KR900008077B1 - High fat low carbohydrate eternal nutritional formula - Google Patents

Abstract

A cpd. of high fat low carbohydrate nutritional cpd. is prepd. by mixing fat, carbohydrate, protein, vitamin and mineral in the presence of an emulsifier and a corpuscular calcium, Ca3 (PO4)2. Calory division of the nutritional cpd. is 45-60% fat e.g. corn oil, 0-30% carbohydrate e.g. sucrose or corn syrup and 8-25% protein e.g. sodium calcium caseinate or sodium caseinate.

Description

Preparation of high fat low sugar intestinal nutrient type

The present invention relates to the preparation of a formulation which provides an improved intestinal nutrient formulation, in particular a high fat low sugar diet.

The main law for patients with respiratory failure is aeration and dosing. Recently, nutrition maintenance has been recognized as another major therapy for these patients. Nutritional maintenance helps to meet the calorie requirements for breathing, maintains respiratory muscle structure, and prevents increased susceptibility to malnutrition and associated infections.

Since patients with respiratory failure have poor CO2 capacities to seal the lungs, it is desirable to reduce the carbon dioxide production of these patients. Control of fat and sugar levels during patient nutrition has been shown to increase or decrease carbon dioxide production. The ratio of carbon dioxide to oxygen consumed per calorie on complete fat burning is lower than for sugars or proteins. Therefore, high fat diets can provide adequate calories while producing less carbon dioxide.

54 : 373-37(1981)]은 영양학적으로 결핍되고 급성적으로 아픈 환자에게 비경구적 영양물중의 지방에 멀젼을 사용하면 이산화탄소 생성 및 통기 필요량이 매우 감소됨을 보고한다.[See: Askanazi et al.,

54: 373-37 (1981), reported that the use of fusion in fat in parenteral nutrients significantly reduced carbon dioxide production and aeration requirements in nutritionally deficient and acutely ill patients.

However, several problems arise in providing high fat feeding through parenteral nutrition. These problems include increased fat metabolism, increased costs and risks for patients involved in parenteral feeding. In addition, nutritionally suitable parenteral high fat feeding is difficult to achieve.

See Heymsfield et al., Am. J. Clin. Nutr. 40: 116-130 (1984) describes the use of high fat low sugar intestinal formulations to reduce carbon dioxide production in undernourished patients. This formulation weighs and mixes each of the modular ingredients, including whey protein, maltodextrin, long-chain triglycerides and safflower oil, vitamins, minerals, and water. It is prepared by forming a phosphorus mixture.

(June 1983)]은 탄수화물이 없는 제형과 포도당 중합체로 이루어진 제형을 혼합하여 장내 제형을 제조했다.Similarly, Garfinkel et al.,

(June 1983) prepared intestinal formulations by mixing a carbohydrate free formulation with a glucose polymer formulation.

This mixed formulation is 14% protein, 31% carbohydrate and 55% fat in each calorie and reduces carbon dioxide production in patients with lung disease.

A problem with these aforementioned high fat low sugar formulations is that they are expensive and time-consuming to manufacture because they require different component parts and have to be weighed and thoroughly mixed before use. Formulations are often difficult to obtain optimally and cannot provide a nutritionally suitable or organoleptically acceptable diet. In addition, these formulations present contamination problems and cannot be prepared in advance and stored for a long time because the component parts fall from the solution or fat buoy to the solution surface.

The present invention is a complete intestinal formulation that is nutritionally improved for the dietary management of patients in need of low sugar intake, such as during respiratory failure. The improved formulation consists of fats, sugars, proteins, vitamins and minerals and utilizes a unique emulsification system based on the use of emulsifiers and granulated calcium salts. This formulation provides a storage stable formulation that can be accommodated in a special sensor that does not need to premix any of the component parts of the formulation.

The fat source of the high fat low sugar formulation can be any acceptable fat source used in nutritional formulations including corn oil, coconut oil, soybean oil, medium chain triglyceride oil, cottonseed oil, safflower oil, sunflower seed oil or mixtures of these fat sources. Can be. Preferably, the fat source is corn oil. The amount of fat source present in the formulation may be from about 45 to about 60% of the total formulation calories, preferably the fat source consists of about 55% of the total calories.

