DESC:NUTRITIONAL COMPOSITION FOR ORAL AND ENTERAL ADMINISTRATION
FIELD OF THE APPLICATION
[001] The present application relates to a nutritional composition suitable for both oral and enteral administration comprising macronutrients and micronutrients. The present application also relates to a nutritional composition in the form of powder or granulates for easy dispersion or reconstitution.
BACKGROUND
[002] In general, the hospitalized patients, and especially the intensive care unit patients who present with malnutrition or a high probability of developing malnutrition during their hospital stay, and those who are not expected to be on a full oral diet within three days should receive tube feeding. It is necessary to provide medical nutrition therapy with nutritional supplements by tube feeding within the first 24 - 48 hours following admission to facilitate diet tolerance, reduce the risk of intestinal barrier dysfunction and infections, and reduce the length of hospital stay and mechanical ventilation. Tube feeding is usually given using a specific device such as a nasogastric feeding tube or a nasojejunal feeding tube, or by using a percutaneous endoscopic gastrostomy (PEG) or jejuno-feeding system.
[003] . Patients in need of intensive medical care have alterations in both the physical and functional aspects of the gastrointestinal tract. Most patients experience gastrointestinal dysfunction due to compromised gastrointestinal motility, digestion, or absorption. None of the known nutritional compositions were suitable for both tube and oral feeding, that too offering different energy densities.
[004] For critically ill patients who are either hospitalized and those who are discharged after hospitalization, the insulin resistance and hyperglycemia are serious health complications in addition to the existing disease condition. The insulin resistance and hyperglycemia in-turn can cause severe cellular damage and reperfusion injury. Additional drug therapy, such as insulin are needed to control this hyperglycemia, which increases the healthcare cost and exposes the subject to additional drug interventions.
[005] The key purpose to provide nutritional support to patients who are critically ill is to avoid malnutrition and the associated complications, by offering suitable amounts of macronutrients and micronutrients. The nutritional composition of the present application with its innovative and specifically curated low glycemic index (GI) formulation helps control the hyperglycemia without the need for excess load of the insulin. The nutritional composition of the present application thus provides the intended dietary and nutritional support, helps reduce nitrogen deficit, and modulate the inflammatory response, in turn helping in speedy recovery.
[006] In the context of this application, the state of being fed by nutritional supplements by a feeding tube is called enteral feeding. This can be any known tube feeding system and the nutrition used in the feeding by nutritional supplements and/or by a feeding tube is called enteral nutrition.
[007] Use of oral or enteral nutrition may be temporary for the treatment of acute conditions or lifelong in the case of chronic disabilities. In the latter case, it is primordial that the enteral nutrition is designed for long-term administration containing all necessary components. Furthermore, the nutritional composition should be easily digestible. It should not cause gastrointestinal complications such as e.g., intestinal discomfort, reflux, aspiration pneumonia, high gastric residual volume (GRV), vomiting, nausea, bloating, and delayed gastric emptying. With advances in medical science resulting in increased life expectancy and better disease treatment, many patients would benefit from such oral and enteral nutrition designed to provide long-term comprehensive nutrition.
[008] Accordingly, the present application relates to a nutritional composition suitable for both oral and enteral administration comprising macronutrients and micronutrients that is easy for titration schedules to offer different calories meeting energy and nutrition needs as per individual requirements.
[009] Technical Problem
[0010] This invention aims to provide a nutritional composition that is suitable to be used as both oral and enteral feed, which provides nutrients to fulfill daily requirements and also mimics a normal healthy diet containing a mix of different nutrients. In that respect, a comprehensive nutrition product should contain proteins, carbohydrates, lipids, and essential micronutrients.
[0011] Also, when intended for enteral administration, the nutritional composition should be well-tolerated, easy to mix with water for administering by tube, i.e. it should have an optimum viscosity and density, be pH neutral, have a good shelf stability, and should not aggregate, agglomerate or precipitate and feasibility to be used as oral feed It should be suitable for heat treatments (such as warming, pasteurization when required) without a substantial change in structure, palatability, (especially for oral nutritional supplements), viscosity, etc. The mixture should be easily mixable with other components, such as a fat fraction, a carbohydrate fraction, a digestible fiber fraction, and other micronutrient components to provide complete nutrition.
[0012] None of the prior references teach a nutritional composition suitable for both oral and enteral feed without compromising on the nutrition provided per unit of the composition, or a single nutrition composition suitable for dilutions and titration as per subjects need for oral or enteral intake.
[0013] Surprisingly, the present inventors have found that the present nutritional composition with a specific combination of proteins, lipids, and carbohydrates, along with micronutrients provide nutritional support to critically ill patients in intensive care to be used as tube feeding and also suitable as oral feed to patients requiring dense nutritional supplement during their hospital stay to bridge the nutritional gap in their diet. It further minimizes clinical complications that are frequently associated with the administration of enteral nutrition using tube feeding, especially with respect to foaming, tube clogging, gastric distress and difficulty in gastric emptying etc.
SUMMARY OF THE APPLICATION
[0014] In one embodiment, the present invention relates to a nutritional composition comprising:
a) a macronutrient portion comprising:
i. a protein fraction,
ii. a fat fraction, and
iii. a carbohydrate fraction; and
b) a micronutrient portion comprising one or more vitamins and minerals.
[0015] In another embodiment, the present invention relates to a nutritional composition comprising:
a) a macronutrient portion comprising:
i. a protein fraction present in an amount of about 10% to about 65 % w/w by weight of the composition,
ii. a fat fraction present in an amount of about 5% to about 70 % w/w by weight of the composition, and
iii. a carbohydrate fraction present in an amount of about 10% to about 70 % w/w by weight of the composition; and
b) a micronutrient portion comprising one or more vitamins and minerals.
[0016] In one embodiment, the present invention relates to a nutritional composition with low glycemic index, the composition comprising:
a) macronutrient portion comprising:
i. a protein fraction,
ii. a fat fraction, and
iii. a carbohydrate fraction; and
b) a micronutrient portion comprising one or more vitamins and minerals.
[0017] In an aspect of the above embodiments, the nutritional composition of the present application is free of added sugar.
[0018] In an aspect of the above embodiments, the nutritional composition of the present application is suitable for both oral and enteral feeding.
[0019] In another aspect of the above embodiments, the nutritional composition of the present application is provided in a powder form for easy reconstitution in a liquid medium (water) to form a dispersion or suspension or slurry.
[0020] In another aspect of the above embodiments, the nutritional composition of the present application when dispersed in a liquid medium, has a viscosity of about 1cps to about 90cps.
[0021] In another aspect of the above embodiments, the nutritional composition of the present application provides calorie content or energy density of about 0.5kcal/ml to about 3kcal/ml.
[0022] In another aspect of the above embodiments, the nutritional composition of the present application which is in a powder form having a median diameter d50 (or d90 value) of about 2µm to about150µm.

BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1: Change in blood glucose levels between reference food (glucose) and nutritional supplement of Example 1 (test food) over 2 hours.
DETAILED DESCRIPTION OF THE APPLICATION
[0024] The details of one or more embodiments of the present invention are set forth in this document. Modifications to embodiments described in this document and other embodiments will be evident to those of ordinary skill in the art after studying the information provided in this document. The information provided in this document, particularly the specific details of the described exemplary embodiments, is provided primarily for clear understanding, and no unnecessary limitations are to be understood therefrom.
[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person having an ordinary skill in the art.
[0026] Definitions: The terms as used herein have the following meanings:
[0027] The term "comprising" is “open-ended” and means the elements recited, or their equivalent in structure or function, plus any other element or elements which are not recited. The terms "having" and "including" are also to be construed as open-ended unless the context suggests otherwise. These terms are not in the exclusive sense of "consisting only of". All ranges recited herein include the endpoints, including those that recite a range "between" two values.
[0028] The terms "a" and "the" as used herein are understood to encompass the plural as well as the singular or otherwise clearly mentioned wherever needed. For example, “an excipient” includes one or more of such excipients.
[0029] As used herein, “about”, “up to” is understood to refer to numbers in a range of numerals. Moreover, all numerical ranges herein should be understood to include all integers, whole or fractions, within the range.
[0030] As used herein, the term “at least” refers to the presence of the recited substance in the composition in recited least amount.
[0031] The terms “excipient” or “additives” are used interchangeably to mention any safe food acceptable material or a component of the composition that is not having any pharmacological effect, which is acceptable for use in nutritional compositions and does not provide any therapeutic effect, and may contribute to physicochemical properties or any relevant nontherapeutic function of the composition. The excipients that are useful in preparing a nutritional composition are generally safe, non-toxic, do not interact with other components of a composition in a deleterious manner, and are acceptable for human or veterinary use. As used in the specification, the term "excipient" includes both one and more than one such excipient.
[0032] The terms “component,” “excipient,” “ingredient,” “substance,” and “fraction” encompass both the singular and plural forms to indicate one or more such components, excipients, ingredients, substances, or fractions.
[0033] The terms “composition” and “formulation” are used interchangeably and refer to a mixture of two or more components, elements, or fractions. Also, the terms “composition” and “formulation” may be used to refer to a mixture of the components with excipients or other carriers. The present nutritional compositions are selected from, but not limited to, powder, microparticles, nanoparticles, powder for reconstitution, dispersion, suspension, and emulsion forming compositions.
[0034] As used herein, “complete or comprehensive nutrition” means nutritional compositions that contain sufficient amounts and levels of macronutrients (protein, fats, and carbohydrates) and micronutrients to be adequate to be a sole source of nutrition for the subjects to whom it is administered.
[0035] As used herein, “effective amount” is an amount that prevents a deficiency, treats a disease or medical condition in an individual, or, more generally, reduces symptoms, manages progression of the diseases, or provides a nutritional, physiological, or medical benefit to the individual. Treatment can be patient- or doctor-related.
[0036] As used herein, “incomplete nutrition” is nutritional composition that does not contain the required amount of macronutrients (protein, fats, and carbohydrates) or micronutrients to be sufficient to be a sole source of nutrition for the subject to whom it is administered.
[0037] As used herein, “sugar-free” and “free of sugar” are often used herein to refer to a nutritional composition that does not contain added sucrose.
[0038] While the terms “subjects,” “individual,” and “patient” are often used herein to refer to a human, the invention is not so limited. Accordingly, the terms “individual” and “patient” refer to any animal, mammal, or human having or at risk for a medical condition that can benefit from or may need the nutritional composition as described herein in the present application
[0039] As used herein, the term “antioxidant” includes any one or more of various substances such as beta-carotene (a vitamin A precursor), vitamin C, vitamin E, and selenium) that inhibit oxidation or reactions promoted by reactive oxygen species (“ROS”) and other radical and non-radical species. Additionally, antioxidants are molecules capable of slowing or preventing the oxidation of other molecules. Non-limiting examples of antioxidants include carotenoids, Ascorbyl Palmitate, coenzyme Q10 (“CoQ10”), flavonoids, glutathione Goji (wolfberry), hesperidin, lacto wolfberry, lignan, lutein, lycopene, polyphenols, selenium, vitamin A, vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, zeaxanthin, or combinations thereof.
[0040] As used herein, the term “amino acid” includes one or more amino acids. The amino acid can be, for example, alanine, arginine, asparagine, aspartate, citrulline, cysteine, glutamate, glutamine, glycine, histidine, hydroxyproline, hydroxyscrinc, hydroxytyrosinc, hydroxylysinc, isolcucinc, leucine, lysine, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, or combinations thereof.
[0041] As used herein, “long term administrations” are continuous for more than 4 weeks.
[0042] As used herein, “short term administrations” are continuous for less than 4 weeks.
[0043] As used herein, the term “minerals” includes boron, chloride, sodium, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, and the like or combinations thereof.
[0044] As used herein, the term “mineral premix” refers to a mixture of one or more of calcium carbonate, copper sulfate, potassium iodide, ferrous sulfate monohydrate, magnesium oxide, manganese sulfate monohydrate, dipotassium phosphate, potassium citrate, potassium chloride, sodium chloride, sodium citrate dihydrate, zinc sulfate monohydrate, sodium selenite, sodium molybdate and other minerals with a base component and the like or combinations thereof.
[0045] “Nutritional compositions,” as used herein, are understood to include any number of additional optional ingredients, including conventional food additives, for example, one or more, acidulants, additional thickeners, buffers or agents for pH adjustment, chelating agents, colorants, emulsifies, excipient, flavor agent, mineral, osmotic agents, a pharmaceutically acceptable carrier, preservatives, stabilizers, sugar, sweeteners, texturizers, and/or vitamins. The optional ingredients can be added in any suitable amount.
[0046] The terms “protein,” “peptide,” “oligopeptides” or “polypeptide” as used herein, are understood to refer to any composition that includes single amino acid (monomer), two or more amino acids joined together by a peptide bond (dipeptide, tripeptide, or polypeptide), collagen, precursor, homolog, analog, mimetic, salt, prodrug, metabolite, or fragment thereof or combinations thereof. For the sake of clarity, the use of any of the above terms is interchangeable unless otherwise specified.
