SI21138B - Stabilna farmacevtska oblika zdravila proti raku - Google Patents
Stabilna farmacevtska oblika zdravila proti raku Download PDFInfo
- Publication number
- SI21138B SI21138B SI200120060A SI200120060A SI21138B SI 21138 B SI21138 B SI 21138B SI 200120060 A SI200120060 A SI 200120060A SI 200120060 A SI200120060 A SI 200120060A SI 21138 B SI21138 B SI 21138B
- Authority
- SI
- Slovenia
- Prior art keywords
- solvents
- mixture
- range
- paclitaxel
- stable pharmaceutical
- Prior art date
Links
- 239000002246 antineoplastic agent Substances 0.000 title abstract 3
- 229940041181 antineoplastic drug Drugs 0.000 title abstract 3
- 239000002904 solvent Substances 0.000 claims abstract 9
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims abstract 6
- 229930012538 Paclitaxel Natural products 0.000 claims abstract 5
- 239000000203 mixture Substances 0.000 claims abstract 5
- 229960001592 paclitaxel Drugs 0.000 claims abstract 5
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims abstract 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract 4
- 238000000859 sublimation Methods 0.000 claims abstract 4
- 230000008022 sublimation Effects 0.000 claims abstract 4
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 claims abstract 2
- 230000036512 infertility Effects 0.000 claims abstract 2
- 238000004519 manufacturing process Methods 0.000 claims abstract 2
- 230000007935 neutral effect Effects 0.000 claims abstract 2
- 239000003960 organic solvent Substances 0.000 claims abstract 2
- 238000000034 method Methods 0.000 claims 3
- 230000001093 anti-cancer Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 230000001954 sterilising effect Effects 0.000 claims 1
- 238000004659 sterilization and disinfection Methods 0.000 claims 1
- 239000013543 active substance Substances 0.000 abstract 1
- 239000000654 additive Substances 0.000 abstract 1
- 230000000996 additive effect Effects 0.000 abstract 1
- 238000004090 dissolution Methods 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D305/00—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms
- C07D305/14—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
Landscapes
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Stabilna farmacevtska oblika zdravila proti raku,ki vsebuje paklitaksel iz slike 1, po iznajdbi oznacena s tem, da je stabilna oblika aktivne snovi z veliko povrsino, amorfna, po moznosti z nekaj finega kristalnega dodatka. Po iznajdbi metoda za proizvodnjo stabilne farmacevtske oblike zdravila proti raku obsega raztopitev kristalnega paklitaksela v nevtralnem organskem topilu, izbranem iz skupine, ki obsega acetonitril, dioksan, etanol, ali mesanico teh topil, z moznim dodatkom vode, pod pogojem, da je vsebnost posameznih topil v mesanici v obmocju od 5% do 95%, med tem ko je vsebnost vode v obmocju od 0 do 60%; nastala raztopina se po moznosti filtrira, zamrzne in topila se odstranijo s sublimacijo pod znizanim pritiskom, pri nizki temperaturi, in potem je pripravek mogoce razposlati vodmerkih v pogojih, ki zagotavljajo sterilnost.
Claims (4)
- PATENTNI ZAHTEVKI 1. Metoda za pridobivanje stabilnega farmacevtskega pripravka, oblike paklitaksela kot zdravila proti raku, označena s tem, da je kristalni paklitaksel raztopljen v nevtralnem organskem topilu, izbranem iz skupine, ki obsega acetonitril, dioksan, etanol, ali mešanico teh topil, z možnim dodatkom vode, pod pogojem, daje vsebnost posameznih topil v mešanici v območju od 5% do 95%, med tem ko je vsebnost vode v območju od 0 do 60%; nastala raztopina se po možnosti filtrira, zamrzne in topila se odstranijo s sublimacijo pod znižanim pritiskom, pri nizki temperaturi, in potem je pripravek mogoče razposlati v odmerkih v pogojih, ki zagotavljajo sterilnost.
- 2. Metoda po zahtevku 1, označena s tem, da se raztopina paklitaksela filtrira skozi sterilizacijski filter in se najprej razdeli v posode v aseptičnih pogojih in nato zamrzne, nato pa se topila odstranijo s sublimacijo pod znižanim pritiskom, pri nizki temperaturi.
- 3. Metoda po zahtevku 1 ali 2, označena s tem, da se odstranitev topila s sublimacijo izvaja pri temperaturi v območju od -60°C do +50°C.
