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    • 专利摘要:
    The present invention provides an improved pediatric formula and methods for nourishing and improving tolerance to pediatric patients. The formula of the present invention may be supplied in powder, concentrate or ready-to-feed form. Pediatric fluids, based on 100 kcal, about 8 to about 16 g carbohydrates (preferably about 9.4 to about 12.3 g), about 3 to about 6 g lipids (preferably about 4.7 to about 5.6 g), protein about 1.8 To about 3.3 g (preferably about 2.4 to about 3.3 g), and xanthan gum about 37 to about 370 mg (preferably about 74 to about 222 mg, more preferably about 111 to about 148 mg) It includes. The formula may be supplied in powder form, based on 100 g of powder, about 30 to about 90 g carbohydrate (preferably about 48 to about 59 g), about 15 to about 30 g lipid (preferably about 22 to about 28 g) , About 8 to about 17 g (preferably about 11 to about 17 g) protein and about 188 to about 1880 mg (preferably about 375 to about 1125 mg, more preferably about 565 to about 750 mg) xanthan gum. The formula preferably further comprises vitamins and minerals and may further comprise stabilizers. The method of the invention, as mentioned above, comprises administering a pediatric fluid effective amount according to the invention to a pediatric patient.
    公开号:KR20020075787A
    申请号:KR1020027009974
    申请日:2001-01-16
    公开日:2002-10-05
    发明作者:보셸말렌더블류；루이버스스티븐티；블랙신시아제이；맥카미다니엘엘；코스티건티모시
    申请人:아보트 러보러터리즈；
    IPC主号:
    专利说明:

    Improved pediatric formula and methods for providing nutrition and improving tolerance
    [1] Field of invention
    [2] The present invention relates to a pediatric formula and, in particular, a method for improving the tolerance of pediatric patients fed with the formula. Pediatric patients include both infants (children 12 months and younger) and children (children 12 months and younger than 13 years old) (hence infants are all children, but not all children are infants). More particularly, the present invention relates to pediatric formulas comprising xanthan gum which have been found to be effective in improving the tolerance of patients fed with these formulas. The invention also relates to a method for nourishing and improving resistance, including administering an effective amount of a pediatric formula comprising xanthan gum.
    [3] Background of the Invention
    [4] Pediatric formulas can be categorized into three general categories based on the type of protein: intact protein classes, hydrolyzed protein classes and free amino acid classes (infant formulas include infant formulas and formulas for children 1 and older). . Commercially available infant formulas may also include carbohydrates, lipids, vitamins and minerals, in addition to protein sources. Free amino acids, the digestion and absorption of dietary problems, severe food allergies, gastrointestinal problems, or basic diet is to target more than one year old children with one or more issues of other diseases that require pediatric formula [EleCare TM; Widely used as a pediatric source in the Ross Products Division of Abbott Laboratories.
    [5] Many pediatric patients experience intolerance to certain formulas (formula intolerance). Intolerance and flow intolerance are used interchangeably herein. Intolerance is an immune-system related reaction, increases in spit-up or vomiting, increases in stool, and in addition to aqueous stool, and is more demanding than normal infants who are highly resistant to fluids, Fecal or dietary pattern changes can be demonstrated. Intolerance is often indicated by gastrointestinal symptoms (eg, vomiting, stool patterns and gases), as well as behavioral characteristics (eg, permissible fluids, difficulty and crying). In a clinical research setting, this behavior allows parents to exclude infants from special studies. Infants excluded from the study because of this behavior are considered fatal by intolerance. In a nonclinical environment, this behavior often causes parents to replace fluids.
    [6] Intolerance can be contrasted with an allergic response that some infants have for certain formulas. This allergic response is associated with the immune system and can be caused by the infant's susceptibility to proteins present in the formula. Most infants who are allergic or susceptible to intact (total) proteins, such as intact milk proteins or proteins in a formula based on intact soy protein separation, may be resistant to significantly hydrolyzed proteins. [The hydrolyzate formula (also called semi-element formula) includes short peptide fragments and proteins that have been hydrolyzed or degraded into amino acids, resulting in easier digestion by all infants.] These immune system related allergies or susceptibility are often vomiting. And skin, respiratory or gastrointestinal symptoms such as diarrhea. Infants who respond to intact protein formulas often do not respond to hydrolyzate formulas because their immune system does not recognize hydrolyzed proteins as intact proteins that cause these symptoms. Infants who exhibit an immune system related response to a formula may also exhibit an immune system related response (flow intolerance) as previously mentioned.
    [7] Many different pediatric formulas exist. Much of the previous interest in the art has been directed to the physical stability of the formulations and incidental processing or manufacturing relationships.
    [8] Masson's US Pat. No. 5,192,577 describes and teaches the use of xanthan gum in nutrient formulations, but stabilizers used in formulas using kappa carrageenan in combination with xanthan gum and specific examples thereof. The range is not described. Mason deals primarily with the physical stability of the nutritional formulas described herein and does not address the problem of intolerance presented by patients fed with the formula.
    [9] US Pat. No. 5,472,952 to Smidt et al. Relates to a nutritionally complete food composition containing partially hydrolyzed pectin for diarrhea management. A method of using xanthan gum as an emulsifier or stabilizer is described, but the amount of xanthan gum is not described.
    [10] U.S. Pat.No. 5,681,600 to Antione et al describes a method of using xanthan gum in a nutritional formula, but the xanthan gum is not allowed because calcium transport is not allowed by using a formula containing xanthan gum. It is not stated that the use of is not allowed.
    [11] Mahmoud, US Pat. No. 4,670,268, describes an enteric nutritional low allergic nutritional formula that may contain xanthan gum as a stabilizer, but no effective amount of xanthan gum is described for this purpose.
    [12] US Pat. No. 5,919,512 to Montezinos describes the use of xanthan gum as a stabilizer in flavor / cloudy emulsions present in dilute juices and tea beverages. The latex described herein does not contain protein and therefore is not satisfactory for use as a pediatric formula.
    [13] U.S. Patent 5,597,595 to DeWille et al describes a method of using xanthan gum as an emulsion stabilizer in low pH beverages fortified with calcium and vitamin D.
    [14] U.S. Patent No. 5,817,351 to Devil et al. Discloses the use of xanthan gum as a stabilizer in calcium-enhanced low pH beverages. The beverages described herein do not contain fats and proteins and are not suitable as a complete nutritional source.
    [15] US Pat. No. 5,609,897 to Chandler et al describes the use of xanthan gum in soft drinks, similar to powdered beverages, fortified with calcium and vitamin D.
    [16] US Patent No. 5,858,449 to Crank et al. Discloses the use of xanthan gum in isoflavone rich soy based frozen desserts.
    [17] In general, the nutritional formula of the prior art did not address the issue of intolerance. Thus, a formula that is more easily resistant to pediatric patients with intolerant symptoms is not needed. Formulas that are well tolerated have behaviors similar to those exhibited by normal pediatric patients who are well tolerated by the formula.
    [18] Summary of the Invention
    [19] The present invention provides an improved pediatric formula and a method for feeding nutrition and increasing the tolerance of children fed with the formula. (As used herein, unless otherwise indicated, a child is meant to include both infants and children 1 year of age or older. Children / children and pediatric patients are also used interchangeably.) The use of xanthan gum unexpectedly improves resistance. The formula may be present in liquid concentrate, ready-to-feed or in powder form. The formula is based on 100 kcal, about 8 to about 16 g carbohydrates (preferably about 9.4 to about 12.3 g), about 3 to about 6 g lipids (preferably about 4.7 to about 5.6 g), protein about 1.8 to about Resistance improvers containing about 3.3 g (preferably about 2.4 to about 3.3 g), and about 37 to about 370 mg (preferably about 74 to about 222 mg, more preferably about 111 to about 148 mg) xanthan gum. Include. When the formula is supplied in powder form, based on 100 g of powder, about 30 to about 90 g of carbohydrates (preferably about 48 to about 59 g), about 15 to about 30 g of lipid (preferably about 20 to about 30 g), protein About 8 to about 17 g (preferably about 10 to about 17 g) and about 188 to about 1880 mg (preferably about 375 to about 1125 mg, more preferably about 565 to about 750 mg) xanthan gum.
