US4563354A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Oil-in-water emulsion for parenteral administration
Assignee: Pfizer Health AB
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Filing: 1983-10-26
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Granted: 1986-01-07
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Expires: 2003-10-26
Abstract
Abstract An emulsifier adapted for use in a nutritive oil-in-water emulsion suitable for parenteral administration is produced by extracting vegetable lecithin with alkyl alcohols having from 1 to 3 carbon atoms, or mixtures thereof, followed by fractional precipitation at specific temperatures and concentrations effective to cause the removal of toxic materials. The alcohol soluble phospholipid fraction produced by the process contains an increased level of phosphatidyl choline and reduced levels of phosphatidyl ethanolamine, inositol phospholipids, phosphatidic acid and glycolipids.
Inventors
- 👤 Stephen S. Chang
- 👤 Lars Lindmark
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 13:30
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/0012; A61K9/0019; A61K9/0029; A23; A23J; A23J7/00
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
85 words
A soybean phospholipid emulsifier adapted for use in nutritive oil-in-water emulsions suitable for parenteral administration, said emulsifier comprising a fraction of soybean lecithin produced by: extracting soybean lecithin with a lower alkyl alcohol having up to 3 carbon atoms; chilling the filtrate of said extraction to between about -20° and -85° C. and at alcohol concentrations between 2.5:1 and 40:1, solvent:phospholipid, for a time effective to precipitate insoluble materials comprising toxic materials; and recovering the soluble soybean lecithin fraction from the solution as the emulsifier.
Claim 2
Dependent Claim
85 words
A soybean phospholipid emulsifier adapted for use in nutritive oil-in-water emulsions suitable for parenteral administration, said emulsifier comprising a fraction of soybean lecithin produced by: extracting soybean lecithin with a lower alkyl alcohol having up to 3 carbon atoms; chilling the filtrate of said extraction to between about -20° and -85° C. and at alcohol concentrations between 2.5:1 and 40:1, solvent:phospholipid, for a time effective to precipitate insoluble materials comprising toxic materials; and recovering the soluble soybean lecithin fraction from the solution as the emulsifier.
Claim 3
Dependent Claim
23 words
A soybean phospholipid emulsifier as described in claim 1, wherein the soybean lecithin is "wet gum" obtained from degumming of crude vegetable oils.
Claim 4
Dependent Claim
17 words
A soybean phospholipid emulsifier as described in claim 1, wherein the lower alkyl alcohol comprises ethyl alcohol.
Claim 5
Dependent Claim
19 words
A soybean phospholipid emulsifier as described in claim 1, wherein the precipitation is carried out at about -20° C.
Claim 6
Dependent Claim
24 words
A soybean phospholipid emulsifier as described in claim 1, wherein the precipitation is carried out at an alcohol concentration of about 5 to 1.
Claim 7
Dependent Claim
76 words
A soybean phospholipid emulsifier adapted for use in nutritive oil-in-water emulsions suitable for parenteral administration, said emulsifier comprising a lower alkyl alcohol-soluble fraction of soybean lecithin produced by removing insolubles precipitated at temperatures between about -20° C. and -80° C. and alcohol to phospholipid ratios between 2.5:1 and 40:1, said fraction comprising about 55% by weight of phosphatidyl choline, about 5% by weight of phosphatidyl ethanol amine and essentially free of inositol phospholipids and phosphatidic acid.
Claim 8
Dependent Claim
76 words
A soybean phospholipid emulsifier adapted for use in nutritive oil-in-water emulsions suitable for parenteral administration, said emulsifier comprising a lower alkyl alcohol-soluble fraction of soybean lecithin produced by removing insolubles precipitated at temperatures between about -20° C. and -80° C. and alcohol to phospholipid ratios between 2.5:1 and 40:1, said fraction comprising about 55% by weight of phosphatidyl choline, about 5% by weight of phosphatidyl ethanol amine and essentially free of inositol phospholipids and phosphatidic acid.
Claim 9
Dependent Claim
30 words
A soybean phospholipid emulsifier as described in claim 6, wherein the alcohol-soluble fraction contains about 12% by weight of saturated fatty acids and about 79% by weight of polyunsaturated acids.
Claim 10
Independent Claim
84 words
A method of preparing a soybean phospholipid emulsifier adapted for use in a nutritive oil-in-water emulsion suitable for parenteral administration comprising extracting soybean lecithin a plurality of times with a lower alkyl alcohol having up to 3 carbon atoms, precipitating the insolubles from each filtrate at temperatures between about -20° and -85° C. and alcohol concentrations between about 2.5 and 40 liters of alcohol per kilogram of lecithin for a time sufficient to precipitate toxic materials, and recovering the alcohol-soluble fraction as the emulsifier.