- 4. Metoda po zahtevku 1 ali 2, označena s tem, daje vsebnost posameznih topil v mešanici od 5% do 95% in vsebnost vode do 1% do 60%.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PL343615A PL203300B1 (pl) | 2000-10-31 | 2000-10-31 | Stabilna postać farmaceutyczna leku przeciwnowotworowego oraz sposób wytwarzania stabilnej postaci farmaceutycznej leku przeciwnowotworowego |
| PCT/PL2001/000082 WO2002036582A1 (en) | 2000-10-31 | 2001-10-19 | Stable pharmaceutical form of an anticancer drug |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI21138A SI21138A (sl) | 2003-08-31 |
| SI21138B true SI21138B (sl) | 2006-10-31 |
Family
ID=20077651
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200120060A SI21138B (sl) | 2000-10-31 | 2001-10-19 | Stabilna farmacevtska oblika zdravila proti raku |
Country Status (15)
| Country | Link |
|---|---|
| EP (1) | EP1363892B1 (sl) |
| AU (1) | AU2002212863A1 (sl) |
| BG (1) | BG65985B1 (sl) |
| CZ (1) | CZ300836B6 (sl) |
| DE (1) | DE60122384T2 (sl) |
| HK (1) | HK1060733A1 (sl) |
| HU (1) | HUP0303089A3 (sl) |
| LT (1) | LT5069B (sl) |
| PL (1) | PL203300B1 (sl) |
| RU (1) | RU2236227C1 (sl) |
| SI (1) | SI21138B (sl) |
| SK (1) | SK287850B6 (sl) |
| UA (1) | UA75620C2 (sl) |
| WO (1) | WO2002036582A1 (sl) |
| ZA (1) | ZA200303276B (sl) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL368945A1 (en) * | 2001-11-30 | 2005-04-04 | Bristol-Myers Squibb Company | Paclitaxel solvates |
| WO2005061474A1 (en) | 2003-12-12 | 2005-07-07 | Quiral Química Do Brasil | Process for the preparation of anhydrous and hydrated active pharmaceutical ingredients (apis); stable pharmaceutical compositions prepared from the same and uses of said compositions |
| AR054215A1 (es) * | 2006-01-20 | 2007-06-13 | Eriochem Sa | Una formulacion farmaceutica de un taxano, una composicion solida de un taxano liofilizado a partir de una solucion de acido acetico, un procedimiento para la preparacion de dicha composicion solida de un taxano, una composicion solubilizante de un taxano liofilizado, y un conjunto de elementos (kit |
| EP2146695A4 (en) * | 2007-04-23 | 2010-05-19 | Sun Pharmaceuticals Ind Ltd | PHARMACEUTICAL COMPOSITIONS |
| CN110437179A (zh) * | 2019-08-22 | 2019-11-12 | 江苏红豆杉药业有限公司 | 一种紫杉醇单晶晶体及其制备方法 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2678833B1 (fr) * | 1991-07-08 | 1995-04-07 | Rhone Poulenc Rorer Sa | Nouvelles compositions pharmaceutiques a base de derives de la classe des taxanes. |
| TW406020B (en) * | 1993-09-29 | 2000-09-21 | Bristol Myers Squibb Co | Stabilized pharmaceutical composition and its method for preparation and stabilizing solvent |
| CA2163837C (en) * | 1994-12-13 | 1999-07-20 | Robert K. Perrone | Crystalline paclitaxel hydrates |
-
2000
- 2000-10-31 PL PL343615A patent/PL203300B1/pl not_active IP Right Cessation
-
2001
- 2001-10-19 CZ CZ20031421A patent/CZ300836B6/cs not_active IP Right Cessation
- 2001-10-19 HU HU0303089A patent/HUP0303089A3/hu unknown
- 2001-10-19 SI SI200120060A patent/SI21138B/sl not_active IP Right Cessation
- 2001-10-19 RU RU2003116136/15A patent/RU2236227C1/ru not_active IP Right Cessation
- 2001-10-19 SK SK629-2003A patent/SK287850B6/sk not_active IP Right Cessation
- 2001-10-19 UA UA2003055025A patent/UA75620C2/uk unknown
- 2001-10-19 DE DE60122384T patent/DE60122384T2/de not_active Expired - Lifetime
- 2001-10-19 AU AU2002212863A patent/AU2002212863A1/en not_active Abandoned
- 2001-10-19 EP EP01981204A patent/EP1363892B1/en not_active Expired - Lifetime
- 2001-10-19 WO PCT/PL2001/000082 patent/WO2002036582A1/en active IP Right Grant
-
2003
- 2003-04-25 BG BG107764A patent/BG65985B1/bg unknown
- 2003-04-29 ZA ZA200303276A patent/ZA200303276B/xx unknown
- 2003-05-05 LT LT2003031A patent/LT5069B/lt not_active IP Right Cessation
-
2004
- 2004-05-25 HK HK04103719A patent/HK1060733A1/xx not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| PL203300B1 (pl) | 2009-09-30 |
| AU2002212863A1 (en) | 2002-05-15 |
| HUP0303089A2 (hu) | 2003-12-29 |
| WO2002036582A1 (en) | 2002-05-10 |
| SK6292003A3 (en) | 2004-08-03 |
| RU2236227C1 (ru) | 2004-09-20 |
| HUP0303089A3 (en) | 2005-02-28 |
| LT5069B (lt) | 2003-11-25 |
| EP1363892A1 (en) | 2003-11-26 |
| CZ20031421A3 (cs) | 2004-06-16 |
| SK287850B6 (sk) | 2012-01-04 |
| PL343615A1 (en) | 2002-05-06 |
| ZA200303276B (en) | 2004-04-21 |
| HK1060733A1 (en) | 2004-08-20 |
| EP1363892B1 (en) | 2006-08-16 |
| BG107764A (bg) | 2004-07-30 |
| DE60122384D1 (de) | 2006-09-28 |
| LT2003031A (en) | 2003-09-25 |
| DE60122384T2 (de) | 2007-08-16 |
| UA75620C2 (en) | 2006-05-15 |
| CZ300836B6 (cs) | 2009-08-19 |
| BG65985B1 (bg) | 2010-08-31 |
| SI21138A (sl) | 2003-08-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| IF | Valid on the event date | ||
| OU02 | Decision according to article 73(2) ipa 1992, publication of decision on partial fulfilment of the invention and change of patent claims |
Effective date: 20060906 |
|
| KO00 | Lapse of patent |
Effective date: 20130522 |