HRP20200897T1 - Parenteralna formulacija esmolola - Google Patents
Parenteralna formulacija esmolola Download PDFInfo
- Publication number
- HRP20200897T1 HRP20200897T1 HRP20200897TT HRP20200897T HRP20200897T1 HR P20200897 T1 HRP20200897 T1 HR P20200897T1 HR P20200897T T HRP20200897T T HR P20200897TT HR P20200897 T HRP20200897 T HR P20200897T HR P20200897 T1 HRP20200897 T1 HR P20200897T1
- Authority
- HR
- Croatia
- Prior art keywords
- solution
- formulation
- esmolol hydrochloride
- use according
- ready
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title claims 9
- 239000000203 mixture Substances 0.000 title claims 9
- AQNDDEOPVVGCPG-UHFFFAOYSA-N esmolol Chemical compound COC(=O)CCC1=CC=C(OCC(O)CNC(C)C)C=C1 AQNDDEOPVVGCPG-UHFFFAOYSA-N 0.000 title 1
- 229960003745 esmolol Drugs 0.000 title 1
- 239000000243 solution Substances 0.000 claims 11
- VZTMYLWJKCAXMZ-UHFFFAOYSA-N 2-[(2-chloroquinazolin-4-yl)amino]ethanol Chemical compound C1=CC=C2C(NCCO)=NC(Cl)=NC2=C1 VZTMYLWJKCAXMZ-UHFFFAOYSA-N 0.000 claims 7
- 229960001015 esmolol hydrochloride Drugs 0.000 claims 7
- 238000001802 infusion Methods 0.000 claims 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 5
- 239000008215 water for injection Substances 0.000 claims 5
- 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 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 3
- 239000008103 glucose Substances 0.000 claims 3
- 206010016803 Fluid overload Diseases 0.000 claims 2
- 239000008156 Ringer's lactate solution Substances 0.000 claims 2
- 208000001871 Tachycardia Diseases 0.000 claims 2
- 239000008176 lyophilized powder Substances 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 230000006794 tachycardia Effects 0.000 claims 2
- 208000010444 Acidosis Diseases 0.000 claims 1
- 206010003658 Atrial Fibrillation Diseases 0.000 claims 1
- 206010003662 Atrial flutter Diseases 0.000 claims 1
- 208000002251 Dissecting Aneurysm Diseases 0.000 claims 1
- 208000029422 Hypernatremia Diseases 0.000 claims 1
- 206010020772 Hypertension Diseases 0.000 claims 1
- 208000001953 Hypotension Diseases 0.000 claims 1
- 208000007888 Sinus Tachycardia Diseases 0.000 claims 1
- 206010040893 Skin necrosis Diseases 0.000 claims 1
- 208000003734 Supraventricular Tachycardia Diseases 0.000 claims 1
- 206010047281 Ventricular arrhythmia Diseases 0.000 claims 1
- 230000007950 acidosis Effects 0.000 claims 1
- 208000026545 acidosis disease Diseases 0.000 claims 1
- 230000001154 acute effect Effects 0.000 claims 1
- 206010002895 aortic dissection Diseases 0.000 claims 1
- 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 1
- 239000008280 blood Substances 0.000 claims 1
- 210000004369 blood Anatomy 0.000 claims 1
- 230000036772 blood pressure Effects 0.000 claims 1
- ZEWYCNBZMPELPF-UHFFFAOYSA-J calcium;potassium;sodium;2-hydroxypropanoic acid;sodium;tetrachloride Chemical compound [Na].[Na+].[Cl-].[Cl-].[Cl-].[Cl-].[K+].[Ca+2].CC(O)C(O)=O ZEWYCNBZMPELPF-UHFFFAOYSA-J 0.000 claims 1
- 230000000747 cardiac effect Effects 0.000 claims 1
- 230000036543 hypotension Effects 0.000 claims 1
- 230000007794 irritation Effects 0.000 claims 1
- 238000012423 maintenance Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 230000002980 postoperative effect Effects 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
- 206010047302 ventricular tachycardia Diseases 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/235—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group
- A61K31/24—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids having an aromatic ring attached to a carboxyl group having an amino or nitro group
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/06—Antiarrhythmics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Cardiology (AREA)
- Emergency Medicine (AREA)
- Dermatology (AREA)
- Heart & Thoracic Surgery (AREA)
- Obesity (AREA)
- Urology & Nephrology (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Hospice & Palliative Care (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (10)
1. Parenteralna formulacija esmolol hidroklorida za uporabu u liječenju pacijenta oboljelog od tahikardije sadrži liofilizirani prah koji se sastoji od čistog esmolol hidroklorida, naznačena time što je navedeni prah rekonstituiran s otapalom odabranim iz skupine koja se sastoji od vode za injekcije (WFI), otopine glukoze, otopine glukoze i Ringera, otopine glukoze i fiziološke otopine, fiziološke otopine, Ringerova otopine laktata ili Ringerova laktata i fiziološke otopine za dobivanje i.v. otopine esmolol hidroklorida spremne za uporabu, u koncentraciji 20-100 mg/mL, i navedena i.v. otopina se izravno daje pacijentu.
