CA2003720A1 - Lipid emulsion for treating aids - Google Patents

Lipid emulsion for treating aids

Info

Publication number
CA2003720A1
CA2003720A1 CA002003720A CA2003720A CA2003720A1 CA 2003720 A1 CA2003720 A1 CA 2003720A1 CA 002003720 A CA002003720 A CA 002003720A CA 2003720 A CA2003720 A CA 2003720A CA 2003720 A1 CA2003720 A1 CA 2003720A1
Authority
CA
Canada
Prior art keywords
approximately
percent
weight
emulsion
composition
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.)
Abandoned
Application number
CA002003720A
Other languages
French (fr)
Inventor
Howard L. Shaw
Jeffrey Askanazi
William D. Leathem
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Howard L. Shaw
Jeffrey Askanazi
William D. Leathem
Abbott Laboratories
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 Howard L. Shaw, Jeffrey Askanazi, William D. Leathem, Abbott Laboratories filed Critical Howard L. Shaw
Publication of CA2003720A1 publication Critical patent/CA2003720A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/683Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV

Abstract

ABSTRACT

A composition for the treatment of patients having Acquired Immune Deficiency Syndrome comprising approximatley 2 to 7 percent by weight soybean oil and approximately 1 to 2 percent by weight egg phosphatide and a method for the parenteral administration of this composition is disclosed.

4632.US.O1

Description

~003~
LIPID EMULSION FOR TREATING AIDS

FIELD OF THE INVENTION
The present invention relates to a composition and method for treating patients with Acquired Immune Deficiency Syndrome. More particularly, this invention relates to a composition for the parenteral administration of a non- or low carbohydrate source of calories for nutritional support and phosphatides to stimulate prostaglandin synthesis.

BACKGROUND OF THE INVENTION
The number of patients suffering from Acquired Immune Deficiency Syndrome (AIDS) has increased dramatically since the first cases were reported a few years ago. The disease has caused opportunistic infections and secondary cancers in more than 50,000 people in the United States and many more throughout the world. Patients suffering from AIDS are often nutritionally unbalanced and wasted. Weight loss and decrease in serum albumin, total iron binding capacity and retinal binding protein are often seen. Body composition analysis in AIDS patients demonstrates a depletion in total body potassium and body fat content with an increase in extracellular water. These symptoms are often seen in those suffering from chronic malnutrition.
A number of factors lead to malnutrition in AIDS patients. These include a decrease in food intake, vomiting, the side effects of therapeutic drugs and a high incidence of malabsorption syndrome with or without dlarrhea.
When malabsorption syndrome and/or diarrhea do not permit effective oral feeding, parenteral nutrition 2 ~3~ ~ O

is indica~ed. Conventional parenteral nutrition compositions and methods of therapy are unbalanced attempts at nutritional restitution. They contain too high a fat content which, if administered too rapidly, can exacerbate the formation of pro-inflammatory prostanoids and prevent the beneficial effects of low-fatty acid administration. This invention permits administration of the desired level of egg phospholipids and triglycerides over a longer period of time without exacerbating pro-inflammatory prostanoids or inducing fat overload.
It is also known that some of the manifestations of AIDS are ameliorated by non-steroidal anti-inflammatory agents. It is believed that these effects are related to a preferential suppression of certain prostaglandins by these agents. Prostaglandins are synthesized in the body from fatty acid precursors which are derived from lipids. The composition, rate of administration and concentration of neutral lipids, fatty acids and lecithins administered parenterally can determine the prostaglandin synthetic pathway and thereby the specific class of eicosanoid being preferentially synthesized.
Thus, there is a need for a low fat - high phosphatide parenteral formulation for the treatment of AIDS patients either as a component of total parenteral nutrition o as a parenteral supplement to patients receiving nutrition orally.

SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a composition and a method for the treatment of AID~ patients which comprises parenterally administering to such patients a composition comprising a soybean oil emulsion containing egg phosphatide. More 2~ %~

particularly, the compositions contain approximately 2 to 7 percent by weight soybean oil and approximately 1 to 2 percent by weight egg phosphatide. The compositions of this invention contain a higher egg phosphatide/triglyceride ratio, in comparison to commercially available fat emulsions, in the range of about 1:1 to 1:3 which makes it possible to provide a sufficient level of egg phosphatide to promote mobilization of tissue cholesterol without inducing fat overload.

