HR P20110113 T1 HRP20110113 T1 HR P20110113T1 HR 20110113 T HR20110113 T HR 20110113T HR P20110113 T HRP20110113 T HR P20110113T HR P20110113 T1 HRP20110113 T1 HR P20110113T1
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- composition according
- capecitabine
- pharmaceutical composition
- mannitol
- microcrystalline cellulose
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- GAGWJHPBXLXJQN-UORFTKCHSA-N Capecitabine Chemical compound C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1[C@H]1[C@H](O)[C@H](O)[C@@H](C)O1 GAGWJHPBXLXJQN-UORFTKCHSA-N 0.000 title claims abstract 29
- GAGWJHPBXLXJQN-UHFFFAOYSA-N Capecitabine Natural products C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1C1C(O)C(O)C(C)O1 GAGWJHPBXLXJQN-UHFFFAOYSA-N 0.000 title claims abstract 29
- 229960004117 capecitabine Drugs 0.000 title claims abstract 29
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract 27
- 239000000203 mixture Substances 0.000 claims abstract 20
- 239000007884 disintegrant Substances 0.000 claims abstract 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract 3
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 36
- 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 21
- 229930195725 Mannitol Natural products 0.000 claims 21
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 21
- 239000000594 mannitol Substances 0.000 claims 21
- 235000010355 mannitol Nutrition 0.000 claims 21
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 21
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 21
- 239000008108 microcrystalline cellulose Substances 0.000 claims 21
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 20
- 229960000913 crospovidone Drugs 0.000 claims 19
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 19
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 19
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 19
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 19
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 19
- 108010011485 Aspartame Proteins 0.000 claims 18
- 241000220223 Fragaria Species 0.000 claims 18
- 235000016623 Fragaria vesca Nutrition 0.000 claims 18
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims 18
- 244000290333 Vanilla fragrans Species 0.000 claims 18
- 235000009499 Vanilla fragrans Nutrition 0.000 claims 18
- 235000012036 Vanilla tahitensis Nutrition 0.000 claims 18
- 239000000605 aspartame Substances 0.000 claims 18
- 235000010357 aspartame Nutrition 0.000 claims 18
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims 18
- 229960003438 aspartame Drugs 0.000 claims 18
- 230000000595 bitter masking effect Effects 0.000 claims 18
- 150000001875 compounds Chemical class 0.000 claims 18
- 239000000796 flavoring agent Substances 0.000 claims 18
- 235000019634 flavors Nutrition 0.000 claims 18
- 229960003943 hypromellose Drugs 0.000 claims 18
- 235000019359 magnesium stearate Nutrition 0.000 claims 18
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims 17
- 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 7
- 229960004977 anhydrous lactose Drugs 0.000 claims 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- 239000011230 binding agent Substances 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims 1
- 229920002261 Corn starch Polymers 0.000 claims 1
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 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 1
- 229920000881 Modified 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
- 239000008120 corn starch Substances 0.000 claims 1
- 229960001681 croscarmellose sodium Drugs 0.000 claims 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 235000019264 food flavour enhancer Nutrition 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl 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
- 229960001375 lactose Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 229940085605 saccharin sodium Drugs 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 239000003765 sweetening agent Substances 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
- A61K9/0056—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
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Abstract
Farmaceutski sastav, naznačen time, da je obložen filmom i sadrži kapecitabin i barem jedan razgrađivač, te se spomenuti sastav razgrađuje u vodi na 37°C u uređaju za razgrađivanje USP za manje od dvije minute te koji ima tvrdoću oko 56 do 91 N (2-13 jačine Cobb-jedinica). Patent sadrži još 41 patentni zahtjev.
Claims (42)
1. Farmaceutski sastav, naznačen time, da je obložen filmom i sadrži kapecitabin i barem jedan razgrađivač, te se spomenuti sastav razgrađuje u vodi na 37°C u uređaju za razgrađivanje USP za manje od dvije minute te koji ima tvrdoću oko 56 do 91 N (2-13 jačine Cobb-jedinica).
2. Sastav prema zahtjevu 1, naznačen time, da on sadrži kapecitabin od oko 10% do 50%, bazirano na ukupnoj masi srži sastava.
