DE3726299A1 - Fat emulsion for intravenous use - Google Patents

Fat emulsion for intravenous use

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Publication number
DE3726299A1
DE3726299A1 DE19873726299 DE3726299A DE3726299A1 DE 3726299 A1 DE3726299 A1 DE 3726299A1 DE 19873726299 DE19873726299 DE 19873726299 DE 3726299 A DE3726299 A DE 3726299A DE 3726299 A1 DE3726299 A1 DE 3726299A1
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Germany
Prior art keywords
fat emulsion
carnitine
patent application
intravenous use
fat
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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.)
Ceased
Application number
DE19873726299
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German (de)
Inventor
Hans Dipl Chem Dr Dietl
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Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from DE19873721137 external-priority patent/DE3721137A1/en
Application filed by Individual filed Critical Individual
Priority to DE19873726299 priority Critical patent/DE3726299A1/en
Publication of DE3726299A1 publication Critical patent/DE3726299A1/en
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/23—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin of acids having a carboxyl group bound to a chain of seven or more carbon atoms
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/60—Fish, e.g. seahorses; Fish eggs

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to fat emulsions for intravenous use which, besides eicosapentaenoic acid and/or docosahexaenoic acid (= omega-3 fatty acids), contain L-carnitine.

Description

Die Patentanmeldung P 37 21 137.4 betrifft Fettemulsionen zur intra­ venösen Anwendung, Verfahren zu ihrer Herstellung und deren Anwen­ dung bei bestimmten Krankheitszuständen.The patent application P 37 21 137.4 relates to fat emulsions for intra venous use, process for their preparation and their uses with certain disease states.

Die erfindungsgemäßen Fettemulsionen der Patentanmeldung P 37 21 137.4 sind gekennzeichnet durch ihren Gehalt an Triglyceriden von Eicosapen­ taensäure und/oder Docosahexaensäure, bzw. durch ihren zusätzlichen Gehalt an pflanzlichen Ölen.The fat emulsions according to the invention of patent application P 37 21 137.4 are characterized by their content of triglycerides of eicosapen taenic acid and / or docosahexaenoic acid, or by their additional Vegetable oil content.

Bei sehr schweren Krankheitszuständen, z.B. bei Patienten in Schock oder Traumazuständen, hervorgerufen beispielsweise durch Verbrennungen, große chirurgische Eingriffe, mehrfache Knochenbrüche, werden die Fett­ emulsionen allgemein und auch die Fettemulsionen nach der Patentanmeldung P 37 21 137.4 relativ langsam verstoffwechselt, so daß bei der Anwendung - insbesondere bei Anwendung großer Mengen und schneller Infusion - es zur Erhöhung der Triglyceride im Blut und in den Geweben kommen kann. Der Erfindung liegt die Aufgabe zugrunde, die Verstoffwechselung der Fettemulsion der Patentanmeldung P 37 21 137.4 noch weiter zu verbessern und damit auch die Verträglichkeit noch günstiger zu gestalten. Diese Aufgabe wird erfindungsgemäß dadurch gelöst, daß die Fettemulsionen nach Patentanmeldung P 37 21 137.4 noch zusätzlich L-Carnitin enthalten. Anstelle von L-Carnitin kann selbstverständlich auch ein pharmazeutisch verträgliches Salz davon, z.B. Carnitinhydrochlorid, L-Carnitinacetat usw. verwendet werden.In the case of very serious illnesses, e.g. in patients in shock or trauma, for example caused by burns, major surgical interventions, multiple broken bones, the fat emulsions in general and also the fat emulsions according to patent application P 37 21 137.4 are metabolized relatively slowly, so that when used - Especially when using large amounts and rapid infusion - there can be an increase in triglycerides in the blood and tissues. The invention has for its object to further improve the metabolism of the fat emulsion of patent application P 37 21 137.4 and thus to make the compatibility even more favorable. This object is achieved in that the fat emulsions according to patent application P 37 21 137.4 additionally contain L-carnitine. Instead of L-carnitine, it is of course also possible to use a pharmaceutically acceptable salt thereof, for example carnitine hydrochloride, L-carnitine acetate, etc.

