HRP20201515T1 - Postupci za liječenje plućnih ne-tuberkuloznih mikobakterijskih infekcija - Google Patents
Postupci za liječenje plućnih ne-tuberkuloznih mikobakterijskih infekcija Download PDFInfo
- Publication number
- HRP20201515T1 HRP20201515T1 HRP20201515TT HRP20201515T HRP20201515T1 HR P20201515 T1 HRP20201515 T1 HR P20201515T1 HR P20201515T T HRP20201515T T HR P20201515TT HR P20201515 T HRP20201515 T HR P20201515T HR P20201515 T1 HRP20201515 T1 HR P20201515T1
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- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- use according
- patient
- administering
- amikacin
- Prior art date
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- 208000019839 Pulmonary non-tuberculous mycobacterial infection Diseases 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 11
- 229960004821 amikacin Drugs 0.000 claims 4
- LKCWBDHBTVXHDL-RMDFUYIESA-N amikacin Chemical compound O([C@@H]1[C@@H](N)C[C@H]([C@@H]([C@H]1O)O[C@@H]1[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O1)O)NC(=O)[C@@H](O)CCN)[C@H]1O[C@H](CN)[C@@H](O)[C@H](O)[C@H]1O LKCWBDHBTVXHDL-RMDFUYIESA-N 0.000 claims 4
- 239000003120 macrolide antibiotic agent Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 208000033126 Colobomatous microphthalmia Diseases 0.000 claims 3
- 208000034367 isolated with coloboma microphthalmia Diseases 0.000 claims 3
- 239000002502 liposome Substances 0.000 claims 3
- 210000004072 lung Anatomy 0.000 claims 3
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- KILNVBDSWZSGLL-KXQOOQHDSA-N 1,2-dihexadecanoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCC KILNVBDSWZSGLL-KXQOOQHDSA-N 0.000 claims 2
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 claims 2
- 229960004099 azithromycin Drugs 0.000 claims 2
- MQTOSJVFKKJCRP-BICOPXKESA-N azithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)N(C)C[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 MQTOSJVFKKJCRP-BICOPXKESA-N 0.000 claims 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 claims 2
- 229960002626 clarithromycin Drugs 0.000 claims 2
- AGOYDEPGAOXOCK-KCBOHYOISA-N clarithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@](C)([C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)OC)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 AGOYDEPGAOXOCK-KCBOHYOISA-N 0.000 claims 2
- AEUTYOVWOVBAKS-UWVGGRQHSA-N ethambutol Chemical compound CC[C@@H](CO)NCCN[C@@H](CC)CO AEUTYOVWOVBAKS-UWVGGRQHSA-N 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 238000002560 therapeutic procedure Methods 0.000 claims 2
- IXXFZUPTQVDPPK-ZAWHAJPISA-N (1r,2r,4r,6r,7r,8r,10s,13r,14s)-17-[4-[4-(3-aminophenyl)triazol-1-yl]butyl]-7-[(2s,3r,4s,6r)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-13-ethyl-10-fluoro-6-methoxy-2,4,6,8,10,14-hexamethyl-12,15-dioxa-17-azabicyclo[12.3.0]heptadecane-3,9,11,16-tet Chemical compound O([C@@H]1[C@@H](C)C(=O)[C@](C)(F)C(=O)O[C@@H]([C@]2(OC(=O)N(CCCCN3N=NC(=C3)C=3C=C(N)C=CC=3)[C@@H]2[C@@H](C)C(=O)[C@H](C)C[C@@]1(C)OC)C)CC)[C@@H]1O[C@H](C)C[C@H](N(C)C)[C@H]1O IXXFZUPTQVDPPK-ZAWHAJPISA-N 0.000 claims 1