3. Sastav prema zahtjevu 2, naznačen time, da on sadrži od oko 50 mg do oko 1500 mg kapecitabina.
4. Sastav prema zahtjevu 3, naznačen time, da on sadrži od oko 100 mg do oko 750 mg kapecitabina.
5. Sastav prema zahtjevu 3, naznačen time, da on sadrži 125 mg, 175 mg, 250 mg, 350 mg ili 500 mg kapecitabina.
6. Farmaceutski sastav prema zahtjevu 1, naznačen time, da se barem jedan razgrađivač odabere iz skupine koja sadrži krospovidon koji ima veličinu čestica u rasponu od 90% manjih od 15 mikrona do veličine čestica u rasponu od 90% manjih od 400 mikrona, natrijevu kroskarmelozu, natrijev škrobni glikolat, slabo-supstituiranu hidroksipropilcelulozu, farmaburst C ili bilo koju kombinaciju spomenutih razgrađivača.
7. Sastav prema zahtjevu 5, naznačen time, da on sadrži razgrađivač od oko 10% do oko 50% po obliku jedinice doziranja.
8. Sastav prema zahtjevu 6, naznačen time, da on sadrži razgrađivač od oko 20% do oko 40% po obliku jedinice doziranja.
9. Sastav prema zahtjevu 7, naznačen time, da on sadrži razgrađivač od oko 30% po obliku jedinice doziranja.
10. Farmaceutski sastav prema zahtjevu 1, naznačen time, da on dodatno sadrži direktno stlačivi polivalentan alkohol.
11. Sastav prema zahtjevu 9, naznačen time, da alkohol je manitol i sadržan je od oko 2% do oko 25% po obliku jedinice doziranja.
12. Sastav prema zahtjevu 10, naznačen time, da on sadrži manitol od oko 4% do oko 20% po obliku jedinice doziranja.
13. Sastav prema zahtjevu 11, naznačen time, da on sadrži manitol od oko 6% do oko 16% po obliku jedinice doziranja.
14. Farmaceutski sastav prema zahtjevu 1, naznačen time, da on sadrži od oko 4% do oko 30% mikrokristalinične celuloze po obliku jedinice doziranja.
15. Sastav prema zahtjevu 13, naznačen time, da on sadrži od oko 8% do oko 25% mikrokristalinične celuloze po obliku jedinice doziranja.
16. Sastav prema zahtjevu 14, naznačen time, da on sadrži od oko 12% do oko 22% mikrokristalinične celuloze po obliku jedinice doziranja.
17. Sastav prema zahtjevu 1, naznačen time, da se farmaceutski sastav razgrađuje za manje od jedne minute.
18. Sastav prema zahtjevu 1, naznačen time, da on sadrži vezivno sredstvo odabrano iz skupine koja se sastoji od hidroksipropilne metilceluloze, hidroksipropilceluloze, povidona, predgeliranog škroba i hladno nabubrenog kukuruznog škroba.
19. Sastav prema zahtjevu 17, naznačen time, da on sadrži kapecitabin od oko 50 mg do oko 1500 mg po obliku jedinice doziranja.
20. Sastav prema zahtjevu 19, naznačen time, da on sadrži kapecitabin od oko 100 mg do oko 750 mg po obliku jedinice doziranja.
21. Sastav prema zahtjevu 18, naznačen time, da on sadrži kapecitabin od 125 mg, 150 mg, 175 mg, 250 mg, 350 mg ili 500 mg po obliku jedinice doziranja.
22. Farmaceutski sastav, naznačen time, da se razgrađuje u vodi na 37°C u uređaju za razgrađivanje USP za manje od jedne minute, a sadrži kapecitabin, barem jedan razgrađivač, vezivno sredstvo, barem jedno punilo, lubrikant, barem jedan zaslađivač i barem jedan pojačivač okusa.
23. Farmaceutski sastav prema zahtjevu 22, naznačen time, da je obložen filmom.
24. Farmaceutski sastav prema zahtjevu 1 ili 22, naznačen time, da ne sadrži laktozu.
25. Farmaceutski sastav prema zahtjevu 23, naznačen time, da sadrži 125 mg kapecitabina, 35,72 mg bezvodne laktoze, 3,57 mg hipromeloze, 37,50 krospovidona, 89,30 farmabursta C, 23,21 mg manitola, 46,82 mg mikrokristalinične celuloze, 8,22 mg magnezij stearata, 15,54 mg aspartama, 3,22 mg natrij saharina, 7,86 mg vanilije, 1,47 mg smjese za maskiranje gorčine i 2,97 mg arome jagode.
