Preparation and use of solidified oils

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical

Reexamination Certificate

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C514S560000, C426S608000

Reexamination Certificate

active

06773715

ABSTRACT:

FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to a method of solidifying at least one oil by the addition of at least one solid fat and, more particularly, to a method of forming a semi-sold paste containing a high concentration of an oil which is normally liquid. The present invention further relates to a soft solid mixture which typically includes 50% or more ethyl esters of natural fatty acids and 50% or less solid fat and, more particularly, to a semi-solid mixture containing fish oil or another source of fat soluble vitamins, including, but not limited to, purified vitamin E. The present invention further relates to a method of using an oil for purposes including, but not limited to, nutritional supplementation, cosmetic treatment, and medical treatment.
Most fats which are nutritionally important substances exist as fluid oils. Their handling, storage and application is therefore limited to containers (e.g., cooking oil) or capsules (e.g., vitamin E). In principle, such oils can be handled in a solidified form by the addition of large excess of solids like starch, calcium carbonate, lactose etc., which is a common practice in the pharmaceutical industry. After addition of solids, the oils may be pressed into tablets. Owing to the physical size limit of tablets or capsules designed to be consumed by humans, high dose therapy with purified vitamin E, or with substances such as wheat germ oil or fish oil has been problematic because treatment regimens require daily consumption of tens of tablets or capsules. Much of the problem stems not from the efficacy of the therapeutic oil, but from poor patient compliance with treatment protocols requiring intake of large numbers of tablets or capsules each day. The root of this compliance problem lies in the fact that preparation of soft-soled mixtures which contain dietary oil at a concentration above 50% while the solidifying agent is biologically compatible, are not taught by prior art.
There is increasing evidence that vitamin e, or fish oil which is rich in omega-3 polyunsaturated fatty acids (&OHgr;-3 PUFA), can be used advantageously to treat or prevent a wide range of conditions including, but not limited to, excess gastric acid secretion, blood clotting, arterial thrombogenesis, various types of cancer, hepatitis, depression, high blood pressure, and heart disease (Riber, C. et al., Scand. J. Gastroenterol. (1999) 34:845-8; Saldeen, T. et al., J. Am. Coll. Cardiol. (1999) 34:1208-15; Ferguson, L. R. Mutat. Res. (1999) 428:329-38; Look, M. P. et al., Antiviral Res. (1999) 43:113-22; Kolleck, I. et al. Free Radic. Biol. Med. (1999) 27:882-90; Shibata, H. et al., J. Epidemiol. (1999) 9:261-7; Cham, B. E. et al., Clin. Chim. Acta. (1999) 287:45-57; Yosefy, C. et al., Prostaglandins Leukot Essent Fatty Acids (1999) 61:83-7; Hardman, W. E. et al. Br. J. Cancer (1999) 81:440-8; Barber, M. D. B. M. J. (1999) 319(7203):187; Adams, A. K. et al., Am. Fam. Physician (1999) 60:895-904; Barber, M. D. et al., Br. J. Cancer (1999) 81:80-6; Latham, P. et al. Biochem. Soc. Trans. (1998) 26:S158; Bang, H. O. Compr. Ther. (1990) 16:31-5; Urakaze, M. et al. J. Hum. Hypertens. (1989) 3:277-8)
Unfortunately, many patients suffering from diseases which may be treated by nutritionally important oils suffer from nausea and reduced appetite. These patients are especially unlikely to comply with treatment protocols which include ingestion of large numbers of pills or tablets each day.
There is thus a widely recognized need for, and it would be highly advantageous to have, nutritionally or medically important oils at high concentration in a semisolid form in order to facilitate better patient compliance with proposed treatment regimens.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a method of solidifying liquid oils, the method comprising the steps of (a) mixing at least one liquid oil and at least one solid fat, thereby forming a mixture of the at least one liquid oil and the at least one solid fat; and (b) transforming the mixture into a homogeneous consistency.
According to another aspect of the present invention there is provided a composition of matter comprising a mixture of at least one liquid oil and at least one solid fat.
According to yet another aspect of the present invention there is provided a composition of matter comprising a mixture of at least one ethyl ester of a natural fatty acid and at least one solid fat.
According to still another aspect of the present invention there is provided a method of using at least one liquid oil for a purpose selected from the group consisting of nutritional supplementation, cosmetic treatment, use as a food additive, medical treatment, medical prophylaxis and cosmetic prophylaxis, the method comprising the steps of using a composition of matter including a mixture of at least one liquid oil and at least one solid fat for accomplishing the purpose.
According to an additional aspect of the present invention there is provided a method of using at least one liquid oil for prevention or treatment of a medical condition selected from the group consisting of cancer, hypertriglyceridemia, hypo HDL, high cholesterol, hyperinsulinemia and hyperglycemia, the method comprising the step of using a composition of matter including a mixture of at least one liquid oil and at least one solid fat for accomplishing the prevention or treatment.
According to further features in preferred embodiments of the invention described below, the composition of matter has a homogeneous consistency.
According to still further features in the described preferred embodiments the at least one liquid oil is at least 50% of the mixture by weight.
According to still further features in the described preferred embodiments the composition of matter further comprising at least one additional ingredient.
According to still further features in the described preferred embodiments the at least one additional ingredient includes at least one flavoring agent.
According to still further features in the described preferred embodiments the at least one additional ingredient includes at least one odorant.
According to still further features in the described preferred embodiments the at least one solid fat is selected from a group of solid fats consisting of bee wax, propolis, butter, artificially hydrogenated vegetable oil, palm oil, cocoa butter, rendered animal fat and lanolin.
According to still further features in the described preferred embodiments the at least one solid fat is a synthetic polyester of fatty acids and a saccharide.
According to still further features in the described preferred embodiments the saccharide is selected from the group of saccharides consisting of sorbitol, glucose, fructose, lactose, mannose, ribose and deoxy-ribose.
According to still further features in the described preferred embodiments the at least one solid fat is a mixture of saccharide is sucrose and further wherein the fatty acid is selected from the group consisting of polypalmitate and polystearate.
According to still further features in the described preferred embodiments the at least one liquid oil includes omega-3 polyunsaturated fatty acids.
According to still further features in the described preferred embodiments the at least one liquid oil includes &agr;-tocopherol (vitamin E).
The present invention successfully addresses the shortcomings of the presently known configurations by providing nutritionally or medically important liquid oils at high concentration in a semi-solid form in order to facilitate better patient compliance with proposed treatment regimens.


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