SI20189B - Farmacevtski sestavki, ki vsebujejo plazemski protein - Google Patents
Farmacevtski sestavki, ki vsebujejo plazemski protein Download PDFInfo
- Publication number
- SI20189B SI20189B SI9820067A SI9820067A SI20189B SI 20189 B SI20189 B SI 20189B SI 9820067 A SI9820067 A SI 9820067A SI 9820067 A SI9820067 A SI 9820067A SI 20189 B SI20189 B SI 20189B
- Authority
- SI
- Slovenia
- Prior art keywords
- protein fraction
- plasma protein
- active substance
- products
- pharmaceutical formulations
- Prior art date
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract 26
- 102000004506 Blood Proteins Human genes 0.000 title claims abstract 4
- 108010017384 Blood Proteins Proteins 0.000 title claims abstract 4
- 108010058237 plasma protein fraction Proteins 0.000 claims abstract 53
- 229940081857 plasma protein fraction Drugs 0.000 claims abstract 53
- 239000013543 active substance Substances 0.000 claims abstract 45
- 239000007787 solid Substances 0.000 claims abstract 13
- 238000000034 method Methods 0.000 claims abstract 7
- 239000007788 liquid Substances 0.000 claims abstract 4
- 102000004169 proteins and genes Human genes 0.000 claims abstract 4
- 108090000623 proteins and genes Proteins 0.000 claims abstract 4
- 230000002776 aggregation Effects 0.000 claims abstract 3
- 238000004220 aggregation Methods 0.000 claims abstract 3
- 238000002360 preparation method Methods 0.000 claims abstract 2
- 239000000047 product Substances 0.000 claims 32
- 108091006905 Human Serum Albumin Proteins 0.000 claims 18
- 102000008100 Human Serum Albumin Human genes 0.000 claims 18
- 102000003886 Glycoproteins Human genes 0.000 claims 15
- 108090000288 Glycoproteins Proteins 0.000 claims 15
- 108060003951 Immunoglobulin Proteins 0.000 claims 15
- 102000014150 Interferons Human genes 0.000 claims 15
- 108010050904 Interferons Proteins 0.000 claims 15
- 102000015696 Interleukins Human genes 0.000 claims 15
- 108010063738 Interleukins Proteins 0.000 claims 15
- 102000018358 immunoglobulin Human genes 0.000 claims 15
- 229940079322 interferon Drugs 0.000 claims 15
- 102000007562 Serum Albumin Human genes 0.000 claims 9
- 108010071390 Serum Albumin Proteins 0.000 claims 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 9
- 239000000243 solution Substances 0.000 claims 8
- -1 taxonoids Substances 0.000 claims 8
- 102000009027 Albumins Human genes 0.000 claims 6
- 108010088751 Albumins Proteins 0.000 claims 6
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 6
- 108010074605 gamma-Globulins Proteins 0.000 claims 6
- 239000003960 organic solvent Substances 0.000 claims 6
- KLWPJMFMVPTNCC-UHFFFAOYSA-N Camptothecin Natural products CCC1(O)C(=O)OCC2=C1C=C3C4Nc5ccccc5C=C4CN3C2=O KLWPJMFMVPTNCC-UHFFFAOYSA-N 0.000 claims 5
- 239000000654 additive Substances 0.000 claims 5
- 230000000996 additive effect Effects 0.000 claims 5
- 239000007864 aqueous solution Substances 0.000 claims 5
- VSJKWCGYPAHWDS-FQEVSTJZSA-N camptothecin Chemical compound C1=CC=C2C=C(CN3C4=CC5=C(C3=O)COC(=O)[C@]5(O)CC)C4=NC2=C1 VSJKWCGYPAHWDS-FQEVSTJZSA-N 0.000 claims 5
- 229940127093 camptothecin Drugs 0.000 claims 5
- VSJKWCGYPAHWDS-UHFFFAOYSA-N dl-camptothecin Natural products C1=CC=C2C=C(CN3C4=CC5=C(C3=O)COC(=O)C5(O)CC)C4=NC2=C1 VSJKWCGYPAHWDS-UHFFFAOYSA-N 0.000 claims 5
- 239000000203 mixture Substances 0.000 claims 5
- 239000003381 stabilizer Substances 0.000 claims 5
