HRP20210342T1 - Pripravci glikopeptida - Google Patents
Pripravci glikopeptida Download PDFInfo
- Publication number
- HRP20210342T1 HRP20210342T1 HRP20210342TT HRP20210342T HRP20210342T1 HR P20210342 T1 HRP20210342 T1 HR P20210342T1 HR P20210342T T HRP20210342T T HR P20210342TT HR P20210342 T HRP20210342 T HR P20210342T HR P20210342 T1 HRP20210342 T1 HR P20210342T1
- Authority
- HR
- Croatia
- Prior art keywords
- pharmaceutical preparation
- vancomycin
- preparation according
- alanine
- lysine
- Prior art date
Links
- DQJCDTNMLBYVAY-ZXXIYAEKSA-N (2S,5R,10R,13R)-16-{[(2R,3S,4R,5R)-3-{[(2S,3R,4R,5S,6R)-3-acetamido-4,5-dihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}-5-(ethylamino)-6-hydroxy-2-(hydroxymethyl)oxan-4-yl]oxy}-5-(4-aminobutyl)-10-carbamoyl-2,13-dimethyl-4,7,12,15-tetraoxo-3,6,11,14-tetraazaheptadecan-1-oic acid Chemical compound NCCCC[C@H](C(=O)N[C@@H](C)C(O)=O)NC(=O)CC[C@H](C(N)=O)NC(=O)[C@@H](C)NC(=O)C(C)O[C@@H]1[C@@H](NCC)C(O)O[C@H](CO)[C@H]1O[C@H]1[C@H](NC(C)=O)[C@@H](O)[C@H](O)[C@@H](CO)O1 DQJCDTNMLBYVAY-ZXXIYAEKSA-N 0.000 title 1
- 102000002068 Glycopeptides Human genes 0.000 title 1
- 108010015899 Glycopeptides Proteins 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 16
- 108010059993 Vancomycin Proteins 0.000 claims 11
- MYPYJXKWCTUITO-LYRMYLQWSA-N vancomycin Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-N 0.000 claims 11
- 229960003165 vancomycin Drugs 0.000 claims 11
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 claims 11
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims 8
- KTHDTJVBEPMMGL-GSVOUGTGSA-N n-acetylalanine Chemical compound OC(=O)[C@@H](C)NC(C)=O KTHDTJVBEPMMGL-GSVOUGTGSA-N 0.000 claims 8
- 235000001014 amino acid Nutrition 0.000 claims 7
- 150000001413 amino acids Chemical class 0.000 claims 7
- 235000019766 L-Lysine Nutrition 0.000 claims 4
- AHLPHDHHMVZTML-BYPYZUCNSA-N L-Ornithine Chemical compound NCCC[C@H](N)C(O)=O AHLPHDHHMVZTML-BYPYZUCNSA-N 0.000 claims 4
- 239000004472 Lysine Substances 0.000 claims 4
- 239000003186 pharmaceutical solution Substances 0.000 claims 4
- KDXKERNSBIXSRK-RXMQYKEDSA-N D-lysine Chemical compound NCCCC[C@@H](N)C(O)=O KDXKERNSBIXSRK-RXMQYKEDSA-N 0.000 claims 3
- AHLPHDHHMVZTML-SCSAIBSYSA-N D-Ornithine Chemical compound NCCC[C@@H](N)C(O)=O AHLPHDHHMVZTML-SCSAIBSYSA-N 0.000 claims 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims 2
- 229930064664 L-arginine Natural products 0.000 claims 2
- 235000014852 L-arginine Nutrition 0.000 claims 2
- AHLPHDHHMVZTML-UHFFFAOYSA-N Orn-delta-NH2 Natural products NCCCC(N)C(O)=O AHLPHDHHMVZTML-UHFFFAOYSA-N 0.000 claims 2
- MYPYJXKWCTUITO-KIIOPKALSA-N chembl3301825 Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)C(O)[C@H](C)O1 MYPYJXKWCTUITO-KIIOPKALSA-N 0.000 claims 2