2. Formulacija za uporabu u skladu s patentnim zahtjevom 1, naznačena time što navedena i.v. otopina ima pH od 4.5 do 5.0.
3. Formulacija za uporabu u skladu s patentnim zahtjevima 1 ili 2, naznačena time što navedena koncentracija esmolol hidroklorida iznosi najmanje 50 mg/mL.
4. Formulacija za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što se navedena i.v. otopina daje kao kontinuirana infuzija.
5. Formulacija za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačena time što se navedena i.v. otopina daje kao infuzija za održavanje u dozi od najmanje 25 μg/kg/min, izborno nakon početne infuzije u dozi od najmanje 300 μg/kg/min.
6. Formulacija za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačena time što je navedena i.v. otopina lokalno tkivo tolerantno na mjestu infuzije, sprečavajući lokalnu vensku iritaciju ili kožnu nekrozu na mjestu infuzije.
7. Formulacija za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačena time što navedeni pacijent
a. pati od bilo koje od akutne tahikardije odabrane od supraventrikularne tahikardije, ventrikularne tahikardije ili hipertenzije i nekompenzacijske sinusne tahikardije, atrijske fibrilacije, atrijalnog podrhtavanja u perioperativnim, postoperativnim ili drugim okolnostima u kojima je poželjna kratkotrajna kontrola ventrikularnog ritma, ili
b. kojem je potrebno snižavanje krvnog tlaka tijekom disekcije aorte ili za kontroliranu hipotenziju kako bi se izbjegao gubitak krvi u operaciji uha / nosa / grla ili u dijagnostičke svrhe.
8. Formulacija za uporabu u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačena time što navedeni pacijent ima srčanu dekompenzaciju i / ili hiperhidrataciju i / ili bubrežnu dekompenzaciju i / ili hipernatremiju i / ili hiperkloroznu acidozu i / ili hiperhidrataciju.
9. Postupak proizvodnje i.v. otopine esmolol hidroklorida spremne za uporabu rekonstituiranjem liofiliziranog praha koji se sastoji od čistog esmolol hidroklorida s vodom za injekcije (WFI) u količini koja je potrebna za dobivanje i.v. otopine spremne za uporabu u koncentraciji 20-100 mg/mL.
10. I.v. otopina spremna za uporabu koja se sastoji od parenteralnog 20-100 mg/ml čistog rekonstituiranog liofiliziranog esmolol hidroklorida i WFI.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12167443 | 2012-05-10 | ||
| EP13721740.2A EP2846776B1 (en) | 2012-05-10 | 2013-05-08 | Parenteral esmolol formulation |
| PCT/EP2013/059594 WO2013167657A1 (en) | 2012-05-10 | 2013-05-08 | Parenteral esmolol formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20200897T1 true HRP20200897T1 (hr) | 2020-11-27 |
Family
ID=48407551
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20200897TT HRP20200897T1 (hr) | 2012-05-10 | 2020-06-04 | Parenteralna formulacija esmolola |
Country Status (28)
| Country | Link |
|---|---|
| US (3) | US20150087704A1 (hr) |
| EP (1) | EP2846776B1 (hr) |
| JP (1) | JP6220383B2 (hr) |
| CN (1) | CN104379134A (hr) |
| AU (1) | AU2013258031B2 (hr) |
| BR (1) | BR112014027870B1 (hr) |
| CA (1) | CA2872953C (hr) |
| CL (1) | CL2014003028A1 (hr) |
| DK (1) | DK2846776T3 (hr) |
| EA (1) | EA032344B1 (hr) |
| ES (1) | ES2794093T3 (hr) |
| HK (1) | HK1204265A1 (hr) |
| HR (1) | HRP20200897T1 (hr) |
| HU (1) | HUE049314T2 (hr) |
| IL (1) | IL235497A0 (hr) |
| LT (1) | LT2846776T (hr) |
| MA (1) | MA37500B1 (hr) |
| MX (1) | MX2014013556A (hr) |
| MY (1) | MY173900A (hr) |