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- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- NIJJYAXOARWZEE-UHFFFAOYSA-N Valproic acid Chemical compound CCCC(C(O)=O)CCC NIJJYAXOARWZEE-UHFFFAOYSA-N 0.000 claims 4
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- 230000004845 protein aggregation Effects 0.000 claims 4
- 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 4
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- PMATZTZNYRCHOR-CGLBZJNRSA-N Cyclosporin A Chemical compound CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](C(C)C)NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O PMATZTZNYRCHOR-CGLBZJNRSA-N 0.000 claims 3
- 108010036949 Cyclosporine Proteins 0.000 claims 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 3
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- APKFDSVGJQXUKY-INPOYWNPSA-N amphotericin B Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@H](C)[C@@H](O)[C@@H](C)[C@H](C)OC(=O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 APKFDSVGJQXUKY-INPOYWNPSA-N 0.000 claims 3
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- HEMJJKBWTPKOJG-UHFFFAOYSA-N Gemfibrozil Chemical compound CC1=CC=C(C)C(OCCCC(C)(C)C(O)=O)=C1 HEMJJKBWTPKOJG-UHFFFAOYSA-N 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- BYBLEWFAAKGYCD-UHFFFAOYSA-N Miconazole Chemical compound ClC1=CC(Cl)=CC=C1COC(C=1C(=CC(Cl)=CC=1)Cl)CN1C=NC=C1 BYBLEWFAAKGYCD-UHFFFAOYSA-N 0.000 claims 2
- ATHHXGZTWNVVOU-UHFFFAOYSA-N N-methylformamide Chemical compound CNC=O ATHHXGZTWNVVOU-UHFFFAOYSA-N 0.000 claims 2
- JZFPYUNJRRFVQU-UHFFFAOYSA-N Niflumic acid Chemical compound OC(=O)C1=CC=CN=C1NC1=CC=CC(C(F)(F)F)=C1 JZFPYUNJRRFVQU-UHFFFAOYSA-N 0.000 claims 2
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- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 2
- 125000002252 acyl group Chemical group 0.000 claims 2
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- 125000000043 benzamido group Chemical group [H]N([*])C(=O)C1=C([H])C([H])=C([H])C([H])=C1[H] 0.000 claims 2
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- DGBIGWXXNGSACT-UHFFFAOYSA-N clonazepam Chemical compound C12=CC([N+](=O)[O-])=CC=C2NC(=O)CN=C1C1=CC=CC=C1Cl DGBIGWXXNGSACT-UHFFFAOYSA-N 0.000 claims 2
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- FBPFZTCFMRRESA-GUCUJZIJSA-N galactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-GUCUJZIJSA-N 0.000 claims 2
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- 229910052739 hydrogen Inorganic materials 0.000 claims 2
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- 241001465754 Metazoa Species 0.000 claims 1
- WDVSHHCDHLJJJR-UHFFFAOYSA-N Proflavine Chemical compound C1=CC(N)=CC2=NC3=CC(N)=CC=C3C=C21 WDVSHHCDHLJJJR-UHFFFAOYSA-N 0.000 claims 1
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- NCDNCNXCDXHOMX-UHFFFAOYSA-N Ritonavir Natural products C=1C=CC=CC=1CC(NC(=O)OCC=1SC=NC=1)C(O)CC(CC=1C=CC=CC=1)NC(=O)C(C(C)C)NC(=O)N(C)CC1=CSC(C(C)C)=N1 NCDNCNXCDXHOMX-UHFFFAOYSA-N 0.000 claims 1
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- 229940116731 Uricosuric agent Drugs 0.000 claims 1
- 125000001931 aliphatic group Chemical group 0.000 claims 1
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- 230000003556 anti-epileptic effect Effects 0.000 claims 1
- 229940121363 anti-inflammatory agent Drugs 0.000 claims 1
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- 229940125681 anticonvulsant agent Drugs 0.000 claims 1
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- 229940121375 antifungal agent Drugs 0.000 claims 1