The sugar source of the formulation is sucrose, corn syrup, fructose, dextrose or other nutritionally acceptable sugar source. Acceptable sugar sources for this formulation have from about 5 to about 42 equivalents of dextrose. Dextrose equivalent (D.E) is an anhydrous dextrose and is a measure of the total reducing power of the saccharide source, calculated as a percentage of total solids. Preferred sugar sources consist of corn syrup having about 15 to 18 equivalents of dextrose and sucrose.

In addition, artificial sweeteners may be used in the formulation to replace or partially replace the glycoside. Examples of suitable artificial sweeteners include saccharin, polydextrose and methylaspartylphenylalanine, which lower the osmoticity and enhance the properties that the formulation is acceptable in special sensory devices.

The amount of saccharide source present in the formulation may be about 0 to about 30% of the total formulation calories. Preferably, the saccharide source consists of about 28% of the total formulation calories.

The protein source for high fat low sugar may be any suitable protein source for nutritional formulations such as casein, whey, soy protein or protein hydrolysate. Preferred protein sources for this formulation are sodium calcium caseinate and sodium caseinate. The protein source of the formulation may be provided at about 8 to about 25% of the total calories, preferably at about 17% of the total formulation calories.

The emulsification system of the high fat low sugar formulation is based on emulsifier + micronized calcium salt. The emulsifier can be any suitable fatty emulsifier such as mono- and di-glycerides, egg lecithin or soy lecithin. Preferred emulsifiers are soy lecithin.

In order to suppress thixotropy resulting from high fat content formulations, the fat: emulsifier nonfat may be about 1 part: emulsifier about 0.05-1 part, and the optimum fat: emulsifier ratio is 1.0: 0.331.

In addition, the granulated calcium salt is used in the emulsification system of the formulation. Examples of suitable calcium salts include granulated tricalcium phosphate, granulated calcium citrate, monobasic calcium phosphate and mixtures of these calcium salts. A preferred calcium salt for high fat low saccharide formulations is granulated tricalcium phosphate (TCP). Preferred micronized TCP particle sizes have a median particle size of about 0.5 to about 1.5 micrometers and are prepared by pulverizing crude TCP (median particle size 2.8 micrometers).

The formulation includes stabilizers such as xanthan gum and carrageenan which increase the viscosity of the formulation and further prevent precipitation. In addition, the formulation contains vitamins and minerals.

The composition of the preferred high fat low sugar formulations of the present invention is shown in Table I below.

TABLE 1

The following shows a method of processing the nutritional formulation of the present invention.

I. Premix

Each of the following mixtures is premixed.

A. Oil Blend

In this premix, 27.75 lbs of corn oil is placed in a mixing pot and heated to 130-160 ° F., preferably 143-150 ° F., with stirring. 0.82 lb of soy lecithin emulsifier is added to the heated corn oil and stirred until dissolved. Then 10.38 g of fat soluble vitamins A, D ₃ , E and D ₁ are added and stirred thoroughly. Hold 130-160 ° F. until the oil mixture is used. It should be noted that the oil mixture should be used within 12 hours of manufacture to prevent rancidity of the oil and loss of potency of fat-soluble vitamins. Emulsifier levels are higher than in most conventional nutritional formulations because of their high fat content. The ratio of 1.00 parts of corn oil to 0.331 parts of emulsifier provides less than 2 μ of acceptable fat globules that do not aggregate any globules in the homogenization product.

B. Soluble Mineral Solution

34.98 lbs of filtered tap water is heated to 135-175 ° F., preferably 150-160 ° F., with constant stirring in a mixing pot. The required amount of the following inorganic salts is dissolved in heated water in the following order.

Magnesium Chloride 6H ₂ O 500. 67 g

Potassium Citrate H ₂ O 471.87 g

Ferrous Sulfate 7H ₂ O 11.95g

Zinc Sulfate 7H ₂ O 12.40g

Copper sulfate 5H ₂ O 1. 39 g

Manganese Sulfate H ₂ O 1. 01g

Sodium chloride 67. 49 g

The material is stirred in heated water until dissolved. The desired temperature of 150-160 ° F. in the mineral solution mixing cooker is maintained under constant stirring. It should be noted that the order in which soluble substances are added promotes optimal physiological absorption by keeping iron in ferrous ion state.