    [20] The formula may further comprise stabilizers and preferably include vitamins and minerals in an amount sufficient to provide a daily nutritional need for infants or children 1 year of age or older. If the formula is an infant formula, the amount of vitamins and minerals is preferably selected according to FDA standards. When feeding the infant formula according to the invention, the infant's resistance is improved compared to infants fed a formula having the same composition, except that there is no resistance improving agent.
    [21] The invention also provides a method for nourishing pediatric patients and improving resistance. The method of the invention, based on 100 kcal, about 8 to about 16 g carbohydrate (preferably about 9.4 to about 12.3 g), about 3 to about 6 g lipid (preferably about 4.7 to about 5.6 g), protein Containing about 1.8 to about 3.3 g (preferably about 2.4 to about 3.3 g), and about 37 to about 370 mg (preferably about 74 to about 222 mg, more preferably about 111 to about 148 mg) xanthan gum Supplying the child with a liquid effective amount comprising a resistance improver. When the formula is supplied in powder form, based on 100 g of powder, about 30 to about 90 g of carbohydrates (preferably about 48 to about 59 g), about 15 to about 30 g of lipid (preferably about 22 to about 28 g), protein About 8 to about 17 g (preferably about 11 to about 17 g) and about 188 to about 1880 mg (preferably about 375 to about 1125 mg, more preferably about 565 to about 750 mg) xanthan gum. Children's formula of the present invention exhibits much less intolerance symptoms than infants fed the same formula, except that there is no xanthan gum resistance improver.
    [22] The present invention provides an improved pediatric formula that can reduce the intolerance of a formula fed child. The invention also provides a method for nourishing pediatric patients and improving resistance, including feeding the formula of the invention. Using xanthan gum unexpectedly improves resistance.
    [23] Infant intolerance (fluid intolerance) is often expressed in gastrointestinal symptoms (eg, vomiting, stool patterns and gases), as well as behavioral characteristics (eg, allowance of fluids, difficulty and crying). For the purposes of the present invention, an improvement in resistance (or reduction in intolerance) is one or more symptoms or features, such as stool pattern, vomiting, saliva spit, allowance of fluid, difficulty, crying, or death due to intolerance (clinical environment). This improvement (change to a normal pattern) is defined as being.
    [24] The pediatric fluid of the present invention may be supplied in powder, liquid concentrate or ready-to-feed phase. Prior to feeding, water is added to both the powder and concentrate phase formulations. In a first embodiment, the pediatric formula of the present invention comprises about 8 to about 16 g carbohydrate (preferably about 9.4 to about 12.3 g), about 3 to about 6 g lipid (preferably about 100 kcal) 4.7 to about 5.6 g), about 1.8 to about 3.3 g protein (preferably about 2.4 to about 3.3 g), and about 37 to about 370 mg (preferably about 74 to about 222 mg, more preferably about Xanthan gum) 111 to about 148 mg). When the formula is supplied in powder form, based on 100 g of powder, about 30 to about 90 g of carbohydrates (preferably about 48 to about 59 g), about 15 to about 30 g of lipid (preferably about 22 to about 28 g), protein About 8 to about 17 g (preferably about 11 to about 17 g) and about 188 to about 1880 mg (preferably about 375 to about 1125 mg, more preferably about 565 to about 750 mg) xanthan gum. A summary of the carbohydrate, lipid and protein ranges (per 100 kcal, per 100 g of powder and per liter as supplied concentration) in the formula according to the invention is shown in Table 1.
    [25] Xanthan gum is a high molecular weight polysaccharide prepared by fermenting carbohydrates by Xanthomonas campestris. Although xanthan gum is commercially available in various mesh sizes, the use of the xanthan gum of the present invention is not limited to any particular mesh size. Appropriate mesh sizes may be selected based on processing parameters, for example, a particulate mesh size (200 mesh) may be desirable when xanthan gum is dry blended in a blend, but a coarser mesh size (80 Mesh) may be desirable when the xanthan gum is not dry blended in a fluid manner. Xanthan gum suitable for use in the present invention is Keltrol F Xanthan Gum (200 mesh) sold by Kelco of the Chicago Division of Monsanto, Illinois, USA.
    [26] Suitable carbohydrates, lipids and proteins can vary widely and are well known to those of skill in the art of pediatric fluid preparation. Thus, suitable carbohydrates include hydrolyzed intact natural starches and / or chemically modified starches supplied from waxed or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And mixtures thereof, but is not limited thereto. Maltodextrins are polysaccharides obtained by acid or enzymatic hydrolysis of such starch, such as starch from corn or rice. Its classification is based on degree of hydrolysis and is reported as dextrose equivalent (DE). When the protein hydrolyzate is a protein source, the DE of any maltodextrin used is preferably about 18-20 or less. If the protein hydrolyzate is a protein source, it is also desirable to avoid the conditions under which excess Maillard browning products can be produced.
    [27] Suitable lipids include coconut oil, soybean oil, corn oil, olive oil, safflower oil, high grade oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high grade oleic sunflower oil, palm oil, palm olein, canola Oils, lipid sources of arachidonic acid and docosahexanoic acid, and mixtures thereof, but are not limited thereto. Lipid sources of arachidonic acid and docosahexanoic acid include, but are not limited to, marine oils, egg yolk oils and fungal oils.
    [28] Suitable protein sources include milk, soybeans, rice, meat (eg beef), animals and plants (eg peas, potatoes), eggs (egg whites), gelatin and fish. Suitable intact proteins include, but are not limited to, soy base, milk base, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein and mixtures thereof. Suitable protein hydrolysates also include soy protein hydrolysates, casein protein hydrolysates, whey protein hydrolysates, rice protein hydrolysates, potato protein hydrolysates, fish protein hydrolysates, egg white hydrolysates, gelatin protein hydrolysates, animal and vegetable protein hydrolysates Combinations of degradants, and mixtures thereof, but are not limited thereto. Hydrolyzed proteins (protein hydrolysates) are proteins that have been digested or hydrolyzed to short peptide fragments and amino acids. Such hydrolyzed peptide fragments and free amino acids are more readily digested. In broad terms, proteins are hydrolyzed when one or more amide bonds are degraded. Degradation of the amide bonds can occur unintentionally or accidentally during manufacture, for example, due to heating or shearing. For the purposes of the present invention, hydrolyzed protein means a protein that is processed or processed in such a way as to break down amide bonds. Intentional hydrolysis can be performed, for example, by treating intact proteins with enzymes or acids. Hydrolyzed proteins that are preferred for use in the formulations according to the present invention have an amino nitrogen (AN) to total nitrogen (TN) ratio of about 0.1AN to 1.0TN to about 0.4AN to about 1.0TN, preferably about 0.25 Hydrolyzed to AN to 1.0TN to about 0.4AN to about 1.0TN. (The predetermined AN: TN ratio is for hydrolyzate protein sources alone and does not exhibit AN: TN ratio in pediatric final nutritional fluid products, since free amino acids can be added as a supplement to change the reported value. The protein can also be supplied in free amino acid form. Formulas according to the invention are preferably supplemented with various free amino acids to provide a nutritionally more complete and balanced formula. Examples of suitable free amino acids include, but are not limited to, tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine and carnitine.
    [29] Formulations of the invention also preferably contain vitamins and minerals in amounts intended to provide a daily nutritional requirement for pediatric patients. Formulas include, but are not limited to, vitamins and minerals such as calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine and vitamins A, E, C, D, K and B complexes no. Additional nutritional guidelines for infant formulas can be found in Article 21 U.S.C. It may be found in section 350 (a). The nutritional guidelines set out in the Infant Formula Ordinance continue to be refined as further work on infant nutritional needs is completed. The present invention is contemplated to include formulas containing vitamins and minerals which may not be presently described in the legislation.
