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DE2900300A1 - Medicaments contg. di:palmitoyl phosphocholine - for prophylaxis of respiratory emergency syndrome - Google Patents

Medicaments contg. di:palmitoyl phosphocholine - for prophylaxis of respiratory emergency syndrome

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Publication number
DE2900300A1
DE2900300A1 DE19792900300 DE2900300A DE2900300A1 DE 2900300 A1 DE2900300 A1 DE 2900300A1 DE 19792900300 DE19792900300 DE 19792900300 DE 2900300 A DE2900300 A DE 2900300A DE 2900300 A1 DE2900300 A1 DE 2900300A1
Authority
DE
Germany
Prior art keywords
dppc
prophylaxis
medicaments
phosphocholine
palmitoyl
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.)
Withdrawn
Application number
DE19792900300
Other languages
German (de)
Inventor
Lebrecht Von Dr Klitzing
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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
Application filed by Individual filed Critical Individual
Priority to DE19792900300 priority Critical patent/DE2900300A1/en
Publication of DE2900300A1 publication Critical patent/DE2900300A1/en
Withdrawn legal-status Critical Current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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Medicaments for prophylaxis of (a) the respiratory emergency syndrome in premature babies and (b) the shock-induced respiratory emergency syndrome contain dipalmitoyl phosphocholine (DPPC). The medicaments are administered intra-amniotically in case (a) and intravenously in case (b). The medicaments produce an enrichment of DPPC on the alveolar surface of the lung, thus preventing the said syndromes. The DPPC is pref. emulsified in an injectable lipid emulsion, e.g. "Intralipid" (RTM), or "EPL" emulsion.

Description

VERFAHREN EINER PROPHYLAXE ZUR VERMEIDUNG DES ATEMNOT-PROPHYLAXIS PROCEDURE TO AVOID BREATHING DISORDERS

SYNDROMS BEI FRÜHGEBORENEN UND BEI DER SCHOCKLUNGE Die Erfindung betrifft ein Verfahren, mit deasen Hilfe das Auftreten des Atemnotsyndroms bei Frühgeborenen prophylaktisch zu verhindern ist. Es liegen bereits klinische Erfolge dieser Prophylaxe vor (Medizinische Hochschule Lübeok, Abt. f. Gynäkologie und Geburtshilfe II).SYNDROMS IN PREMATURE BABIES AND IN SHOCK LUNG. The invention relates to a method with the help of dease the occurrence of the respiratory distress syndrome in premature babies is to be prevented prophylactically. There are already clinical successes in this prophylaxis before (Lübeok Medical University, Department of Gynecology and Obstetrics II).

Nach den vorliegenden Statistiken liegt in Mitteleuropa die Rate des Atemnotsyndroms bei Frühgeborenen zwischen 15 und 20 %. Die bisherigen Behandlungsformen auf hormoneller Basis sind unspezifisch und nach neuesten Erkenntnissen abzulehnen. Nach z.B. GUSDON et al. (Americ. J. Obatet. Gynec.According to the available statistics, the rate of the Respiratory distress syndrome in premature babies between 15 and 20%. The previous forms of treatment on a hormonal basis are unspecific and should be rejected according to the latest findings. According to e.g. GUSDON et al. (Americ. J. Obatet. Gynec.

112 (1972)i 62) und anderen ist das Atemnotsyndrom selbst Folge einer nioht ausreichenden Versorgung der fetalen Lungenalveolaroberfläche mit dem "surfactant-factor", insbesondere dem speziellen Lecithinmolekül DPPC (=di-palmitoyl phospho-chloin). Eine Möglichkeit zur Anreicherung dieses Lecithins an der Alveolaroberfläche der fetalen Lunge gab es bisher nicht.112 (1972) i 62) and others, respiratory distress syndrome is itself the result of one insufficient supply of the fetal lung alveolar surface with the "surfactant-factor", especially the special lecithin molecule DPPC (= di-palmitoyl phospho-chloin). One way to accumulate this lecithin on the alveolar surface of the fetal lungs did not exist before.

Der Erfindung liegt daher die Aufgabe zugrunde, sowohl ein Verfahren als auch eine Substanz zu schaffen, um dem Auftreten eines Atemnotsyndroms prophylaktisch entgegenzuwirken.The invention is therefore based on the object both of a method as well as to create a substance to prevent the occurrence of respiratory distress syndrome to counteract.

Hierbei muß von der Tatsache ausgegangen werden, daß erstens nur das intakte DPPC-Molekül auf der Alveolaroberfläche den gewünschten Effekt bringt und zweitens diese Substanz bei einer drohenden Frühgeburt der Lunge r e 0 h t z 5 i t i g zur Verfügung stehen muß.It must be assumed here that, firstly, only that intact DPPC molecule on the alveolar surface brings the desired effect and second, this substance in the event of a threatened premature birth of the lungs r e 0 h t z 5 i t i g must be available.