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- 239000003443 antiviral agent Substances 0.000 claims 1
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- 239000002249 anxiolytic agent Substances 0.000 claims 1
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- WOIIIUDZSOLAIW-NSHDSACASA-N azapropazone Chemical compound C1=C(C)C=C2N3C(=O)[C@H](CC=C)C(=O)N3C(N(C)C)=NC2=C1 WOIIIUDZSOLAIW-NSHDSACASA-N 0.000 claims 1
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- AAOVKJBEBIDNHE-UHFFFAOYSA-N diazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 AAOVKJBEBIDNHE-UHFFFAOYSA-N 0.000 claims 1
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- UVTNFZQICZKOEM-UHFFFAOYSA-N disopyramide Chemical compound C=1C=CC=NC=1C(C(N)=O)(CCN(C(C)C)C(C)C)C1=CC=CC=C1 UVTNFZQICZKOEM-UHFFFAOYSA-N 0.000 claims 1
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- ADIMAYPTOBDMTL-UHFFFAOYSA-N oxazepam Chemical compound C12=CC(Cl)=CC=C2NC(=O)C(O)N=C1C1=CC=CC=C1 ADIMAYPTOBDMTL-UHFFFAOYSA-N 0.000 claims 1
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- DDBREPKUVSBGFI-UHFFFAOYSA-N phenobarbital Chemical compound C=1C=CC=CC=1C1(CC)C(=O)NC(=O)NC1=O DDBREPKUVSBGFI-UHFFFAOYSA-N 0.000 claims 1
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- NCDNCNXCDXHOMX-XGKFQTDJSA-N ritonavir Chemical compound N([C@@H](C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC=1C=CC=CC=1)NC(=O)OCC=1SC=NC=1)CC=1C=CC=CC=1)C(=O)N(C)CC1=CSC(C(C)C)=N1 NCDNCNXCDXHOMX-XGKFQTDJSA-N 0.000 claims 1
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- QJJXYPPXXYFBGM-SHYZHZOCSA-N tacrolimus Natural products CO[C@H]1C[C@H](CC[C@@H]1O)C=C(C)[C@H]2OC(=O)[C@H]3CCCCN3C(=O)C(=O)[C@@]4(O)O[C@@H]([C@H](C[C@H]4C)OC)[C@@H](C[C@H](C)CC(=C[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)C)OC QJJXYPPXXYFBGM-SHYZHZOCSA-N 0.000 claims 1
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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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
-
- 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
- A61K31/33—Heterocyclic compounds
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Abstract
Izum se nanaša na vodotopne produkte in farmacevtske formulacije v trdni ali tekoči obliki v glavnem za parenteralno uporabo. Obstoje iz ali obsegajo terapevtsko aktivno snov (z nizko vodotopnostjoin znatno povezovalno afiniteto do plazemskih proteinov) in plazemsko proteinsko frakcijo v kontroliranem agregacijskem stanju, pri čemer sta aktivna snov in proteinska frakcija druga na drugo vezane z nekovalentnimi vezmi. Zajema tudi postopke za pripravo produkta in farmacevtske formulacije.
Claims (36)
1 PATENTNI ZAHTEVKI 1. Vodotopni produkti ali farmacevtske formulacije brez organskega topila v trdni ali tekoči obliki in njihove prave vodne raztopine brez organskega topila v glavnem za parenteralno uporabo, označene s tem, da vsebujejo A) terapevtsko aktivno spojino z nizko vodotopnostjo (< 1.10'4 Μ/l] in znatno povezovalno afiniteto do plazemskih proteinov (aktivna snov) in B) plazemsko proteinsko frakcijo v kontroliranem agregacijskem stanju pri čemer sta aktivna snov (A) in proteinska frakcija (B) vezani druga na drugo z nekovalentnimi vezmi, in po želji nadalje vsebujejo C) farmacevtsko sprejemljiv in v glavnem parenteralno sprejemljiv formulacijski aditiv (aditive), kot vodo, stabilizator (stabilizatorje) in proteinski agregacijski kontrolor (kontrolorje).
