NO325154B1 - Belagte cyklofosfamid tabletter, fremgangsmate for fremstilling av tablettkjerner og filmtabletter samt tablettkjerne og filmtabletter oppnadd ved disse fremgangsmater - Google Patents
Belagte cyklofosfamid tabletter, fremgangsmate for fremstilling av tablettkjerner og filmtabletter samt tablettkjerne og filmtabletter oppnadd ved disse fremgangsmater Download PDFInfo
- Publication number
- NO325154B1 NO325154B1 NO20006325A NO20006325A NO325154B1 NO 325154 B1 NO325154 B1 NO 325154B1 NO 20006325 A NO20006325 A NO 20006325A NO 20006325 A NO20006325 A NO 20006325A NO 325154 B1 NO325154 B1 NO 325154B1
- Authority
- NO
- Norway
- Prior art keywords
- cyclophosphamide
- talc
- tablet
- magnesium stearate
- silicon dioxide
- Prior art date
Links
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 title claims description 29
- 229960004397 cyclophosphamide Drugs 0.000 title claims description 29
- 238000000034 method Methods 0.000 title claims description 19
- 238000002360 preparation method Methods 0.000 title description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 26
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 26
- 239000000454 talc Substances 0.000 claims description 16
- 229910052623 talc Inorganic materials 0.000 claims description 16
- 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 description 13
- 229920002261 Corn starch Polymers 0.000 claims description 13
- 239000001913 cellulose Substances 0.000 claims description 13
- 229920002678 cellulose Polymers 0.000 claims description 13
- 239000008120 corn starch Substances 0.000 claims description 13
- 229960001021 lactose monohydrate Drugs 0.000 claims description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims description 13
- 239000000377 silicon dioxide Substances 0.000 claims description 13
- 235000012239 silicon dioxide Nutrition 0.000 claims description 13
- 238000004519 manufacturing process Methods 0.000 claims description 9
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 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 description 5
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 4
- PWOQRKCAHTVFLB-UHFFFAOYSA-N cyclophosphamide hydrate Chemical compound O.ClCCN(CCCl)P1(=O)NCCCO1 PWOQRKCAHTVFLB-UHFFFAOYSA-N 0.000 claims description 4
- 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 3
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 229920001577 copolymer Polymers 0.000 claims description 3
- 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 3
- 239000006185 dispersion Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 3
- 229920000053 polysorbate 80 Polymers 0.000 claims description 3
- 229940068968 polysorbate 80 Drugs 0.000 claims description 3
- 229940083037 simethicone Drugs 0.000 claims description 3
- 239000000725 suspension Substances 0.000 claims description 3
- 239000004408 titanium dioxide Substances 0.000 claims description 3
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims description 2
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 2
- BYNVYIUJKRRNNC-UHFFFAOYSA-N docosanoic acid;propane-1,2,3-triol Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCCCCCCCC(O)=O BYNVYIUJKRRNNC-UHFFFAOYSA-N 0.000 claims description 2
- 239000002706 dry binder Substances 0.000 claims description 2
- 239000000945 filler Substances 0.000 claims description 2
- 239000007888 film coating Substances 0.000 claims description 2
- 238000009501 film coating Methods 0.000 claims description 2
- 235000011187 glycerol Nutrition 0.000 claims description 2
- 239000000314 lubricant Substances 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 238000007873 sieving Methods 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 229920003123 carboxymethyl cellulose sodium Polymers 0.000 claims 1
- 229940063834 carboxymethylcellulose sodium Drugs 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
- 239000003826 tablet Substances 0.000 description 28
- 229920002472 Starch Polymers 0.000 description 3
- 239000008107 starch Substances 0.000 description 3
- 235000019698 starch Nutrition 0.000 description 3
- 239000013543 active substance Substances 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000000259 anti-tumor effect Effects 0.000 description 1
- 239000004202 carbamide Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000002512 chemotherapy Methods 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 231100000433 cytotoxic Toxicity 0.000 description 1
