Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Fat or oil is basic ingredient other than butter in emulsion...
Reexamination Certificate
1997-08-22
2002-07-23
Paden, Carolyn (Department: 1761)
Food or edible material: processes, compositions, and products
Products per se, or processes of preparing or treating...
Fat or oil is basic ingredient other than butter in emulsion...
C426S603000, C426S602000
Reexamination Certificate
active
06423363
ABSTRACT:
BACKGROUND OF THE INVENTION
Hydrogenation, fractionation and interesterification are the most common processes utilized within the fats and oils industry to modify the chemical and/or physical properties of conventional triglyceride fats or other lipids to improve their utility and functionality, e.g. to modify melting points, increase hardness or the solid fat content, increase oxidative stability, etc. These processes may be used individually or can be combined to produce fats and oils with very specific characteristics. When employing these processes to increase hardness or the solid fat content in the simplest of terms, these processes rely on the reduction of unsaturation or the increase of saturation and/or the formation of trans fatty acids.
Considerable attention has been drawn in recent years to the relatively high total fat, saturated fat and trans fat content of the typical diet.
Related health issues which have been greatly publicized are elevated cholesterol levels and low HDL/LDL cholesterol ratios reportedly resulting from ingestion of saturated fats and cholesterol. And, in addition to saturated fats, some reports have implicated trans fatty acids, which are generated when liquid oils are partially hydrogenated to increase their solid fat content.
Phytosterols are sterols found in plants. While these compounds have long been touted for their cholesterol lowering effects, they tend to be very high melting compounds (melting points around 150° C.), and they are difficult to formulate into consumer food products due to poor solubility in fats and immiscibility in water. This solubility problem has been partially mitigated by esterification of the sterol. Nevertheless, this still limits use of sterols to food compositions with moderate to high fat contents.
U.S. Pat. No. 5,156,866 discloses sterols used in chewing gums. An emulsifier is added to decrease viscosity.
U.S. Pat. No. 5,445,811 is directed to phytosterols used in an oil-in-water emulsion intended for intravenous administration as a contrasting agent for visibilizing the presence of tumors. Synthetic emulsifiers of the type normally used for preparing oil-in-water emulsions are said to be of particular interest. The weight ratio between emulsifier and cholesterol or phytosterol can range between 1:1 and 1:2. In Example 2, 0.06 g cholesterol is used per 100 ml of mixture. The mixture is homogenized and autoclaved at 121° C. In Example 1, 2 g of cholesterol are used and the mean particle size of the emulsion is 0.25 mu m. In Example 6, 1.5 g of cholesterol per 100 ml mixture are used. It is said that the mean size of the emulsion particles will preferably be beneath 1 mu m.
U.S. Pat. No. 5,244,887 is directed to the use of plant stanols to reduce cholesterol absorption from foods. It is said that the greatest effectiveness is obtained when the stanols are evenly distributed in finely divided form throughout the food product or beverage. This can be accomplished by dissolving the stanols in a solubilizing agent such as vegetable oil, monoglyceride, diglycerides, tocopherols, and mixtures thereof and making suspensions or emulsions of the solubilized stanols in carriers such as water, alcohol, polyols and other edible compounds or by suspension of the stanols in an emulsion. Solubilizing agents such as monoglycerides and diglycerides are mentioned. A preferred food additive is said to comprise, in addition to 25% stanols, 74.8% vegetable oil and tocopherol. The compounds of the invention are used as food additives to foods such as meats, eggs, and dairy products. The stanols are said to remain in solution or uniformly suspended.
U.S. Pat. No. 4,160,850 mentions low fat margarine products having less than 60 wt. % fat. The invention is directed to a shelf stable mix suitable for consumer preparation of a spreadable butter substitute having from about 20-80% oil and from about 10 to about 80% water. A water-in-oil emulsifier is included. Preferred emulsifiers are phytosterols. In preparing the solid form of the mix, the emulsifier and hard fat having a melting point of from about 29° C. to about 66° C. are formed together as a mixture and solidified. The emulsifier is then added to the melted fat and mixed until a clear solution is obtained.
U.S. Patent No. 3,865,939 is directed to edible cooking and salad oil compositions having enhanced hypocholesterolemic properties including plant sterols. The limited solubility of plant sterols in any solvent system is noted. A solubilizing agent to solubilize the plant sterol in the oil is selected from the group consisting of fatty acids, monoesters of fatty acids with polyhydric alcohols and alkanols. The invention is said also to contemplate peanut better, mayonnaise, ice cream and margarine spreads. A solubilizing agent may be selected from a group including simple esters of fatty acids such as monoglycerides.
U.S. Pat. No. 5,502,045 is directed to a beta-sitostanol fatty acid ester or mixture thereof which lowers cholesterol levels. In Example 5 a beta-sitostanol ester mixture is added to the fatty part of a conventional soft margarine.
Ong, U.S. Pat. No. 4,195,084 is directed to a pharmaceutical preparation comprising a taste-stable aqueous suspension of tall oil sitosterols.
Beta sitosterol is described as being the most effective of the sterols for lowering serum cholesterol. Because of certain physical properties of the sterols, it is said not to have been practical to provide a pharmaceutical suspension for oral administration which contains much more than 20 w/v of sitosterols. It is said that in order for sitosterols to be the most effective in lowering serum cholesterol the medicament must reach the gastrointestinal tract in a finally divided dispersed state.
Ong also reports that sitosterols do not lend themselves readily to incorporation into an aqueous preparation for oral administration that has a pleasant mouthfeel.
The Ong invention is directed to an aqueous pharmaceutical suspension comprised of finally divided tall oil sitosterols, a pharmaceutically acceptable chelating agent, sodium carboxymethylcellulose, sorbitol, a pharmaceutically acceptable surfactant, simethicone and water. The product is said to have an acceptable taste and mouthfeel that does not change over an extended storage period.
The pharmaceutical suspension of Ong may contain up to about 25 w/v of finally divided tall oil sitosterols. At about 20% tall oil sitosterols, the suspension is said not to be excessively viscous and is relatively easy to pour, having both good physical and chemical stability. A tall oil sitosterols preparation is said to develop no taste change after one year of shelf storage as compared with bitter taste development within two weeks at room temperature for a suspension of tall oil sitosterols not within the Ong invention. It is said that tall oil sitosterols are very hydrophobic and stubbornly resist wet wetting. Vigorous continuous agitation is said to be required to disperse the tall oil sitosterols in the vehicle.
The Ong phytosterol are said to be ground to a mean particle size of 25 microns or below by use of an air mill, high energy hammermill or air filtration mill under refrigeration or through the use of finely ground dry ice.
EP 289 636 discloses an emulsified or solubilized sterol composition wherein the sterols are emulsified or solubilized in an aqueous solution of polyhydroxy compounds containing sucrose fatty acid esters and/or polyglycerol fatty acid esters or liquid polyhydroxy compounds. A considerably high shelf stability is said to result and the invention is said to be extremely useful in various products including food, cosmetics, drugs and agricultural chemicals.
Sterols are described as high melting compounds which are hardly soluble in water and have a melting point of approximately 150° C. It is said to be difficult to obtain a stabily emulsified or solubilized composition. Beta-sitosterol is mentioned among the sterols which may be used in the '636 invention.
The compositions are prepared by, for example, adding sucrose este
Patrick Matthew
Traska Alexander Wolodymyr
Lipton division of Conopco, Inc.
McGowan, Jr. Gerard J.
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