HRP20201179T1 - Pripravci s kontinuiranim oslobađanjem na bazi nevodenih nosača - Google Patents
Pripravci s kontinuiranim oslobađanjem na bazi nevodenih nosača Download PDFInfo
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- HRP20201179T1 HRP20201179T1 HRP20201179TT HRP20201179T HRP20201179T1 HR P20201179 T1 HRP20201179 T1 HR P20201179T1 HR P20201179T T HRP20201179T T HR P20201179TT HR P20201179 T HRP20201179 T HR P20201179T HR P20201179 T1 HRP20201179 T1 HR P20201179T1
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- fatty acid
- weight percent
- fractionated
- unfractionated
- oil
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- 239000008365 aqueous carrier Substances 0.000 title claims 6
- 239000000203 mixture Substances 0.000 title claims 2
- 238000009472 formulation Methods 0.000 title 1
- 238000013268 sustained release Methods 0.000 title 1
- 239000012730 sustained-release form Substances 0.000 title 1
- 235000014113 dietary fatty acids Nutrition 0.000 claims 37
- 229930195729 fatty acid Natural products 0.000 claims 37
- 239000000194 fatty acid Substances 0.000 claims 37
- 150000004665 fatty acids Chemical class 0.000 claims 34
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims 13
- 150000002148 esters Chemical class 0.000 claims 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims 6
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 6
- -1 caltitol Chemical compound 0.000 claims 5
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 claims 5
- 239000004615 ingredient Substances 0.000 claims 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 4
- 235000000346 sugar Nutrition 0.000 claims 4
- 150000003626 triacylglycerols Chemical class 0.000 claims 4
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 3
- HTQBXNHDCUEHJF-XWLPCZSASA-N Exenatide Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 HTQBXNHDCUEHJF-XWLPCZSASA-N 0.000 claims 3
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 3
- 229960001519 exenatide Drugs 0.000 claims 3
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- 229920000642 polymer Polymers 0.000 claims 3
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- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 2
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- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims 2
- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 claims 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 2
- 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 2
- HEBKCHPVOIAQTA-QWWZWVQMSA-N D-arabinitol Chemical compound OC[C@@H](O)C(O)[C@H](O)CO HEBKCHPVOIAQTA-QWWZWVQMSA-N 0.000 claims 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 2
- FBPFZTCFMRRESA-ZXXMMSQZSA-N D-iditol Chemical compound OC[C@@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-ZXXMMSQZSA-N 0.000 claims 2
- UNXHWFMMPAWVPI-QWWZWVQMSA-N D-threitol Chemical compound OC[C@@H](O)[C@H](O)CO UNXHWFMMPAWVPI-QWWZWVQMSA-N 0.000 claims 2
- 229930091371 Fructose Natural products 0.000 claims 2
- 239000005715 Fructose Substances 0.000 claims 2
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- 108060003199 Glucagon Proteins 0.000 claims 2
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- 229930195725 Mannitol Natural products 0.000 claims 2
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims 2
- JVWLUVNSQYXYBE-UHFFFAOYSA-N Ribitol Natural products OCC(C)C(O)C(O)CO JVWLUVNSQYXYBE-UHFFFAOYSA-N 0.000 claims 2
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 2
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims 2
- 230000036528 appetite Effects 0.000 claims 2
- 235000019789 appetite Nutrition 0.000 claims 2
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical compound OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 2
- 239000008121 dextrose Substances 0.000 claims 2
- 206010012601 diabetes mellitus Diseases 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 239000003937 drug carrier Substances 0.000 claims 2
- 230000037406 food intake Effects 0.000 claims 2
- 235000012631 food intake Nutrition 0.000 claims 2
- 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
- 229930182830 galactose Natural products 0.000 claims 2
- 230000030136 gastric emptying Effects 0.000 claims 2
- 230000030135 gastric motility Effects 0.000 claims 2
- MASNOZXLGMXCHN-ZLPAWPGGSA-N glucagon Chemical compound C([C@@H](C(=O)N[C@H](C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(O)=O)C(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CO)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C1=CC=CC=C1 MASNOZXLGMXCHN-ZLPAWPGGSA-N 0.000 claims 2
- 229960004666 glucagon Drugs 0.000 claims 2
- 239000008103 glucose Substances 0.000 claims 2