- 230000001472 cytotoxic effect Effects 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 231100001261 hazardous Toxicity 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000000126 substance 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 (3)
| Publication Number | Publication Date |
|---|---|
| NO20006325D0 NO20006325D0 (no) | 2000-12-12 |
| NO20006325L NO20006325L (no) | 2000-12-12 |
| NO325154B1 true NO325154B1 (no) | 2008-02-11 |
Family
ID=7870877
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| NO20006325A NO325154B1 (no) | 1998-06-15 | 2000-12-12 | Belagte cyklofosfamid tabletter, fremgangsmate for fremstilling av tablettkjerner og filmtabletter samt tablettkjerne og filmtabletter oppnadd ved disse fremgangsmater |
Country Status (28)
| Country | Link |
|---|---|
| US (1) | US20010046504A1 (https=) |
| EP (1) | EP1089739B1 (https=) |
| JP (1) | JP4891478B2 (https=) |
| KR (1) | KR100679872B1 (https=) |
| CN (1) | CN1177590C (https=) |
| AR (1) | AR019670A1 (https=) |
| AT (1) | ATE310523T1 (https=) |
| AU (1) | AU771284B2 (https=) |
| BG (1) | BG65253B1 (https=) |
| BR (1) | BR9911276A (https=) |
| CA (1) | CA2333682C (https=) |
| CO (1) | CO5070588A1 (https=) |
| CZ (1) | CZ302157B6 (https=) |
| DE (3) | DE19826517B4 (https=) |
| DK (1) | DK1089739T3 (https=) |
| ES (1) | ES2255276T3 (https=) |
| HU (1) | HU226528B1 (https=) |
| IL (2) | IL139944A0 (https=) |
| NO (1) | NO325154B1 (https=) |
| NZ (1) | NZ508888A (https=) |
| PL (1) | PL193398B1 (https=) |
| RU (1) | RU2236231C2 (https=) |
| SK (1) | SK286185B6 (https=) |
| TR (1) | TR200003702T2 (https=) |
| TW (1) | TWI242450B (https=) |
| UA (1) | UA75566C2 (https=) |
| WO (1) | WO1999065499A1 (https=) |
| ZA (1) | ZA200006998B (https=) |
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 |
| CA2476201C (en) | 2002-02-21 | 2009-09-01 | Biovail Laboratories Incorporated | Modified release formulations of at least one form of tramadol |
| 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 |
| WO2016046797A1 (en) | 2014-09-26 | 2016-03-31 | Intas Pharmaceuticals Ltd. | Pharmaceutical composition having improved content uniformity |
| WO2017157873A1 (en) | 2016-03-17 | 2017-09-21 | F. Hoffmann-La Roche Ag | 5-ethyl-4-methyl-pyrazole-3-carboxamide derivative having activity as agonist of 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 |
| UA26305A (uk) * | 1990-07-16 | 1999-08-30 | Аста Медіка Аг | Таблетка, спосіб її одержаhhя, граhулят та спосіб одержаhhя граhулята |
| EP0468245B1 (de) * | 1990-07-16 | 1994-04-20 | ASTA Medica Aktiengesellschaft | Tablette und Granulat welche als Wirkstoff Mesna enthalten |
| 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 |
| DE69628750T2 (de) * | 1996-02-22 | 2004-04-29 | Samjin Pharm, Co., Ltd. | Neue antivirale, homocarbozklische nukleosidderivate von substituierten pyrimidindionen, verfahren zu ihrer herstellung und zusammensetzungen, die diese als aktiven bestandteil enthalten |
| 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 CA CA002333682A patent/CA2333682C/en not_active Expired - Fee Related
- 1999-06-08 ES ES99927902T patent/ES2255276T3/es not_active Expired - Lifetime
- 1999-06-08 CZ CZ20004489A patent/CZ302157B6/cs not_active IP Right Cessation
- 1999-06-08 HU HU0102788A patent/HU226528B1/hu not_active IP Right Cessation
- 1999-06-08 DK DK99927902T patent/DK1089739T3/da active
- 1999-06-08 CN CNB998074330A patent/CN1177590C/zh not_active Expired - Fee Related
- 1999-06-08 NZ NZ508888A patent/NZ508888A/en not_active IP Right Cessation
- 1999-06-08 SK SK1858-2000A patent/SK286185B6/sk not_active IP Right Cessation
- 1999-06-08 PL PL99344832A patent/PL193398B1/pl not_active IP Right Cessation
- 1999-06-08 KR KR1020007014142A patent/KR100679872B1/ko not_active Expired - Fee Related
- 1999-06-08 AT AT99927902T patent/ATE310523T1/de active
- 1999-06-08 IL IL13994499A patent/IL139944A0/xx active IP Right Grant
- 1999-06-08 DE DE59912829T patent/DE59912829D1/de not_active Expired - Lifetime
- 1999-06-08 TR TR2000/03702T patent/TR200003702T2/xx unknown
- 1999-06-08 BR BR9911276-0A patent/BR9911276A/pt not_active Application Discontinuation
- 1999-06-08 EP EP99927902A patent/EP1089739B1/de not_active Expired - Lifetime
- 1999-06-08 JP JP2000554378A patent/JP4891478B2/ja not_active Expired - Fee Related
- 1999-06-08 RU RU2001101903/15A patent/RU2236231C2/ru not_active IP Right Cessation
- 1999-06-08 AU AU45085/99A patent/AU771284B2/en not_active Ceased
- 1999-06-08 WO PCT/EP1999/003920 patent/WO1999065499A1/de not_active Ceased
- 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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM1K | Lapsed by not paying the annual fees |