CA2452638A1 - Optimised formulation of tobramycin for aerosolization - Google Patents
Optimised formulation of tobramycin for aerosolization Download PDFInfo
- Publication number
- CA2452638A1 CA2452638A1 CA002452638A CA2452638A CA2452638A1 CA 2452638 A1 CA2452638 A1 CA 2452638A1 CA 002452638 A CA002452638 A CA 002452638A CA 2452638 A CA2452638 A CA 2452638A CA 2452638 A1 CA2452638 A1 CA 2452638A1
- Authority
- CA
- Canada
- Prior art keywords
- tobramycin
- aerosolization
- formulation
- aerosol formulation
- optimised
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/12—Mucolytics
-
- 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
-
- 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
Abstract
The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.
Claims (3)
1. An aerosol formulation consisting of 75 mg/ml of tobramycin dissolved in a 0.45% sodium chloride wherein the pH is comprised between 4.0 and 5.5 and the osmolarity ranges between 250 and 450 mOsm/1.
2. An aerosol formulation according to claim 1 wherein the pH is 5.2 and the osmolarity is between 280 and 350 mOsm/1.
3. A process for the preparation of an aerosol formulation according to claim 1, said process including the steps of:
i) preparing an aqueous solution containing 0.45% w/v of sodium chloride;
ii) adjusting the pH with a concentrated strong acid;
iii) adding the active ingredient and mixing to complete dissolution ;
iv) re-adjusting the pH to the desired value;
v) filling the solution in suitable containers, preferably pre-sterilised by filtration.
i) preparing an aqueous solution containing 0.45% w/v of sodium chloride;
ii) adjusting the pH with a concentrated strong acid;
iii) adding the active ingredient and mixing to complete dissolution ;
iv) re-adjusting the pH to the desired value;
v) filling the solution in suitable containers, preferably pre-sterilised by filtration.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP01116071A EP1273292B1 (en) | 2001-07-02 | 2001-07-02 | Optimised formulation of tobramycin for aerosolization |
| EP01116071.0 | 2001-07-02 | ||
| PCT/EP2002/006544 WO2003004005A1 (en) | 2001-07-02 | 2002-06-14 | Optimised formulation of tobramycin for aerosolization |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2452638A1 true CA2452638A1 (en) | 2003-01-16 |
| CA2452638C CA2452638C (en) | 2010-10-05 |
Family
ID=8177921
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2452638A Expired - Lifetime CA2452638C (en) | 2001-07-02 | 2002-06-14 | Optimised formulation of tobramycin for aerosolization |
Country Status (27)
| Country | Link |
|---|---|
| US (5) | US6987094B2 (en) |
| EP (1) | EP1273292B1 (en) |
| JP (1) | JP4262086B2 (en) |
| KR (1) | KR100910888B1 (en) |
| CN (1) | CN1234346C (en) |
| AT (1) | ATE267591T1 (en) |
| AU (1) | AU2002319226B2 (en) |
| BG (1) | BG66328B1 (en) |
| BR (1) | BRPI0211320B8 (en) |
| CA (1) | CA2452638C (en) |
| CZ (1) | CZ299348B6 (en) |
| DE (1) | DE60103527T2 (en) |
| DK (1) | DK1273292T3 (en) |
| EA (1) | EA006068B1 (en) |
| EE (1) | EE05392B1 (en) |
| EG (1) | EG24019A (en) |
| ES (1) | ES2222294T3 (en) |
| HK (1) | HK1068784A1 (en) |
| HU (1) | HU230807B1 (en) |
| PL (1) | PL202598B1 (en) |
| PT (1) | PT1273292E (en) |