2. Produkti in farmacevtske formulacije po zahtevku 1, označene s tem, da je plazemska proteinska frakcija (B) humana plazemska proteinska frakcija.
3. Produkti in farmacevtske formulacije po zahtevku 1, označene s tem, da je plazemska proteinska frakcija (B) živalska plazemska proteinska frakcija.
4. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 3, označene s tem, da je plazemska proteinska frakcija (B) komponenta naravne plazme, kot je serumski albumin ali rekombinant serumskega albumina, naravni imunoglobulin, glikoprotein, interferon in/ali interlevkin ali rekombinantni imunoglobulin, glikoprotein, interferon in/ali interlevkin.
5. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 4, označene s tem, da aktivno snov (A) izberemo izmed citostatikov, kot so taksonoidi, antibiotiki, vitamini, protivnetna sredstva, analgetiki, antivirusna sredstva, antikonvulzanti, 2 imunosupresanti, antiepileptiki, anksiolitiki, hipnotiki, protiglivična sredstva, antikoagulanti, lipidni peroksidazni inhibitorji, koronami vazodilatorji, antiaritmična sredstva, kardiotoniki, urikozuriki, antitrombotiki, steroidni hormoni (progestogeni, androgeni, testogeni) in fotosenzibilizatoiji.
6. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 5, označene s tem, da vsebujejo vsaj eno od naslednjiih aktivnih snovi (A), kot so: amphotericin B, adriamicinski analog, apazone, azathioprine, bromazepam, camptothecin, carbamazepine, clonazepam, cyclosporine A, diazepam, dicumarol, digitoxine, dipyridamole, disopyramide, flunitrazepam, gemfrbrozil, ketochlorin, ketoconazole, miconazole, nifluminska kislina, oxazepam, phenobarbital, phenytoin, progesteron, propofol, ritonavir, sulfinpyrazone, suprofene, tacrolimus, tamoxifen, taksonoid, testosteron, tirilazad, trioxsalen, valprojska kislina in warfarin in kjer je molsko razmerje aktivne snovi (A) proti plazemski proteinski frakciji (B) v območju 1:0,05 do 1:100, prednostno 1:0,1 do 1:50.
7. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 6, označene s tem, da vsebujejo kot aktivno snov (A) taksonoid s splošno formulo I
I v kateri R1 predstavlja terc.butiloksikarbonilamino ali benzoilamino, 3 R2 predstavlja vodik ali acilno skupino, prednostno acetil.
8. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) taksonoid paclitaxel in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
9. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) azathioprine in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmerje aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
10. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) camptothecin in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
11. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) gemfibrozil in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50. 4
12. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) miconazole in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinatno humano plazemsko proteinsko frakcijo, kjer je molsko razmerje aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
13. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) propofol in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
14. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) tamoxifen in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
15. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) ritonavir in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
16. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) tacrolimus in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, 5 interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmerje aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
17. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) tirilazad in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
18. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 7, označene s tem, da vsebujejo kot aktivno snov (A) trioxsalen in kot plazemsko proteinsko frakcijo (B) humani serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin ali katero drugo naravno ali rekombinantno humano plazemsko proteinsko frakcijo, kjer je molsko razmeije aktivne snovi (A) proti plazemski proteinski frakciji (B) 1:0,05 do 1:100 in prednostno 1:0,1 do 1:50.
19. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 18, označene s tem, da so v trdnem stanju ali v obliki vodne raztopine.
20. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 19, označene s tem, da kot aditiv vsebujejo sredstvo, ki stabilizira raztopino in/ali proteinsko komponento.