[0047] Non-limiting examples of proteins include dairy-based proteins, plant-based proteins, animal-based proteins, and artificial proteins. Dairy-based proteins include, for example, casein, caseinates (e.g., all forms including sodium, calcium, potassium caseinates), casein hydrolysates, whey (e.g., all forms including concentrate, isolate, demineralized), whey hydrolysates, milk protein concentrate, and milk protein isolate. Plant-based proteins include, for example, soy protein (e.g., all forms including concentrate and isolate), pea protein (e.g., all forms including concentrate and isolate), canola protein (e.g., all forms including concentrate and isolate), other plant proteins that commercially are wheat and fractionated wheat proteins, corn and its fractions including zein, rice, oat, potato, peanut, green pea powder, green bean powder, and any proteins derived from beans, lentils, pulses and the like or combinations thereof.
[0048] As used herein, the term “vitamin” includes any of various fat-soluble or water-soluble organic substances (non-limiting examples include vitamin A, vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin or niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folic acid), and vitamin B12 (various cobalamins; commonly cyanocobalamin in vitamin supplements), vitamin C, vitamin D, vitamin E, vitamin K, folic acid and biotin) essential in minute amounts for normal growth and activity of the body and obtained naturally from plant and animal foods or synthetically made, pro-vitamins, derivatives, analogs and the like or combinations thereof.
[0049] As used herein, the term “vitamin premix” includes a mixture of one or more of vitamin A acetate, ergocalciferol, vitamin E acetate, phylloquinone, thiamine hydrochloride, riboflavin, niacinamide, calcium D-pantothenate, pyridoxine hydrochloride, ascorbic acid, chromium chloride, L-carnitine-L-tartrate, taurine, folic acid, D-biotin, vitamin B12, and other vitamins and the like or combinations thereof.
Enteral Nutrition
[0050] Enteral nutrition is the preferred nutrient delivery method for individuals who are unable to consume orally due to hospitalization or admission in intensive care unit and/or do not meet their nutritional needs orally. In the past, fiber-free enteral formulas were preferred due to problems with tube clogging and/or gastric irritation in few patients and also following that the notion bowel rest was beneficial in such conditions.
[0051] Enteral feeding or enteral route as used herein means the state of being fed by a feeding tube comprising all of the known tube feeding modes, and the nutrition used in such feeding is called enteral nutrition. Use of such enteral nutrition may be temporary or lifelong depending on the subject’s medical condition and nutrition needs.
[0052] Therefore, it is very crucial to develop and formulate curated nutritional composition, (1) to fulfil the nutritional needs, especially with regard to the carbohydrates, protein, fat and other micro elements and (2) to eliminate or reduce the clinical complications that are usually associated with the administration of enteral nutrition via tube feeding.
[0053] As used herein, a “tube feed” is a complete or incomplete nutritional composition that is administered to gastrointestinal system, other than through oral administration, including but not limited to a nasogastric tube, orogastric tube, gastric tube, Jejunostomy tube (J-tube”), percutaneous endoscopic gastrostomy (“PEG”), port, such as a chest wall port that provides access to the stomach, jejunum and other suitable access ports.
[0054] The composition of the present application may be included as a partial or complete nutritional composition for use in enteral formulations that are administered for providing nutrition in Intensive Care Unit (“ICU”) patients and also for improving gut health. It has been found that catch up weight gain is improved in such patients, most likely as the caloric intake of critically ill patients receiving artificial nutrition is much lower than desired, recommended or measured, especially with the enteral route and additional of such nutritional supplements might help in bridging the nutritional gap as they add up the calories, protein and micronutrients and also improved tolerance of the composition.
[0055] In several surgical interventions, many patients are unconscious and cannot eat voluntarily. If such patients are 50 years old or more, they tend to suffer with nutritional deficiencies. The nutritional composition of the present invention, therefore, plays a vital role in nutrition management. In patients with multi-organ disorders who also suffer from renal failure or liver complications, abnormalities in water-electrolyte tend to occur, leading to a hindrance to enteral nutrition from an early stage. There is accordingly a demand for a nutritional composition designed to suit patients with renal or liver failure. The nutritional composition of the present invention can serve as the best solution to provide complete nutritional support by increasing the number of serves per day to meet their daily nutrient requirements, which is usually done by a trained nutritionist and/or dietitian.
[0056] The nutritional composition of the present application is suitable for diabetic patients as it does not have any added sugar and has a low glycemic index.
[0057] Among all the macronutrients, carbohydrates are the favored substrates to produce energy, but the quantity and quality of the type of carbohydrates plays a crucial role in energy production while reducing the possibility of hyperglycemia. Most dietary recommendations focus on the quantity of carbohydrates without much consideration of the quality.
[0058] The quality of carbohydrates can be asserted by estimating the glycemic index (GI) of the food components. GI estimation is a method to relatively rank the carbohydrates in foods with respect to their effect on blood glucose levels. It has been demonstrated that carbohydrates with low GI value (<55) cause a lower and slower rise in the blood glucose as well as insulin levels, which is a highly desirable quality of a nutritional product. This is especially important for subjects who are on nutritional supplements, either oral or enteral, as the clinical conditions might worsen or exaggerate due to hyperglycemia caused by high GI feeds. In these patients, the risk of hyperglycemia is high and can result in poor clinical outcomes and delayed recovery. It is therefore critical to provide and ensure low GI nutritional supplements for subjects with critical illness.
[0059] The glycemic index (GI) is defined as a rating system for foods containing carbohydrates that shows how quickly each food affects your blood sugar (glucose) level when that food is consumed. The glycemic index compares the potential of foods containing the same amount of carbohydrate to raise blood glucose
[0060] Food and nutritional supplements are classified as low, medium, or high glycemic foods or supplements and ranked on a scale of 0–100. The lower the GI of a specific food or supplement, the lesser and slower the tendency it has to affect your blood sugar levels.
[0061] The general GI ratings followed in the nutritional and medical context are
Low GI: 55 or less, Medium GI: 56–69, and High GI: 70 or above.
Glycemic index values were computed by using the method suggested by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO).
Glycemic index value is calculated by expressing each subject’s IAUC after the test food as a percentage of the same subject’s mean reference IAUC.
GI value?of?test?food (%) =