| NZ (1) | NZ701429A (hr) |
| PH (1) | PH12014502494B1 (hr) |
| PL (1) | PL2846776T3 (hr) |
| PT (1) | PT2846776T (hr) |
| SI (1) | SI2846776T1 (hr) |
| TN (1) | TN2014000464A1 (hr) |
| UA (1) | UA115333C2 (hr) |
| WO (1) | WO2013167657A1 (hr) |
| ZA (1) | ZA201408149B (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019122157A1 (en) * | 2017-12-21 | 2019-06-27 | Ipsol Ag | A lyophilisate comprising esmolol and adenosine for use in cardioplegia |
| CN111848420A (zh) * | 2020-07-22 | 2020-10-30 | 杭州煌森生物科技有限公司 | 一种盐酸艾司洛尔的新晶型及制备方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI277414B (en) | 2001-01-12 | 2007-04-01 | Baxter Int | Esmolol formulation |
| US6310094B1 (en) * | 2001-01-12 | 2001-10-30 | Baxter International Inc. | Ready-to-use esmolol solution |
| SE0401842D0 (sv) * | 2004-07-12 | 2004-07-12 | Dizlin Medical Design Ab | Infusion and injection solution of levodopa |
| WO2007026771A1 (ja) * | 2005-08-31 | 2007-03-08 | Ono Pharmaceutical Co., Ltd. | 点滴用注射剤 |
| US20080293814A1 (en) * | 2007-05-22 | 2008-11-27 | Deepak Tiwari | Concentrate esmolol |
| SI2234614T1 (sl) | 2007-12-21 | 2013-01-31 | Aop Orphan Pharmaceuticals Ag | Farmacevtska zmes za parenteralno administracijo ultra-kratko delujočega blokatorja beta-adrenoreceptorja |
| CN102106846A (zh) * | 2009-12-23 | 2011-06-29 | 南京海辰药业有限公司 | 左旋盐酸艾司洛尔药物组合物及其制备方法 |
-
2013
- 2013-05-08 PL PL13721740T patent/PL2846776T3/pl unknown
- 2013-05-08 JP JP2015510815A patent/JP6220383B2/ja active Active
- 2013-05-08 CA CA2872953A patent/CA2872953C/en active Active
- 2013-05-08 WO PCT/EP2013/059594 patent/WO2013167657A1/en active Application Filing
- 2013-05-08 NZ NZ701429A patent/NZ701429A/en unknown
- 2013-05-08 UA UAA201413014A patent/UA115333C2/uk unknown
- 2013-05-08 MX MX2014013556A patent/MX2014013556A/es active IP Right Grant
- 2013-05-08 CN CN201380028099.XA patent/CN104379134A/zh active Pending
- 2013-05-08 HU HUE13721740A patent/HUE049314T2/hu unknown
- 2013-05-08 LT LTEP13721740.2T patent/LT2846776T/lt unknown
- 2013-05-08 EP EP13721740.2A patent/EP2846776B1/en active Active
- 2013-05-08 US US14/398,312 patent/US20150087704A1/en not_active Abandoned
- 2013-05-08 SI SI201331732T patent/SI2846776T1/sl unknown
- 2013-05-08 PT PT137217402T patent/PT2846776T/pt unknown
- 2013-05-08 EA EA201491841A patent/EA032344B1/ru not_active IP Right Cessation
- 2013-05-08 DK DK13721740.2T patent/DK2846776T3/da active
- 2013-05-08 AU AU2013258031A patent/AU2013258031B2/en active Active
- 2013-05-08 ES ES13721740T patent/ES2794093T3/es active Active
- 2013-05-08 MY MYPI2014703249A patent/MY173900A/en unknown
- 2013-05-08 BR BR112014027870-9A patent/BR112014027870B1/pt active IP Right Grant
-
2014
- 2014-10-31 TN TN2014000464A patent/TN2014000464A1/fr unknown
- 2014-11-04 IL IL235497A patent/IL235497A0/en active IP Right Grant
- 2014-11-05 MA MA37500A patent/MA37500B1/fr unknown
- 2014-11-07 PH PH12014502494A patent/PH12014502494B1/en unknown
- 2014-11-07 CL CL2014003028A patent/CL2014003028A1/es unknown
- 2014-11-07 ZA ZA2014/08149A patent/ZA201408149B/en unknown
-
2015
- 2015-05-19 HK HK15104754.1A patent/HK1204265A1/xx unknown
-
2017
- 2017-07-28 US US15/663,645 patent/US20170326095A1/en not_active Abandoned
-
2020
- 2020-06-04 HR HRP20200897TT patent/HRP20200897T1/hr unknown
-
2022
- 2022-01-24 US US17/582,945 patent/US11963940B2/en active Active
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