21. Produkti in farmacevtske formulacije po zahtevku 20, označene s tem, da kot sredstvo za stabiliziranje raztopine in/ali proteina vsebujejo naslednje: natrijev klorid, pufer, alkohol, kot glicerol in/ali vodotopen sladkorni derivat, prednostno manitol, sorbitol, dulcitol. 6
22. Homogeni trdni vodotopni produkti po kateremkoli od zahtevkov 1 do 19 za farmacevtsko uporabo, označeni s tem, da obstoje iz vsaj ene aktivne snovi (A) izbrane izmed amphotericina B, adriamicinskega analoga, apazona, azathioprina, bromazepama, camptothecina, carbamazepina, clonazepama, cyclosporina A, diazepama, dicumarola, digitoxina, dipyridamola, disopyramida, flunitrazepama, gemfibrozila, ketochlorina, ketoconazola, miconazola, nifluminske kisline, oxazepama, phenobarbitala, phenytoina, progesterona, propofola, ritonavira, sulfinpyrazona, suprofena, tacrolimusa, tamoxifena, taksonoida, testosterona, tirilazada, trioxsalena, valprojske kisline in warfarina, in tudi obstoji iz vsaj ene proteinske frakcije (B), izbrane izmed humanega serumskega albumina, imunoglobulina, glikoproteina, interferona in/ali interlevkina ali katere druge naravne ali rekombinantne humane plazemske proteinske frakcije, in kjer je molsko razmerje aktivne snovi (A) proti plazemski proteinski frakciji (B) v območju od 1:0,05 do 1:100 in prednostno od 1:0,1 do 1:50.
23. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz taksonoida s splošno formulo I
v kateri R1 predstavlja terc.butiloksikarbonilamino ali benzoilamino, 7 R2 predstavlja vodik ali acilno skupino, prednostno acetil, kot aktivne snovi (A) in plazemske proteinske frakcije (B).
24. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz paclitaxela kot aktivne snovi (A) in humanega serumskega albumina, rekombinantnega humanega plazemskega albumina in/ali γ-globulina kot plazemske proteinske frakcije (B).
25. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz amphotericina B kot aktivne snovi (A) in humanega serumskega albumina, rekombinantnega humanega plazemskega albumina in/ali γ-globulina kot plazemske proteinske frakcije (B).
26. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz camptothecina kot aktivne snovi (A) in humanega serumskega albumina, rekombinantnega humanega plazemskega albumina in/ali γ-globulina kot plazemske proteinske frakcije (B).
27. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz carbamazepina kot aktivne snovi (A) in humanega serumskega albumina, rekombinantnega humanega plazemskega albumina in/ali γ-globulina kot plazemske proteinske frakcije (B).
28. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz cyclosporina A kot aktivne snovi (A) in humanega serumskega albumina, rekombinantnega humanega plazemskega albumina in/ali γ-globulina kot plazemske proteinske frakcije (B).
29. Homogeni trdni vodotopni produkti po zahtevku 22, označeni s tem, da obstoje iz propofola kot aktivne snovi (A) in humanega serumskega albumina, rekombinantnega 8 humanega plazemskega albumina in/ali γ-globulina kot plazemske proteinske frakcije (B).
30. Produkti in farmacevtske formulacije po kateremkoli od zahtevkov 1 do 29, formulirane v dozirnih oblikah za dajanje, prednostno parenteralno dajanje, v humani terapiji v sledečih dozah, od katerih je vsaka preračunana na osnovi aktivne snovi (Α): paclitaxel/albumin 70-280 mg/zdravljenje propofol/albumin 6-10 mg/kg/uro; camptothecin/albumin, gemfibrozil/albumin, 3-5 mg/kg/dan; cyclosporin A/albumin amphothericin B/albumin do 1,5 mg/kg/dan pri čemer ista območja doz uporabimo za sestavke, ki vsebujejo rekombinantne proteine.