C. Insoluble Mineral Solution

In a mixing pot, 29.92 lbs of filtered tap water is heated to 90-160 ° F., preferably 110-140 ° F. with constant stirring. To the heated water is added 244.25 g of sodium citrate and 416.14 g of granulated tricalcium phosphate (M-TCP) and stirred for up to 10 minutes. The preferred temperature of 110 to 140 ° F. is maintained under stirring. Note that the use of M-TCP with a median particle size of 1.5μ or less and a preferred particle size of 1.0μ or less reduces the settling rate, so that products after 24 hours of suspension provide 100% of calcium, phosphorus and other nutrients to consumers. Should be.

D. Carbohydrate Mixture

Under the trade name Lodex 15, 13.42 lb of 15 dextrose equivalent corn syrup solids and 15.51 lb of sucrose, commercially available from American Maize Co. Cover and keep dry.

E. Protein Slurry

In a mixer pot, 130 lbs of filtered tap water are heated to 135-175 ° F., preferably 145-165 ° F., with constant stirring. The following ingredients in the amounts described are anhydrous mixed by hand and slowly added to the heated water with stirring:

Sodium Calcium Casein 7.41lb

Sodium Caseinate 14.00lb

Calcium Carrageenan 5.40g

The mixture is maintained at 145-165 ° F., which is the preferred temperature with stirring. After the protein slurry is complete, it begins to mix within 2 hours. Protein slurries may remain for 4 hours before mixing into the nutrient formulation, but it should be noted that increasing the viscosity of the slurry will inhibit processing.

Carrageenan is added together with the caseate which caused the caseinate to remain in suspension. The protein slurry is kept separated from the saccharide and mineral solution to reduce browning caused by Maillard reaction.

II. mix

The insoluble mineral solution is transferred to a soluble mineral solution mixing pot with stirring. The saccharide mixture is added slowly and stirred until dissolved. The inorganic and saccharide slurry is maintained at 130 to 170 ° F., preferably 140 to 160 ° F. with stirring. The contents of the mineral and sugar slurry are transferred to a protein slurry mixing pot with stirring. The oil mixture is added immediately with stirring. After stirring for 10 minutes, a sample is taken to measure pH. The pH is 6.50 to 6.90, preferably 6.60 to 6.80. If the pH is not in this range, adjust using 1N potassium hydroxide or 1N citric acid. The mixed mixture is maintained at 135 to 175 ° F, preferably 155 to 166 ° F. It should be noted that mixing and processing should be done within 2 hours after checking the pH in order to avoid fat separation in the heterogeneous mixture and to reduce air incorporation from stirring.

III. Homogenization process

The mixed mixture is heated to 145-175 ° F., preferably 155-165 ° F., via a plate or coil heater, followed by a mercury vacuum of 8-17 inches, preferably 10-15 inches, using an air separator. The mixed mixture is emulsified with a single stage homogenizer at 700 to 1200 lb.in ² (PSIG), preferably 980 to 1100 lb / IN ² (PSIG). The mixture is then homogenized with a two stage homogenizer in a first stage PSIG of 3500-4200 PSIG, preferably 3900-4200 PSIG and a second stage PSIG of 250-700 PSIG, preferably 400-600 PSIG. The mixture is passed through a holding tube with a holding time of 16 seconds at 165 to 190 ° F., preferably 165 to 175 ° F. This step consists of high temperature short time (HTST) pasteurization. The mixture is fed through a plate cooler so that the product temperature is between 34 and 48 ° F, preferably between 39 and 44 ° F. From the cooling substrate, the mixture is fed to a cooled storage tank which can keep the desired product temperature constant. The mixture is measured for pH and optionally adjusted to 6.60 to 6.80 with 1N potassium hydroxide or 1N citric acid.

IV. Water soluble vitamin solution

In a mixer pot, 3 lbs of filtered tap water are maintained at 40-90 ° F., preferably 60-80 ° F. with constant stirring. The required amount of the following components are added to the water with stirring:

18.59 g of all residual water soluble vitamins

Ascorbic acid 80.30 g

Choline chloride 100.37 g

Once all ingredients are dissolved, the pH of the vitamin solution sample is measured. The pH of the vitamin solution is 5.50 to 13.00, preferably 6.00 to 12.00. If the pH is not in this range, adjust the pH with 1N, potassium hydroxide or 1N citric acid. Once the acceptable pH range is reached, all vitamin solutions are slowly added to the processed mixture in the storage tank with constant stirring. Note that a low pH will cause protein degradation in the product, so the pH range of the vitamin solution is critical.