Von allen zur Verfügung stehenden Applikationsformen scheiden zunächst alle über die Mutter applizierbaren Methoden aus, da DPPC nicht plazentargängig ist (z.B. GROSSPIETZSCH et al., Fortschr. Med. 94 (1976), 1465) Es bleibt daher nur die Möglichkeit der intraamnialen Applikation mithilfe der Amnioscentese (KLINK et al., Fortsohr. Med. 94 (197-6), 1783; GROSS-PIETZSCH et al., Geburteh, u. Frauenheilk. 37 (1977), 527; von KLITZING et al., Fortschr. Med. 95 (1977), 501). Als weiteres muß das wasserunlösliche Lecithin als injektionsfähige flüssige Emulsion angeboten werden. Als Lösungsvermittler eignet sich einige auf dem Markt befindliche emulgierte Lipide (z.B. INTRALIPIDR oder EPL-Nattermann). In jedem Fall muß aber darauf geachtet werden, daß das DPPC vollständig emulgiert ist.First of all, different types of application are available all methods that can be applied via the mother, there DPPC does not is placental (e.g. GROSSPIETZSCH et al., Fortschr. Med. 94 (1976), 1465) Therefore, the only option left is intraamnial application using amnioscentesis (KLINK et al., Fortsohr. Med. 94 (197-6), 1783; GROSS-PIETZSCH et al., Birth, u. Frauenheilk. 37: 527 (1977); von KLITZING et al., Fortschr. Med. 95: 501 (1977)). The water-insoluble lecithin must also be used as an injectable liquid emulsion Tobe offered. Some on the market are suitable as solubilizers emulsified lipids (e.g. INTRALIPIDR or EPL-Nattermann). In any case, it must care must be taken that the DPPC is completely emulsified.

Ansatz für eine intraamniale Applikation: 500 mg DPPC mit 30 ml Methanol/Benzol-Gemisch (1:1) bis zur vollständigen Lösung schütteln und anschließend am Rotationsterdampfer die Lösungsmittel entfernen. Dann 20 ml INTRALIPIDR oder 20 ml EPL-Emulsion (ca. 1,5 g EPL puriss. + 20 ml 0,9 % NaCl) zugeben und vollständig emulgieren (z.B. Ultraschall, Vibrationsmisoher). Anschließende Sterilisation bei 121 0C (1 bar Wasserdampf) über 20 min. Applikation über Amniosoentese.Approach for intraamnial application: 500 mg DPPC with 30 ml methanol / benzene mixture Shake (1: 1) until completely dissolved and then shake on the rotary steamer remove the solvents. Then 20 ml INTRALIPIDR or 20 ml EPL emulsion (approx. 1.5 g EPL puriss. + 20 ml 0.9% NaCl) and emulsify completely (e.g. ultrasound, Vibration misoher). Subsequent sterilization at 121 0C (1 bar steam) over 20 min.application via amniosoentesis.

Da im Fruchtwasser keine Immunreaktionen bekannt sind, ist eine absolute Pyrogenfreiheit nicht zwingend. Die Applikation erfolgt bei drohender Frühgeburt, mit dem Bestreben, diese medikamentös um mindestens zwölf Stunden zu verzögern.Since no immune reactions are known in the amniotic fluid, it is an absolute one Pyrogen-free not mandatory. The application takes place in the case of impending premature birth, with the aim of delaying this with medication by at least twelve hours.

Im weiteren eignet sich die intravenöse Tropfapplikation dieser Substanz zur Vermeidung einer Schocklunge (nach spontaner Frühgeburt oder nach Schockzuständen wie Verbrennungen usw.). Bisher wird hier ein undefiniertes Lecithin-Gemisch (z.B. INTRALIPIDR) angeboten als Tropfinjektion.The intravenous drip application of this substance is also suitable to avoid a shock lung (after spontaneous premature birth or after shock states such as burns, etc.). So far, an undefined lecithin mixture (e.g. INTRALIPIDR) offered as a drip injection.

Nachteilig ist hier die Belastung durch unspezifische Lipide, insbesondere da häufig bei diesen Zuständen ein Kreislaufversagen auftritt.The disadvantage here is the exposure to unspecific lipids, in particular since circulatory failure often occurs in these conditions.

Das beschriebene erfindungsgemäße Verfahren ist hier zur Problemlösung insofern geeignet, da überwiegend die dem Atemnotsyndrom entgegenwirkende Substanz angeboten wird.The described method according to the invention is here to solve the problem insofar as suitable, as it is predominantly the substance that counteracts the respiratory distress syndrome is offered.