31. Postopek za pripravo vodotopnih produktov in farmacevtskih formulacij v trdni ali tekoči obliki in njihovih pravih vodnih raztopin brez organskega topila po kateremkoli od zahtevkov 1 do 30, označen s tem, da izvedemo naslednje stopnje a) raztopimo aktivno snov (A) v farmacevtsko sprejemljivem organskem topilu, ki se meša z vodo, b) združimo dobljeno raztopino z vodno raztopino izbrane plazemske proteinske frakcije (B) v kontroliranem agregacijskem stanju, po želji z nadaljnjim farmacevtsko sprejemljivim vodotopnim pomožnim aditivom, kot proteinskim agregacijskim kontrolorjem in/ali stabilizatorjem, pri čemer dobimo pravo raztopino, ki vsebuje aktivno snov (A) in plazemsko proteinsko frakcijo (B) vezano z nekovalentnimi vezmi; c) odstranimo organsko topilo in po želji vodo, prednostno z ultrafrltracijo, dializo, diafrltracijo in/ali liofrlizacijo raztopine ali njenega koncentrata ali s kombinacijo teh obdelav, pri čemer dobimo homogen vodotopen tekoč ali trden 9 farmacevtski produkt, ki vsebuje aktivno snov (A), nekovalentno vezano s plazemsko proteinsko frakcijo (B); d) po želji raztopimo trden produkt v vodi ali razredčimo tekoč produkt z vodo, pri čemer dobimo bistro pravo vodno raztopino brez organskega topila, ki je primerna za terapevtsko dajanje, in e) po želji vdelamo ta produkt v parenteralno formulacijo/dozimo obliko za direktno uporabo.
32. Postopek po zahtevku 31, označen s tem, da v stopnji (b) uporabimo raztopino, ki nadalje vsebuje farmacevtsko sprejemljiv pomožni aditiv, kot proteinski agregacijski kontrolor in/ali stabilizator, in/ali v stopnji (c) liofiliziramo raztopino ali njen koncentrat.
33. Postopek po zahtevku 31 ali 32, označen s tem, da v stopnji (a) uporabimo za raztapljanje aktivne snovi (A) topilo z naslednjimi lastnostmi: (i) je sposobno, da popolnoma raztopi aktivno snov (A) v njeni zmesi z vodo in (ii) njena zmes z <50 % vode ne denaturira uporabljene plazemske proteinske frakcije (B).
34. Postopek po zahtevku 33, označen s tem, da kot topilo v stopnji (a) uporabimo alifatski (C2-4)monoalkohol ali polialkohol, 70 do 100 % etanol, dimetil formamid in/ali metil formamid.
35. Postopek po kateremkoli od zahtevkov 31 do 34, označen s tem, da v stopnji (b) kot proteinski agregacijski kontrolor ali stabilizator in/ali pomožen aditiv, ki stabilizira raztopino, uporabimo vodo, natrijev klorid, pufer, polialkohol, kot glicerol in/ali vodotopen sladkorni derivat, prednostno manitol, sorbitol in/ali dulcitol.
