UA75566C2 - Cyclophosphamide tablets, tablet cores, process for their manufacture - Google Patents
Cyclophosphamide tablets, tablet cores, process for their manufacture Download PDFInfo
- Publication number
- UA75566C2 UA75566C2 UA2001010222A UA2001010222A UA75566C2 UA 75566 C2 UA75566 C2 UA 75566C2 UA 2001010222 A UA2001010222 A UA 2001010222A UA 2001010222 A UA2001010222 A UA 2001010222A UA 75566 C2 UA75566 C2 UA 75566C2
- Authority
- UA
- Ukraine
- Prior art keywords
- cyclophosphamide
- tablet
- talc
- core
- magnesium stearate
- Prior art date
Links
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 title claims abstract description 25
- 229960004397 cyclophosphamide Drugs 0.000 title claims abstract description 25
- 238000000034 method Methods 0.000 title claims description 11
- 238000004519 manufacturing process Methods 0.000 title description 6
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 18
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 15
- 239000000454 talc Substances 0.000 claims abstract description 11
- 229910052623 talc Inorganic materials 0.000 claims abstract description 11
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims abstract description 9
- 229960001021 lactose monohydrate Drugs 0.000 claims abstract description 9
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 9
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 4
- 239000000314 lubricant Substances 0.000 claims abstract description 4
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract 8
- 235000011187 glycerol Nutrition 0.000 claims abstract 3
- 235000021355 Stearic acid Nutrition 0.000 claims abstract 2
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims abstract 2
- 235000019700 dicalcium phosphate Nutrition 0.000 claims abstract 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract 2
- 239000008117 stearic acid Substances 0.000 claims abstract 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 9
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 9
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 9
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 9
- 229920002261 Corn starch Polymers 0.000 claims description 8
- 239000008120 corn starch Substances 0.000 claims description 8
- 239000000377 silicon dioxide Substances 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 6
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000000725 suspension Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 3
- 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 description 2
- 229920001577 copolymer Polymers 0.000 claims description 2
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 claims description 2
- 239000002706 dry binder Substances 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 229910052710 silicon Inorganic materials 0.000 claims description 2
- 239000010703 silicon Substances 0.000 claims description 2
- 229940083037 simethicone Drugs 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 239000004408 titanium dioxide Substances 0.000 claims description 2
- 239000003826 tablet Substances 0.000 claims 11
- 235000012239 silicon dioxide Nutrition 0.000 claims 6
- 230000008961 swelling Effects 0.000 claims 5
- 239000007888 film coating Substances 0.000 claims 4
- 238000009501 film coating Methods 0.000 claims 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- JIGUQPWFLRLWPJ-UHFFFAOYSA-N Ethyl acrylate Chemical compound CCOC(=O)C=C JIGUQPWFLRLWPJ-UHFFFAOYSA-N 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 239000007941 film coated tablet Substances 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- PNJWIWWMYCMZRO-UHFFFAOYSA-N pent‐4‐en‐2‐one Natural products CC(=O)CC=C PNJWIWWMYCMZRO-UHFFFAOYSA-N 0.000 claims 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 1
- 229940068968 polysorbate 80 Drugs 0.000 claims 1
- 229920000053 polysorbate 80 Polymers 0.000 claims 1
- 239000002562 thickening agent Substances 0.000 claims 1
- 238000012876 topography Methods 0.000 claims 1
- 229920002472 Starch Polymers 0.000 abstract description 6