    [30] In a second embodiment of the present invention, the formula of the present invention further comprises a stabilizer. Stabilizers suitable for use in pediatric nutritional formulas are well known to those skilled in the art. Suitable stabilizers include gum arabic, ghatti gum, karaya gum, tragacanth gum, agar, furcellaran, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin, gelatin, Microcrystalline cellulose, hydroxypropyl cellulose, DATEM (diaryl tartaric acid ester of monoglycerides and diglycerides), dextran, carrageenan and mixtures thereof, but are not limited thereto. The formula according to the invention is free of kappa carrageenan as stabilizer and most preferably free of carrageenan. The formula is defined as the absence of kappa carrageenan when any carrageenan used is present in another form (iota (ι) or lambda (λ)) significantly. For the purposes of the present invention, the absence of kappa carrageenan or the absence of carrageenan means that neither kappa carrageenan or carrageenan is added during preparation. The amount of stabilizer used may vary depending on the stabilizer selected, the presence or absence of other components, and the stability and viscosity of the formula to be obtained. Appropriate amounts can be determined by one skilled in the art based on the particular properties (eg, viscosity) desired to be obtained in the formulation.
    [31] The invention also provides a method for nourishing pediatric patients and improving resistance. The method comprises about 8 to about 16 g carbohydrate (preferably about 9.4 to about 12.3 g), about 3 to about 6 g (preferably about 4.7 to about 5.6 g) lipid, about 1.8 to about 100 kcal, based on 100 kcal. Resistance improvers containing about 3.3 g (preferably about 2.4 to about 3.3 g), and about 37 to about 370 mg (preferably about 74 to about 222 mg, more preferably about 111 to about 148 mg) xanthan gum. Supplying the child with an effective amount of the formula containing it. When the formula is supplied in powder form, based on 100 g of powder, about 30 to about 90 g of carbohydrates (preferably about 48 to about 59 g), about 15 to about 30 g of lipid (preferably about 22 to about 28 g), protein About 8 to about 17 g (preferably about 11 to about 17 g) and about 188 to about 1880 mg (preferably about 375 to about 1125 mg, more preferably about 565 to about 750 mg) xanthan gum.
    [32] In another embodiment, the formula further comprises a stabilizer. One embodiment also preferably includes vitamins and minerals in the amounts mentioned above. Suitable carbohydrates, lipids, proteins or proteins and stabilizers are well known to those skilled in the art and include, but are not limited to, the materials mentioned above. Preferably, if the formula is an infant formula, the method includes supplying a sufficient amount of formula to meet all of the daily nutritional needs of the infant.
    [33] Pediatric formula of the present invention can be prepared using methods well known to those skilled in the art. Various processing methods are not used to prepare the formula into powder, ready-to-feed and liquid concentrates. Typically, such methods involve the formation of a slurry from water and one or more solutions that may contain one or more carbohydrates, proteins, lipids, stabilizers, vitamins, and minerals. This slurry is emulsified, homogenized and cooled. Various other solutions can be added to the slurry before processing, after processing or before and after processing. If the resulting fluid is present in a ready-to-feed liquid phase or concentrated liquid phase, an appropriate amount of water is added and then sterilized. If the resulting fluid is present in powder form, the slurry is heated and dried to give a powder. The powder produced by drying may, if desired, be dry blended with further components.
    [34] The following examples illustrate the methods and compositions of the present invention to improve resistance in pediatric patients. Although the present invention is described in terms of infant powdery nutritional formulas in the Examples below, it is not to be considered as limiting, because it includes both infant formulas of ready-to-feed phases and liquid concentrates as well as children formulas of children 1 years of age or older. Because it is interpreted as. The examples are not to be considered as limiting, as other carbohydrates, lipids, proteins, stabilizers, vitamins and minerals may be used without departing from the scope of the present invention.
    [35] Example 1-Clinical Study
    [36] The following summarizes the results of clinical studies on tolerance when infants are fed any one of four different formulas. Three different formulations and control formulations of the present invention (the same except for the absence of xanthan gum resistance improving agent) are used. Randomized parallel resistance studies indicated are performed in healthy infants within 28 days of age. Almentum Protein Hydrolysate Formula With Iron, which is marketed as a ready-to-feed phase composition for 1 week as a reference to the infant; Abbott Laboratories' Los Products Division]. Immediately, either a control formula or one of formulas B, C or D is fed at random. The composition of the control formula is the same as the composition of formulas B-D, except that different amounts of xanthan gum are present in formulas B-D. The composition of all four formulas is listed in Tables II and IIa. Control formulas and formulas B to D are supplied in powdered form in metal cans of a size sufficient to contain 350 g when reconstituted with water.
    [37] Judged to be in good health; The gestation period was 37 to 42 weeks; Weight at birth is at least 2500 g; More than 28 days old; Formula was supplied exclusively at the time of study; The informed consent has been voluntarily signed by the parent; The parent does not allow administration of mineral or vitamin supplements; Parents fed infants only the formula under study during the study period; It was a single birth pregnancy; There is no maternal medical history that can cause side effects to the fetus, such as diabetes, tuberculosis, perinatal infection or substance abuse; No signs of heart, respiration, gastrointestinal tract, hematological or metabolic diseases; For infants whose mothers have had gestational diabetes, infants whose weight is not higher than the 95 percentile (National Center for Health Statistics) are suitable for the study.
    [38] Infants are identified by a researcher from a specific population and supplement appropriate infants. In the study, a total of 182 infants were listed from three different sites. Of the first 182, 45 died during the base period and did not consume the control formula or formulas B to D. Of the 137 who took either the control formula or the formulas B to D, 12 infants did not complete the study.
    [39] The first day of the study is defined as the study entry date. On day 1, demographic / posting data is collected and the infant is undressed and weighed. Parents place a standard Almentum Protein Hydrolysate Formula With Iron in about 12 32-fl oz cans ready to feed the composition. Parents are instructed to continue supplying the formula in circulation until 6 pm on day 1, and then begin feeding the reference formula to the first feed after 6 pm. Intake and variance data begin to collect at 6 pm on day 1 and end at 5:59 pm on day 7.
    [40] On day 8 of the study, the investigator reviews the parent's completed records for completeness and accuracy, re-weighs the infant, and surveys the fluid satisfaction, and the parent completes the fluid and stool pattern. The parent retrieves the unused reference formula and adds one of the control formula, Formula B, C, or D, which is the formula assigned to about four cans. Parents are instructed to continue to feed the reference formula until 6 pm on day 1, begin to feed the assigned formula after 6 pm, and record feed and stool information. Intake and variance data are collected from 6 pm on day 8 and terminated at 5:59 pm on day 14 of study. On day 6 the control formulas and formulas B to D are collected. Regarding the reference feed, the researcher visits on day 15 to review the meal intake and large variance records completed by the parent during days 8-14.
    [41] On day 15, the infant is weighed and the questionnaire survey completed, then the parent retrieves any unused portion of the formula.
    [42] Statistical analysis
    [43] Key variables are mean daily fecal recovery, mean grade fecal concentration, and incidence of vomiting and saliva spitting. The first analysis is made by analyzing key results that vary according to intentional treatment criteria. The second analysis is performed by a research expert. Study duration data is analyzed using one-way analysis of site and variability as blocking factors. In addition, covariance analysis with study duration data as response and baseline data as covariate is performed as corroborating analysis. Where appropriate, deformation (ranking arcsine) is applied. Analyze categorical and subject data using ancillary tabulation. All tests are double sided and performed at an importance of 0.05. In a number of tests using Holm's stepdown Bonferroni method, the importance of three major analyses was adjusted.