Es wurde festgestellt, daß L-Carnitin die Wirksamkeit der Gabe der Fett­ emulsionen nach Patentanmeldung P 37 21 137.4 erhöht, da die Verstoff­ wechselung der darin enthaltenen Triglyceride von Eicosapentaensäure und/oder Docosahexaensäure gesteigert wird, insbesondere bei Patienten mit Schock - und Traumazuständen.It was found that L-carnitine emulsions the effectiveness of the administration of the fat according to Patent Application P 37 21 137.4 increased because the Verstoff wechselung of the triglycerides contained therein, of eicosapentaenoic acid and / or docosahexaenoic acid is increased, especially in patients with shock - and trauma conditions.

Die erfindungsgemäßen Fettemulsionen mit L-Carnitin werden analog wie in der Patentanmeldung P 37 21 137.4 beschrieben hergestellt.The fat emulsions with L-carnitine according to the invention are analogous to in the patent application P 37 21 137.4 described.

Die verwendeten Mengen von L-Carnitin liegen dabei zwischen 0.1 g bis 4 g pro Liter Fettemulsion, wobei 0.5 g bis 2.5 g pro Liter Fettemulsion be­ vorzugt sind.The amounts of L-carnitine used are between 0.1 g and 4 g per liter of fat emulsion, with 0.5 g to 2.5 g per liter of fat emulsion are preferred.

Beispielexample

Zu 1 kg eines Fischöls werden 120 g gereinigte Eigelb-Phosphatide (enthal­ tend ca. 70% 3-sn-Phosphatidyl-Cholin ) und 250 Gramm Glycerin gegeben. 120 g of purified egg yolk phosphatides (incl 70% 3-sn-phosphatidyl-choline) and 250 grams of glycerin.  

Das verwendete Fischöl (= Triglycerid ) hat die folgende Fettsäure­ zusammensetzung:
Myristinsäure 7%, Palmitinsäure 16%, Palmitoleinsäure 10%, Stearin­ säure 4%, Ölsäure 14%, Linolsäure 3.5%, Linoleinsäure 0.5%, Arachi­ donsäure 1%, Eicosapentaensäure 18%, Docosapentaensäure 3%, Docosa­ hexaensäure 12%.The fish oil used (= triglyceride) has the following fatty acid composition:
Myristic acid 7%, palmitic acid 16%, palmitoleic acid 10%, stearic acid 4%, oleic acid 14%, linoleic acid 3.5%, linoleic acid 0.5%, arachonic acid 1%, eicosapentaenoic acid 18%, docosapentaenoic acid 3%, docosa hexaenoic acid 12%.

Es werden 5 g Natriumoleat zugegeben. Der Ansatz wird auf 50°C erwärmt und mit einem schnellaufenden Rührer gemischt.5 g of sodium oleate are added. The batch is heated to 50 ° C and mixed with a high-speed stirrer.

Nach Vorliegen einer gleichmäßigen Dispersion werden 4 l Aqua ad injekta­ bilia unter Rühren zugefügt und mit einem schnellaufenden Rührer (z.B. Ultra-Turrax) grob voremulgiert. Anschließend wird die so erhaltene Rohemulsion in einem Hochdruck-Homogenisator mit drei Kolben (z.B. Manton-Gaulin Typ M3) bei einer Temperatur von 35-45°C und einem Druck von 400 kg/cm2 homogenisiert. Die Homogenisierung wird vier Mal durchgeführt. Dabei erhält man eine Emulsion, in der alle Partikel kleiner als 2 Mikron sind, im Mittel 0.2-0.4 Mikron.After a uniform dispersion is present, 4 l of aqua ad injekta bilia are added with stirring and roughly pre-emulsified with a high-speed stirrer (eg Ultra-Turrax). The crude emulsion obtained in this way is then homogenized in a high-pressure homogenizer with three flasks (eg Manton-Gaulin type M3) at a temperature of 35-45 ° C. and a pressure of 400 kg / cm 2 . The homogenization is carried out four times. This gives an emulsion in which all particles are smaller than 2 microns, on average 0.2-0.4 microns.

In die so erhaltene Emulsion werden nun 10 g L-Carnitin, gelöst in 100 ml Aqua ad injektabilia, gegeben und mit sauerstofffreiem, mit Stickstoff gesättigtem Aqua ad injektabilia auf 10 l aufgefüllt, in Glasflaschen geeigneter Qualität abgefüllt und in einem Rotations­ autoklaven hitzesterilisiert. Die Teilchen der sterilen, carnitin-hal­ tigen Fettemulsion sind kleiner als 2 Mikron, im Mittel 0.2-0.4 Mikron.10 g of L-carnitine, dissolved in, are then dissolved in the emulsion thus obtained 100 ml of Aqua ad injektabilia, given and with oxygen-free, with Nitrogen saturated aqua ad injektabilia to 10 l, in Glass bottles of suitable quality filled and in a rotation autoclave heat sterilized. The particles of sterile, carnitine hal fat emulsions are smaller than 2 microns, on average 0.2-0.4 Micron.

