LV12493B - Plazmas olbaltumvielas saturoša farmaceitiska kompozīcija - Google Patents
Plazmas olbaltumvielas saturoša farmaceitiska kompozīcija Download PDFInfo
- Publication number
- LV12493B LV12493B LVP-00-38A LV000038A LV12493B LV 12493 B LV12493 B LV 12493B LV 000038 A LV000038 A LV 000038A LV 12493 B LV12493 B LV 12493B
- Authority
- LV
- Latvia
- Prior art keywords
- water
- product
- serum albumin
- protein fraction
- solution
- Prior art date
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- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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- A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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Landscapes
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Claims (39)
- LV 12493 Izgudrojuma formula 1. Odenī šķīstošs produkts, kas nesatur organisko šķīdinātāju vai zāļu forma cietā vai šķidrā veidā, kā arī to īstie ūdens šķīdumi, kas nesatur organisko šķīdinātāju, galvenokārt parenterālai ievadīšanai, satur a) ārstnieciski aktīvu vielu ar mazu šķīdību ūdenī (<1 χίΟ"4 M/L) un ievērojamu afinitāti pret plazmas olbaltumvielām (tālāk saukta “aktīvā viela"), b) plazmas olbaltumvielu frakciju ar noteiktu agregātstāvokli, pie kam minētā aktīvā viela un minētā olbaltumvielu frakcija ir savstarpēji saistītas ar nekovalentām saitēm, kas neobligāti papildus satur c) vienu vai vairākas farmaceitiski pieņemamas un, galvenokārt parenterālai ievadīšanai piemērotas zāļu formas palīgvielas, tādas kā ūdens, stabilizators(i) un olbaltumvielu agregācijas novērsējs(i).
- 2. Ūdenī šķīstošs produkts vai zāļu forma medicīniskām vajadzībām pēc 1. punkta, kas satur cilvēka plazmas olbaltumvielu frakciju ar noteiktu agregātstāvokli.
- 3. Ūdenī šķīstošs produkts vai zāļu forma veterinārām vajadzībām pēc 1. punkta, kas satur dzīvnieka plazmas olbaltumvielu frakciju ar noteiktu agregātstāvokli.
- 4. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas kā plazmas olbaltumvielu frakciju satur dabīgās plazmas sastāvdaļu, piemēram, seruma albumīnu vai rekombinanto seruma albumīnu.
- 5. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas kā plazmas olbaltumvielu frakciju satur dabīgo imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai rekombinanto imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu.
- 6. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas kā ūdenī nešķīstošo aktīvo vielu satur citostatiķi, piemēram, taksonoīdu, antibiotiķi, vitamīnu, pretiekaisuma vielu, analgētikas, antivirālu vielu, antikonvulsantu, imūndepresantu, antiepileptisku vielu, anksiofītiķi, hipnotiķi, pretsēnīšu vielu, antikoagulantu, lipīdu peroksidāzes inhibitoru, koronāro vazodilatoru, antiaritmisku vielu, kardiotoniķi, urīndzenošu vielu, prettrombu vielu, steroīdhormonu (progesteronu, androgēnu, testogēnu) un/vai fotosensitizējošu vielu.
- 7. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas satur vismaz vienu no šādām aktīvām vielām: amfotericīns B, adriamicīna analogs, apzaons, azatioprins, bromazepams, kamptotecins, karbamazepins, klonazepams, ciklosporīns A, diazepams, dikumarols, digitoksīns, dipiridamols, dizopiramids, flunitrazepams, gemfobrozils, ketohlorins, ketokonazols, mikonazols, niflumskābe, oksazepams, fenobarbitals, fenitoins, progesterons, propofols, ritonavirs, sulfinpirazons, suprofens, takrolims, tamoksifens, taksonoids, testosterons, tirilazads, trioksaiens, valprojskābe, varfarins, un kurā aktīvās vielas un olbaltumvielas molārās attiecības ir robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 8. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas satur taksonoīdu ar kopējo formulu (I)kurā: R1 ir t-butoksikarboksamīda grupa vai benzamīda grupa. R2 ir ūdeņraža atoms vai acilgrupa, vēlams acetilgrupa.