Claim 11
Independent Claim
84 words
A method of preparing a soybean phospholipid emulsifier adapted for use in a nutritive oil-in-water emulsion suitable for parenteral administration comprising extracting soybean lecithin a plurality of times with a lower alkyl alcohol having up to 3 carbon atoms, precipitating the insolubles from each filtrate at temperatures between about -20° and -85° C. and alcohol concentrations between about 2.5 and 40 liters of alcohol per kilogram of lecithin for a time sufficient to precipitate toxic materials, and recovering the alcohol-soluble fraction as the emulsifier.
Claim 12
Dependent Claim
21 words
A method as described in claim 8 wherein the lower alkyl alcohol used for one extraction consists essentially of ethyl alcohol.
Claim 13
Dependent Claim
20 words
A method as described in claim 9 wherein the lower alkyl alcohol for all extractions consists essentially of ethyl alcohol.
Claim 14
Dependent Claim
20 words
A method as described in claim 8 wherein the first extraction comprises mixing lecithin with alcohol at about 50° C.
Claim 15
Dependent Claim
29 words
A method as described in claim 11 wherein the alcohol-soluble fraction is separated from the insoluble fractions by chilling the alcohol-phosphatide mixture to about -20° C. followed by filtration.
Claim 16
Dependent Claim
27 words
A method as described in claim 11 wherein the insolubles are precipitated using an alcohol concentration of about 5 liters of alcohol to 1 kilogram of lecithin.
Claim 17
Dependent Claim
112 words
A nutritive oil-in-water emulsion suitable for parenteral administration comprising soybean oil, an emulsifier for said oil, and water: said emulsifier consisting essentially of a fraction of soybean lecithin produced by: extracting a weight of soybean lecithin with a lower alkyl alcohol having up to 3 carbon atoms, the volume of alcohol being a ratio of at least 2 liters of alcohol for each kilogram of lecithin; chilling the filtrate of said extraction to between about -20° and -85° C. and at alcohol concentrations between 2.5:1 and 40:1, solvent:phospholipid, for a time effective to precipitate insoluble materials comprising toxic materials; and recovering the soluble soybean lecithin fraction from the solution as the emulsifier.
Claim 18
Dependent Claim
112 words
A nutritive oil-in-water emulsion suitable for parenteral administration comprising soybean oil, an emulsifier for said oil, and water: said emulsifier consisting essentially of a fraction of soybean lecithin produced by: extracting a weight of soybean lecithin with a lower alkyl alcohol having up to 3 carbon atoms, the volume of alcohol being a ratio of at least 2 liters of alcohol for each kilogram of lecithin; chilling the filtrate of said extraction to between about -20° and -85° C. and at alcohol concentrations between 2.5:1 and 40:1, solvent:phospholipid, for a time effective to precipitate insoluble materials comprising toxic materials; and recovering the soluble soybean lecithin fraction from the solution as the emulsifier.
Claim 19
Dependent Claim
17 words
A nutritive oil-in-water emulsion as described in claim 14, wherein the lower alkyl alcohol comprises ethyl alcohol.
Claim 20
Dependent Claim
19 words
A nutritive oil-in-water emulsion as described in claim 14, wherein the precipitation is carried out at about -20° C.
Claim 21
Dependent Claim
24 words
A nutritive oil-in-water emulsion as described in claim 14, wherein the precipitation is carried out at an alcohol concentration of about 5 to 1.
Claim 22
Dependent Claim
17 words
A nutritive oil-in-water emulsion as described in claim 14 which comprises 10-30% by weight of soybean oil.
Claim 23
Dependent Claim
21 words
A nutritive oil-in-water emulsion as described in claim 14 which comprises from about 0.4% to 2% by weight of said emulsifier.
Claim 24
Dependent Claim
89 words
A nutritive oil-in-water emulsion suitable for parenteral administration comprising soybean oil, an emulsifier for said vegetable oil, and water: said emulsifier comprising a lower alkyl alcohol-soluble fraction of soybean lecithin produced by removing insolubles precipitated at temperatures between about -20° C. and -80° C. and alcohol to phospholipid ratios between 2.5:1 and 40:1 said alcohol having no more than 3 carbon atoms, said fraction comprising about 55% by weight of phosphatidyl choline, about 5% by weight of phosphatidyl ethanol amine and essentially free of inositol phospholipids and phosphatidic acid.
Claim 25
Dependent Claim
89 words
A nutritive oil-in-water emulsion suitable for parenteral administration comprising soybean oil, an emulsifier for said vegetable oil, and water: said emulsifier comprising a lower alkyl alcohol-soluble fraction of soybean lecithin produced by removing insolubles precipitated at temperatures between about -20° C. and -80° C. and alcohol to phospholipid ratios between 2.5:1 and 40:1 said alcohol having no more than 3 carbon atoms, said fraction comprising about 55% by weight of phosphatidyl choline, about 5% by weight of phosphatidyl ethanol amine and essentially free of inositol phospholipids and phosphatidic acid.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1989-01-06 | 1989-07-08 | 1990-01-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-01-06 | 1993-07-08 | 1994-01-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1997-01-06 | 1997-07-08 | 1998-01-07 | $7700.00 | Window Closed / Lapsed |