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims 2
- 238000002347 injection Methods 0.000 claims 2
- 239000007924 injection Substances 0.000 claims 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 2
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- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 2
- 239000000845 maltitol Substances 0.000 claims 2
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- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims 2
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims 2
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims 2
- HEBKCHPVOIAQTA-ZXFHETKHSA-N ribitol Chemical compound OC[C@H](O)[C@H](O)[C@H](O)CO HEBKCHPVOIAQTA-ZXFHETKHSA-N 0.000 claims 2
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 claims 2
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- XUFXOAAUWZOOIT-SXARVLRPSA-N (2R,3R,4R,5S,6R)-5-[[(2R,3R,4R,5S,6R)-5-[[(2R,3R,4S,5S,6R)-3,4-dihydroxy-6-methyl-5-[[(1S,4R,5S,6S)-4,5,6-trihydroxy-3-(hydroxymethyl)-1-cyclohex-2-enyl]amino]-2-oxanyl]oxy]-3,4-dihydroxy-6-(hydroxymethyl)-2-oxanyl]oxy]-6-(hydroxymethyl)oxane-2,3,4-triol Chemical compound O([C@H]1O[C@H](CO)[C@H]([C@@H]([C@H]1O)O)O[C@H]1O[C@@H]([C@H]([C@H](O)[C@H]1O)N[C@@H]1[C@@H]([C@@H](O)[C@H](O)C(CO)=C1)O)C)[C@@H]1[C@@H](CO)O[C@@H](O)[C@H](O)[C@H]1O XUFXOAAUWZOOIT-SXARVLRPSA-N 0.000 claims 1
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- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims 1
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- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims 1
- 229940043253 butylated hydroxyanisole Drugs 0.000 claims 1
- 229940067596 butylparaben Drugs 0.000 claims 1
- 239000000828 canola oil Substances 0.000 claims 1
- 235000019519 canola oil Nutrition 0.000 claims 1
- 239000004359 castor oil Substances 0.000 claims 1
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- 239000002285 corn oil Substances 0.000 claims 1
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- 235000012343 cottonseed oil Nutrition 0.000 claims 1
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N d-alpha-tocopherol Natural products OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims 1
- 235000019414 erythritol Nutrition 0.000 claims 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 1
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- BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 claims 1
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- 230000002335 preservative effect Effects 0.000 claims 1
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- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 claims 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims 1
- 235000010234 sodium benzoate Nutrition 0.000 claims 1
- 239000004299 sodium benzoate Substances 0.000 claims 1
- 229960003885 sodium benzoate Drugs 0.000 claims 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims 1
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Claims (15)
1. Proizvedeni gotovi pripravak za injekciju koji sadrži suspenziju s
(i) farmaceutski prihvatljivim nevodenim nosačem koji sadrži jedan ili više triglicerida masnih kiselina C6-C12 i
(ii) mikrosferama koje sadrže biokompatibilan, biorazgradivi polimer koji je polimer poli(laktid-ko-glikolida) i djelatnu farmaceutsku tvar koja je eksenatid.
2. Pripravak prema patentnom zahtjevu 1, naznačen time, što su mikrosfere koje pripravak sadrži raspršile 1 % do 10 % (m/m) eksenatida i 0,1 % do 5 % (m/m) šećera; posebice naznačeno time, što je šećer glukoza, dekstroza, galaktoza, maltoza, fruktoza, manoza, sukroza, laktoza, trehaloza, rafinoza, akarboza, glikol, glicerol, eritriol, treitol, arabitol, ribitol, sorbitol, dulcitol, iditol, isomalt, maltitol, kaltitol, manitol, ksilitol ili kombinacija dva ili više navedenih šećera.
3. Pripravak prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačen time što je prihvatljivi nevodeni nosač frakcionirano ili nefrakcionirano kokosovu ulje, frakcionirano ili nefrakcionirano palmino ulje, frakcionirano ili nefrakcionirano ulje palminih koštica, frakcionirano ili nefrakcionirano ulje sezama, frakcionirano ili nefrakcionirano sojino ulje, frakcionirano ili nefrakcionirano bademovo ulje, frakcionirano ili nefrakcionirano ulje repice, frakcionirano ili nefrakcionirano kukuruzno ulje, frakcionirano ili nefrakcionirano suncokretovo ulje, frakcionirano ili nefrakcionirano ulje od kikirikija, frakcionirano ili nefrakcionirano maslinovo ulje, frakcionirano ili nefrakcionirano ricinusovo ulje, frakcionirano ili nefrakcionirano sojino ulje, frakcionirano ili nefrakcionirano ulje šafranike, frakcionirao ili nefrakcionirano ulje od sjemena pamuka, etil oleat ili kombinacija dva ili više navedenih sastojaka.