V. Vanilla Flavoring System

In a mixer pot, 2.5 lbs of filtered tap water is maintained at 40-90 ° F., preferably 60-80 ° F. with constant stirring. 0.33 lb of vanilla flavor is added to the water and stirred for up to 5 minutes, then slowly added to the mixture in the storage tank with constant stirring. Other suitable fragrances can be added to provide a variety of fragrances and to improve the psychosensory satisfaction accommodated in special sensory devices.

VI. PH and total solids adjustment of final product

21.4 lbs of filtered tap water and 2.4 lbs of 1N potassium hydroxide are added to the mixed mixture in the storage tank with constant stirring to maintain a pH of 6.50 to 6.90, preferably 6.60 to 6.80, and total solids content of 24.10 to 27.30%, preferably about 25 to 26%.

Iii. Filling and Sterilization

Containers such as cans or vials are filled with liquid formulations and sterilized according to FDA guidelines. Preferably, the high fat low sugar formulations are provided in ready-to-feed form, while also being concentrated by increasing the total solids percentage or sprayed in powder form by methods well known to those skilled in the art. It can also be dried. The concentrate or powder is then reconstituted for diet by adding water.

The following examples illustrate the clinical efficacy of high fat low sugar formulations.

Example 1

The efficacy of the formulation is assessed in 14 outpatients with chronic obstructive pulmonary artery disease. All patients without metabolic alkalosis as a cause of carbon dioxide retention have arterial PCO ₂ of 45 mmHg or more. In addition to high fat low sugar formulations, conventional enteric formulations of high sugar low fat mixed with calorie distribution are evaluated.

Eat liquid foods as your only source of nutrition. The wetness index is greatly reduced when the high fat low sugar diet of the present invention is compared with the other two formulations. For high fat low sugar diets, carbon dioxide production and arterial carbon dioxide retention are reduced. Maintain all measured pharmacologic parameters including blood chemistry, nitrogen balance, and anthropometric measures during the three diets. This study indicates that the formulation of the present invention reduces carbon dioxide production while maintaining the nutritional status of outpatients.

Example 2

Seven patients with respiratory failure requiring mechanical aeration are fed a high fat low sugar formulation or a conventional parenteral or enteric diet. A high fat low sugar diet reduces carbon dioxide production, blood carbon dioxide retention, aeration per minute and respiratory index. It also reduces the total days of mechanical aeration supports when ingesting high fat formulations. Based on these results, the formulations of the present invention are beneficial for dietary management of patients in need of aeration support.

Advantages of the present invention include (1) formulations that do not need to be pre-measured or mixed with each component, and (2) formulations that are stable upon storage, remain in solution, and do not brown.

While the above embodiments illustrate the invention, it should be understood by those skilled in the art that modifications may be made without departing from the spirit and scope of the invention.

Claims (10)

High fat low sugar with a caloric distribution of about 45 to 60% fat, 0 to 30% sugar and 8 to 25% protein, characterized by mixing fats, sugars, proteins, vitamins and minerals in the presence of emulsifiers and granulated calcium salts How to prepare nutritional formulations. The method of claim 1, wherein the calorie distribution of the formulation is about 55% fat, about 28% sugars, and about 17% protein. The method of claim 1 wherein the calcium salt is particulate tricalcium phosphate. The method of claim 3 wherein the median particle size of the microparticles and tricalcium phosphate is from about 0.5 to about 1.5 μm. The method of claim 1 wherein the ratio of fat to emulsifier is about 1.0 part fat: about 0.05 to 1.0 part emulsifier. The method of claim 5 wherein the ratio of fat to emulsifier is 1.0: 0.331. 7. The method of claim 6, wherein the fat consists of corn oil, the sugar consists of sucrose and corn syrup, and the protein consists of sodium calcium caseinate and sodium caseinate. 8. The method of claim 7, wherein the dextrose equivalent of corn syrup is about 15-18. 8. The method of claim 7, wherein the emulsifier consists of soy lecithin. 8. The method of claim 7, wherein the pH is about 6.5 to about 6.9.