26. Farmaceutski sastav prema zahtjevu 23, naznačen time, da sadrži 150 mg kapecitabina, 42,90 mg bezvodne laktoze, 4,28 mg hipromeloze, 45,00 krospovidona, 107,16 farmabursta C, 27,85 mg manitola, 56,18 mg mikrokristalinične celuloze, 9,86 mg magnezij stearata, 18,64 mg aspartama, 3,86 mg natrij saharina, 9,43 mg vanilije, 1,76 mg smjese za maskiranje gorčine i 3,56 mg arome jagode.
27. Farmaceutski sastav prema zahtjevu 23, naznačen time, da sadrži 175 mg kapecitabina, 50,06 mg bezvodne laktoze, 5,00 mg hipromeloze, 52,50 krospovidona, 125,00 farmabursta C, 32,50 mg manitola, 65,54 mg mikrokristalinične celuloze, 11,50 mg magnezij stearata, 21,75 mg aspartama, 4,50 mg natrij saharina, 11,00 mg vanilije, 2,06 mg smjese za maskiranje gorčine i 4,15 mg arome jagode.
28. Farmaceutski sastav prema zahtjevu 23, naznačen time, da sadrži 250 mg kapecitabina, 71,49 mg bezvodne laktoze, 7,14 mg hipromeloze, 75,00 krospovidona, 178,60 farmabursta C, 46,43 mg manitola, 93,63 mg mikrokristalinične celuloze, 16,43 mg magnezij stearata, 31,07 mg aspartama, 6,43 mg natrij saharina, 15,71 mg vanilije, 2,94 mg smjese za maskiranje gorčine i 5,93 mg arome jagode.
29. Farmaceutski sastav prema zahtjevu 23, naznačen time, da sadrži 350 mg kapecitabina, 100,12 mg bezvodne laktoze, 10,00 mg hipromeloze, 105,00 krospovidona, 250,00 farmabursta C, 65,00 mg manitola, 131,08 mg mikrokristalinične celuloze, 23,00 mg magnezij stearata, 43,50 mg aspartama, 9,00 mg natrij saharina, 22,00 mg vanilije, 4,12 mg smjese za maskiranje gorčine i 8,30 mg arome jagode.
30. Farmaceutski sastav prema zahtjevu 23, naznačen time, da sadrži 500 mg kapecitabina, 132,88 mg bezvodne laktoze, 14,28 mg hipromeloze, 150,00 krospovidona, 357,20 farmabursta C, 92,84 mg manitola, 187,28 mg mikrokristalinične celuloze, 32,88 mg magnezij stearata, 62,16 mg aspartama, 12,88 mg natrij saharina, 31,44 mg vanilije, 5,88 mg smjese za maskiranje gorčine i 11,88 mg arome jagode.
31. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 125,00 mg kapecitabina, 3,57 mg hipromeloze, 37,50 krospovidona, 89,30 farmabursta C, 58,93 mg manitola, 46,82 mg mikrokristalinične celuloze, 8,22 mg magnezij stearata, 15,54 mg aspartama, 3,22 mg natrij saharina, 7,86 mg vanilije, 1,47 mg smjese za maskiranje gorčine i 2,97 mg arome jagode.
32. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 150,00 mg kapecitabina, 4,28 mg hipromeloze, 45,00 krospovidona, 107,16 farmabursta C, 70,75 mg manitola, 56,18 mg mikrokristalinične celuloze, 9,86 mg magnezij stearata, 18,64 mg aspartama, 3,86 mg natrij saharina, 9,43 mg vanilije, 1,76 mg smjese za maskiranje gorčine i 3,56 mg arome jagode.
33. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 175,00 mg kapecitabina, 5,00 mg hipromeloze, 52,50 krospovidona, 125,00 farmabursta C, 82,56 mg manitola, 65,54 mg mikrokristalinične celuloze, 11,50 mg magnezij stearata, 21,75 mg aspartama, 4,50 mg natrij saharina, 11,00 mg vanilije, 2,06 mg smjese za maskiranje gorčine i 4,15 mg arome jagode.
34. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 250,00 mg kapecitabina, 7,14 mg hipromeloze, 75,00 krospovidona, 178,60 farmabursta C, 117,92 mg manitola, 93,63 mg mikrokristalinične celuloze, 16,43 mg magnezij stearata, 31,07 mg aspartama, 6,43 mg natrij saharina, 15,71 mg vanilije, 2,94 mg smjese za maskiranje gorčine i 5,93 mg arome jagode.
35. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 350,00 mg kapecitabina, 10,00 mg hipromeloze, 105,00 krospovidona, 250,00 farmabursta C, 165,12 mg manitola, 131,08 mg mikrokristalinične celuloze, 23,00 mg magnezij stearata, 43,50 mg aspartama, 9,00 mg natrij saharina, 22,00 mg vanilije, 4,12 mg smjese za maskiranje gorčine i 8,30 mg arome jagode.
36. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 500,00 mg kapecitabina, 14,28 mg hipromeloze, 150,00 krospovidona, 357,20 farmabursta C, 235,72 mg manitola, 187,28 mg mikrokristalinične celuloze, 32,88 mg magnezij stearata, 62,16 mg aspartama, 12,88 mg natrij saharina, 31,44 mg vanilije, 5,88 mg smjese za maskiranje gorčine i 11,88 mg arome jagode.
37. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 125,00 mg kapecitabina, 3,57 mg hipromeloze, 62,50 krospovidona, 58,93 mg manitola, 82,26 mg mikrokristalinične celuloze, 7,41 mg magnezij stearata, 15,54 mg aspartama, 3,22 mg natrij saharina, 7,86 mg vanilije, 1,47 mg smjese za maskiranje gorčine i 2,97 mg arome jagode.
38. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 150,00 mg kapecitabina, 4,28 mg hipromeloze, 75,01 krospovidona, 70,75 mg manitola, 98,71 mg mikrokristalinične celuloze, 8,90 mg magnezij stearata, 18,64 mg aspartama, 3,86 mg natrij saharina, 9,43 mg vanilije, 1,76 mg smjese za maskiranje gorčine i 3,56 mg arome jagode.
39. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 175,00 mg kapecitabina, 5,00 mg hipromeloze, 87,50 krospovidona, 82,50 mg manitola, 115,16 mg mikrokristalinične celuloze, 10,37 mg magnezij stearata, 21,76 mg aspartama, 4,50 mg natrij saharina, 11,00 mg vanilije, 2,06 mg smjese za maskiranje gorčine i 4,15 mg arome jagode.
40. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 250,00 mg kapecitabina, 7,14 mg hipromeloze, 125,00 krospovidona, 117,86 mg manitola, 164,52 mg mikrokristalinične celuloze, 14,82 mg magnezij stearata, 31,08 mg aspartama, 6,44 mg natrij saharina, 15,72 mg vanilije, 2,94 mg smjese za maskiranje gorčine i 5,94 mg arome jagode.
41. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 350,00 mg kapecitabina, 10,00 mg hipromeloze, 175,00 krospovidona, 165,00 mg manitola, 230,32 mg mikrokristalinične celuloze, 20,74 mg magnezij stearata, 43,52 mg aspartama, 9,00 mg natrij saharina, 22,00 mg vanilije, 4,12 mg smjese za maskiranje gorčine i 8,30 mg arome jagode.
42. Farmaceutski sastav prema zahtjevu 1, naznačen time, da sadrži 500,00 mg kapecitabina, 14,28 mg hipromeloze, 250,00 krospovidona, 235,72 mg manitola, 329,04 mg mikrokristalinične celuloze, 29,64 mg magnezij stearata, 62,16 mg aspartama, 12,88 mg natrij saharina, 31,44 mg vanilije, 5,88 mg smjese za maskiranje gorčine i 11,88 mg arome jagode.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US85017406P | 2006-10-06 | 2006-10-06 | |
| US95155707P | 2007-07-24 | 2007-07-24 | |
| PCT/EP2007/060186 WO2008040665A2 (en) | 2006-10-06 | 2007-09-26 | Capecitabine pediatric tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20110113T1 true HRP20110113T1 (hr) | 2011-03-31 |
Family
ID=39186803
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20110113T HRP20110113T1 (hr) | 2006-10-06 | 2011-02-16 | Kapecitabin tablete za djecu |
Country Status (31)
| Country | Link |
|---|---|