Blood glucose IAUC value of the test food × 100
IAUC value of the reference food

IUAC is Incremental area under the curve (IAUC)
[0062] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition having low glycemic index.
[0063] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition having low glycemic index wherein the GI is 55 or less.
[0064] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition having low glycemic index wherein the GI is between 50 to 25.
[0065] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition having low glycemic index wherein the GI is between 50 to 25.
[0066] In yet another embodiment, the nutritional composition of the present application provides an oral and enteral nutrition having low glycemic index wherein the GI is between 45 to 30.
[0067] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition, wherein the change in blood glucose concentration is less than 45 mg/dl within 2 hours of administration compared to the reference food.
[0068] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition, wherein the change in blood glucose concentration is less than 30 mg/dl within 2 hours of administration compared to the reference food.
[0069] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition, wherein the change in blood glucose concentration is between 5mg/dl to 45mg/dl within 2 hours of administration compared to the reference food.
[0070] In an embodiment, the nutritional composition of the present application provides an oral and enteral nutrition, wherein the change in blood glucose concentration is between 5 mg/dl to 35 mg/dl within 2 hours of administration compared to the reference food.
[0071] The nutritional composition of the present application may also be used to improve tolerance of various treatments that lead to GI disorders such as radiotherapy, chemotherapy, antibiotics, diarrhea treatments, gastrointestinal surgery, anesthesia, and analgesic drugs.
[0072] One of the significant problems in enteral nutrition is the occurrence of diarrhea, constipation in some patients and other gastrointestinal side effects during nutrition. There are reports about the diarrhea rate between 2% and 63% of patients receiving enteral nutrition. See Patti Eisenberg, “An Overview of Diarrhea in the Patient Receiving Enteral Nutrition,” Gastroenterology Nursing, 25(3):95-104 (2002).
[0073] The composition of the present application uses soluble, insoluble fibers and combinations thereof, within a range that allows for smooth passage along the entire length of the colon.
[0074] The nutritional compositions of the present application may be prepared in liquid form. While water is the most common carrier for the other components, it is also envisioned to add the compositions to other liquids such as milk, fruit juice, coffee, tea, or other beverages when such compositions are orally administered as per the preference of patient and recommendation by health care professional or nutritionist. Water is the most commonly used carrier or vehicle for both oral, as well as enteral administrations.
[0075] The present application also provides dry powdered formulations. These powdered formulations can be made by combining dry powdered ingredients, or they can be made from one of the liquid nutritional compositions described herein. Typically, the powdered formulations are prepared by drying liquid nutritional compositions using spray drying, freeze-drying, or other drying techniques known in the art. If desired, other nutritional components or compositions can be added to the liquid before drying to provide enhanced nutritional benefits to the powdered formulation. Such powdered formulations have a much greater shelf life and can be packaged for storage and transport for future use. At that time, the powdered formulations can be reconstituted with water or other fluids and then administered to the individual orally. The powdered formulation can be packaged in various containers, including those for bulk provision for adding to a liquid in a glass bottle, or other fluid containing vessel, or a single serving can be provided with the powder present in a container to which water or other fluids can be added to form the liquid before administration.
[0076] It is also contemplated that various conventional additives can be included in the nutritional formulations of the present disclosure. For example, various flavorant, colorants, minerals, antioxidants, preservatives, or health benefit additives can be included in conventional amounts for their traditional purposes.
[0077] The nutritional composition in the directly usable form is preferred. The composition in this form can be administered via tube from nose—stomach and then jejunum or orally. Such a nutritional composition may take various forms preferably as a slurry when mixed with plain water. The nutritional composition may be a soluble or insoluble powder that can be reconstituted before use and to be consumed immediately.
[0078] The nutritional composition may contain various flavors (ex. vanilla), additives, and it does not contain added sugar.
[0079] The nutritional compositions may also be helpful for diabetic subjects in need of such nutrition. Administering one of the nutritional compositions disclosed herein can reduce insulin resistance, decrease blood glucose excursions, or lower CVD risk.
[0080] In an embodiment, the nutritional composition comprises a macronutrient portion.
[0081] In an embodiment, the nutritional composition comprises a micronutrient portion.
[0082] In an embodiment, the nutritional composition comprises a macronutrient portion comprising proteins, fats or lipids, and carbohydrates.
[0083] In an embodiment, the nutritional composition comprises a micronutrient portion comprising one or more vitamins, minerals, and additives.
[0084] In another embodiment, the nutritional composition comprises a macronutrient portion comprising a protein fraction present in an amount of about 10% to about 65 % w/w of the composition.
[0085] In another embodiment, the nutritional composition comprises a protein fraction present in an amount of about 10% to about 65 % w/w of the composition.
[0086] In another embodiment, the nutritional composition comprises a protein fraction present in an amount of about 15% to about 60 % w/w of the composition.
[0087] In another embodiment, the nutritional composition comprises a protein fraction present in an amount of about 18 % to about 55 % w/w of the composition.
[0088] In yet another embodiment, the nutritional composition comprises a macronutrient portion comprising a fat fraction present in an amount of about 5% to about 70 % w/w of the composition.
[0089] In yet another embodiment, the nutritional composition comprises a fat fraction present in an amount of about 5% to about 70 % w/w of the composition.
[0090] In yet another embodiment, the nutritional composition comprises a fat fraction present in an amount of about 8 % to about 60% w/w of the composition.
[0091] In another embodiment, the nutritional composition comprises a fat fraction present in an amount of about 10 % to about 55 % w/w of the composition.
[0092] In another embodiment, the nutritional composition comprises a fat fraction present in an amount of about 12 % to about 50 % w/w of the composition.
[0093] In another embodiment, the nutritional composition comprises a macronutrient portion comprising a carbohydrate fraction present in an amount of about 10% to about 70 % w/w of the composition.
[0094] In an embodiment, the nutritional composition comprises a carbohydrate fraction present in an amount of about 10% to about 70 % w/w of the composition.
[0095] In an embodiment, the nutritional composition comprises a carbohydrate fraction present in an amount of about 15% to about 60 % w/w of the composition.
[0096] In an embodiment, the nutritional composition comprises a carbohydrate fraction present in an amount of about 20% to about 50 % w/w of the composition.
[0097] In an embodiment, the nutritional composition further comprises one or more vitamins and minerals;
[0098] In an embodiment, the nutritional composition further comprises antioxidant nutrients.
[0099] In an embodiment, the nutritional composition further comprises docosahexaenoic acid (“DHA”) and eicosapentaenoic acid (“EPA”) or combinations thereof.