DESCRIPTION OF THE PREFERRED_EMBODIMENTS

The presently preferred parenteral compositions of this invention contain approximately 2 percent by weight soybean oil and approximately 1.2 percent by weight egg phosphatide.
The most preferred parenteral composition of the present invention contains the following:
Inqredient Per mL
Soybean Oil, Wiwnterized 20 mg Egg Phosphatide 12 mg Glycerin, USP 25 mg Nitrogen, USP q.s.
Sodium Hydroxide q.s.
Water q.s.

The soybean oil utilized in the composition of the present invention may be obtained from any commercially available source and should have a fatty acid composition of from about 44 to about 62 weight percent linoleic acid, from about 19 to about 30 weight percent oleic acid, from about 7 to about 14 weight percent palmitic acid, from about 1 to about 6 weight percent stearic acid, and from about 4 to about 11 3~72~) weight percent linolenic acid. The egg phosphatide utilized in the composition of the present invention may also be obtained from commercially available sources and should preferably ha~e a nitrogen to phosphorous molar ratio of from about 0.97 to about 1.17.
The composition of the present invention may be prepared in accordance with known procedures in the art as illustrated by the following example.

Water for injection (approximately 1 L) is heated and protected by a nitrogen atmosphere. Egg phosphatide (12g) is added to the wa~er and dispersed by agitation at a temperature in the range of 50 to 90C.
Glycerin (25g) is filtered through an 0.8 micrometer membrane filter and added to the dispersion using a Manton-Gaulin homogenizer to finely divide the egg phosphatide and increase the degree of dispersion. The aqueous phosphatide dispersion is then filtered through a nylon or equivalent membrane of 0.45 micrometer porosity and the pH is adjusted to a range of 8.5 to 10.5 with sodium hydroxide. Soybean oil, winterized, (20g) is filtered through a 0.45 micrometer membrane, heated to a temperature in the range of 55 to 95C and added to the egg phosphatide dispersion with agitation to form a coarse emulsion concentrate which is then homogenized using a Manton-Gaulin homogenizer at a pressure of 2000 to 5000 psi. The pH is then adjusted to a rang~ of 8.5 to 9.5, if necessary, with sodium hydroxide and the emulsion is filtered through a nylon membrane of at least 0.8 micrometer porosity with sufficient surface area to provide minimum restriction of flow. The emulsion is then further homogenized in a Manton-Gaulin homogenizer, diluted to a desired concentration with sterile water and the pH adjusted to ~3~

a range of 8.5 to 9.6 with sodium hydroxide.
When used in treating patients with AIDS the emulsions of this invention should be administered parenterally in amounts su~ficient to provide approximately 50 to 30 mL/Kg day.

.

Claims (6)

1. An emulsion composition for parenteral adminis-tration comprising approximately from about 2 to about 7 percent by weight soybean oil and approximately from about 1 to about 2 percent by weight egg phosphatide.
2. An emulsion as in Claim 1, wherein the soybean oil comprises aproximately 2 percent by weight of said emul-sion and the egg phosphatide comprises approximately 1.2 percent by weight of said emulsion.
3. An emulsion as in Claim 1 having a pH in the range of approximately 8.5 to approximately 9.5.
4. An emulsion as in Claim 1 which contains glyc-erine.
5. The use of an emulsion composition according to Claim 1 against Acquired Immune Deficiency Syndrome, in host mammal, said composition comprising approximately from about 2 to 7 percent by weight soybean oil, and approximately from about 1 to about 2 percent by weight egg phosphatide.
6. The use of an emulsion composition according to Claim 5, wherein the effective amount used is in the range of approximately 5 to 30 mL/Kg.
CA002003720A 1988-11-23 1989-11-23 Lipid emulsion for treating aids Abandoned CA2003720A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US27618188A 1988-11-23 1988-11-23
US276,181 1988-11-23

Publications (1)