4. Pripravak prema bilo kojem patentnom zahtjevu od 1 do 3, naznačen time, što farmaceutski prihvatljivi nevodeni nosač dodatno sadrži jedan ili više monoglicerida, jedan ili više diglicerida, jedan ili više triglicerida ili kombinaciju jednog ili više navedenih sastojaka.
5. Pripravak prema bilo kojem patentnom zahtjevu od 1 do 3, naznačen time, što farmaceutski prihvatljivi nosač sadrži
(i) triglicerid koji sadrži ester masne kiseline C6;
(ii) triglicerid koji sadrži estere masne kiseline C8;
(iii) triglicerid koji sadrži ester masne kiseline C10;
(iv) triglicerid koji sadrži ester masne kiseline C12;
(v) triglicerid koji sadrži estere tri masne kiseline C8;
(vi) triglicerid koji sadrži estere tri masne kiseline C10;
(vii) triglicerid koji sadrži estere dvije masne kiseline C8 i jedne masne kiseline C10;
(viii) triglicerid koji sadrži estere dvije masne kiseline C10 i jedne masne kiseline C8;
(ix) triglicerid koji sadrži estere dvije masne kiseline C8 i jedne masne kiseline C6;
(x) triglicerid koji sadrži estere dvije masne kiseline C10 i jedne masne kiseline C6;
(xi) triglicerid koji sadrži estere jedne masne kiseline C8, jedne masne kiseline C10 i jedne masne kiseline C12;
(xii) triglicerid koji sadrži estere jedne masne kiseline C8, jedne masne kiseline C10 i jedne masne kiseline C6 ili
(xiii) kombinaciju dva ili više navedenih sastojaka.
6. Pripravak prema bilo kojem patentnom zahtjevu od 1 do 3, naznačen time, što farmaceutski prihvatljivi nevodeni nosač sadrži triglicerid koji sadrži estere s
(i) 0 do 2 težinskog postotka masne kiseline C6, 65 do 80 težinskog postotka masne kiseline C8, 20 do 35 težinskog postotka masne kiseline C10 i 0 do 2 težinskog postotka masne kiseline C12;
(ii) 0 do 2 težinskog postotka masne kiseline C6, 50 do 65 težinskog postotka masne kiseline C8, 30 do 45 težinskog postotka masne kiseline C10 i 0 do 2 težinskog postotka masne kiseline C12;
(iii) 0 do 2 težinskog postotka masne kiseline C6, 45 do 65 težinskog postotka masne kiseline C8, 30 do 45 težinskog postotka masne kiseline C10, 0 do 3 težinskog postotka masne kiseline C12 i 0 do 5 težinskog postotka linolne kiseline; ili
(iv) 0 do 2 težinskog postotka masne kiseline C6, 45 do 45 težinskog postotka masne kiseline C8, 30 do 40 težinskog postotka masne kiseline C10, 0 do 3 težinskog postotka masne kiseline C12 i 10 do 2' težinskog postotka jantarne kiseline.
7. Pripravak prema patentnom zahtjevu 6, naznačen time, što farmaceutski prihvatljivi nevodeni nosač sadrži 0 do 2 težinskog postotka masne kiseline C6, 50 do 65 težinskog postotka masne kiseline C8, 30 do 45 težinskog postotka masne kiseline C10 i 0 do 2 težinskog postotka masne kiseline C12.
8. Pripravak prema bilo kojem patentnom zahtjevu od 3 do 6, naznačen time, što trigliceridi sadrže do 2 % masnih kiselina C14.
9. Pripravak prema patentnom zahtjevu 1, koji dodatno sadrži farmaceutski prihvatljivi ekscipijens; posebice naznačen time, što je farmaceutski prihvatljivi ekscipijens šećer, šećerni alkohol, antioksidans, konzervans ili kombinacija dva ili više navedenih sastojaka; i/ili naznačen time, što je farmaceutski prihvatljivi ekscipijens sukroza, glukoza, dekstroza, galaktoza, maltoza, trehaloza, fruktoza, maltodekstrin, glikol, glicerol, eritritol, treitol, arabitol, ribitol, sorbitol, dulcitol, iditol, isomalt, maltitol, laktitol, manitol, ksilitol, benzojeva kiselina, sorbinska kiselian, meta kresol, natrijev benzoat, kalijev sorbat, metilparaben, propilparaben, butilparaben, benzalkonijev klorid, natrijev metabisulfit, butilirani hidroksianizol, natrijev sulfit, tokoferol, timol, askorbat, propil galat ili kombinacija dva ili više navedenih sastojaka.