- 235000019698 starch Nutrition 0.000 abstract description 6
- 239000008107 starch Substances 0.000 abstract description 5
- 239000013543 active substance Substances 0.000 abstract description 3
- 239000000945 filler Substances 0.000 abstract description 3
- 239000001913 cellulose Substances 0.000 abstract description 2
- 229920002678 cellulose Polymers 0.000 abstract description 2
- 239000011230 binding agent Substances 0.000 abstract 2
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- BYNVYIUJKRRNNC-UHFFFAOYSA-N docosanoic acid;propane-1,2,3-triol Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCCCCCCCC(O)=O BYNVYIUJKRRNNC-UHFFFAOYSA-N 0.000 abstract 1
- 229910052814 silicon oxide Inorganic materials 0.000 abstract 1
- 239000000126 substance Substances 0.000 description 7
- 239000002775 capsule Substances 0.000 description 3
- 239000002552 dosage form Substances 0.000 description 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
- 206010006187 Breast cancer Diseases 0.000 description 1
- 208000026310 Breast neoplasm Diseases 0.000 description 1
- 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 description 1
- LCGLNKUTAGEVQW-UHFFFAOYSA-N Dimethyl ether Chemical compound COC LCGLNKUTAGEVQW-UHFFFAOYSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 150000001805 chlorine compounds Chemical class 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 231100000433 cytotoxic Toxicity 0.000 description 1
- 230000001472 cytotoxic effect Effects 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
Classifications
-
- 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
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE19826517A DE19826517B4 (de) | 1998-06-15 | 1998-06-15 | Verfahren zur Herstellung von Filmtabletten mit Cyclophosphamid als Wirkstoff und daraus hergestellte Cyclophosphamid-Filmtablette |
| PCT/EP1999/003920 WO1999065499A1 (de) | 1998-06-15 | 1999-06-08 | Cyclophosphamid filmtabletten |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| UA75566C2 true UA75566C2 (en) | 2006-05-15 |
Family
ID=7870877
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| UA2001010222A UA75566C2 (en) | 1998-06-15 | 1999-08-06 | Cyclophosphamide tablets, tablet cores, process for their manufacture |
Country Status (28)
| Country | Link |
|---|---|
| US (1) | US20010046504A1 (cs) |
| EP (1) | EP1089739B1 (cs) |
| JP (1) | JP4891478B2 (cs) |
| KR (1) | KR100679872B1 (cs) |
| CN (1) | CN1177590C (cs) |
| AR (1) | AR019670A1 (cs) |
| AT (1) | ATE310523T1 (cs) |
| AU (1) | AU771284B2 (cs) |
| BG (1) | BG65253B1 (cs) |
| BR (1) | BR9911276A (cs) |
| CA (1) | CA2333682C (cs) |
| CO (1) | CO5070588A1 (cs) |
| CZ (1) | CZ302157B6 (cs) |
| DE (3) | DE19826517B4 (cs) |
| DK (1) | DK1089739T3 (cs) |
| ES (1) | ES2255276T3 (cs) |
| HU (1) | HU226528B1 (cs) |
| IL (2) | IL139944A0 (cs) |
| NO (1) | NO325154B1 (cs) |
| NZ (1) | NZ508888A (cs) |
| PL (1) | PL193398B1 (cs) |
| RU (1) | RU2236231C2 (cs) |
| SK (1) | SK286185B6 (cs) |
| TR (1) | TR200003702T2 (cs) |
| TW (1) | TWI242450B (cs) |
| UA (1) | UA75566C2 (cs) |
| WO (1) | WO1999065499A1 (cs) |
| ZA (1) | ZA200006998B (cs) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AT500063A1 (de) | 1999-11-23 | 2005-10-15 | Sandoz Ag | Beschichtete tablettenkerne |
| JP4704685B2 (ja) | 2002-02-21 | 2011-06-15 | バイオヴェイル ラボラトリーズ インターナショナル エスアールエル | 徐放性製剤 |
| DE102005008797A1 (de) * | 2005-02-25 | 2006-09-07 | Baxter International Inc., Deerfield | Trofosfamid-haltige Filmtabletten und Verfahren zu deren Herstellung |
| US9452980B2 (en) | 2009-12-22 | 2016-09-27 | Hoffmann-La Roche Inc. | Substituted benzamides |
| JO3659B1 (ar) * | 2010-06-02 | 2020-08-27 | Astellas Deutschland Gmbh | أشكال جرعات بينداموستين عن طريق الفم وإستخداماته العلاجية |
| UA112170C2 (uk) | 2010-12-10 | 2016-08-10 | Санофі | Протипухлинна комбінація, що містить антитіло, яке специфічно розпізнає cd38, і бортезоміб |
| EP2745833A1 (en) * | 2012-12-21 | 2014-06-25 | Institut Gustave Roussy | Soluble, dispersible or orodispersible tablets comprising cyclophosphamide |
