Food or edible material: processes – compositions – and products – Product with added vitamin or derivative thereof for...
Reexamination Certificate
1999-04-16
2002-11-05
Pratt, Helen (Department: 1761)
Food or edible material: processes, compositions, and products
Product with added vitamin or derivative thereof for...
C426S074000, C426S573000, C426S577000, C426S580000, C426S583000
Reexamination Certificate
active
06475539
ABSTRACT:
TECHNICAL FIELD
This invention relates to a low pH enteral formula that contains high levels of macronutrients, vitamins and minerals. The inventive formula possesses excellent physical stability and taste. The inventive formula also exhibits a shelf life of at least one year in a liquid state with minimal or no sedimentation. The formula of this invention utilizes a unique stabilizing system, antioxidant system and method of production to produce a physically stable, low pH nutritional beverage that contains high levels of protein and delivers at least 25% of the Reference Daily Intake (RDI) for selected vitamins and minerals in approximately a 250 ml serving. The formula can be adjusted to meet the nutritional needs of adults and children over 4 years age or to children under 4 years of age.
BACKGROUND OF THE INVENTION
Nutritionally complete, balanced, isotonic enteral formula have been known for some time. These formula are designed to be used as the sole source of nutrition for a patient or as a supplement. Typically, these liquid products are designed to provide approximately 100% of the patient's nutritional needs in about 1,000 ml. These formula may also be designed to be disease specific in that they fulfill the special nutritional requirements of patients afflicted with conditions such as glucose intolerance, pulmonary disease or those who have been subjected to surgery or trauma. These nutritionally complete formula are known by the artisan to be prone to physical stability problems such as syneresis and the formation of non-dispersible sediments. These problems are caused by the high level of protein, fats and minerals that these nutritional formula must contain to provide adequate nutrition in a reasonable volume.
Most nutritionally complete enteral formula have a neutral pH and have flavors that are limited to the traditional “milkshake” types. Acidified or low pH nutritionals offer several advantages in that the possibility of microbial contamination can be reduced and a variety of refreshing fruit flavors can be used. However, acidification of the traditional enteral formula leads to protein precipitation, phase separation and the formation of non-dispersible sediments. These problems result in the product being aesthetically unacceptable to the patient and the formula may fail to deliver adequate nutrition due to the formation of the non-dispersible sediments.
PediaSure®, complete liquid nutrition, is manufactured by the Ross Products Division of Abbott laboratories (Columbus, Ohio) and is designed to be a nutritionally complete, balanced, isotonic enteral formula especially designed for tube or oral feeding of children 1 to 10 years of age. This product is used as a sole source of nutrition or as a supplement and meets or exceeds 100% of the U.S. RDI's for protein, vitamins and minerals for children 1-6 years of age in 1000 mL and for children 7-10 years of age in 1300 mL. PediaSure contains 1.0 calorie per mL and has a caloric distribution of 12.0% protein, 44.8% fat and 43.9% carbohydrate. This product has a pH of about 7.0 and is available in a variety of “milk shake” flavors. This product is not intended for infants under 1 year of age.
Ensures®, complete, balanced nutrition, is manufactured and distributed by the Ross Products Division of Abbott Laboratories for adult consumption. This formula contains 1.06 calories per mL and has a caloric distribution of 14% from protein, 31.5% from fat and 54.5% from carbohydrate. The formula meets or surpasses 100% of the U.S. RDI for vitamins and minerals for adults and children 4 or more years of age in 2000 calories (two quarts or 1.892 L). Ensure is available in numerous milk shake type flavors. It is also available in high nitrogen, high calorie as well as with dietary fiber. While PediaSure® and Ensure® nutritional products have been accepted by the public and health care providers, a need exists to present the patient with flavor alternatives that will increase patient enjoyment and thereby compliance.