[00100] In an embodiment, the nutritional composition further comprises phytonutrients.
[00101] In an embodiment, the protein is selected from one or more of casein, micellar casein, calcium caseinate, skim milk powder, whey protein concentrate, whole milk powder, milk protein concentrate, whey protein isolates, and the like or mixtures thereof.
[00102] In another embodiment, the fats or lipids are selected from one or more short-chain fatty acid, medium-chain fatty acid, long-chain fatty acid, monounsaturated fatty acid, and/or mixtures thereof.
[00103] In another embodiment, the carbohydrate is selected from one or more sorbitol, xylitol, or maltitol, trehalose, palatinite, maltodextrin, processed starch, amylose starch, tapioca starch, fructose, lactose, and the like or mixtures thereof.
[00104] In an embodiment, the nutritional composition further comprises a fiber component.
[00105] The nutritional composition of the present invention is intended to comprise any dietary fiber, or any mixture of dietary fibers. In particular, the nutritional composition according to the invention is intended to comprise one or more of fructo oligosaccharides, soluble non-starch polysaccharides, insoluble non-starch polysaccharides, non-digestible oligosaccharides, inulin, acacia fiber, arabic gum, soy polysaccharide, alpha-cellulose, resistant starch, and the like or mixtures thereof.
[00106] In an embodiment, the nutritional composition comprises a macronutrient portion comprising a fiber fraction.
[00107] In an embodiment, the nutritional composition comprises a micronutrient portion comprising a fiber fraction.
[00108] In an embodiment, the nutritional composition comprises a fiber fraction in an amount of about 0.5% to about 8% by weight of the composition.
[00109] In an embodiment, the nutritional composition comprises one or more vitamins selected from vitamin A (retinol), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 (biotin), vitamin B11 (folic acid), vitamin B12 (cyanocobalamin), vitamin C (ascorbic acid), vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), vitamin E (alpha-tocopherol), vitamin K and , and the like or mixtures thereof.
[00110] In an embodiment, the nutritional composition comprises a micronutrient portion comprising one or more vitamins selected from vitamin A (retinol), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 (biotin), vitamin B11 (folic acid), vitamin B12 (cyanocobalamin), vitamin C (ascorbic acid), vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), vitamin E (alpha-tocopherol), vitamin K and , and the like or mixtures thereof.
[00111] In an embodiment, the nutritional composition comprises one or more minerals selected from boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, and the like or mixtures thereof.
[00112] In an embodiment, the nutritional composition comprises a micronutrient portion comprising one or more minerals selected from boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, and the like or mixtures thereof.
[00113] In another embodiment, the nutritional composition comprises protein fraction and fat fraction in a weight ratio of about 10:0.5 to about 1:10.
[00114] In yet another embodiment, the nutritional composition comprises protein fraction and fat fraction in a weight ratio of about 5:1 to about 1:5.
[00115] In another embodiment, the nutritional composition comprises is used for oral administration.
[00116] In another embodiment, the nutritional composition comprises is used for enteral or tube feed administration.
[00117] In an embodiment, the nutritional composition is a powder for reconstitution or powder for dispersion.
[00118] In an embodiment, the nutritional composition is a powder for reconstitution in a liquid medium to form a dispersion or suspension, or slurry.
[00119] In another embodiment, when dispersed in the liquid medium, the nutritional composition can be administered through naso-gastric tube with outer diameter of about 2mm to about 7mm, preferably with outer diameter of about 3mm to about 6mm.
[00120] In another embodiment, when dispersed in the liquid medium, the nutritional composition provides smooth flow through naso-gastric tube with outer diameter of about 2mm to about 7mm, preferably with outer diameter of about 3mm to about 6mm.
[00121] In an embodiment, the nutritional composition is a dry powdered formulation. In another embodiment, the nutritional composition is made by preparing one of the compositions as a liquid and drying the liquid composition by one of the processes known in the art, including spray drying, freeze-drying, or other drying techniques to produce a dry powdered composition.
[00122] In a further embodiment, additional nutritional components or compositions to the liquid prior to drying provide enhance nutritional benefits to the powdered composition. In a further embodiment, a nutritional composition is obtained by reconstituting the dry powdered formulations formulation with a liquid.
Viscosity
[00123] In one embodiment of the present invention, the viscosity of the liquid enteral nutritional composition is lower than 100 cps, measured at room temperature at a shear rate of 100 s-1, preferably between 2 and 80 cps, more preferably between 5 and 50 cps. The viscosity may suitably be determined using a cone/plate geometry with a rotational viscosity meter. According to the invention, this viscosity is ideal for orally administering or tube feeding the nutritional composition because a person may easily consume a serving with low viscosity such as that displayed by the present invention.
[00124] The viscosity of the nutritional composition, when measured at room temperature, is from about 1 to 90 cps, preferably from about 2 to 80 cps.
[00125] In an embodiment, the nutritional composition has a viscosity of about 1cps to about 90cps when mixed, dispersed, or reconstituted in a liquid medium.
[00126] In an embodiment, the nutritional composition has a viscosity of about 2 cps to about 80cps when mixed, dispersed, or reconstituted in a liquid medium.
[00127] In an embodiment, the nutritional composition has a viscosity of about 3 cps to about 70cps when mixed, dispersed, or reconstituted in a liquid medium.
[00128] In an embodiment, the nutritional composition has a viscosity of about 4 cps to about 60cps when mixed, dispersed, or reconstituted in a liquid medium.
[00129] In an embodiment, the nutritional composition has a viscosity of about 5 cps to about 50cps when mixed, dispersed, or reconstituted in a liquid medium.
[00130] In one embodiment of the present invention, the density of the composition ranges between 1.0 g/ml and 4.0 g/ml, especially between 1.05 g/ml and 3.5 g/ml.
[00131] In an embodiment, the nutritional composition is free of added sugar.
[00132] In an embodiment, the nutritional composition is substantially free of sugar.
[00133] The nutritional composition of the present application has an osmotic pressure of about from 300 to 1000 mOsm/L, for example, from about 300 to 750 mOsm/L.
[00134] The nutritional composition of the present application is specifically designed to address the issues of titration difficulties. Different subjects need different calorie intake depending on the clinical condition and at different time through the therapy and recovery stage. The required quantity of nutritional composition is mixed with carrier and diluted with sufficient fluid to achieve the desired calorie and nutrients levels in the feed. For example, if 1kcal/ml is the desired calorie intake in the initial 1-4 days of hospitalization, days 5-7 may warrant increased calorie intake upto 1.5 kcal/ml or 2 kcal/ml and so on until the subject is recovered and able to take oral food on his own.
[00135] Currently, no single nutritional composition is able to provide various dilutions ex. 0.5kcal/ml to 3 kcal/ml; with the same composition. As a result, in practice the nutritionist or medical care giver is forced to switch and try different supplement products for each Kcal/ml calorie or energy dilutions. This results in multiple trial and error set-ups and leaves room for subjectivity, which can further result in under or over nutrition causing unnecessary clinical complications and errors. Also, switching to different products poses a challenge to the caregiver such as increased therapy cost and may cause confusion and leading to erroneous use of products. Similarly, for the patients, switching to multiple different products may stress or burden the already weakened gastro-intestinal system and also pose major tolerability issues.