Claims (7)

1. Fettemulsion zur intravenösen Anwendung nach Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß die Fettemulsion Eicosapentaensäure als Triglycerid sowie L-Carnitin enthält.1. Fat emulsion for intravenous use according to patent application P 37 21 137.4, characterized in that the fat emulsion contains eicosapentaenoic acid as a triglyceride and L-carnitine. 2. Fettemulsion zur intravenösen Anwendung nach Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß die Fettemulsion Docosahexaensäure als Triglycerid sowie L-Carnitin enthält.2. Fat emulsion for intravenous use after patent application P 37 21 137.4 characterized in that the fat emulsion Contains docosahexaenoic acid as triglyceride and L-carnitine. 3. Fettemulsion zur intravenösen Anwendung nach Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß die Fettemulsion sowohl Eicosapentaensäure wie Docosahexaensäure als Trigly­ cerid sowie L-Garnitin enthält.3. Fat emulsion for intravenous use after patent application P 37 21 137.4 characterized in that the fat emulsion both eicosapentaenoic acid and docosahexaenoic acid as trigly contains cerid and L-garnitin. 4. Fettemulsion zur intravenösen Anwendung nach Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß die Fettemulsion Fett tierischen Ursprungs sowie L-Carnitin enthält.4. Fat emulsion for intravenous use after patent application P 37 21 137.4 characterized in that the fat emulsion Contains fat of animal origin as well as L-carnitine. 5. Fettemulsion zur intravenösen Anwendung nach Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß die Fettemulsion Fischöl sowie L-Carnitin enthält.5. Fat emulsion for intravenous use after patent application P 37 21 137.4 characterized in that the fat emulsion Contains fish oil and L-carnitine. 6. Fettemulsion zur intravenösen Anwendung gemäß Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß als Fett ein Gemisch aus Fischöl und/oder Fischöl-Konzentraten und pflanzlichen Ölen sowie zusätzlich L-Carnitin enthält.6. Fat emulsion for intravenous use according to the patent application P 37 21 137.4 characterized in that a mixture as fat from fish oil and / or fish oil concentrates and vegetable oils and also contains L-carnitine. 7. Fettemulsion zur intravenösen Anwendung gemäß Patentanmeldung P 37 21 137.4 dadurch gekennzeichnet, daß in der Fettemulsion zusätzlich L-Carnitin in einer Menge von 0.1 Gramm bis 4 Gramm pro Liter, bevorzugt 0.5 Gramm bis 2.5 Gramm pro Liter, enthal­ ten ist.7. Fat emulsion for intravenous use according to the patent application P 37 21 137.4 characterized in that in the fat emulsion additionally L-carnitine in an amount of 0.1 grams to 4 grams per liter, preferably 0.5 grams to 2.5 grams per liter, included is.
DE19873726299 1987-06-26 1987-08-07 Fat emulsion for intravenous use Ceased DE3726299A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE19873726299 DE3726299A1 (en) 1987-06-26 1987-08-07 Fat emulsion for intravenous use

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19873721137 DE3721137A1 (en) 1987-06-26 1987-06-26 Fat emulsion for intravenous use
DE19873726299 DE3726299A1 (en) 1987-06-26 1987-08-07 Fat emulsion for intravenous use

Publications (1)

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DE3726299A1 true DE3726299A1 (en) 1989-02-23

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2628419A1 (en) * 1988-03-09 1989-09-15 Biorex Kft NOVEL ANTIVIRAL SALTS, PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME, AND PROCESS FOR THEIR PREPARATION
FR2628324A1 (en) * 1988-03-09 1989-09-15 Biorex Kft ANTIVIRAL AND IMMUNOSTIMULANT PHARMACEUTICAL COMPOSITIONS AND PROCESS FOR PREPARING THE SAME
DE4012894A1 (en) * 1990-04-23 1991-10-24 L A B Gmbh & Co Compsns. contg. carnitine and fish oil - for preventing and treating fat metabolism disorders, esp. hyperlipidaemia
US5390840A (en) * 1989-03-08 1995-02-21 Industri Ab Thule Apparatus in load carriers
DE19503993A1 (en) * 1995-02-08 1996-08-14 Johann Friedrich Dr Med Desaga Enteral product contg n-3-fatty acid or deriv and medium chain length tri:glyceride
DE19527281A1 (en) * 1995-07-26 1997-01-30 Hans Guenter Berner Gmbh Food supplements
EP0780124A1 (en) * 1995-12-21 1997-06-25 Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Pharmaceutical composition comprising L-carnitine or an alkanoyl L-carnitine in combination with a polyunsaturated fatty acid of the omega-3 series for the prevention and the treatment of lipid metabolism disorders
EP0922457A1 (en) * 1997-11-26 1999-06-16 The Procter & Gamble Company Skin protection composition