- 229960003104 ornithine Drugs 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- WPLOVIFNBMNBPD-ATHMIXSHSA-N subtilin Chemical compound CC1SCC(NC2=O)C(=O)NC(CC(N)=O)C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(C)CC)C(=O)NC(=C)C(=O)NC(CCCCN)C(O)=O)CSC(C)C2NC(=O)C(CC(C)C)NC(=O)C1NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C1NC(=O)C(=C/C)/NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)CNC(=O)C(NC(=O)C(NC(=O)C2NC(=O)CNC(=O)C3CCCN3C(=O)C(NC(=O)C3NC(=O)C(CC(C)C)NC(=O)C(=C)NC(=O)C(CCC(O)=O)NC(=O)C(NC(=O)C(CCCCN)NC(=O)C(N)CC=4C5=CC=CC=C5NC=4)CSC3)C(C)SC2)C(C)C)C(C)SC1)CC1=CC=CC=C1 WPLOVIFNBMNBPD-ATHMIXSHSA-N 0.000 claims 2
- 208000035143 Bacterial infection Diseases 0.000 claims 1
- MTCFGRXMJLQNBG-UWTATZPHSA-N D-Serine Chemical compound OC[C@@H](N)C(O)=O MTCFGRXMJLQNBG-UWTATZPHSA-N 0.000 claims 1
- 229930195711 D-Serine Natural products 0.000 claims 1
- QNAYBMKLOCPYGJ-UWTATZPHSA-N D-alanine Chemical compound C[C@@H](N)C(O)=O QNAYBMKLOCPYGJ-UWTATZPHSA-N 0.000 claims 1
- QNAYBMKLOCPYGJ-UHFFFAOYSA-N D-alpha-Ala Natural products CC([NH3+])C([O-])=O QNAYBMKLOCPYGJ-UHFFFAOYSA-N 0.000 claims 1
- ROHFNLRQFUQHCH-RXMQYKEDSA-N D-leucine Chemical compound CC(C)C[C@@H](N)C(O)=O ROHFNLRQFUQHCH-RXMQYKEDSA-N 0.000 claims 1
- 229930182819 D-leucine Natural products 0.000 claims 1
- KZSNJWFQEVHDMF-SCSAIBSYSA-N D-valine Chemical compound CC(C)[C@@H](N)C(O)=O KZSNJWFQEVHDMF-SCSAIBSYSA-N 0.000 claims 1
- 229930182831 D-valine Natural products 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 208000022362 bacterial infectious disease Diseases 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000003960 organic solvent Substances 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 230000006641 stabilisation Effects 0.000 claims 1
- 238000011105 stabilization Methods 0.000 claims 1
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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/14—Peptides containing saccharide radicals; Derivatives thereof, e.g. bleomycin, phleomycin, muramylpeptides or vancomycin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Gastroenterology & Hepatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Communicable Diseases (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Claims (19)
1. Vodeni farmaceutski pripravak koji sadrži vankomicin i N-acetil-D-alanin.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time što se farmaceutski pripravak priprema za parenteralnu primjenu.
3. Farmaceutski pripravak prema zahtjevu 1 ili 2, nadalje sadrži aminokiselinu.
4. Farmaceutski pripravak prema zahtjevu 3, naznačen time što je aminokiselina odabrana između D-alanina, D-serina, D-leucina, D-valina, L-lizina, D-lizina, L-ornitina, D-ornitina ili L-arginina.
5. Farmaceutski pripravak prema zahtjevu 4, naznačen time što je aminokiselina odabrana između L-lizina, D-lizina, L-ornitina, D-ornitina ili L-arginina.
6. Farmaceutski pripravak prema zahtjevu 5, naznačen time što je aminokiselina odabrana između L-lizina ili D-lizina.
7. Farmaceutski pripravak prema zahtjevu 6, naznačen time što je aminokiselina L-lizin.
8. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 7 ima pH oko 3-6.
9. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time što sadrži 0.5-15% w/V vankomicina i N-acetil-D-alanina u molarnom omjeru 1:1 do 1:30 imajući pH od 3-6 i nadalje sadrži aminokiselinu.