[00136] The nutritional composition of the present application address this serious issue and provides a single composition that is easy to titrate from 0.5 kcal/ml to up to 5 kcal/ml based on the needs for different calorie intake for different subjects.
[00137] With extensive research and experimentations, the inventors of the present application were able to design and develop a nutritional composition combining specific ingredient’s in a specific ratio and with unique manufacturing method, that provides desired-viscosity and titration ability to the nutritional composition which is easy for tube feeding as well as oral feed. The viscosity of the composition is such that even at different titrations or dilutions it maintains excellent fluidity, and does not need a strainer to pass the slurry composition before tube-feeding.
[00138] For tube feeding or oral ingestion of the nutritional composition, it can be dispersed in the required amount of liquid medium to prepare a slurry or smooth paste and then further diluted with additional amount of liquid medium to achieve the desired calorie content or energy density per milliliter of the preparation, as per the patient’s calorie requirement. For example, if 1kcal/ml is the desired calorie intake, about 45-55g of the nutritional composition is mixed with sufficient amount of liquid medium to prepare a smooth slurry, and the slurry is further diluted about 150-200ml of the liquid medium.
[00139] Different types of feeding tubes that can be used for enteral feedings are: Nasogastric tubes, Nasojejunal tube (NJT), Jejunostomy tubes (JEJ), and Percutaneous endoscopic gastrostomy tubes (PEG tube)
[00140] The most commonly used tubes are the Nasogastric (NG) tubes also known as the Ryle's tube or French Ryle’s tube.
[00141] The Nasogastric tubes are available as different size tubes ranging from size 8 FG (French Gauge) upto 20 FG with varying outer diameter (OD) of the tube from 2.7mm for 8FG tube to 6.7mm for 20FG tube. Most commonly used Ryle’s tube sizes are 10FG to 16FG having OD of 3.3mm to 5.3mm.
[00142] The nutritional composition of the present application provides a single composition that is suitable to be administered through Ryle’s tube 8FG to 20FG with easy flowing and non-clogging properties.
[00143] The nutritional composition allows for titrations to achieve a calorie content or energy density from about 0.5 to 5 kcal/mL, preferably from 1 to 3.5 kcal/mL.
[00144] The nutritional composition has a calorie content or provides an energy density of about 0.5 to 5 kcal/mL, preferably from 1 to 3.5 kcal/mL.
[00145] In an embodiment, the nutritional composition has a calorie content or provides an energy density of about 0.5 kcal/ml to about 5 kcal/ml.
[00146] In another embodiment, the nutritional composition has a calorie content or provides an energy density of about 0.5 kcal/ml to about 4 kcal/ml.
[00147] In yet another embodiment, the nutritional composition has a calorie content or provides an energy density of about 0.5 kcal/ml to about 3.5 kcal/ml.
[00148] In yet another embodiment, the nutritional composition has a calorie content or provides an energy density of about 1 kcal/ml to about 2.5 kcal/ml.
[00149] In yet another embodiment, the nutritional composition has particle size or median diameter (d50) of the particles is about 400µm or less, and preferably about 2µm to about 200µm. When the average particle diameter within the above range is contained in the nutritional composition, the composition can be administered for both oral feed and tube feed without any flavor and tube fluidity problems.
[00150] The nutritional composition of the present invention has a median diameter (d50) of is about 2µm to about 200µm, and preferably about 10µm to about 90µm. In addition, there are fat or lipid globule particles. The median diameter (d50) of all these particles is about 2µm to 200µm.
[00151] In an embodiment, the nutritional composition is powder form with a median diameter d50 of about 2µm to about 200µm.
[00152] In an embodiment, the nutritional composition is powder form with a median diameter d50 of about 5µm to about 150µm.
[00153] In an embodiment, the nutritional composition is powder form with a median diameter d50 of about 5µm to about 130µm.
[00154] In an embodiment, the nutritional composition is powder form with a median diameter d50 of about 10 µm to about 120µm.
[00155] An embodiment of the invention relates to the process of preparation of the nutritional composition.
[00156] In an aspect of the above embodiment, the invention relates to preparing the nutritional composition comprising a macronutrient portion.
[00157] In an aspect of the above embodiment, the invention relates to preparing the nutritional composition comprising a micronutrient portion.
[00158] In an aspect of the above embodiment, the invention relates to preparing the nutritional composition comprising a macronutrient portion and a micronutrient portion.
[00159] In an embodiment, the present nutritional composition is prepared by spray drying.
[00160] In another embodiment, the present nutritional composition is prepared by dry blending.
[00161] In a further embodiment, the present nutritional composition is prepared by simple mixing, spray drying, dry blending, lyophilization or a combination of these methods.
[00162] In an aspect of the above embodiment, the invention relates to the process for preparation of the nutritional composition comprising a macronutrient portion and a micronutrient portion, wherein the macronutrient portion comprises proteins, fats or lipids, carbohydrates and wherein the micronutrient portion comprises one or more vitamins, minerals and additives.
[00163] An embodiment further relates to a process of preparation of the nutritional composition comprising:
a) a macronutrient portion comprising
i. a protein fraction,
ii. a fat fraction, and
iii. a carbohydrate fraction; and
b) a micronutrient portion.
[00164] An embodiment further relates to a process of preparation of the nutritional composition comprising:
a) a macronutrient component comprising
i. a protein fraction present in an amount of about 10% to about 65 % w/w by weight of the composition,
ii. a fat fraction present in an amount of about 5% to about 70 % w/w by weight of the composition, and
iii. a carbohydrate fraction present in an amount of about 10% to about 70 % w/w by weight of the composition; and
b) a micronutrient component.
[00165] In an aspect of the above embodiments, the invention further relates to a process of preparation of the nutritional composition comprising:
a) spray drying the macronutrient portion and
b) dry blending the micronutrient portion with the spray-dried macronutrient portion.
[00166] The present application is further illustrated by the examples provided merely to be exemplary of the pharmaceutical composition described above and do not limit the scope of the application. Certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present application.
[00167] The present invention is illustrated below by reference to the following examples. However, one skilled in the art will appreciate that the specific methods and results discussed are merely illustrative of the present invention and not to be construed as limiting the application. The following examples may include compilations of data that are representative of data gathered at various times during development and experimentation related to the present invention.
EXAMPLES 1- 4:
Ingredients Quantity
(In g/100g )
Macronutrients Example 1 Example 2 Example 3 Example 4 Example 5
Calcium Caseinate 7.5 8.5 8.53 3.1 11.72
Whey Protein Concentrate 23.00 25.00 6.4 -
Whole Milk Powder - - 21.5 - -
Milk Protein Concentrate - - 21.5 -
Whey Protein Isolates - - - - 21.60
High Oleic Sunflower Oil 3.00 3.00 3.00 3.00 3.00
MCT Oil 17.00 17.00 17.00 17.00 17.00
Soya Lecithin Liquid 0.10 0.10 0.10 0.10 0.10
FOS Powder 2.70 1.80 4.60 4.20 2.675
Maltodextrin 33.29 31.29 31.40 31.8 30.29
Fructose 13.30 13.30 13.30 13.30 13.30
Ascorbyl Palmitate 0.010 0.010 0.010 0.010 0.010

