Process for purifying alkoxylated fats

Details Process for purifying alkoxylated fats Process for purifying alkoxylated fats

1998-03-24

2000-08-01

Carr, Deborah D.

Organic compounds -- part of the class 532-570 series

Organic compounds

Fatty compounds having an acid moiety which contains the...

554193, 554198, 554202, C11B 310

Patent

active

060969113

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The invention relates to a process for purifying alkoxylated fats by treatment with a solid substance, to alkoxylated fats obtainable by this process, and to the use thereof.
Alkoxylated fats are employed for a large number of purposes. One purpose, which is increasing in importance, is the use as constituent of the solvent for preparing solutions of active substances which are insoluble in water, especially drugs. For administration of drugs it is necessary in certain cases that the drugs are present in stable solutions, eg. when the drugs are to be infused.
EP 645 145 A discloses pharmaceutical formulations which consist of a solution of an antineoplastic active substance and of a solvent, with the solvent comprising alkoxylated fats as cosolvent or solubilizer. The pharmaceutical formulation is stabilized by addition of an acid or of a salt or by treatment of the alkoxylated fat with aluminum oxide, in particular owing to the fact that the carboxylate content is reduced to a particular level.
WO 94/12030 discloses that pharmaceutical formulations as described in EP 645 145 can be stabilized by adding particular acids, in which case the resulting pH must be below 8.1.
However, these prior art constituents of pharmaceutical formulations often do not yet meet the requirements to be met by such constituents in respect of the stability of the resulting formulation.


BRIEF SUMMARY OF THE INVENTION

It is an object of the present invention to provide a process with which alkoxylated fats can be purified so that they are more suitable for use in pharmaceutical formulations.
We have found that this object is achieved by a process for purifying alkoxylated fats by treatment with a solid substance, wherein a mixture of aluminum oxide and a silicate is employed as solid substance.
Not only is it possible with the process according to the invention to reduce the content of impurities, it is also possible to diminish the water content and lower the pH.
Surprisingly, the process according to the invention also reducers the viscosity of the alkoxylated fat, which results in products which can be administered better. If the viscosities of the starting material are in the range 700-850 mPa.multidot.s, the product purified according to the invention has a viscosity in the range 600-750 mPa.multidot.s, ie. a reduction of 100 mPa.multidot.s in each case. In addition, a reduction in catalyst residues can also be achieved.


DETAILED DESCRIPTION OF THE INVENTION

A preferred embodiment of the process according to the invention comprises mixing and stirring the alkoxylated fats with the aluminum oxide and the silicate (adsorbents) and then filtering off the solid substances. It was surprising that the desired purifying effect is achieved simply by mixing the components, where appropriate at elevated temperature. The treatment of the alkoxylated fat preferably takes place by mixing with the adsorbents and stirring at 15-180.degree. C., preferably at 30-100.degree. C., in particular 40-80.degree. C. The pressure can be reduced to 10-800 mbar during the reaction. The reaction can also be carried out under protective gas (eg. N.sub.2). The reaction time is preferably from 1 to 12 h. 0.5-15% by weight, in particular 1-10% by weight, of adsorbents are preferably added. It is also possible additionally for 0-3% by weight of a filtration aid, such as diatomaceous earth (kieselguhr), to be added.
The silicates preferably employed are alkali metal and/or alkaline earth metal silicates, especially Mg silicate or Ca silicate, or Al silicates, but also fuller's earth. Commercial products which may be mentioned by way of example are Ambosol, Tonsil FF or Magnesol.
The mixture of aluminum oxide and silicate is, as a rule, obtained by mechanically mixing the two constituents, eg. in the reaction vessel.
A preferred embodiment of the process furthermore comprises adding an acid before, during or after the treatment with the solid substances. The purified final product can be acidified, for example with short-chain

REFERENCES:
patent: 4735815 (1988-04-01), Taylor et al.
patent: 5504102 (1996-04-01), Agharkar et al.
JP 58020152--Derwent Abst, 1983.
JP 1099518--Derwent Abst, 1989.

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