10. Pripravak prema patentnom zahtjevu 1, naznačen time, što pripravak ne sadrži dodatno sredstvo za formiranje gela.
11. Pripravak prema bilo kojem patentnom zahtjevu od 1 do 10 za primjenu u liječenju dijabetesa, za stimulaciju oslobađanja inzulina, snižavanje razine glukagona u plazmi, smanjivanje unosa hrane, smanjivanje apetita, smanjivanje motiliteta želuca, odgađanje pražnjenja želuca, snižavanje razina lipida u plazmi, za liječenje narušene tolerancije na glukozu, liječenje hiperglikemije, liječenje pretilosti, liječenje prekomjerne težine, liječenje bolesti masne jetre ili liječenje nealkoholnog steatohepatitisa u pacijenta kojem je takvo liječenje potrebno, pri čemu se liječenje sastoji od primjene kod pacijenta pripravka prema bilo kojem patentnom zahtjevu od 1 do 10.
12. Pripravak prema patentnom zahtjevu 11 za primjenu u liječenju dijabetesa, za stimulaciju oslobađanja inzulina, snižavanje razine glukagona u plazmi, smanjivanje unosa hrane, smanjivanje apetita, smanjivanje motiliteta želuca ili odgađanje pražnjenja želuca.
13. Komplet koji se sadrži od spremnika u kojem se nalaze pripravak prema bilo kojem patentnom zahtjevu od 1 do 10 i upute za upotrebu.
14. Komplet prema patentnom zahtjevu 13, naznačen time, što je spremnik brizgalica s pojedinačnom dozom ili s višekratnim dozama, bočica s pojedinačnom dozom ili s višekratnim dozama, ili patrona s pojedinačnom dozom ili višekratnim dozama.
15. Proizvedeni gotovi pripravak prema patentnom zahtjevu 1 za injekciju koji u osnovi sadrži suspenziju s:
(i) farmaceutski prihvatljivim nosačem koji sadrži jedan ili više triglicerida masnih kiselina C6-C12 i
(ii) mikrosferama koje u osnovi sadrže polimer poli(laktid-ko-glikolida) u kojem je raspršeno oko 5 % (m/m) eksenatida kao djelatne farmaceutske tvari i oko 2 % (m/m) sukroze; naznačeno time, što je omjer laktida i glikolida u polimeru približno 1:1.
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| PCT/US2009/056058 WO2010028257A1 (en) | 2008-09-04 | 2009-09-04 | Sustained release formulations using non-aqueous carriers |
| EP09812292.2A EP2341905B2 (en) | 2008-09-04 | 2009-09-04 | Sustained release formulations using non-aqueous carriers |
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| HRP20201179T1 true HRP20201179T1 (hr) | 2020-11-13 |
| HRP20201179T4 HRP20201179T4 (hr) | 2024-02-16 |
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| EP (2) | EP3685837A1 (hr) |
| JP (2) | JP5744735B2 (hr) |
| KR (1) | KR101760953B1 (hr) |
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| AU (1) | AU2009289529B2 (hr) |
| BR (1) | BRPI0918904B8 (hr) |
| CA (1) | CA2734525C (hr) |
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| ES (1) | ES2809178T3 (hr) |
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| HU (1) | HUE050125T2 (hr) |
| IL (1) | IL211231A (hr) |
| LT (1) | LT2341905T (hr) |
| MX (1) | MX352189B (hr) |
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| PL (1) | PL2341905T5 (hr) |
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| SG (1) | SG10201703039SA (hr) |
| SI (1) | SI2341905T2 (hr) |
| WO (1) | WO2010028257A1 (hr) |
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| CN110267648A (zh) | 2016-11-21 | 2019-09-20 | 艾格尔峰生物制药有限公司 | 毒蜥外泌肽(9-39)的缓冲制剂 |
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2009
- 2009-09-04 US US13/060,225 patent/US8895033B2/en active Active
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- 2009-09-04 JP JP2011526233A patent/JP5744735B2/ja active Active
- 2009-09-04 DK DK09812292.2T patent/DK2341905T4/da active
- 2009-09-04 SI SI200932079T patent/SI2341905T2/sl unknown
- 2009-09-04 EP EP20163108.2A patent/EP3685837A1/en active Pending
- 2009-09-04 ES ES09812292T patent/ES2809178T3/es active Active
- 2009-09-04 KR KR1020117007223A patent/KR101760953B1/ko active IP Right Grant
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- 2009-09-04 EP EP09812292.2A patent/EP2341905B2/en active Active
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