- 9. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas kā taksonoīdu satur paklitakselu kopā ar cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 10. Produkts vai zāļu forma pēc jebkura no iepriekšējiem punktiem, kas satur azatioprinu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka LV 12493 plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 11. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur kamptotecinu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 12. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur gemfibrozilu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 13. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur mikonazolu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 14. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur propofolu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 15. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur tamoksifenu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai Interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 16. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur ritonaviru un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 17. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur takrolimu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 18. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur tirilazadu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 līdz 1:50.
- 19. Produkts vai zāļu forma pēc jebkura no 1. līdz 8. punktam, kas satur trioksalenu un cilvēka seruma albumīnu, imūnglobulīnu, glikoproteīnu, interferonu un/vai interleikīnu vai kādu citu dabīgas vai rekombinantas cilvēka plazmas olbaltumvielas frakciju molārā attiecībā robežās no 1:0,05 līdz 1:100, vēlams - no 1:0,1 fīdz 1:50.
- 20. Zāļu forma pēc jebkura no iepriekšējiem punktiem, kas ir cietā vai ūdens šķīduma veidā.
- 21. Zāļu forma pēc jebkura no iepriekšējiem punktiem, kas kā piedevu satur šķīduma un/vai olbaltumvielas stabilizatoru.
- 22. Zāļu forma pēc 21. punkta, kas kā šķīduma un/vai olbaltumvielas stabilizatoru satur vielu no rindas: nātrija hlorīds, bufers, spirts, piemēram, glicerīns, un/vai ūdenī šķīstošu cukura atvasinājumu, vēlams mannitolu, sorbitolu vai dulcitolu.
- 23. Paņēmiens ūdenī šķīstoša produkta vai zāļu formas cietā vai šķīuma veidā pēc jebkura no iepriekšējiem punktiem iegūšanai vai produkta pēc jebkura no 29. līdz 36. punktam iegūšanai vai to īstu, organisko šķīdinātāju nesaturošu, ūdens šķīdumu iegūšanai, kas atšķiras ar to, ka īstu ūdens šķīdumu pagatavo a) izšķīdinot ārstnieciski aktīvu vielu ar mazu šķīdību ūdenī (c^lO"4 M/L) un ievērojamu afinitāti pret plazmas olbaltumvielām (tālāk saukta “aktīvā viela”) farmaceitiski pieņemamā organiskā šķīdinātājā, kas jaucas ar ūdeni, b) sajaucot minēto šķīdinātāju ar plazmas olbaltumvielu frakcijas, kas atrodas noteiktā agregātstāvoklī, ūdens šķīdumu un c) neobligātu farmaceitiski pieņemamu ūdenī šķīstošu palīgvielu, piemēram, olbaltumvielas agregācijas novērsēju un/vai stabilizētāju, pie kam iegūst īstu šķīdumu, kas satur minēto aktīvo vielu un minēto olbaltumvielas frakciju, kas savstarpēji saistītas ar nekovalentām saitēm; d) aizvācot organisko šķīdinātāju un neobligāti arī ūdeni, vēlams šķīduma vai tā koncentrāta ultrafiltrācijas, dialīzes, diafiltrācijas un/vai liofilizācijas palīdzību vai minēto paņēmienu kombināciju, pie kam tiek iegūts homogēns, ūdenī šķīstošs šķidrums vai ciets farmaceitiskais produkts, kas satur aktīvo vielu, kas ir saistīta ar plazmas olbaltumvielu frakciju; e) neobligāti šķīdinot iegūto produktu ūdenī vai atšķaidot šķidro produktu ar ūdeni, tā iegūstot dzidru, īstu ūdens šķīdumu, kas nesatur nevienu organisko šķīdinātāju un ir piemērots ievadīšanai terapeitiskos nolūkos, un f) neobligāti sagatavojot minēto produktu parenterālā zāļu formā tiešai izmantošanai.
- 24. Paņēmiens ūdenī šķīstoša produkta vai zāļu formas cietā vai šķīuma veidā pēc jebkura no 1. līdz 22. punktam iegūšanai vai produkta pēc LV 12493 jebkura no 29. līdz 36. punktam iegūšanai vai to īstu, organisko šķīdinātāju nesaturošu, ūdens šķīdumu iegūšanai, kas atšķiras ar to, ka īstu ūdens šķīdumu pagatavo a) izšķīdinot ārstnieciski aktīvu vielu farmaceitiski pieņemamā organiskā šķīdinātājā, kas jaucas ar ūdeni, b) sajaucot minēto šķīdinātāju ar plazmas olbaltumvielu frakcijas, kas atrodas noteiktā agregātstāvoklī, ūdens šķīdumu, c) pie kam minētais šķīdums neobligāti satur arī farmaceitiski pieņemamu ūdenī šķīstošu palīgvielu, piemēram, olbaltumvielas agregācijas novērsēju un/vai stabilizētāju, pie kam iegūst īstu šķīdumu, kas satur minēto aktīvo vielu un minēto olbaltumvielas frakciju, kas savstarpēji saistītas ar nekovaientām saitēm; d) aizvācot organisko šķīdinātāju un liofilizējot šķīdumu vai tā koncentrātu.