36. Postopek po kateremkoli od zahtevkov 31 do 35, označen s tem, da v stopnji (a) uporabimo paclitaxel in komponento naravne plazme, kot serumski albumin, imunoglobulin, glikoprotein, interferon in/ali interlevkin.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SI20189A SI20189A (sl) | 2000-10-31 |
| SI20189B true SI20189B (sl) | 2007-10-31 |
Family
ID=90014222
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI9820067A SI20189B (sl) | 1997-09-18 | 1998-09-17 | Farmacevtski sestavki, ki vsebujejo plazemski protein |
Country Status (33)
| Country | Link |
|---|---|
| US (5) | US6743826B1 (sl) |
| EP (1) | EP0981375B1 (sl) |
| JP (1) | JP2001508806A (sl) |
| KR (1) | KR100587962B1 (sl) |
| CN (1) | CN1189216C (sl) |
| AR (1) | AR017120A1 (sl) |
| AT (1) | ATE230611T1 (sl) |
| AU (1) | AU734695B2 (sl) |
| BG (1) | BG64749B1 (sl) |
| BR (1) | BR9812469A (sl) |
| CA (1) | CA2269923C (sl) |
| CZ (1) | CZ301326B6 (sl) |
| DE (1) | DE69810612T2 (sl) |
| DK (1) | DK0981375T3 (sl) |
| EA (1) | EA004700B1 (sl) |
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-
1997
- 1997-09-18 HU HU9701554A patent/HUP9701554D0/hu unknown
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1998
- 1998-09-10 HR HRP9701554A patent/HRP980499A2/hr not_active Application Discontinuation
- 1998-09-17 AT AT98946629T patent/ATE230611T1/de active
- 1998-09-17 CZ CZ20000952A patent/CZ301326B6/cs not_active IP Right Cessation
- 1998-09-17 CN CNB988092514A patent/CN1189216C/zh not_active Expired - Fee Related
- 1998-09-17 DE DE69810612T patent/DE69810612T2/de not_active Expired - Lifetime
- 1998-09-17 PL PL339369A patent/PL193067B1/pl unknown
- 1998-09-17 BR BR9812469-2A patent/BR9812469A/pt not_active Application Discontinuation
- 1998-09-17 SI SI9820067A patent/SI20189B/sl active Search and Examination
- 1998-09-17 AU AU93623/98A patent/AU734695B2/en not_active Ceased
- 1998-09-17 RS YUP-166/00A patent/RS50102B/sr unknown
- 1998-09-17 KR KR1020007002810A patent/KR100587962B1/ko not_active IP Right Cessation
- 1998-09-17 RO ROA200000315A patent/RO118695B1/ro unknown
- 1998-09-17 WO PCT/HU1998/000086 patent/WO1999013914A1/en not_active Application Discontinuation
- 1998-09-17 EA EA200000331A patent/EA004700B1/ru not_active IP Right Cessation
- 1998-09-17 JP JP51757699A patent/JP2001508806A/ja not_active Withdrawn
- 1998-09-17 DK DK98946629T patent/DK0981375T3/da active
- 1998-09-17 SK SK329-2000A patent/SK284683B6/sk not_active IP Right Cessation
- 1998-09-17 ES ES98946629T patent/ES2187062T3/es not_active Expired - Lifetime
- 1998-09-17 NZ NZ503302A patent/NZ503302A/en unknown
- 1998-09-17 EP EP98946629A patent/EP0981375B1/en not_active Expired - Lifetime
- 1998-09-17 PT PT98946629T patent/PT981375E/pt unknown
- 1998-09-17 IL IL13505598A patent/IL135055A/en not_active IP Right Cessation
- 1998-09-17 CA CA002269923A patent/CA2269923C/en not_active Expired - Lifetime
- 1998-09-17 TR TR2000/01545T patent/TR200001545T2/xx unknown
- 1998-09-18 AR ARP980104659A patent/AR017120A1/es not_active Application Discontinuation
- 1998-09-18 TW TW087115619A patent/TWI222365B/zh not_active IP Right Cessation
- 1998-09-18 ZA ZA9808585A patent/ZA988585B/xx unknown
-
1999
- 1999-04-27 US US09/299,562 patent/US6743826B1/en not_active Expired - Lifetime
-
2000
- 2000-03-14 LV LVP-00-38A patent/LV12493B/en unknown
- 2000-03-16 NO NO20001371A patent/NO325294B1/no not_active IP Right Cessation
- 2000-03-16 BG BG104245A patent/BG64749B1/bg unknown
- 2000-03-17 LT LT2000018A patent/LT4736B/lt not_active IP Right Cessation
-
2003
- 2003-01-21 US US10/349,492 patent/US7119124B2/en not_active Expired - Lifetime
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2004
- 2004-03-17 US US10/802,528 patent/US7501455B2/en not_active Expired - Fee Related
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- 2006-10-10 US US11/546,518 patent/US20070232536A1/en not_active Abandoned
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