- RXZBMPWDPOLZGW-XMRMVWPWSA-N (E)-roxithromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=N/OCOCCOC)/[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 RXZBMPWDPOLZGW-XMRMVWPWSA-N 0.000 claims 1
- ACTOXUHEUCPTEW-BWHGAVFKSA-N 2-[(4r,5s,6s,7r,9r,10r,11e,13e,16r)-6-[(2s,3r,4r,5s,6r)-5-[(2s,4r,5s,6s)-4,5-dihydroxy-4,6-dimethyloxan-2-yl]oxy-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-10-[(2s,5s,6r)-5-(dimethylamino)-6-methyloxan-2-yl]oxy-4-hydroxy-5-methoxy-9,16-dimethyl-2-o Chemical compound O([C@H]1/C=C/C=C/C[C@@H](C)OC(=O)C[C@@H](O)[C@@H]([C@H]([C@@H](CC=O)C[C@H]1C)O[C@H]1[C@@H]([C@H]([C@H](O[C@@H]2O[C@@H](C)[C@H](O)[C@](C)(O)C2)[C@@H](C)O1)N(C)C)O)OC)[C@@H]1CC[C@H](N(C)C)[C@@H](C)O1 ACTOXUHEUCPTEW-BWHGAVFKSA-N 0.000 claims 1
- YWMSSKBMOFPBDM-UHFFFAOYSA-N 4-carbamoylbenzenesulfonyl chloride Chemical group NC(=O)C1=CC=C(S(Cl)(=O)=O)C=C1 YWMSSKBMOFPBDM-UHFFFAOYSA-N 0.000 claims 1
- UKXFZNMZXWBSGH-UHFFFAOYSA-N Carbomycin A Natural products COC1C(OC2OC(C)C(OC3CC(C)(O)C(OC(=O)CC(C)C)C(C)O3)C(C2O)N(C)C)C(CC=O)CC(C)C(=O)C=CC4OC4CC(C)OC(=O)CC1C(=O)C UKXFZNMZXWBSGH-UHFFFAOYSA-N 0.000 claims 1
- 208000035473 Communicable disease Diseases 0.000 claims 1
- 208000032376 Lung infection Diseases 0.000 claims 1
- 241000513886 Mycobacterium avium complex (MAC) Species 0.000 claims 1
- 239000004104 Oleandomycin Substances 0.000 claims 1
- RZPAKFUAFGMUPI-UHFFFAOYSA-N Oleandomycin Natural products O1C(C)C(O)C(OC)CC1OC1C(C)C(=O)OC(C)C(C)C(O)C(C)C(=O)C2(OC2)CC(C)C(OC2C(C(CC(C)O2)N(C)C)O)C1C RZPAKFUAFGMUPI-UHFFFAOYSA-N 0.000 claims 1
- 229930189077 Rifamycin Natural products 0.000 claims 1
- 239000004187 Spiramycin Substances 0.000 claims 1
- 239000004182 Tylosin Substances 0.000 claims 1
- 229930194936 Tylosin Natural products 0.000 claims 1
- FQVHOULQCKDUCY-OGHXVOSASA-N [(2s,3s,4r,6s)-6-[(2r,3s,4r,5r,6s)-6-[[(1s,3r,7r,8s,9s,10r,12r,14e,16s)-7-acetyloxy-8-methoxy-3,12-dimethyl-5,13-dioxo-10-(2-oxoethyl)-4,17-dioxabicyclo[14.1.0]heptadec-14-en-9-yl]oxy]-4-(dimethylamino)-5-hydroxy-2-methyloxan-3-yl]oxy-4-hydroxy-2,4-dimeth Chemical compound O([C@@H]1[C@@H](C)O[C@H]([C@@H]([C@H]1N(C)C)O)O[C@H]1[C@@H](CC=O)C[C@@H](C)C(=O)/C=C/[C@@H]2O[C@H]2C[C@@H](C)OC(=O)C[C@H]([C@@H]1OC)OC(C)=O)[C@H]1C[C@@](C)(O)[C@@H](OC(=O)CC(C)C)[C@H](C)O1 FQVHOULQCKDUCY-OGHXVOSASA-N 0.000 claims 1
- 229960001656 amikacin sulfate Drugs 0.000 claims 1
- 238000006243 chemical reaction Methods 0.000 claims 1
- 235000012000 cholesterol Nutrition 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 229960003276 erythromycin Drugs 0.000 claims 1
- 229960000285 ethambutol Drugs 0.000 claims 1