    [44] result
    [45] On day 1 of the study no statistically significant differences in ethnic or age were observed. Significant differences were observed in the sex distribution among the groups at the time of introduction (P <0.05). The weight on day 1 of the group fed with formula B was significantly greater than the group fed with control formula on day 1. A significant number of infants who consumed the control formula died of intolerance compared to infants who received the formula B, C, or D (the formula containing xanthan gum resistance improver).
    [46] In terms of average daily stool recovery, a statistically significant difference was observed between the groups (P = 0.0073 multiple controlled). Infants fed the control formula had significantly more feces recovery than infants fed the formulas B (P = 0.0001) and D (P = 0.0073). During the experimental period (8-14 days), infants who received the control formula had an average stool count of 2.7 ± 0.2 per day, and infants who had formulas B and D had 1.6 ± 0.2 and 2.1 ± average feces counts per day. 0.3. There is no statistically significant difference among the groups in terms of mean rank stool concentration. The proportion of aqueous feces varies considerably among the groups. When reference measurements are added as covariates at the time of analysis, infants fed the control formula have significantly more aqueous feces compared to infants fed the formula C and D groups (P <0.01). For other stool variables, no significant differences were observed among the groups (diarrhea / soft, soft, hard). Results for daily stool recovery, average rank stool concentration, aqueous stool, diarrhea / soft stool, soft stool and hard stool are shown in Table III.
    [47] No statistically significant difference was observed among the groups in the ratio of saliva spit or the rate of vomiting. In terms of number of feeds per day, intake per day (ml) or intake per day (ml / kg), no statistically significant differences were observed among the groups. The results for spit saliva, vomiting, daily feed, daily intake (ml) and daily intake (ml / kg) are shown in Table IV.
    [48] On day 15 no significant difference was observed among the groups in terms of weight NCHS Z-score, or weight gain during the experimental period (8-14 days). No significant difference was observed among the groups in terms of infant weight at the 15th visit. Infants who consumed Formula B were significantly heavier than infants who received control formula (P <0.01) as present on day 1. When using body weight on day 8 as a covariate, no significant difference was observed between groups in body weight at study completion. The results are shown in Table V.
    [49] discussion
    [50] Studies have shown that adding xanthan gum to formulas improves the tolerance of infants who consume these formulas. Infants fed Formulas B, C and D (with Xanthan Gum Tolerance Enhancers) generally have less variance per day compared to infants fed control formula (Table II). Conclusive results indicate that infants fed Formula B, C, and D had too many stool counts and too few days of stool compared to infants fed the control formula. In addition, the number of infants who died due to formula intolerance is significantly less in the groups that consumed Formulas B, C, and D than in the group that received the control formula. The results are shown in Table VI. The mortality rate of the group that received the control formula was 22% without resistance improver. Thus, the reduction in lethality (0-6%) in infants fed Formulas B, C and D is clinically significant compared to the control formula. Infants enrolled in this study are healthy infants (no sensitivity to intact proteins or known allergic symptoms), while improving resistance, thereby being intolerant by one or more children exhibiting intolerant symptoms and against current hydrolyzate formulas. Infants with symptoms or insensitivity to intact symptomatic proteins should be experienceable.
    [51] Example 2
    [52] About 6870lbs of corn maltodextrin, 3095lbs sucrose, 24.4kg magnesium chloride, 54.9kg potassium citrate, 17.8kg sodium chloride, 114.5kg calcium tribasic phosphate, 25.5kg calcium carbonate, 16.4kg potassium chloride and 13.7kg potassium iodide in water at 160 ° F The powdery formula is prepared by dissolving in to form an aqueous solution. The amount of water used to prepare the aqueous solution is optimized when a special manufacturing apparatus is used. The solution contained 1911 lbs. Of MCT oil, 130.6 kg of diacetyl tartaric acid ester of monoglycerides and diglycerides, 26.1 kg of monoglycerides and diglycerides, 2020 lbs of higher oleic acid safflower oil, 1.1 lbs of mixed tocopherols, 1613 lbs of soymilk, ascorbyl palmi A slurry is prepared by blending with a second solution comprising 2.1 kg of tate and 3.2 kg of a vitamin premix containing vitamin A palmitate, vitamin E acetate, piloquinone and vitamin D3. The slurry is mixed at 68-74 ° C. for 30 minutes to 2 hours. The slurry is emulsified at 1000 psi, homogenized with a two stage homogenizer at 2500 psi / 500 psi and then cooled to about 4 ° C. through a plate heat exchanger. A solution containing free amino acids, water soluble vitamins and trace minerals is added to the processed slurry. The slurry is heated to 74.4 to 85 ° C. for at least 16 seconds and spray dried to produce a powder having a moisture content of about 1.5%. The spray dried powder is dry blended with about 3430 lbs of casein hydrolysate and 51.2 kg of xanthan gum.
    [53] Example 3
    [54] About 6870lbs of corn maltodextrin, 3095lbs sucrose, 24.4kg magnesium chloride, 54.9kg potassium citrate, 17.8kg sodium chloride, 114.5kg calcium tribasic phosphate, 25.5kg calcium carbonate, 16.4kg potassium chloride and 13.7kg potassium iodide in water at 160 ° F The powdery formula is prepared by dissolving in to form an aqueous solution. The amount of water used to prepare the aqueous solution is optimized when a special manufacturing apparatus is used. The solution contained 1911 lbs. Of MCT oil, 130.6 kg of diacetyl tartaric acid ester of monoglycerides and diglycerides, 26.1 kg of monoglycerides and diglycerides, 2020 lbs of higher oleic acid safflower oil, 1.1 lbs of mixed tocopherols, 1613 lbs of soymilk, ascorbyl palmi A slurry is prepared by blending with a second solution comprising 2.1 kg of tate and 3.2 kg of a vitamin premix containing vitamin A palmitate, vitamin E acetate, piloquinone and vitamin D3. The slurry is mixed at 68-74 ° C. for 30 minutes to 2 hours. The slurry is emulsified at 1000 psi, homogenized with a two stage homogenizer at 2500 psi / 500 psi and then cooled to about 4 ° C. through a plate heat exchanger. About 3430 lbs of casein hydrolyzate is blended in water at 68-74 ° C. for 30 minutes to 2 hours. The slurry is emulsified at 1000 psi, homogenized with a two stage homogenizer at 2500 psi / 500 psi, then cooled to about 4 ° C. via a plate heat exchanger and added to the carbohydrate / fat / lipid blend. A solution containing free amino acids, water soluble vitamins and trace minerals is added to the processed slurry. The slurry is heated to 74.4 to 85 ° C. for at least 16 seconds and spray dried to produce a powder having a moisture content of about 1.5%. The spray dried powder is dry blended with 51.2 kg of xanthan gum.
    [55] Example 4
    [56] About 6870lbs of corn maltodextrin, 3095lbs sucrose, 24.4kg magnesium chloride, 54.9kg potassium citrate, 17.8kg sodium chloride, 114.5kg calcium tribasic phosphate, 25.5kg calcium carbonate, 16.4kg potassium chloride and 13.7kg potassium iodide in water at 160 ° F The powdery formula is prepared by dissolving in to form an aqueous solution. The amount of water used to prepare the aqueous solution is optimized when a special manufacturing apparatus is used. The solution contained 1911 lbs. Of MCT oil, 130.6 kg of diacetyl tartaric acid ester of monoglycerides and diglycerides, 26.1 kg of monoglycerides and diglycerides, 2020 lbs of higher oleic acid safflower oil, 1.1 lbs of mixed tocopherols, 1613 lbs of soymilk, ascorbyl palmi A slurry is prepared by blending with a second solution comprising 2.1 kg of tate and 3.2 kg of a vitamin premix containing vitamin A palmitate, vitamin E acetate, piloquinone, vitamin D3 and xanthan gum. The slurry is mixed at 68-74 ° C. for 30 minutes to 2 hours. The slurry is emulsified at 1000 psi, homogenized with a two stage homogenizer at 2500 psi / 500 psi and then cooled to about 4 ° C. through a plate heat exchanger. About 3430 lbs of casein hydrolyzate is blended in water at 68-74 ° C. for 30 minutes to 2 hours. The slurry is emulsified at 1000 psi, homogenized with a two stage homogenizer at 2500 psi / 500 psi, then cooled to about 4 ° C. via a plate heat exchanger and added to the carbohydrate / fat / lipid blend. A solution containing free amino acids, water soluble vitamins and trace minerals is added to the processed slurry. The slurry is heated to 74.4 to 85 ° C. for at least 16 seconds and spray dried to produce a powder having a moisture content of about 1.5%.