10. Farmaceutski pripravak prema zahtjevu 1 ili 2, sadrži 0.5-15% w/V vankomicina i N-acetil-D-alanina u molarnom omjeru od 1:1 do 1:30 imajući pH od 3-6 i nadalje sadrži L-lizin u molarnom omjeru prema vankomicinu od 1:1 do 30:1.
11. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time što je molarni omjer N-acetil-D-alanina prema vankomicinu 5:1 do 40:1 i pri čemu otopina sadrži 0.5% w/V vankomicina.
12. Farmaceutski pripravak prema zahtjevu 1 ili 2, naznačen time što molarni omjer N-acetil-D-alanina prema vankomicinu iznosi 0.1:1 do 10:1 i pri čemu otopina sadrži 5% w/V vankomicina.
13. Farmaceutski pripravak prema zahtjevu 1 ili 2, sadrži 0.5 15% w/V vankomicina i N-acetil-D-alanina u molarnom omjeru 1:1-1:40 i nadalje sadrži aminokiselinu.
14. Farmaceutski pripravak prema zahtjevu 1 ili 2, sadrži 0.5% w/V vankomicina i L-lizina i N-acetil-D-alanina u molarnom omjeru 1:20:30 s pH 4.5-5.5.
15. Farmaceutski pripravak prema bilo kojem od prethodnih zahtjeva, nadalje sadrži organsko otapalo odabrano između etanola i polietilen glikola.
16. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 15 koristi se kao lijek.
17. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 do 15 za uporabu u liječenju bakterijskih infekcija.
18. Uporaba N-acetil-D-alanina za stabilizaciju vankomicina u farmaceutskoj otopini.
19. Uporaba prema zahtjevu 18, naznačena time što je farmaceutska otopina stabilna najmanje 4 tjedna na 25 Celzijevih stupnjeva što se pokazuje određivanjem količine vankomicina preostalog u farmaceutskoj otopini nakon najmanje 4 tjedna na 25 Celzijevih stupnjeva i pri čemu je količina vankomicina preostalog u farmaceutskoj otopini između 90% i 100%.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462076400P | 2014-11-06 | 2014-11-06 | |
| US201562168749P | 2015-05-30 | 2015-05-30 | |
| EP19174849.0A EP3542812B1 (en) | 2014-11-06 | 2015-11-06 | Glycopeptide compositions |
| PCT/EP2015/075918 WO2016071495A1 (en) | 2014-11-06 | 2015-11-06 | Glycopeptide compositions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HRP20210342T1 true HRP20210342T1 (hr) | 2021-04-30 |
| HRP20210342T8 HRP20210342T8 (hr) | 2022-01-21 |
Family
ID=54478023
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200101TT HRP20200101T1 (hr) | 2014-11-06 | 2020-01-21 | Glikopeptidni pripravci |
| HRP20210342TT HRP20210342T8 (hr) | 2014-11-06 | 2021-03-01 | Pripravci glikopeptida |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200101TT HRP20200101T1 (hr) | 2014-11-06 | 2020-01-21 | Glikopeptidni pripravci |
Country Status (30)
| Country | Link |
|---|---|
| US (7) | US10188697B2 (hr) |
| EP (4) | EP3542812B1 (hr) |
| JP (2) | JP6797795B2 (hr) |
| KR (2) | KR20230096142A (hr) |
| CN (1) | CN107073072B (hr) |
| AU (1) | AU2015341763B2 (hr) |
| BR (1) | BR112017009405B1 (hr) |
| CA (1) | CA2964524A1 (hr) |
| CL (1) | CL2017001139A1 (hr) |
| CO (1) | CO2017005391A2 (hr) |
| CR (1) | CR20170234A (hr) |
| CY (2) | CY1122960T1 (hr) |