| SI (1) | SI1273292T1 (en) |
| SK (1) | SK285806B6 (en) |
| TN (1) | TNSN03149A1 (en) |
| TR (1) | TR200401980T4 (en) |
| WO (1) | WO2003004005A1 (en) |
| ZA (1) | ZA200400026B (en) |
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| SI1273292T1 (en) * | 2001-07-02 | 2004-12-31 | Chiesi Farmaceutici S.P.A. | Optimised formulation of tobramycin for aerosolization |
| CA2468958C (en) | 2001-12-19 | 2012-07-03 | Nektar Therapeutics | Pulmonary delivery of aminoglycosides |
| SI1480615T1 (en) * | 2002-03-01 | 2010-07-30 | Chiesi Farma Spa | Formoterol superfine formulation |
| EP1673074B1 (en) * | 2003-10-15 | 2007-01-03 | PARI GmbH Spezialisten für effektive Inhalation | Liquid preparation containing tobramycin |
| US8442280B2 (en) * | 2004-01-21 | 2013-05-14 | Edda Technology, Inc. | Method and system for intelligent qualitative and quantitative analysis of digital radiography softcopy reading |
| WO2005110022A2 (en) | 2004-05-17 | 2005-11-24 | Corus Pharma, Inc. | Aerosolized fosfomycin/aminoglycoside combination for the treatment of bacterial respiratory infections |
| US7838532B2 (en) * | 2005-05-18 | 2010-11-23 | Mpex Pharmaceuticals, Inc. | Aerosolized fluoroquinolones and uses thereof |
| US8546423B2 (en) | 2005-05-18 | 2013-10-01 | Mpex Pharmaceuticals, Inc. | Aerosolized fluoroquinolones and uses thereof |
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| US20090246146A1 (en) * | 2008-01-25 | 2009-10-01 | Botond Banfi | Halides in the treatment of pathogenic infection |
| AU2009302478B2 (en) | 2008-10-07 | 2015-09-03 | Horizon Orphan Llc | Aerosol fluoroquinolone formulations for improved pharmacokinetics |
| ES2809177T3 (en) * | 2008-10-07 | 2021-03-03 | Horizon Orphan Llc | Inhalation of levofloxacin to reduce lung inflammation |
| WO2010096242A1 (en) * | 2009-02-18 | 2010-08-26 | Aradigm Corporation | Ph-modulated formulations for pulmonary delivery |
| CA2938650C (en) | 2009-09-04 | 2018-01-09 | Raptor Pharmaceuticals Inc. | Use of aerosolized levofloxacin for treating cystic fibrosis |
| EP2388008A1 (en) | 2010-05-14 | 2011-11-23 | Combino Pharm, S.L. | Stable, preservative-free, aqueous formulation for the administration by aerosolization comprising tobramycin |
| AU2011278693B2 (en) * | 2010-07-12 | 2015-02-19 | Xellia Pharmaceuticals Aps | Treatment of lung infections by administration of Tobramycin by aerolisation |
| CN111481562A (en) * | 2010-09-13 | 2020-08-04 | 苏黎世大学 | Application of apramycin in preparation of bacterial infectious disease treatment |
| US10105356B2 (en) | 2011-01-31 | 2018-10-23 | Avalyn Pharma Inc. | Aerosol pirfenidone and pyridone analog compounds and uses thereof |
| EP2670242B1 (en) * | 2011-01-31 | 2022-03-16 | Avalyn Pharma Inc. | Aerosol pirfenidone and pyridone analog compounds and uses thereof |
| EP2567691B1 (en) | 2011-09-12 | 2014-12-24 | Meiji Seika Pharma Co., Ltd. | Aqueous compositions comprising arbekacin |
| GB201208080D0 (en) | 2012-05-09 | 2012-06-20 | Norton Healthcare Ltd | Tobramycin formulation |
| CN105534961B (en) * | 2015-12-30 | 2019-06-04 | 孙红娟 | Tobramycin inhalation solution and preparation method thereof |