    [57] Example 5
    [58] About 6870lbs of rice maltodextrin, 3095lbs sucrose, 24.4kg magnesium chloride, 54.9kg potassium citrate, 17.8kg sodium chloride, 114.5kg calcium tribasic phosphate, 25.5kg calcium carbonate, 16.4kg potassium chloride and 13.7kg potassium iodide in water at 160 ° F The powdery formula is prepared by dissolving in to form an aqueous solution. The solution contained 1911 lbs. Of MCT oil, 130.6 kg of diacetyl tartaric acid ester of monoglycerides and diglycerides, 26.1 kg of monoglycerides and diglycerides, 2020 lbs of higher oleic acid safflower oil, 1.1 lbs of mixed tocopherols, 1613 lbs of soymilk, ascorbyl palmi A slurry is prepared by blending with a second solution comprising 2.1 kg of tate and 3.2 kg of a vitamin premix containing vitamin A palmitate, vitamin E acetate, piloquinone and vitamin D3. The slurry is mixed at 68-74 ° C. for 30 minutes to 2 hours. The slurry is emulsified at 1000 psi, homogenized with a two stage homogenizer at 2500 psi / 500 psi and then cooled to about 4 ° C. through a plate heat exchanger. A solution containing water soluble vitamins and trace minerals is added to the processed slurry. The slurry is heated to 74.4 to 85 ° C. for at least 16 seconds and spray dried to produce a powder having a moisture content of about 1.5%. The spray dried powder is dry blended with about 3430 lbs. Of whey protein hydrolysate, 41.2 kg of free amino acid, 41.2 kg of soybean gum and 51.2 kg of xanthan gum.
    [59] Although the present invention is described herein with reference to specific examples, it is believed that this should not be construed to limit the invention to the specific forms described. On the contrary, it is considered to include all modifications and other forms falling within the spirit and scope of the present invention.
    [60] Range of carbohydrates, lipids and proteins per 100 kcal, per 100 g of powder and per liter (as supplied concentration) Nutrition Facts (g) range Per 100kcal Per 100 g of powder Per liter (as supplied concentration) carbohydrate Broad 8-16 30-90 53-107 Desirable 9.4-12.3 48-59 64-83 Geology Broad 3-6 15-30 22-40 Desirable 4.7-5.6 22-28 32-38 protein Broad 1.8-3.3 8-17 12-22 Desirable 2.4-3.3 11-17 16-22
    [61] Nutrient Content in Control Formulas and Formulas B, C, and D * Nutrition Facts 1 Per liter Per 100kcal Per 100 g of powder Protein (g) 18.6 2.75 13.9 Fat (g) 37.5 5.55 28.1 Carbs (g) 73 10.8 54.6 Calcium (mg) 710 105 531 Phosphorus (mg) 507 75 379 Magnesium (mg) 51 7.5 38.1 Iron (mg) 12.2 1.8 9.1 Zinc (mg) 5 0.74 3.7 Manganese (mcg) 34 5 25 Copper (mcg) 500 74 374 Iodine (mcg) 100 14.8 75 Sodium (mg) 297 43.9 222 Potassium (mg) 800 118.3 598 Chloride (mg) 541 80 405 Selenium (mcg) 16 2.4 12 Vitamin A (IU) 2,200 325 1,646 Vitamin D (IU) 400 59 299 Vitamin E (IU) 20.8 3.1 15.6 Vitamin K 1 (IU) 101 14.9 75.5 Thiamine (mcg) 580 86 434 Riboflavin (mcg) 600 89 449 Vitamin B-6 (mcg) 530 78 396 Vitamin B-12 (mcg) 3 0.44 2.24 Niacin (mg) 9 1.33 6.73 Folic Acid (mcg) 100 14.8 74.8 Pantothenic Acid (mg) 5 0.74 3.74 Biotin (mcg) 30 4.4 22.4 Vitamin C (mg) 90 13.3 67.3 Choline (mg) 53 7.8 39.6 Inositol (mg) 30 4.4 22.4
    [62] * Values are lowest except for carbohydrate maximums based on protein and fat minimums.
    [63] Control Formulas: Corn Maltodextrin, Casein Hydrolyzate (Enzymatically Hydrolyzed and Charcoalized), Sucrose, Higher Oleic Acid Safflower Oil, Fractionated Coconut Oil (Medium Chain Triglycerides), Soy Milk, Monoglycerides and Diglycerides Diacetyl tartaric acid ester, tribasic calcium phosphate, potassium citrate, monoglyceride and diglycerides, calcium carbonate, magnesium chloride, ascorbic acid, L-cystine dihydrochloride, sodium chloride, potassium chloride, L-tyrosine, choline chloride , L-tryptophan, ferrous sulfate, taurine, m-inositol, ascorbyl palmitate, vitamin E acetate, zinc sulfate, mixed tocopherols, L-carnitine, niacinamide, calcium pantothenate, copper sulfate, vitamin A palmitate, thiamine chloride Hydrochloride, riboflavin, pyridoxine hydrochloride, folic acid, iodide Potassium, magnesium sulfate, phylloquinone, biotin, sodium selenite, vitamin D 3 , cyanocobalamin.
    [64] Formula B, C, and D ingredients: corn maltodextrin, casein hydrolyzate (enzymatically hydrolyzed and charcoalized), sucrose, high oleic safflower oil, fractional distilled coconut oil (medium chain triglycerides), soy milk, monoglycerides and Diacetyl tartaric acid ester of diglycerides, tribasic calcium phosphate, potassium citrate, xanthan gum, monoglycerides and diglycerides, calcium carbonate, magnesium chloride, ascorbic acid, L-cystine dihydrochloride, sodium chloride, potassium chloride , L-tyrosine, choline chloride, L-tryptophan, ferrous sulfate, taurine, m-inositol, ascorbyl palmitate, vitamin E acetate, zinc sulfate, mixed tocopherols, L-carnitine, niacinamide, calcium pantothenate, copper sulfate, Vitamin A Palmitate, Thiamine Chloride Hydrochloride, Riboflavin, Pyridoxine Hydrochloride, Lobe , Potassium iodide, magnesium sulfate, Philo quinone, biotin, sodium selenite, vitamin D 3, four cyano cobalamin.