Publication Number Publication Date
CA2003720A1 true CA2003720A1 (en) 1990-05-23

Family

ID=23055541

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002003720A Abandoned CA2003720A1 (en) 1988-11-23 1989-11-23 Lipid emulsion for treating aids

Country Status (8)

Country Link
US (1) US5134130A (en)
EP (1) EP0370457B1 (en)
JP (1) JPH02184633A (en)
AU (1) AU641369B2 (en)
CA (1) CA2003720A1 (en)
DE (1) DE68903930T2 (en)
ES (1) ES2053925T3 (en)
GR (1) GR3006646T3 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5817646A (en) * 1991-11-15 1998-10-06 Laboratoires Inocosm Polar lipid composition of plant origin
US6784326B1 (en) * 1998-06-17 2004-08-31 Cognis Corporation Process for improving stability of glycerin
US20080187562A1 (en) * 2007-02-02 2008-08-07 Aixing Fan Antiperspirant/Deodorant Compositions
US9789038B2 (en) 2007-02-02 2017-10-17 Colgate-Palmolive Company Antiperspirant/deodorant compositions
US7976828B2 (en) * 2007-02-02 2011-07-12 Colgate-Palmolive Company Antiperspirant/deodorant composition

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA725596A (en) * 1960-08-26 1966-01-11 J. Wretlind Arvid Method of preparing intravenously injectable fat emulsions free from side reactions or complications
DE1249454B (en) * 1960-08-26 1967-09-07 Vitrum Apoteksvar Process for the preparation of intravenously administrable fat emulsions
DE2533612A1 (en) * 1974-08-19 1976-03-04 Pharmacia Ab PARENTERALLY ADMINISTRATIVE OIL AND PROCESS FOR ITS MANUFACTURING
US4073943A (en) * 1974-09-11 1978-02-14 Apoteksvarucentralen Vitrum Ab Method of enhancing the administration of pharmalogically active agents
US4157404A (en) * 1978-07-28 1979-06-05 Asahi Kasei Kogyo Kabushiki Kaisha Process for obtaining yolk lecithin from raw egg yolk
JPS5810365B2 (en) * 1978-09-08 1983-02-25 田辺製薬株式会社 fat emulsion
GB2046092B (en) * 1979-03-05 1983-11-02 Toyama Chemical Co Ltd Pharmaceutical composition containing a lysophospholid and a phospholipid
DE2948607A1 (en) * 1979-12-03 1981-06-11 Chemische Fabrik Dr. Meyer-Castens & Co Nfg., 2000 Hamburg METHOD FOR PRODUCING A LECITHIN-BASED EMULSIFIER
US4677099A (en) * 1981-09-04 1987-06-30 Yeda Research And Development Co., Ltd. Medical processes employing a novel lipid fraction
IL63734A (en) * 1981-09-04 1985-07-31 Yeda Res & Dev Lipid fraction,its preparation and pharmaceutical compositions containing same
DE3339236A1 (en) * 1983-10-28 1985-05-09 Bayer Ag PREPARATION OF MEDICINAL PRODUCTS
EP0145873B1 (en) * 1983-12-16 1989-01-04 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Transfusion emulsion
NO862999L (en) * 1985-07-26 1987-01-27 Yeda Res & Dev LIPID MIXTURE FOR MEMBRANE FLUIDIZATION.
IL78930A0 (en) * 1985-07-29 1986-09-30 Abbott Lab Lyophilized emulsion compositions for parenteral administration
US4857514A (en) * 1985-09-17 1989-08-15 Yeda Research And Development Company, Ltd. Virus inactivation

Also Published As

Publication number Publication date
EP0370457A1 (en) 1990-05-30
JPH02184633A (en) 1990-07-19
DE68903930T2 (en) 1993-05-19
GR3006646T3 (en) 1993-06-30
DE68903930D1 (en) 1993-01-28
ES2053925T3 (en) 1994-08-01
AU641369B2 (en) 1993-09-23
US5134130A (en) 1992-07-28
EP0370457B1 (en) 1992-12-16
AU4545189A (en) 1990-05-31

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Legal Events

Date Code Title Description
FZDE Discontinued