- 229960004144 josamycin Drugs 0.000 claims 1
- XJSFLOJWULLJQS-NGVXBBESSA-N josamycin Chemical compound CO[C@H]1[C@H](OC(C)=O)CC(=O)O[C@H](C)C\C=C\C=C\[C@H](O)[C@H](C)C[C@H](CC=O)[C@@H]1O[C@H]1[C@H](O)[C@@H](N(C)C)[C@H](O[C@@H]2O[C@@H](C)[C@H](OC(=O)CC(C)C)[C@](C)(O)C2)[C@@H](C)O1 XJSFLOJWULLJQS-NGVXBBESSA-N 0.000 claims 1
- 229930192532 kitamycin Natural products 0.000 claims 1
- 150000002632 lipids Chemical class 0.000 claims 1
- -1 midekamycin Chemical compound 0.000 claims 1
- 239000006199 nebulizer Substances 0.000 claims 1
- 229960002351 oleandomycin Drugs 0.000 claims 1
- RZPAKFUAFGMUPI-KGIGTXTPSA-N oleandomycin Chemical compound O1[C@@H](C)[C@H](O)[C@@H](OC)C[C@@H]1O[C@@H]1[C@@H](C)C(=O)O[C@H](C)[C@H](C)[C@H](O)[C@@H](C)C(=O)[C@]2(OC2)C[C@H](C)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C RZPAKFUAFGMUPI-KGIGTXTPSA-N 0.000 claims 1
- 235000019367 oleandomycin Nutrition 0.000 claims 1
- 229960003292 rifamycin Drugs 0.000 claims 1
- HJYYPODYNSCCOU-ODRIEIDWSA-N rifamycin SV Chemical compound OC1=C(C(O)=C2C)C3=C(O)C=C1NC(=O)\C(C)=C/C=C/[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@H](C)[C@@H](OC)\C=C\O[C@@]1(C)OC2=C3C1=O HJYYPODYNSCCOU-ODRIEIDWSA-N 0.000 claims 1
- 229960005224 roxithromycin Drugs 0.000 claims 1
- 229950008588 solithromycin Drugs 0.000 claims 1
- 229960001294 spiramycin Drugs 0.000 claims 1
- 235000019372 spiramycin Nutrition 0.000 claims 1
- 229930191512 spiramycin Natural products 0.000 claims 1
- 229940124597 therapeutic agent Drugs 0.000 claims 1
- 210000000115 thoracic cavity Anatomy 0.000 claims 1
- 229960005041 troleandomycin Drugs 0.000 claims 1
- LQCLVBQBTUVCEQ-QTFUVMRISA-N troleandomycin Chemical compound O1[C@@H](C)[C@H](OC(C)=O)[C@@H](OC)C[C@@H]1O[C@@H]1[C@@H](C)C(=O)O[C@H](C)[C@H](C)[C@H](OC(C)=O)[C@@H](C)C(=O)[C@@]2(OC2)C[C@H](C)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)OC(C)=O)[C@H]1C LQCLVBQBTUVCEQ-QTFUVMRISA-N 0.000 claims 1
- 229960004059 tylosin Drugs 0.000 claims 1
- WBPYTXDJUQJLPQ-VMXQISHHSA-N tylosin Chemical compound O([C@@H]1[C@@H](C)O[C@H]([C@@H]([C@H]1N(C)C)O)O[C@@H]1[C@@H](C)[C@H](O)CC(=O)O[C@@H]([C@H](/C=C(\C)/C=C/C(=O)[C@H](C)C[C@@H]1CC=O)CO[C@H]1[C@@H]([C@H](OC)[C@H](O)[C@@H](C)O1)OC)CC)[C@H]1C[C@@](C)(O)[C@@H](O)[C@H](C)O1 WBPYTXDJUQJLPQ-VMXQISHHSA-N 0.000 claims 1
- 235000019375 tylosin Nutrition 0.000 claims 1
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (8)
1. Farmaceutski pripravak koji sadrži 500 mg do 650 mg amikacina ili njegovu farmaceutski prihvatljivu soli, inkapsuliran u mnoštvu liposoma, pri čemu se lipidna komponenta iz mnoštva liposoma sastoji od dipalmitoilfosfatidilkolina (DPPC) i kolesterola za upotrebu u liječenju infekcije pluća s kompleksom Mycobacterium avium (MAC) kod pacijenta koji ranije nije reagirao na MAC terapiju, a liječenje uključuje:
davanje farmaceutskog pripravka u pluća pacijenta tijekom razdoblja primjene od najmanje 3 mjeseca,