| DK (2) | DK3542812T3 (hr) |
| EA (1) | EA035368B1 (hr) |
| ES (2) | ES2769849T3 (hr) |
| HR (2) | HRP20200101T1 (hr) |
| HU (2) | HUE049857T2 (hr) |
| IL (1) | IL252120B (hr) |
| MX (1) | MX2017005749A (hr) |
| NZ (1) | NZ731955A (hr) |
| PH (1) | PH12017500720A1 (hr) |
| PL (2) | PL3215173T3 (hr) |
| PT (2) | PT3215173T (hr) |
| RS (2) | RS61418B1 (hr) |
| SA (1) | SA517381446B1 (hr) |
| SG (1) | SG11201703568WA (hr) |
| SI (2) | SI3542812T1 (hr) |
| TN (1) | TN2017000182A1 (hr) |
| WO (1) | WO2016071495A1 (hr) |
| ZA (1) | ZA201702767B (hr) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ731955A (en) | 2014-11-06 | 2023-07-28 | Xellia Pharmaceuticals Aps | Glycopeptide compositions |
| US20190000789A1 (en) * | 2015-12-24 | 2019-01-03 | Universiteit Leiden | Composition and method for treating infections caused by vancomycin-resistant infectious agents in a subject |
| EP3454883A1 (en) * | 2016-05-09 | 2019-03-20 | Xellia Pharmaceuticals ApS | Stabilized glycopeptide antibiotic formulations |
| WO2018096556A1 (en) * | 2016-11-23 | 2018-05-31 | Gufic Biosciences Limited | Lyophilized pharmaceutical compositions of dalbavancin |
| JP7118412B2 (ja) * | 2017-07-31 | 2022-08-16 | 東洋製薬化成株式会社 | バンコマイシン懸濁液充填カプセル製剤 |
| CN109725101B (zh) * | 2017-10-31 | 2021-11-19 | 正大天晴药业集团股份有限公司 | 盐酸特拉万星原料中有关物质的检测方法 |
| CN109078001B (zh) * | 2018-09-21 | 2021-05-07 | 深圳浦瑞健康科技有限公司 | 一种万古霉素纳米脂质体组合物及其制备方法 |
| US20220184173A1 (en) | 2019-03-08 | 2022-06-16 | Emphascience, Inc. | Stable pharmaceutical formulations of peptide and protein drugs |
| US11433115B2 (en) * | 2020-10-30 | 2022-09-06 | Somerset Therapeutics, Llc | Glycopeptide antibiotics liquid formulations and methods and uses thereof |
| EP4014969A1 (en) * | 2020-12-16 | 2022-06-22 | EVER Valinject GmbH | Aqueous solution |
| EP4014965A1 (en) * | 2020-12-16 | 2022-06-22 | EVER Valinject GmbH | Aqueous solution |
| WO2022234036A1 (en) * | 2021-05-07 | 2022-11-10 | Xellia Pharmaceuticals Aps | Oral liquid vancomycin formulations |
| CN115804832A (zh) * | 2021-09-14 | 2023-03-17 | 海南普利制药股份有限公司 | 一种万古霉素水溶液组合物 |
| WO2023171588A1 (ja) * | 2022-03-08 | 2023-09-14 | 国立大学法人大阪大学 | 抗菌薬を含有するｐｌｇａ製剤 |
| GB202207345D0 (en) | 2022-05-19 | 2022-07-06 | Arecor Ltd | Novel composition |
| GB202207344D0 (en) | 2022-05-19 | 2022-07-06 | Arecor Ltd | Novel composition |
| WO2024079224A1 (en) * | 2022-10-12 | 2024-04-18 | Xellia Pharmaceuticals Aps | Liquid dalbavancin composition |
| US12070485B2 (en) | 2022-10-12 | 2024-08-27 | Xellia Pharmaceuticals Aps | Liquid dalbavancin compositions |
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| JPH1180021A (ja) | 1997-09-02 | 1999-03-23 | Kayaku:Kk | バンコマイシン注射剤 |
| US6800608B2 (en) | 2001-06-22 | 2004-10-05 | Beckman Coulter, Inc. | Homogeneous assay of vancomycin using a stable particle-vancomycin conjugate, a novel rate enhancer, and a novel dose response modulator |
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