| CN105616345B (en) * | 2016-03-01 | 2018-08-21 | 上海方予健康医药科技有限公司 | A kind of tobramycin composition for inhalation and its preparation method and application |
| US20200069714A1 (en) * | 2016-12-09 | 2020-03-05 | Enbiotix, Inc. | Aminoglycoside potentiation for treatment of pulmonary bacterial infection |
| CN108014099B (en) * | 2017-12-15 | 2019-03-01 | 武汉兴华智慧医药科技有限公司 | A kind of sucking tobramycin solution and preparation method thereof |
| GB2565941A (en) * | 2018-11-27 | 2019-02-27 | Norton Healthcare Ltd | A process for preparing a formulation |
| CN113018443B (en) * | 2019-12-27 | 2022-09-13 | 海南斯达制药有限公司 | Pharmaceutical composition for treating respiratory system diseases and preparation method thereof |
| CN113952320B (en) * | 2021-09-18 | 2022-03-18 | 健康元药业集团股份有限公司 | Drug assembly containing tobramycin inhalation solution and application thereof |
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2001
- 2001-07-02 SI SI200130154T patent/SI1273292T1/en unknown
- 2001-07-02 DK DK01116071T patent/DK1273292T3/en active
- 2001-07-02 ES ES01116071T patent/ES2222294T3/en not_active Expired - Lifetime
- 2001-07-02 EP EP01116071A patent/EP1273292B1/en not_active Expired - Lifetime
- 2001-07-02 PT PT01116071T patent/PT1273292E/en unknown
- 2001-07-02 DE DE60103527T patent/DE60103527T2/en not_active Expired - Lifetime
- 2001-07-02 AT AT01116071T patent/ATE267591T1/en active
- 2001-07-02 TR TR2004/01980T patent/TR200401980T4/en unknown
-
2002
- 2002-06-14 KR KR1020037017141A patent/KR100910888B1/en active IP Right Grant
- 2002-06-14 AU AU2002319226A patent/AU2002319226B2/en not_active Expired
- 2002-06-14 WO PCT/EP2002/006544 patent/WO2003004005A1/en active Application Filing
- 2002-06-14 CA CA2452638A patent/CA2452638C/en not_active Expired - Lifetime
- 2002-06-14 SK SK1643-2003A patent/SK285806B6/en not_active IP Right Cessation
- 2002-06-14 HU HU0400387A patent/HU230807B1/en unknown
- 2002-06-14 EE EEP200400050A patent/EE05392B1/en unknown
- 2002-06-14 BR BRPI0211320A patent/BRPI0211320B8/en not_active IP Right Cessation
- 2002-06-14 CN CNB028143140A patent/CN1234346C/en not_active Expired - Lifetime
- 2002-06-14 US US10/482,224 patent/US6987094B2/en not_active Expired - Lifetime
- 2002-06-14 PL PL367139A patent/PL202598B1/en unknown
- 2002-06-14 EA EA200301305A patent/EA006068B1/en active Protection Beyond IP Right Term
- 2002-06-14 CZ CZ20033580A patent/CZ299348B6/en not_active IP Right Cessation
- 2002-06-14 JP JP2003510016A patent/JP4262086B2/en not_active Expired - Lifetime
- 2002-06-29 EG EG2002060744A patent/EG24019A/en active
-
2003
- 2003-07-08 TN TNPCT/EP2002/006544A patent/TNSN03149A1/en unknown
- 2003-12-19 BG BG108475A patent/BG66328B1/en unknown
-
2004
- 2004-01-05 ZA ZA2004/00026A patent/ZA200400026B/en unknown
-
2005
- 2005-02-03 HK HK05100912A patent/HK1068784A1/en not_active IP Right Cessation
- 2005-03-18 US US11/083,139 patent/US7696178B2/en not_active Expired - Lifetime
-
2009
- 2009-12-18 US US12/642,336 patent/US7939502B2/en not_active Expired - Fee Related
-
2011
- 2011-05-06 US US13/102,378 patent/US8168598B2/en not_active Expired - Lifetime
-
2012
- 2012-03-26 US US13/429,624 patent/US20120184502A1/en not_active Abandoned
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| MKEX | Expiry |
Effective date: 20220614 |