davanje pacijentu jednog ili više dodatnih terapijskih sredstava odabranih od makrolidnog antibiotika, rifamicina i etambutola,
pri čemu davanje u pluća pacijenta obuhvaća aerosoliziranje farmaceutskog pripravka kako bi se dobio aerosolizirani farmaceutski pripravak koji sadrži smjesu slobodnog amikacina ili njegove farmaceutski prihvatljive soli i liposomski kompleksiranog amikacina ili njegove farmaceutski prihvatljive soli, te davanje aerosoliziranog farmaceutskog pripravka putem raspršivača u pluća pacijenta jednom dnevno u jednom doziranju tijekom razdoblja primjene,
pri čemu pacijent doživljava pretvorbu MAC kulture u negativnu tijekom ili nakon razdoblja primjene.
2. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što liječenje obuhvaća davanje pacijentu MAC terapije temeljene na smjernicama Američkog torakalnog društva (ATS) / Društva za zarazne bolesti Amerike (IDSA).
3. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time što amikacin ili njegova farmaceutski prihvatljiva sol je amikacin sulfat.
4. Farmaceutski pripravak za uporabu u skladu s bilo kojim prethodnim patentnim zahtjevom, naznačen time što mnoštvo liposoma sadrži jednoslojne mjehuriće, višeslojne mjehuriće, ili njihovu smjesu.
5. Farmaceutski pripravak za uporabu u skladu s bilo kojim prethodnim patentnim zahtjevom, naznačen time što se tijekom jednostrukog doziranja, aerosolizirani farmaceutski pripravak primjenjuje za manje od oko 15 minuta.
6. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 5, naznačen time što se aerosolizirani farmaceutski pripravak primjenjuje za oko 10 minuta do oko 14 minuta.
7. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što je makrolidni antibiotik azitromicin, klaritromicin, eritromicin, karbomicin A, josamicin, kitamicin, midekamicin, oleandomicin, solitromicin, spiramicin, troleandomicin, tilozin, roksitromicin, ili njihova kombinacija.
8. Farmaceutski pripravak za uporabu prema patentnom zahtjevu 1, naznačen time što je a) makrolidni antibiotik azitromicin ili (b) makrolidni antibiotik je klaritromicin.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461993439P | 2014-05-15 | 2014-05-15 | |
| EP18203799.4A EP3466432B1 (en) | 2014-05-15 | 2015-05-15 | Methods for treating pulmonary non-tuberculous mycobacterial infections |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201515T1 true HRP20201515T1 (hr) | 2020-12-11 |
Family
ID=73787775
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20201515TT HRP20201515T1 (hr) | 2014-05-15 | 2020-09-22 | Postupci za liječenje plućnih ne-tuberkuloznih mikobakterijskih infekcija |
Country Status (1)
| Country | Link |
|---|---|
| HR (1) | HRP20201515T1 (hr) |
-
2020
- 2020-09-22 HR HRP20201515TT patent/HRP20201515T1/hr unknown
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