Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex
Patent
1993-06-16
1995-08-15
Robinson, Douglas W.
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Conjugate or complex
514783, 426601, A61K 3578
Patent
active
054417384
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of the Invention.
The invention relates to a process for improving a glycerolysed oil; it also relates to the oils thus improved.
2. Description of the Prior Art.
As is known, glycerolysed oils, which are well known as excipients in the pharmaceutical industry, are obtained by glycerolysis in the presence of alkaline catalysts. In one embodiment, these oils contain a residual glycerol level at most equal to one percent (1%).
In the text and the claims, "glycerolysed oil" designates a natural oil of plant or animal origin which has undergone alcoholysis treatment with glycerol, or a direct esterification of its fatty acids on glycerol.
These glycerolysed oils are essentially characterized by the fact that they consist of a mixture of mainly mono- and diesters of glycerol and of a smaller quantity of triesters. These glycerolysed oils must contain at least 90% by weight of glycerides (FDA-21 CFR requirements--Chapter I--.sctn.184.1505), and must have a high proportion (at least 50% and in practice of the order of 80%) of unsaturated fatty acids. Oils which may be mentioned are those of plant origin, such as those of corn, sunflower (high and low linoleic acid content) safflower (high and low linoleic acid content), palm (fractionated or otherwise), groundnut or colza, or of animal origin, such as that of tallow.
However, these glycerolysed oils have the bad tendency, when they are stored at room temperature, to crystallize partially and gradually, forming small white crystals which settle after a few hours to several days depending on the thermal history of the samples. These white crystals swell rapidly and render this oil unsuitable for its use as pharmaceutical excipient and partially mask the properties of the active ingredients.
To prevent the formation of these crystals, it has been suggested to add to the oil during the glycerolysis unsaturated fatty acids which form esters which do not precipitate. Unfortunately, this solution is poorly adapted to the pharmaceutical industry since the oil thus treated does not always correspond to the requirements of international standards for the "glycerolysed oil" designation, especially to the requirements of the GRAS (generally recognized as safe) standard based on the FDA (Food and Drug Administration) rules mentioned above.
SUMMARY OF THE INVENTION
The invention overcomes these disadvantages. It relates to a process for improving these glycerolysed oils, and more particularly aims to extract, by a physical process, the portion liable to crystallize, so that the oils thus treated can satisfy the requirements of the pharmaceutical industry.
The invention relates more particularly to a process which makes it possible to obtain a glycerolysed oil which is liquid and clear for at least three days at 15.degree. C., which could not be obtained up until now.
This process for improving a glycerolysed oil is characterized in that it consists: hours until an end of crystallization temperature of between 0.degree. and 15.degree. C. is reached; at the same temperature as the end of crystallization temperature.
While this process can be carried out in a single step, it is also possible to use an operation comprising several successive steps. In this case it is important for the characteristic treatment temperature to be lower from one step to the next, and for the temperature of the last step to be between 0.degree. and 15.degree. C.
In a two-stage end of crystallization process, the procedure is advantageously carried out, in a first stage, between 15.degree. and 25.degree. C., and then, in a second stage, between 0.degree. and 15.degree. C.
"End of crystallization temperature" designates the temperature at which the thermal cycle used for the partial crystallization of the product ends, which is in fact carried out over a range of temperatures, and at which the separation stages begin and are carried out.
Advantageously, in practice: crystals formed, but also to destroy the thermal history of the oil; it was observed that good resu
REFERENCES:
patent: 3012890 (1961-12-01), Dutton et al.
patent: 4265826 (1981-05-01), Iida et al.
patent: 4272447 (1981-06-01), Beharry
G. Hoffman `The Chemistry and Technology of Edible Oils and Fats and Their High Fat Products`, (1990) Academic Press Chapter 5.
Denis Joel
Klein Jean-Marie
Gattefosse SA
Lee Howard C.
Robinson Douglas W.
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