    [65] Amount of Xanthan Gum in Control Formula and Formulas B, C, and D (mg) liquid Per liter Per 100kcal Per 100 g of powder A 0 0 0 B 500 74 374 C 1,000 148 748 D 1,500 222 1,122
    [66] Stool recovery per day, mean rank stool concentration, and the ratio of aqueous, diarrhea / soft, soft, and hard stools during the baseline and experimental periods. variable Group / Fluid Criteria (1-7 days) Experiment (1-8 days) Credit (recovery / day) Control Formula 2.7 ± 0.2 2.7 ± 0.2 Formula B 2.6 ± 0.3 1.6 ± 0.2 Formula C 2.6 ± 0.3 1.9 ± 0.2 Formula D 2.5 ± 0.3 2.1 ± 0.3 Average rank stool concentration 2 Control Formula 2.5 ± 0.1 2.1 ± 0.1 Formula B 2.4 ± 0.1 2.0 ± 0.1 Formula C 2.3 ± 0.1 2.3 ± 0.1 Formula D 2.3 ± 0.1 2.3 ± 0.1 Aqueous Stool (%) Control Formula 6.9 ± 2.3 29.0 ± 6.1 Formula B 8.9 ± 2.7 22.6 ± 5.4 Formula C 13.2 ± 3.6 11.0 ± 4.3 Formula D 11.6 ± 2.7 14.2 ± 4.2 Diarrhea / stool (%) Control Formula 41.6 ± 5.1 42.1 ± 5.5 Formula B 47.7 ± 5.3 51.9 ± 6.3 Formula C 49.1 ± 5.4 51.3 ± 7.2 Formula D 52.6 ± 4.3 42.6 ± 6.2 Soft stools (%) Control Formula 45.4 ± 5.4 22.6 ± 4.9 Formula B 38.0 ± 5.4 25.4 ± 6.3 Formula C 31.6 ± 5.0 33.8 ± 7.5 Formula D 31.8 ± 4.0 37.0 ± 5.8 Firm stools (%) Control Formula 5.7 ± 1.9 6.3 ± 3.2 Formula B 5.3 ± 1.9 0.0 ± 0.0 Formula C 5.8 ± 2.7 2.2 ± 1.4 Formula D 3.4 ± 1.2 5.4 ± 2.3
    [67] 1 Mean ± standard error of the mean.
    [68] 2 1 = aqueous stool, 2 = diarrhea / soft stools, 3 = soft stools, 4 = hard stools, 5 = hard stools.
    [69] Number of diets per day, mean intake, and saliva spitting, vomiting and spitting and vomiting, both during baseline and experimental period 1 variable Group / Fluid Criteria (1-7 days) Experiment (1-8 days) Dietary Recovery / Day Control Formula 7.5 ± 0.2 7.3 ± 0.3 Formula B 7.4 ± 0.2 7.3 ± 0.3 Formula C 7.4 ± 0.3 7.1 ± 0.3 Formula D 7.2 ± 0.2 6.9 ± 0.2 Average intake (ml / day) Control Formula 524 ± 19 568 ± 26 Formula B 556 ± 28 624 ± 32 Formula C 525 ± 21 605 ± 24 Formula D 551 ± 26 608 ± 21 % Of diets accompanied by spit of saliva Control Formula 11.1 ± 2.0 13.3 ± 3.5 Formula B 17.0 ± 3.1 11.7 ± 2.1 Formula C 23.8 ± 4.3 15.0 ± 4.2 Formula D 11.5 ± 2.2 9.0 ± 1.8 Percentage of Diet with Any Vomiting Control Formula 8.2 ± 2.9 2.0 ± 1.0 Formula B 4.1 ± 1.4 3.9 ± 2.9 Formula C 7.3 ± 2.6 3.6 ± 2.0 Formula D 4.8 ± 1.6 2.6 ± 1.0 % Of diet with spit or vomiting Control Formula 19.3 ± 3.5 15.3 ± 3.5 Formula B 21.0 ± 3.8 15.6 ± 3.3 Formula C 31.2 ± 5.1 18.6 ± 4.5 Formula D 16.3 ± 3.2 11.5 ± 2.3
    [70] 1 Mean ± standard error of the mean.
    [71] Weight gain in infants during baseline and experimental period variable Group / Fluid Criteria (1-7 days) Experiment (8-14 days) Weight gain (g / day) Control Formula 2 30.2 ± 2.7 31.1 ± 2.9 Formula B 3 33.6 ± 2.6 34.4 ± 2.1 Formula C 4 29.3 ± 2.8 30.9 ± 2.8 Formula D 5 26.6 ± 2.4 34.1 ± 2.7
    [72] 1 Mean ± standard error of the mean.
    [73] 2 Number of infants: Baseline: 44, Experimental period: 35.
    [74] 3 Number of infants: Base period: 43, Experimental period: 35.
    [75] 4 Number of infants: base period: 39, test period: 28.
    [76] 5 Number of infants: base period: 44, experimental period: 36.
    [77] Subject Result by Diet (n = 182) Exit status liquid Control Formula Formula B Formula C Formula D Successful completion 29 33 28 35 Initial mortality (8-14 days) 1 8 2 0 2 Standard lethality (1-7 days) 9 11 17 8 % Mortality 2 22 6 0 5 sum 46 46 45 45
    [78] 1 In 1,500 infant groups, all but one infant result in fluid intolerance or pediatric dissatisfaction.
    [79] 2 Ratio = [Initial Lethality (8-14 Days) / [Successful Completer + Baseline Deaths (1-7 Days)) x 100
    权利要求:
    Claims (84)
    [1" claim-type="Currently amended] A pediatric fluid formulation comprising a resistance improver comprising about 8 to about 16 g carbohydrate, about 3 to about 6 g lipid, about 1.8 to about 3.3 g protein, and about 37 to about 370 mg xanthan gum, based on 100 kcal.
    [2" claim-type="Currently amended] The pediatric formula of claim 1, wherein the xanthan gum comprises about 74 to about 222 mg.
    [3" claim-type="Currently amended] The pediatric fluid formulation of claim 1, wherein the xanthan gum comprises about 111 to about 148 mg.
    [4" claim-type="Currently amended] The pediatric fluid formulation of claim 1 wherein the carbohydrate comprises from about 9.4 to about 12.3 g.
    [5" claim-type="Currently amended] The pediatric fluid formulation of claim 1, comprising about 4.7 to about 5.6 g of lipid.
    [6" claim-type="Currently amended] The pediatric fluid formulation of claim 1, comprising about 2.4 to about 3.3 g protein.
    [7" claim-type="Currently amended] The pediatric formula of claim 1 further comprising vitamins and minerals.
    [8" claim-type="Currently amended] The complex of claim 1 wherein the vitamins and minerals are calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, vitamins A, E, C, D, K and B complexes, and mixtures thereof Pediatric fluid selected from the group consisting of.
    [9" claim-type="Currently amended] The method of claim 1, wherein the lipid is coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein ( palm olein), canola oil, lipid sources of arachidonic acid and docosahexanoic acid, and mixtures thereof.
    [10" claim-type="Currently amended] The protein of claim 1, wherein the protein comprises an intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein and mixtures thereof. Pediatric Formula Containing.
    [11" claim-type="Currently amended] The protein of claim 1 wherein the protein is soy protein hydrolyzate, casein protein hydrolyzate, whey protein hydrolyzate, rice protein hydrolyzate, potato protein hydrolyzate, fish protein hydrolyzate, egg white hydrolyzate, gelatin protein hydrolyzate, animal and vegetable A pediatric formula comprising a hydrolyzed protein selected from the group consisting of combinations of protein hydrolysates, and mixtures thereof.
    [12" claim-type="Currently amended] The pediatric formula of claim 1, wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, carnitine, and mixtures thereof.
    [13" claim-type="Currently amended] 2. The composition of claim 1, wherein the carbohydrates comprise hydrolyzed intact natural starches and chemically modified starches supplied from waxy or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And a pediatric fluid formula selected from the group consisting of mixtures thereof.
    [14" claim-type="Currently amended] The method of claim 1, comprising gum arabic, ghatti gum, karaya gum, tragacanth gum, agar, furcellaran, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin And a stabilizer selected from the group consisting of gelatin, microcrystalline cellulose, CMC, methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl cellulose, dextran, carrageenan and mixtures thereof.
    [15" claim-type="Currently amended] A powdered pediatric formula comprising about 30 to about 90 g carbohydrates, about 15 to about 30 g lipids, about 8 to about 17 g protein and about 188 to about 1880 mg xanthan gum, based on 100 g of powder.
    [16" claim-type="Currently amended] The pediatric fluid formulation of claim 15, wherein the xanthan gum comprises from about 375 to about 1125 mg.
    [17" claim-type="Currently amended] The pediatric fluid formulation of claim 15, wherein the xanthan gum comprises about 565 to about 750 mg.
    [18" claim-type="Currently amended] 16. The infant formula of claim 15, wherein the carbohydrate comprises about 48 to about 59 g.