Macronutrient bend 91 91 91 91 91
Mineral premix 7.2 7.2 7.2 7.2 7.2
Vitamin Premix 0.33 0.33 0.33 0.33 0.33
Flavor 1.23 1.23 1.23 1.23 1.23
Manufacturing process:
Step 1: Preparation of macronutrient blend
1. The required quantity of calcium caseinate, whey protein concentrate, whole milk powder, milk protein concentrate, whey protein isolates, high oleic sunflower oil, MCT oil, soya lecithin liquid, FOS powder, maltodextrin, fructose and ascorbyl palmitate was weighed.
2. Water was heated at a temperature between 60-80?.
3. Calcium caseinate, whey protein concentrate, whole milk powder, milk protein concentrate, whey protein isolates, and other powder ingredients were mixed with the water to make a slurry.
4. High oleic sunflower oil, MCT oil, soya lecithin liquid, and ascorbyl palmitate were blended.
5. The powder slurry was then mixed with the oil blend and then further homogenized and pasteurized.
6. The resulting mixture was spray-dried and later stored in a suitable container.

Step 2: Preparation of micronutrient premix
1. Required quantities of vitamins and minerals were weighed and mixed with the maltodextrin to obtain a premix.
2. Flavor is added to the premix and blended.

Step 3: Dry blending of the macronutrient blend and micronutrient premix.
1. The macronutrient blend was blended with vitamin and mineral premix, and the final blend was transferred and stored in a suitable container.
EXPERIMENTAL DATA
Physical Evaluation
The examples 1-5 were subjected to physical tests i.e. Appearance, dispersibilty, foaming tendency.
Procedure: 50g of the powdered mixtures for examples 1-5 were taken in glass beakers and observed for physical characteristics. Lukewarm water was added in quantity sufficient to make a thick paste like slurry. Finally, the remaining lukewarm water was added with stirring to make up the volume upto 90ml.
The results of the tests are as given in the Table 1 below.

Table 1:
Test Example 1 Example 2 Example 3 Example 4 Example 5
Appearance Pale yellow to white powdered mixture Pale yellow to white powdered mixture Pale yellow to white powdered mixture Pale yellow to white powdered mixture Pale yellow to white powdered mixture
Dispersibilty Easily dispersed with no lump formation Easily dispersed with no lump formation Lump formation observed Dispersed with additional shaking in a closed container Lump formation observed
Foaming on dispersion No foaming observed No foaming observed Foam formation observed while stirring Foam formation observed while stirring Foam formation observed while stirring
Viscosity (cps) 37 36 Not calculated 44 Not calculated

Viscosity:
The composition of Example 1 and Example 2 were evaluated for viscosity at different titration levels. The results are presented in Table 2 and Table 3 below

Table 2:
Nutritional powder Ex 1 (g) Water (ml) Viscosity of the dispersion (cps)
50 90 38.0
50 110 33.0
50 125 26.4
50 200 7.25

Table 3:
Nutritional powder Ex 2 (g) Water (ml) Viscosity of the dispersion (cps)
50 90 35.5
50 110 31.0
50 125 27.0
50 200 9.10

Clinical Study Data:
Glycemic Index (GI) estimation: To estimate the GI of a nutritional formulations as per Example 1.

Method
Fifteen healthy participants (mean age: 25 years; mean body mass index: 21 kg/m2) were enrolled in the study. The test food supplement was prepared as per Example 1 of the present application and was designed to accommodate the ease of titrations from 0.5 kcal/mL to 3 kcal/mL for tube feeding. The exemplary dilutions are presented in table 4 below. To provide 25 g of available carbohydrates, 51 g of this nutritional supplement was mixed in 167 mL of lukewarm water. Reference food was 27.5 g of glucose monohydrate dissolved in 125 mL of water. Capillary blood glucose was measured at fasting (0 minutes) and at an interval of 15 minutes till 120 minutes, after consuming the reference and test food, for estimating the GI.