- 25. Paņēmiens pēc 23. vai 24. punkta, kurā posms a) atšķiras ar to, ka aktīvās vielas šķīdināšanai tiek izmantots šķīdinātājs ar šādām īpašībām: a) maisījumā ar ūdeni tas spēj pilnībā izšķīdināt aktīvo vielu un b) maisījumā, kur ūdens saturs ir <50%, tas nedenaturalizē izmantoto olbaltumvielu. fif SĶ
- 26. Paņēmiens pēc 25. punkta, kas atšķiras ar to, ka par šķīdinātāju izmanto vielu no rindas: alifātiskais C2^alkanols vai poliols, 70-100% etanols, dimetilformamīds, metilformamīds.
- 27. Paņēmiens pēc jebkura no 23. līdz 26. punktam, kas atšķiras ar to, ļ; ka par olbaltumvielas agregācijas novērsēju vai stabilizatoru un/vai šķīdumu ^ stabilizējošo palīgvielu izmanto vielu no rindas: ūdens, nātrija hlorīds, bufers, poliols, piemēram, glicerīns un/vai ūdenī šķīstošs cukura atvasinājums, vēlams mannltols, sorbitols un/vai dulcitols.
- 28. Paņēmiens pēc jebkura no 23. līdz 27. punktam, kurā punkts a) atšķiras ar to, ka tiek izmantots paklitaksels un dabīgās plazmas olbaltumviela, piemēram, seruma albumīns, imūnglobulīns, glikoproteīns, interferons un/vai interleikīns vai rekombinantais seruma albumīns, imūnglobulīns, glikoproteīns, interferons un/vai interleikīns.
- 29. Homogēns, ciets, ūdenī šķīstošs produkts, kas paredzēts pielietojumam ārstniecībā un kas sastāv vismaz no vienas aktīvās vielas ar mazu šķīdību ūdenī (<1 ^10-4 M/L), kas ņemts no rindas: amfotericīns B, adriamicīna analogs, apzaons, azatioprins, bromazepams, kamptotecins, karbamazepins, klonazepams, ciklosporīns A, diazepams, dikumarols, digitoksīns, dipiridamols, dizopiramids, flunitrazepams, gemfobrozils, ketohlorins, ketokonazols, mikonazols, niflumskābe, oksazepams, fenobarbitals, fenitoins, progesterons, propofols, ritonavirs, sulfinpirazons, suprofens, takrolims, tamoksifens, taksonoids, testosterons, tirilazads, trioksalens, valprojskābe un varfarins, vismaz vienas olbaltumvielas, kas ņemta no rindas: cilvēka seruma albumīns, imūnglobulīns, glikoproteīns, interferons un interleikīns vai cita dabīgā vai rekombinantā cilvēka plazmas seruma olbaltumvielas frakcija, pie kam minētā aktīvā viela un minētā olbaltumvielas frakcija ir savstarpēji saistītas ar nekovalentām saitēm, pie tam minētās aktīvās vielas un minētās olbaltumvielas frakcijas molārās attiecības ir robežās no 1:0,05 līdz 1:100, vēlams no 1:0,1 līdz 1:50.
- 30. Homogēns, ciets, ūdenī šķīstošs produkts pēc 30. punkta, kas satur taksonoīdu ar kopējo formulu (I)kurā: R1 ir t-butoksikarboksamīda grupa vai benzamīda grupa, R2 ir ūdeņraža atoms vai acilgrupa, vēlams acetilgrupa, kopā ar plazmas olbaltumvielas frakciju.
- 31. Homogēns, ciets, ūdenī šķīstošs produkts pēc 29. punkta, kas satur paklitakselu un cilvēka seruma albumīnu, rekombinanto cilvēka plazmas albumīnu un/vai γ-globulīnu.