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3032300A1 (en) * 1980-08-27 1982-04-01 Alfred Ing. Wien Lohninger Parenteral nutrition fatty emulsion - contg. fatty acid tri:glyceride(s), glycerol, carnitine or acyl-carnitine, phospholipid, and carrier or diluent
DE3409793A1 (en) * 1983-03-18 1984-09-20 Terumo K.K., Tokio/Tokyo LIQUID EMULSION FOR TRANSFUSION
DE3524788A1 (en) * 1985-07-11 1987-01-22 Lentia Gmbh STABLE, INTRAVENOES APPLICABLE, AQUEOUS FAT EMULSION AND A METHOD FOR THE PRODUCTION THEREOF

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3032300A1 (en) * 1980-08-27 1982-04-01 Alfred Ing. Wien Lohninger Parenteral nutrition fatty emulsion - contg. fatty acid tri:glyceride(s), glycerol, carnitine or acyl-carnitine, phospholipid, and carrier or diluent
DE3409793A1 (en) * 1983-03-18 1984-09-20 Terumo K.K., Tokio/Tokyo LIQUID EMULSION FOR TRANSFUSION
DE3524788A1 (en) * 1985-07-11 1987-01-22 Lentia Gmbh STABLE, INTRAVENOES APPLICABLE, AQUEOUS FAT EMULSION AND A METHOD FOR THE PRODUCTION THEREOF

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DE-Z.: KLEINBERGER, G.: Parenterale Ernährung leberinsuffizienter Patienten: Energiezufuhr, Krankenhausarzt Nr. 57, 1984, S. 1037-1045 *

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2628419A1 (en) * 1988-03-09 1989-09-15 Biorex Kft NOVEL ANTIVIRAL SALTS, PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME, AND PROCESS FOR THEIR PREPARATION
FR2628324A1 (en) * 1988-03-09 1989-09-15 Biorex Kft ANTIVIRAL AND IMMUNOSTIMULANT PHARMACEUTICAL COMPOSITIONS AND PROCESS FOR PREPARING THE SAME
BE1002890A3 (en) * 1988-03-09 1991-07-16 Biorex Kft ANTIVIRAL AND IMMUNOSTIMULANT PHARMACEUTICAL COMPOSITIONS AND PROCESS FOR PREPARING THE SAME.
BE1003663A3 (en) * 1988-03-09 1992-05-19 Biorex Kft NEW ANTIVIRAL SALTS, pharmaceutical compositions containing AND METHOD FOR PREPARING.
US5390840A (en) * 1989-03-08 1995-02-21 Industri Ab Thule Apparatus in load carriers
DE4012894A1 (en) * 1990-04-23 1991-10-24 L A B Gmbh & Co Compsns. contg. carnitine and fish oil - for preventing and treating fat metabolism disorders, esp. hyperlipidaemia
DE4012894C2 (en) * 1990-04-23 1998-11-12 Werner Dr Gielsdorf Pharmaceutical agent for the treatment of disorders of the fat metabolism
DE19503993A1 (en) * 1995-02-08 1996-08-14 Johann Friedrich Dr Med Desaga Enteral product contg n-3-fatty acid or deriv and medium chain length tri:glyceride
DE19527281A1 (en) * 1995-07-26 1997-01-30 Hans Guenter Berner Gmbh Food supplements
EP0780124A1 (en) * 1995-12-21 1997-06-25 Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Pharmaceutical composition comprising L-carnitine or an alkanoyl L-carnitine in combination with a polyunsaturated fatty acid of the omega-3 series for the prevention and the treatment of lipid metabolism disorders
EP0922457A1 (en) * 1997-11-26 1999-06-16 The Procter & Gamble Company Skin protection composition

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