| US (2) | US20080085310A1 (hr) |
| EP (1) | EP2073791B1 (hr) |
| JP (1) | JP5330248B2 (hr) |
| KR (1) | KR101177730B1 (hr) |
| CN (1) | CN101522168B (hr) |
| AR (1) | AR063138A1 (hr) |
| AT (1) | ATE492267T1 (hr) |
| AU (1) | AU2007304293A1 (hr) |
| BR (1) | BRPI0719241A2 (hr) |
| CA (1) | CA2664922C (hr) |
| CL (1) | CL2007002875A1 (hr) |
| CO (1) | CO6150122A2 (hr) |
| CR (1) | CR10668A (hr) |
| CY (1) | CY1111223T1 (hr) |
| DE (1) | DE602007011475D1 (hr) |
| DK (1) | DK2073791T3 (hr) |
| HK (1) | HK1135905A1 (hr) |
| HR (1) | HRP20110113T1 (hr) |
| IL (1) | IL197767A0 (hr) |
| MA (1) | MA30779B1 (hr) |
| MX (1) | MX2009003317A (hr) |
| MY (1) | MY145637A (hr) |
| NO (1) | NO20090980L (hr) |
| NZ (1) | NZ575280A (hr) |
| PE (1) | PE20081106A1 (hr) |
| PL (1) | PL2073791T3 (hr) |
| PT (1) | PT2073791E (hr) |
| RU (1) | RU2455979C2 (hr) |
| SI (1) | SI2073791T1 (hr) |
| TW (1) | TW200825096A (hr) |
| WO (1) | WO2008040665A2 (hr) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110027374A1 (en) * | 2008-12-16 | 2011-02-03 | Maria Oksana Bachynsky | Capecitabine rapidly disintegrating tablets |
| TWI455733B (zh) * | 2009-03-30 | 2014-10-11 | Toray Industries | 口腔內崩壞性被覆錠劑 |
| CN102266303A (zh) * | 2011-07-07 | 2011-12-07 | 程雪翔 | 一种卡培他滨药用组合物及其制备方法 |
| CN102516338B (zh) * | 2011-12-09 | 2014-04-02 | 海南锦瑞制药股份有限公司 | 一种卡培他滨化合物、其药物组合物及其制备方法 |
| CN103156877B (zh) * | 2011-12-13 | 2015-11-25 | 深圳海王药业有限公司 | 一种卡培他滨速释微丸及其制备方法 |
| CN102988320B (zh) * | 2012-12-13 | 2014-04-16 | 哈药集团技术中心 | 一种卡培他滨分散片及其制备方法 |
| CN104739800A (zh) * | 2015-02-03 | 2015-07-01 | 吉林修正药业新药开发有限公司 | 一种卡培他滨片组合物及其制备方法 |
| JP6673798B2 (ja) * | 2016-10-12 | 2020-03-25 | 日本化薬株式会社 | カペシタビンを有効成分とするフィルムコート医薬製剤 |
| JP6866113B2 (ja) * | 2016-11-01 | 2021-04-28 | 日本化薬株式会社 | カペシタビンを有効成分とする医薬製剤 |
| JP6792418B2 (ja) * | 2016-11-08 | 2020-11-25 | 日本化薬株式会社 | カペシタビンを有効成分とする医薬製剤の製造方法 |
| JP7170554B2 (ja) | 2019-02-06 | 2022-11-14 | ゼネラル株式会社 | 感熱転写媒体 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB8628359D0 (en) * | 1986-11-27 | 1986-12-31 | Zyma Sa | Galenical formulation |
| CA1327358C (en) * | 1987-11-17 | 1994-03-01 | Morio Fujiu | Fluoro cytidine derivatives |
| TW254946B (hr) * | 1992-12-18 | 1995-08-21 | Hoffmann La Roche | |
| AU671491B2 (en) * | 1992-12-18 | 1996-08-29 | F. Hoffmann-La Roche Ag | N-oxycarbonyl substituted 5'-deoxy-5-fluorcytidines |
| US5476932A (en) * | 1994-08-26 | 1995-12-19 | Hoffmann-La Roche Inc. | Process for producing N4-acyl-5'-deoxy-5-fluorocytidine derivatives |
| JPH0971523A (ja) * | 1995-09-07 | 1997-03-18 | Riyuukakusan:Kk | 口腔内で崩壊性の速い錠剤 |
| CA2322315C (en) * | 1998-03-06 | 2008-09-16 | Eurand International S.P.A. | Fast disintegrating tablets |
| RU2135169C1 (ru) * | 1998-12-02 | 1999-08-27 | Государственное предприятие Казанское производственное химико-фармацевтическое объединение "Татхимфармпрепараты" | Противовоспалительное, болеутоляющее, жаропонижающее лекарственное средство и способ его получения |
| JP2000273039A (ja) * | 1999-01-20 | 2000-10-03 | Taisho Pharmaceut Co Ltd | 口腔内崩壊性組成物 |
| US6248363B1 (en) * | 1999-11-23 | 2001-06-19 | Lipocine, Inc. | Solid carriers for improved delivery of active ingredients in pharmaceutical compositions |
| FR2790387B1 (fr) * | 1999-03-01 | 2001-05-18 | Prographarm Laboratoires | Comprime orodispersible presentant une faible friabilite et son procede de preparation |