Numerous investigators have reported on various approaches to overcome the problems associated with low pH formula. U.S. Pat. No. 5,409,725 to Connolly discloses a process for stabilizing protein in an acidic media through a chemical reaction between the protein and galactomannan to produce a glycoprotein. The galactomannan used by Connolly is a linear polysaccharide, such as locust bean gum (LBG) and guar gum. This patent also discloses the optional use of a heat stability agent such as pectin or high methoxy pectin. This reference provides one example of a low pH (2.0-6.0), milk based beverage that was not fortified with the levels of calcium and protein required for a nutritionally complete beverage. As will be demonstrated in the comparative examples herein, the stabilization system of U.S. Pat. No. 5,409,725 is not effective in a low pH nutritional matrix that contains high levels of protein and macronutrients.
U.S. Pat. No. 3,692,532 to Shenkenberg, et al., discloses a stable milk-fruit juice beverage consisting essentially of milk, fruit juice, sweetener and sodium carboxymethylcellulose (NaCMC) wherein the beverage has a viscosity of less than 30 cp and is stable at pH levels below 5.0. This patent teaches that sufficient time be allowed for the carboxyl groups of the carboxymethylcellulose (CMC) to react with the casein molecules to form a complex which results in a stable, free flowing, non-congealing, low-viscosity beverage.
U.K. Patent 1,440,161 to Nishiyama teaches a milk-fruit juice beverage which contains 4.2-6.2 w/v % of NaCMC as a stabilizer to prevent the coagulation of milk protein, 10-50 w/v % of a fruit juice and 3.1-5.0 w/v % of citric, lactic, malic or tartaric acid. In the process of Nishiyama, the NaCMC is added to hot water with vigorous agitation at neutral pH and then the juice is added. After cooling, the solution is acidified with the recited food grade acid. No additional protein, fat, carbohydrates, minerals and/or vitamins are added to the beverage. In a related case, U.S. Pat. No. 4,078,092, Nishiyama discloses a milk-apple juice drink having a pH of 3.6-4.5 wherein 100 ml of the drink contains 4.2-6.0 gms of a carboxylic acid.
Pedersen, et al., in an article entitled: “Influence of pectin on the stability of casein solutions studied in dependence of varying pH and salt concentration”,
Food Hydrocolloids,
Vol. 5, No. 4, pp. 323-328, (1991), discusses pectin-casein interactions and teaches that the addition of pectin to casein solutions lowers the pH value at which the casein precipitates. The effect was studied in the presence of various salts and polysaccharides and concluded that the stabilization of pectin-casein systems is primarily of an electrostatic nature.
U.S. Pat. No. 4,212,893 to Takahata discloses a stable, emulsified, acidified whole milk beverage made by: (1) preparing an aqueous solution of LBG and adding it to whole milk at a concentration to result in 0.3% by weight LBG based on the total weight of the beverage; (2) acidifying the milk emulsion with fruit juice or organic acids to a pH of between 3.4 and 3.6; (3) stabilizing the emulsion by stirring the acidified mixture for 10-30 minutes; (4) homogenizing the acidified emulsion; and (5) sterilizing and packaging the acidified emulsion.
EP 0 486 425 A2 to Kvamme relates to a nutritional formulation containing from 40-90% of the calories from carbohydrates, from 2-30% of the calories from protein, from 0-35% of the calories from fat and from 0-17% of the calories from fiber. The protein source is at least 60% by weight whey protein concentrate and the pH of the formulation is 3.5-3.9. This reference discloses the use of polyglycerol esters and hydrolyzed guar gum as an emulsification system for the nutritional product containing fat and fiber.
U.S. Pat. Nos. 4,931,300; 5,156,875; 5,141,758; and 5,389,391 to Monte disclose various low pH, antimicrobial food compositions. These foods are powdered compositions that may later be reconstituted with liquids. The Monte compositions usually comprise a protein
Anloague Paul S.
Chandler Michael A.
DeWille Normanella T.
Garcia Diane M.
Mazer Terrence B.
Abbott Laboratories
Dixon J Michael
Parlet Nickki L.
Pratt Helen
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