Table 4:
Nutritional powder (g) Water (ml) Energy density
kcal/ml
50 90 2.0
50 110 1.7
50 125 1.5
50 200 1.0

Data Analysis
The trapezoid rule was applied to estimate the incremental area under the curve (IAUC) of blood glucose for the reference and test foods. The IAUC mean and standard errors for the reference and test foods were calculated. Glycemic index value was calculated by expressing each subject’s IAUC after the test food as a percentage of the same subject’s mean reference IAUC. The mean of the resulting values was taken as the GI of the respective test food. The GI values were further tested to see the influence (interaction) by age (years), sex, diet (energy [kcal], protein [g], fat [g], carbohydrates [g], and dietary fiber [g]), and physical activity level, using a generalized linear model.

GI value?of?test?food (%) = Blood glucose IAUC value of the test food × 100
IAUC value of the reference food

Results
The change in blood glucose levels between the reference food (glucose) and the test food over 2 hours is depicted in Figure 1. At the tested nutrient concentration, the change in blood glucose level varied from 15 minutes up to 120 minutes. At 120 minutes, a negative value could be observed pertaining to the blood glucose concentration for both the test food and the reference food. The mean IAUC of the reference food and test food and the GI of the test food are reported in Table 5. As observed, the mean IAUC of the reference food was found to be 3626±269 mg/dL*min and the mean IAUC of the test food was found to be 1459±132 mg/dL* min; thus, according to the estimated GI test, the GI of the test food supplement was 39±3, proving it as a low-GI food category.

Table 5: Mean IAUC of the reference food and the GI of the test food
Mean IAUC–reference food
(mg/dL*min) Mean IAUC–test food
(mg/dL*min)
GI of the nutritional supplement (test food)
3626±269 1459±132 39±3
IAUC: Incremental area under the curve; GI: Glycemic index. ,CLAIMS:We Claim:
1. A nutritional composition comprising:
a. a macronutrient portion comprising:
i. a protein fraction present in an amount of about 10% to about 65 % w/w by weight of the composition;
ii. a fat fraction present in an amount of about 5% to about 70 % w/w by weight of the composition; and
iii. a carbohydrate fraction present in an amount of about 10% to about 70 % w/w by weight of the composition.
b. a micronutrient portion comprising, one or more vitamins and minerals;
wherein said composition has low glycemic index value.
2. The composition as claimed in claim 1, wherein said composition has glycemic index between 30 and 50.
3. The composition as claimed in claim 1, wherein said composition has glycemic index between 35 and 45.
4. The composition as claimed in claim 1, wherein said protein fraction comprising one or more proteins selected from casein, micellar casein, calcium caseinate, skim milk powder, whey protein concentrate, whole milk powder, milk protein concentrate, whey protein isolates, and the like or mixtures thereof.
5. The composition as claimed in claim 1, wherein said fat fraction comprising one or more fats selected from a short-chain fatty acid, medium-chain fatty acid, long-chain fatty acid, mono-unsaturated fatty acid, and the like or mixtures thereof.
6. The composition as claimed in claim 1, wherein said carbohydrate fraction comprising one or more carbohydrates selected from sugar alcohols like sorbitol, xylitol or maltitol; trehalose, palatinite, maltodextrin, processed starch, amylose starch, tapioca starch, fructose, lactose, and the like or mixtures thereof.
7. The composition as claimed in claim 1, wherein said macronutrient portion further comprises a fibre fraction.
8. The composition as claimed in claim 5, wherein said fibre fraction is present in an amount of about 0.5% to about 8% w/w by weight of the composition.
9. The composition as claimed in claim 1, wherein micronutrient portion comprising one or more vitamins selected from vitamin A (retinol), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 (biotin), vitamin B11 (folic acid), vitamin B12 (cyanocobalamin), vitamin C (ascorbic acid), vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), vitamin E (alpha-tocopherol), vitamin K and mixture thereof.
10. The composition as claimed in claim 1, wherein micronutrient portion comprising one or more minerals selected from boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, nickel, phosphorus, potassium, selenium, silicon, tin, vanadium, zinc, or combinations thereof.
11. The composition as claimed in claim 1, wherein said protein fraction and fat fraction are present in a weight ratio of about 10:0.5 to about 1:10.
12. The composition as claimed in claim 1, wherein said composition is meant for oral administration.
13. The composition as claimed in claim 1, wherein said composition is meant for enteral or tube feed administration.
14. The composition as claimed in claim 1, wherein said composition is a powder for reconstitution in liquid medium to form a dispersion or suspension or slurry.
15. The composition as claimed in claim 14, wherein said dispersion has a viscosity of about 1 cps to about 80 cps.
16. The composition as claimed in claim 14, wherein said dispersion has a viscosity of about 2 cps to about 60 cps.
17. The composition as claimed in claim 1, wherein said composition provides an energy density of about 0.5 kcal/ml to about 3 kcal/ml.
18. The composition as claimed in claim 1, wherein said composition provides an energy density of about 1 kcal/ml to about 2.5 kcal/ml.
19. The composition as claimed in claim 1, wherein said composition provides an energy density of about 1.5 kcal/ml to about 2 kcal/ml.
20. The composition as claimed in claim 1, wherein said composition is in a powder form having a median diameter d50 (or d90 value) of about 2µm to about 150µm.
21. A process of preparation for the nutritional composition comprising:
a) spray drying the macronutrient portion comprising:
i) a protein fraction;
ii) a fat fraction; and
iii) a carbohydrate fraction; and
b) dry blending the micronutrient portion with the spray-dried macronutrient portion.

Dated this on 29th day of December, 2022

For DR. REDDY’S LABORATORIES LIMITED

Dr. M Jayakumar Ph.D., LL. B
Associate Vice President-Intellectual Property Management,
Dr. Reddy’s Laboratories Ltd.,
Survey Nos. 42, 45, 46 & 54,
Bachupally Village, Medchal Malkajgiri District,
Hyderabad– 500 090, Telangana, India.
Telephone No.: +914044346861
Mobile No.: +918008555309
E-mail: ipm@drreddys.com,
jayakumarm@drreddys.com