| CA2403594A1 (en) * | 2000-03-27 | 2002-09-18 | Kyowa Hakko Kogyo Co., Ltd. | Granules having good taking property |
| WO2002069934A1 (fr) * | 2001-03-06 | 2002-09-12 | Kyowa Hakko Kogyo Co., Ltd. | Préparations se délitant rapidement dans la bouche |
| US8377952B2 (en) * | 2003-08-28 | 2013-02-19 | Abbott Laboratories | Solid pharmaceutical dosage formulation |
| US8545881B2 (en) * | 2004-04-19 | 2013-10-01 | Eurand Pharmaceuticals, Ltd. | Orally disintegrating tablets and methods of manufacture |
| DE102004028940A1 (de) * | 2004-06-15 | 2006-01-12 | Krka Tovarna Zdravil, D.D. | Oral zerfallende pharmazeutische Zusammensetzung, die Risperidon enthält |
| DE112006000873T5 (de) * | 2005-04-12 | 2008-03-06 | Elan Pharma International Ltd. | Zusammensetzungen mit modifizierter Freisetzung, umfassend ein Fluorcytidin-Derivate zur Behandlung von Krebs |
-
2007
- 2007-09-25 US US11/860,708 patent/US20080085310A1/en not_active Abandoned
- 2007-09-26 WO PCT/EP2007/060186 patent/WO2008040665A2/en active Application Filing
- 2007-09-26 EP EP07820581A patent/EP2073791B1/en active Active
- 2007-09-26 AT AT07820581T patent/ATE492267T1/de active
- 2007-09-26 JP JP2009530851A patent/JP5330248B2/ja active Active
- 2007-09-26 MX MX2009003317A patent/MX2009003317A/es active IP Right Grant
- 2007-09-26 SI SI200730529T patent/SI2073791T1/sl unknown
- 2007-09-26 RU RU2009116816/15A patent/RU2455979C2/ru not_active IP Right Cessation
- 2007-09-26 DE DE602007011475T patent/DE602007011475D1/de active Active
- 2007-09-26 PL PL07820581T patent/PL2073791T3/pl unknown
- 2007-09-26 KR KR1020097006166A patent/KR101177730B1/ko active IP Right Grant
- 2007-09-26 CA CA2664922A patent/CA2664922C/en not_active Expired - Fee Related
- 2007-09-26 AU AU2007304293A patent/AU2007304293A1/en not_active Abandoned
- 2007-09-26 CN CN2007800362049A patent/CN101522168B/zh active Active
- 2007-09-26 MY MYPI20091372A patent/MY145637A/en unknown
- 2007-09-26 PT PT07820581T patent/PT2073791E/pt unknown
- 2007-09-26 NZ NZ575280A patent/NZ575280A/en not_active IP Right Cessation
- 2007-09-26 DK DK07820581.2T patent/DK2073791T3/da active
- 2007-09-26 BR BRPI0719241-0A patent/BRPI0719241A2/pt not_active Application Discontinuation
- 2007-10-03 TW TW096137096A patent/TW200825096A/zh unknown
- 2007-10-04 CL CL2007002875A patent/CL2007002875A1/es unknown
- 2007-10-04 AR ARP070104409A patent/AR063138A1/es not_active Application Discontinuation
- 2007-10-04 PE PE2007001349A patent/PE20081106A1/es not_active Application Discontinuation
-
2009
- 2009-03-04 NO NO20090980A patent/NO20090980L/no not_active Application Discontinuation
- 2009-03-11 CO CO09025204A patent/CO6150122A2/es unknown
- 2009-03-18 CR CR10668A patent/CR10668A/es not_active Application Discontinuation
- 2009-03-23 IL IL197767A patent/IL197767A0/en unknown
- 2009-04-06 MA MA31762A patent/MA30779B1/fr unknown
-
2010
- 2010-02-22 HK HK10101826.6A patent/HK1135905A1/xx not_active IP Right Cessation
-
2011
- 2011-02-10 CY CY20111100161T patent/CY1111223T1/el unknown
- 2011-02-16 HR HR20110113T patent/HRP20110113T1/hr unknown
-
2014
- 2014-10-22 US US14/521,357 patent/US20150044287A1/en not_active Abandoned
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