- 32. Homogēns, ciets, ūdenī šķīstošs produkts pēc 29. punkta, kas satur amfotericinu B un cilvēka seruma albumīnu, rekombinanto cilvēka plazmas albumīnu un/vai γ-globulīnu.
- 33. Homogēns, ciets, ūdenī šķīstošs produkts pēc 29. punkta, kas satur kamptotecinu un cilvēka seruma albumīnu, rekombinanto cilvēka plazmas albumīnu un/vai γ-globulīnu. 7 7 LV 12493
- 34. Homogēns, ciets, ūdenī šķīstošs produkts pēc 29. punkta, kas satur karbamazepinu un cilvēka seruma albumīnu, rekombinanto cilvēka plazmas albumīnu un/vai γ-globulīnu.
- 35. Homogēns, ciets, ūdenī šķīstošs produkts pēc 29. punkta, kas satur ciklosporinu A un cilvēka seruma albumīnu, rekombinanto cilvēka plazmas albumīnu un/vai γ-globulīnu.
- 36. Homogēns, ciets, ūdenī šķīstošs produkts pēc 29. punkta, kas satur propofolu un cilvēka seruma albumīnu, rekombinanto cilvēka plazmas albumīnu un/vai γ-globulīnu.
- 37. Vielas vai zāļu formas pēc jebkura no/ pagatavotas pēc jebkura no 1-36 punktam pielietojums ārstniecības preparāta ražošanai, kas paredzēts humāno vai veterināro pacientu ārstēšanai.
- 38. Pielietojums pēc 37. punkta parenterāli ievadāma ārstniecības preparāta ražošanai, izmantojot šādas vielas un, attiecīgi, devas (vēlamo devu robežas dotas attiecībā uz aktīvo vielu): paklitaksels/albumīns 70-280 mg/ārstēšanas kursam; propofols/albumīns 6-10 mg/kg/h; kamptotecins/albumīns; gemfibrozils/albumīns; ciklosporīns A/albumīns 3-5 mg/kg/dienā; amfotericins B/albumīns līdz 1,5 mg/kg/dienā, attiecīgi tādu pašu devu izmantojot rekombinanto olbaltumvielu gadījumā.
- 39. Kompozīcijas pēc jebkura no/ pagatavotas pēc jebkura no 1-28 punktam pielietojums parenterāli ievadāma ārstniecības preparāta iegūšanai.
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HU9701554A HUP9701554D0 (en) | 1997-09-18 | 1997-09-18 | Pharmaceutical composition containing plazma proteins |
PCT/HU1998/000086 WO1999013914A1 (en) | 1997-09-18 | 1998-09-17 | Pharmaceutical compositions containing plasma protein |
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LV12493A LV12493A (en) | 2000-06-20 |
LV12493B true LV12493B (lv) | 2001-01-20 |
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US5439686A (en) * | 1993-02-22 | 1995-08-08 | Vivorx Pharmaceuticals, Inc. | Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor |
US8137684B2 (en) * | 1996-10-01 | 2012-03-20 | Abraxis Bioscience, Llc | Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof |
US8853260B2 (en) | 1997-06-27 | 2014-10-07 | Abraxis Bioscience, Llc | Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof |
HUP9701554D0 (en) * | 1997-09-18 | 1997-11-28 | Human Oltoanyagtermeloe Gyogys | Pharmaceutical composition containing plazma proteins |
WO2000047187A1 (en) * | 1999-02-11 | 2000-08-17 | Kinetana Inc. | Serum albumin-based parenteral formulations of polyene macrolides |
IL148234A0 (en) | 1999-09-16 | 2002-09-12 | Novo Nordisk As | Composition for ivf |
AU2001253336A1 (en) * | 2000-04-10 | 2001-10-23 | Teva Pharmaceutical Industries Ltd. | Method 0f administration of paclitaxel-plasma protein formulation |
IL152180A0 (en) * | 2000-04-10 | 2003-05-29 | Teva Pharma | Method and composition for treating cancer by administration of apoptosis-inducing chemotherapeutic agents |
CA2445763A1 (en) * | 2001-05-01 | 2002-11-07 | Angiotech Pharmaceuticals Inc. | Compositions comprising an anti-microtubule agent and a polypeptide or a polysaccharide and the use thereof for the preparation of a medicament for the treatment of inflammatory conditions |
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1997
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1998
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- 1998-09-17 SI SI9820067A patent/SI20189B/sl active Search and Examination
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