    [19" claim-type="Currently amended] The pediatric fluid formulation of claim 15, wherein the lipophilic formula comprises about 22 to about 28 g of lipid.
    [20" claim-type="Currently amended] The pediatric formula of claim 15, wherein the formula comprises about 11 to about 17 grams of protein.
    [21" claim-type="Currently amended] The pediatric formula of claim 15, further comprising vitamins and minerals.
    [22" claim-type="Currently amended] The complex of claim 15 wherein the vitamins and minerals are calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, vitamins A, E, C, D, K and B complexes, and mixtures thereof. Pediatric fluid selected from the group consisting of.
    [23" claim-type="Currently amended] 16. The oil according to claim 15, wherein the lipids are coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, arachidone A pediatric fluid formula selected from the group consisting of lipid sources of acid and docosahexanoic acid, and mixtures thereof.
    [24" claim-type="Currently amended] 16. The pediatric formula of claim 15, wherein the protein comprises an intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein and mixtures thereof. .
    [25" claim-type="Currently amended] 16. The protein of claim 15 wherein the protein is soy protein hydrolyzate, casein protein hydrolyzate, whey protein hydrolyzate, rice protein hydrolyzate, potato protein hydrolyzate, fish protein hydrolyzate, egg white hydrolyzate, gelatin protein hydrolyzate, animal and vegetable A pediatric formula comprising a hydrolyzed protein selected from the group consisting of combinations of protein hydrolysates, and mixtures thereof.
    [26" claim-type="Currently amended] The pediatric formula of claim 15, wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, carnitine and mixtures thereof.
    [27" claim-type="Currently amended] 16. The composition of claim 15, wherein the carbohydrates comprise hydrolyzed intact natural starches and chemically modified starches supplied from waxy or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And a pediatric fluid formula selected from the group consisting of mixtures thereof.
    [28" claim-type="Currently amended] The method of claim 15, comprising gum arabic, garty gum, karaya gum, tragacanth gum, agar, purcellan, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin, gelatin, microcrystalline cellulose, A pediatric fluid formula further comprising a stabilizer selected from the group consisting of CMC, methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl cellulose, DATEM, dextran, carrageenan, and mixtures thereof.
    [29" claim-type="Currently amended] Based on 100 kcal, a pediatric fluid effective amount comprising a resistance enhancing agent comprising about 8 to about 16 g carbohydrates, about 3 to about 6 g lipids, about 1.8 to about 3.3 g protein, and about 37 to about 370 mg xanthan gum A method of nourishing a pediatric patient, including administering to the patient.
    [30" claim-type="Currently amended] The method of claim 29, wherein the xanthan gum comprises about 74 to about 222 mg.
    [31" claim-type="Currently amended] The method of claim 29, wherein the xanthan gum comprises about 111 to about 148 mg.
    [32" claim-type="Currently amended] The method of claim 29, wherein the carbohydrate comprises from about 9.4 to about 12.3 g.
    [33" claim-type="Currently amended] The method of claim 29, wherein the lipid comprises from about 4.7 to about 5.6 g.
    [34" claim-type="Currently amended] The method of claim 29, wherein the protein comprises about 2.4 to about 3.3 g.
    [35" claim-type="Currently amended] 30. The method of claim 29, further comprising vitamins and minerals.
    [36" claim-type="Currently amended] 36. The complex of claim 35 wherein the vitamins and minerals are calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, vitamins A, E, C, D, K and B complexes, and mixtures thereof. Selected from the group consisting of:
    [37" claim-type="Currently amended] 30. The method of claim 29, wherein the lipid is coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm oleic, canola oil, arachidone A source of lipids of acid and docosahexanoic acid, and mixtures thereof.
    [38" claim-type="Currently amended] The method of claim 29, wherein the protein comprises an intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein and mixtures thereof.
    [39" claim-type="Currently amended] 30. The protein of claim 29 wherein the protein is soy protein hydrolyzate, casein protein hydrolyzate, whey protein hydrolyzate, rice protein hydrolyzate, potato protein hydrolyzate, fish protein hydrolyzate, egg white hydrolyzate, gelatin protein hydrolyzate, animal and vegetable A method comprising a hydrolyzed protein selected from the group consisting of combinations of protein hydrolysates, and mixtures thereof.
    [40" claim-type="Currently amended] The method of claim 29, wherein the protein comprises a free amino acid selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, carnitine and mixtures thereof.
    [41" claim-type="Currently amended] 30. The method of claim 29, wherein the carbohydrates comprise hydrolyzed intact natural starches and chemically modified starches supplied from waxy or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And mixtures thereof.
    [42" claim-type="Currently amended] 30. The method of claim 29 comprising gum arabic, garty gum, karaya gum, tragacanth gum, agar, purcellane, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin, gelatin, microcrystalline cellulose, And a stabilizer selected from the group consisting of CMC, methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl cellulose, DATEM, dextran, carrageenan and mixtures thereof.
    [43" claim-type="Currently amended] Based on 100 g of powder, a pediatric patient is formulated with a pediatric fluid effective amount reconstituted from a powdered composition comprising about 30 to about 90 g carbohydrate, about 15 to about 30 g lipid, about 8 to about 17 g protein and about 188 to about 1880 mg xanthan gum. A method of nourishing a pediatric patient, including administering to a patient.
    [44" claim-type="Currently amended] The method of claim 43, wherein the xanthan gum comprises about 375 to about 1125 mg.
    [45" claim-type="Currently amended] The method of claim 43, wherein the xanthan gum comprises about 565 to about 750 mg.
    [46" claim-type="Currently amended] The method of claim 43, wherein the carbohydrate comprises about 48 to about 59 g.
    [47" claim-type="Currently amended] The method of claim 43, wherein the lipid comprises about 22 to about 28 g.
    [48" claim-type="Currently amended] The method of claim 43, wherein the protein comprises about 11 to about 17 g.
    [49" claim-type="Currently amended] 44. The method of claim 43, wherein the formula further comprises vitamins and minerals.
    [50" claim-type="Currently amended] The complex of claim 49 wherein the vitamins and minerals are calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, vitamins A, E, C, D, K and B complexes, and mixtures thereof. Selected from the group consisting of:
    [51" claim-type="Currently amended] 44. The method of claim 43, wherein the lipids are coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, arachidone A source of lipids of acid and docosahexanoic acid, and mixtures thereof.
    [52" claim-type="Currently amended] The method of claim 43, wherein the protein comprises an intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein and mixtures thereof.
    [53" claim-type="Currently amended] The protein of claim 43 wherein the protein is soy protein hydrolyzate, casein protein hydrolyzate, whey protein hydrolyzate, rice protein hydrolyzate, potato protein hydrolyzate, fish protein hydrolyzate, egg white hydrolyzate, gelatin protein hydrolyzate, animal and vegetable A method comprising a hydrolyzed protein selected from the group consisting of combinations of protein hydrolysates, and mixtures thereof.
    [54" claim-type="Currently amended] The method of claim 43, wherein the protein comprises free amino acids selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, carnitine, and mixtures thereof.
    [55" claim-type="Currently amended] 44. The composition of claim 43, wherein the carbohydrates comprise hydrolyzed intact natural starches and chemically modified starches supplied from waxy or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And mixtures thereof.
    [56" claim-type="Currently amended] 44. The method of claim 43, comprising gum arabic, garty gum, karaya gum, tragacanth gum, agar, purcellane, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin, gelatin, microcrystalline cellulose, And a stabilizer selected from the group consisting of CMC, methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl cellulose, DATEM, dextran, carrageenan and mixtures thereof.
    [57" claim-type="Currently amended] Based on 100 kcal, a pediatric fluid effective amount comprising a resistance enhancing agent comprising about 8 to about 16 g carbohydrates, about 3 to about 6 g lipids, about 1.8 to about 3.3 g protein, and about 37 to about 370 mg xanthan gum A method for improving the tolerance of a pediatric patient, including administering to the patient.