| EP3197438A4 (en) | 2014-09-26 | 2018-06-20 | Intas Pharmaceuticals Ltd. | Pharmaceutical composition having improved content uniformity |
| PE20181446A1 (es) | 2016-03-17 | 2018-09-12 | Hoffmann La Roche | Derivados de 5-etil-4-metil-pirazol-3-carboxamida con actividad como de taar |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5047246A (en) * | 1988-09-09 | 1991-09-10 | Bristol-Myers Company | Direct compression cyclophosphamide tablet |
| US5110814A (en) * | 1989-01-11 | 1992-05-05 | Asta Pharma Ag | Azelastine and its salts used to combat psoriasis |
| DK0468245T3 (da) * | 1990-07-16 | 1994-05-16 | Asta Medica Ag | Tablet og granulat indeholdende mesna som aktivt middel |
| UA26305A (uk) * | 1990-07-16 | 1999-08-30 | Аста Медіка Аг | Таблетка, спосіб її одержаhhя, граhулят та спосіб одержаhhя граhулята |
| RO113611B1 (ro) * | 1990-08-03 | 1998-09-30 | Asta Pharma Ag | Preparate solide de ifosfamida, administrate oral si procedeu de obtinere |
| GB9115160D0 (en) * | 1991-07-12 | 1991-08-28 | Erba Carlo Spa | Methylen-oxindole derivatives and process for their preparation |
| GB9119983D0 (en) * | 1991-09-19 | 1991-11-06 | Erba Carlo Spa | Dihydropyridine derivatives useful in antitumor therapy |
| DE4433764A1 (de) * | 1994-09-22 | 1996-03-28 | Asta Medica Ag | Darreichungsformen enthaltend alpha-Liponsäure, feste Salze von R-Thioctsäure mit verbesserter Freisetzung und Bioverfügbarkeit |
| CN1092647C (zh) * | 1996-02-22 | 2002-10-16 | 三进制药株式会社 | 新抗病毒的取代嘧啶二酮同素碳环核苷衍生物及其制备方法与含有其为活性成分的组合物 |
| JPH11322596A (ja) * | 1998-05-12 | 1999-11-24 | Shionogi & Co Ltd | 白金錯体および環状リン酸エステルアミドを含有する抗癌剤 |
| US20040034099A1 (en) * | 2002-06-27 | 2004-02-19 | Ramsey Beverly J. | Pharmaceutical composition |
-
1998
- 1998-06-15 DE DE19826517A patent/DE19826517B4/de not_active Expired - Fee Related
-
1999
- 1999-06-08 CN CNB998074330A patent/CN1177590C/zh not_active Expired - Fee Related
- 1999-06-08 PL PL99344832A patent/PL193398B1/pl not_active IP Right Cessation
- 1999-06-08 DK DK99927902T patent/DK1089739T3/da active
- 1999-06-08 KR KR1020007014142A patent/KR100679872B1/ko not_active Expired - Fee Related
- 1999-06-08 WO PCT/EP1999/003920 patent/WO1999065499A1/de active IP Right Grant
- 1999-06-08 CZ CZ20004489A patent/CZ302157B6/cs not_active IP Right Cessation
- 1999-06-08 JP JP2000554378A patent/JP4891478B2/ja not_active Expired - Fee Related
- 1999-06-08 SK SK1858-2000A patent/SK286185B6/sk not_active IP Right Cessation
- 1999-06-08 TR TR2000/03702T patent/TR200003702T2/xx unknown
- 1999-06-08 DE DE59912829T patent/DE59912829D1/de not_active Expired - Lifetime
- 1999-06-08 AT AT99927902T patent/ATE310523T1/de active
- 1999-06-08 NZ NZ508888A patent/NZ508888A/en not_active IP Right Cessation
- 1999-06-08 EP EP99927902A patent/EP1089739B1/de not_active Expired - Lifetime
- 1999-06-08 RU RU2001101903/15A patent/RU2236231C2/ru not_active IP Right Cessation
- 1999-06-08 CA CA002333682A patent/CA2333682C/en not_active Expired - Fee Related
- 1999-06-08 IL IL13994499A patent/IL139944A0/xx active IP Right Grant
- 1999-06-08 HU HU0102788A patent/HU226528B1/hu not_active IP Right Cessation
- 1999-06-08 AU AU45085/99A patent/AU771284B2/en not_active Ceased
- 1999-06-08 BR BR9911276-0A patent/BR9911276A/pt not_active Application Discontinuation
- 1999-06-08 ES ES99927902T patent/ES2255276T3/es not_active Expired - Lifetime
- 1999-06-09 TW TW088109644A patent/TWI242450B/zh not_active IP Right Cessation
- 1999-06-10 DE DE29921466U patent/DE29921466U1/de not_active Expired - Lifetime
- 1999-06-11 CO CO99036819A patent/CO5070588A1/es unknown
- 1999-06-15 US US09/333,256 patent/US20010046504A1/en not_active Abandoned
- 1999-06-15 AR ARP990102862A patent/AR019670A1/es not_active Application Discontinuation
- 1999-08-06 UA UA2001010222A patent/UA75566C2/uk unknown
-
2000
- 2000-11-27 IL IL139944A patent/IL139944A/en not_active IP Right Cessation
- 2000-11-28 ZA ZA200006998A patent/ZA200006998B/en unknown
- 2000-12-12 NO NO20006325A patent/NO325154B1/no not_active IP Right Cessation
-
2001
- 2001-01-10 BG BG105139A patent/BG65253B1/bg unknown
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