Claims (4)

P atentansprüche 1. Intraamnial verabreichbares Arzneimittel zur Prophylaxe des Atemnotsyndroms bei Frühgeborenen, d a d u r c h g e k e n n z e i c h n e t, daß es Di-palmitoylphosphocholin (DPPC) als Wirkstoff enthält.P atent claims 1. Intraamnially administrable medicament for prophylaxis respiratory distress syndrome in premature babies that it contains di-palmitoylphosphocholine (DPPC) as an active ingredient. 2. Mittel nach Patentanspruch 1, d a d u r c h g e k e n n z e i c h n e t , daß DPPC in einem injektionsfähigen Lipid-Emulgat zusätzlich emulgiert ist.2. Means according to claim 1, d a d u r c h g e k e n n z e i c Not that DPPC also emulsifies in an injectable lipid emulsifier is. 3. Intravenös verabreichbares Arzneimittel zur Prophylaxe des Atemnotsyndroms infolge einer SchocklungS d a d u r c h g e k e n n z e i c h n e t , daß es DPPC als Wirkstoff enthält 3. Intravenous drug for prophylaxis of respiratory distress syndrome As a result of a shock, it is not stated that it is DPPC contains as an active ingredient 4. Mittel nach Patentanspruch 3, d a d u r c h g e k e n n z e i c h n e t, daß DPPC in einem injektionsfähigen Lipid-Emulgat zusätzlich emulgiert ist.4. Means according to claim 3, d a d u r c h g e k e n n notices that DPPC also emulsifies in an injectable lipid emulsifier is.
DE19792900300 1979-01-05 1979-01-05 Medicaments contg. di:palmitoyl phosphocholine - for prophylaxis of respiratory emergency syndrome Withdrawn DE2900300A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE19792900300 DE2900300A1 (en) 1979-01-05 1979-01-05 Medicaments contg. di:palmitoyl phosphocholine - for prophylaxis of respiratory emergency syndrome

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE19792900300 DE2900300A1 (en) 1979-01-05 1979-01-05 Medicaments contg. di:palmitoyl phosphocholine - for prophylaxis of respiratory emergency syndrome

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0050793A1 (en) * 1980-10-24 1982-05-05 The Regents Of The University Of California Lung surfactant compositions
DE3228629A1 (en) * 1982-07-31 1984-02-02 Reifenrath, Rainer Richard Otto, Dr., 3104 Unterlüß Pharmaceutical product for the treatment of the airways and process for its production
EP0100910A2 (en) * 1982-08-05 1984-02-22 A. Nattermann & Cie. GmbH Lung surfactant
EP0110498A1 (en) * 1982-11-22 1984-06-13 Teijin Limited Artificial lung surfactant and remedy for respiratory distress syndrome containing it as active principle
EP0119056A2 (en) * 1983-03-10 1984-09-19 Tokyo Tanabe Company Limited Surfactant composition and pharmaceutical compositions containing same for use in the treatment of respiratory distress syndrome
FR2586587A1 (en) * 1985-08-30 1987-03-06 Adir NEW ARTIFICIAL SURFACTANTS, THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM.

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0050793A1 (en) * 1980-10-24 1982-05-05 The Regents Of The University Of California Lung surfactant compositions
DE3228629A1 (en) * 1982-07-31 1984-02-02 Reifenrath, Rainer Richard Otto, Dr., 3104 Unterlüß Pharmaceutical product for the treatment of the airways and process for its production
EP0100910A2 (en) * 1982-08-05 1984-02-22 A. Nattermann & Cie. GmbH Lung surfactant
EP0100910A3 (en) * 1982-08-05 1985-11-21 A. Nattermann & Cie. Gmbh Lung surfactant
EP0110498A1 (en) * 1982-11-22 1984-06-13 Teijin Limited Artificial lung surfactant and remedy for respiratory distress syndrome containing it as active principle
EP0119056A2 (en) * 1983-03-10 1984-09-19 Tokyo Tanabe Company Limited Surfactant composition and pharmaceutical compositions containing same for use in the treatment of respiratory distress syndrome
EP0119056A3 (en) * 1983-03-10 1986-06-25 Tokyo Tanabe Company Limited Surfactant and pharmaceutical compositions thereof for use in the treatment of respiratory distress syndrome
FR2586587A1 (en) * 1985-08-30 1987-03-06 Adir NEW ARTIFICIAL SURFACTANTS, THEIR PREPARATION AND THE PHARMACEUTICAL COMPOSITIONS CONTAINING THEM.
EP0214055A1 (en) * 1985-08-30 1987-03-11 Adir Et Compagnie Synthetic surface-active agents, their preparation and pharmaceutical compositions containing them
US4765987A (en) * 1985-08-30 1988-08-23 Adir & Cie Artificial surfactants, pharmaceutical compositions containing them and use thereof

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