    [58" claim-type="Currently amended] The method of claim 57, wherein the xanthan gum comprises about 74 to about 222 mg.
    [59" claim-type="Currently amended] The method of claim 57, wherein the xanthan gum comprises about 111 to about 148 mg.
    [60" claim-type="Currently amended] 59. The method of claim 57, wherein the carbohydrate comprises from about 9.4 to about 12.3 g.
    [61" claim-type="Currently amended] The method of claim 57, wherein the lipid comprises about 4.7 to about 5.6 g.
    [62" claim-type="Currently amended] The method of claim 57, wherein the protein comprises about 2.4 to about 3.3 g.
    [63" claim-type="Currently amended] 58. The method of claim 57, further comprising vitamins and minerals.
    [64" claim-type="Currently amended] The complex of claim 57 wherein the vitamins and minerals are calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, vitamins A, E, C, D, K and B complexes, and mixtures thereof. Selected from the group consisting of:
    [65" claim-type="Currently amended] 58. The method of claim 57, wherein the lipid is coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm oleic, canola oil, arachidone A source of lipids of acid and docosahexanoic acid, and mixtures thereof.
    [66" claim-type="Currently amended] 58. The method of claim 57, wherein the protein comprises an intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein and mixtures thereof.
    [67" claim-type="Currently amended] The protein of claim 57 wherein the protein is soy protein hydrolyzate, casein protein hydrolyzate, whey protein hydrolyzate, rice protein hydrolyzate, potato protein hydrolyzate, fish protein hydrolyzate, egg white hydrolyzate, gelatin protein hydrolyzate, animal and vegetable A method comprising a hydrolyzed protein selected from the group consisting of combinations of protein hydrolysates, and mixtures thereof.
    [68" claim-type="Currently amended] The method of claim 57, wherein the protein comprises a free amino acid selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, carnitine, and mixtures thereof.
    [69" claim-type="Currently amended] 59. The composition of claim 57, wherein the carbohydrates comprise hydrolyzed intact natural starches and chemically modified starches supplied from waxy or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And mixtures thereof.
    [70" claim-type="Currently amended] 58. The composition of claim 57 comprising gum arabic, garty gum, karaya gum, tragacanth gum, agar, purcellane, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin, gelatin, microcrystalline cellulose, And a stabilizer selected from the group consisting of CMC, methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl cellulose, DATEM, dextran, carrageenan and mixtures thereof.
    [71" claim-type="Currently amended] Based on 100 g of powder, a pediatric patient is formulated with a pediatric fluid effective amount reconstituted from a powdered composition comprising about 30 to about 90 g carbohydrate, about 15 to about 30 g lipid, about 8 to about 17 g protein and about 188 to about 1880 mg xanthan gum. A method for improving the tolerance of a pediatric patient, including administering to a.
    [72" claim-type="Currently amended] The method of claim 71, wherein the xanthan gum comprises about 375 to about 1125 mg.
    [73" claim-type="Currently amended] The method of claim 71, wherein the xanthan gum comprises about 565 to about 750 mg.
    [74" claim-type="Currently amended] The method of claim 71, wherein the carbohydrate comprises about 48 to about 59 g.
    [75" claim-type="Currently amended] The method of claim 71, wherein the lipid comprises about 22 to about 28 g.
    [76" claim-type="Currently amended] The method of claim 71, wherein the protein comprises about 11 to about 17 g.
    [77" claim-type="Currently amended] The method of claim 71, wherein the formula further comprises vitamins and minerals.
    [78" claim-type="Currently amended] 78. The composition of claim 77, wherein the vitamins and minerals are calcium, phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, selenium, iodine, vitamins A, E, C, D, K and B complexes, and mixtures thereof Selected from the group consisting of:
    [79" claim-type="Currently amended] 72. The method of claim 71, wherein the lipid is coconut oil, soybean oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm oil, palm olein, canola oil, arachidone A source of lipids of acid and docosahexanoic acid, and mixtures thereof.
    [80" claim-type="Currently amended] The method of claim 71, wherein the protein comprises an intact protein selected from the group consisting of soy based protein, milk based protein, casein protein, whey protein, rice protein, beef collagen, pea protein, potato protein, and mixtures thereof.
    [81" claim-type="Currently amended] 72. The protein of claim 71 wherein the protein is soy protein hydrolyzate, casein protein hydrolyzate, whey protein hydrolyzate, rice protein hydrolyzate, potato protein hydrolyzate, fish protein hydrolyzate, egg white hydrolyzate, gelatin protein hydrolyzate, animal and vegetable A method comprising a hydrolyzed protein selected from the group consisting of combinations of protein hydrolysates, and mixtures thereof.
    [82" claim-type="Currently amended] The method of claim 71, wherein the protein comprises a free amino acid selected from the group consisting of tryptophan, tyrosine, cystine, taurine, L-methionine, L-arginine, carnitine, and mixtures thereof.
    [83" claim-type="Currently amended] 72. The composition of claim 71, wherein the carbohydrates comprise hydrolyzed intact natural starches and chemically modified starches supplied from waxy or non-waxed corn, tapioca, rice or potatoes; Sugars such as glucose, fructose, lactose, sucrose, maltose and higher fructose corn syrup; And mixtures thereof.
    [84" claim-type="Currently amended] 72. The formulation of claim 71 wherein the formula is Arabian gum, Gati gum, Karaya gum, tragacanth gum, agar, purcellane, guar gum, gellan gum, soybean gum, pectin, lower methoxyl pectin, gelatin, microcrystalline And a stabilizer selected from the group consisting of cellulose, CMC, methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl cellulose, DATEM, dextran, carrageenan and mixtures thereof.
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    同族专利:
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    US6589576B2|2003-07-08|
    IL150326D0|2002-12-01|
    MXPA02006938A|2003-01-28|
    AU2949001A|2001-08-14|
    AT321462T|2006-04-15|
    EP1251750B1|2006-03-29|
    HK1050983B|2006-10-27|
    TWI241167B|2005-10-11|
    CA2396148C|2011-09-06|
    CA2396148A1|2001-08-09|
    TR200201921T2|2003-01-21|
    WO2001056406A1|2001-08-09|
    DE60118387T2|2006-12-07|
    IL150326A|2005-06-19|
    KR100767202B1|2007-10-17|
    BR0106681A|2002-04-30|
    NZ519695A|2004-10-29|
    CZ20022743A3|2002-11-13|
    HU0204382A3|2004-07-28|
    DE60118387D1|2006-05-18|
    CY1108033T1|2013-09-04|
    HK1050983A1|2006-10-27|
    US20020176911A1|2002-11-28|
    DK1251750T3|2006-08-07|
    AU780438B2|2005-03-24|
    NO20023684L|2002-10-02|
    JP2003521501A|2003-07-15|
    CN1400870A|2003-03-05|
    SI21018A|2003-04-30|
    EP1251750A1|2002-10-30|
    ES2261432T3|2006-11-16|
    HU0204382A2|2003-04-28|
    US6365218B1|2002-04-02|
    BG107019A|2003-04-30|
    PL357134A1|2004-07-12|
    NO20023684D0|2002-08-02|
    SK12562002A3|2002-12-03|
    PT1251750E|2006-08-31|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    2000-02-04|Priority to US09/498,350
    2000-02-04|Priority to US09/498,350
    2001-01-16|Application filed by 아보트 러보러터리즈
    2002-10-05|Publication of KR20020075787A
    2006-12-22|First worldwide family litigation filed
    2007-10-17|Application granted
    2007-10-17|Publication of KR100767202B1
    优先权:
    申请号 | 申请日 | 专利标题
    US09/498,350|2000-02-04|
    US09/498,350|US6365218B1|2000-02-04|2000-02-04|Pediatric formula and methods for providing nutrition and improving tolerance|
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