WO2014087422A1

WO2014087422A1 - Chewable milk compositions and fortified powder formulations thereof

Info

Publication number: WO2014087422A1
Application number: PCT/IN2013/000737
Authority: WO
Inventors: Anwar Siraj DAUD; Nidhi Prakash SAPKAL; Minal Nandkumar BONDE
Original assignee: Zim Laboratories Limited
Priority date: 2012-12-03
Filing date: 2013-12-02
Publication date: 2014-06-12

Abstract

The invention comprises a solid dosage form of milk that is essentially substantially water insoluble in water and does not contain rice flour or any other staple food source that is used as food in daily diet by a human being or dried egg yolk powder. The invention also includes a process of making the said solid dosage form of milk. The solid dosage form of milk comprises milk powder and at least one binder; and may contain other ingredients. The solid dosage form of milk may be or an essentially water insoluble granulated milk powder when the milk powder composition with or without other ingredients is granulated and dried with a binder that essentially or substantially reduces the solubility of the milk powder in water upon granulation and drying. The granulated and dried milk powder, upon pressing, results into a chewable tablet or other chewable compressed formulation.

Description

TITLE

CHEWABLE MILK COMPOSITIONS AND FORTIFIED POWDER FORMULATIONS THEREOF.

TECHNICAL FIELD The invention relates to chewable milk compositions and method of making the same

BACKGROUND OF THE INVENTION

Milk has been considered as very important source of nutrition, since time immemorial. During the early years of growth milk constitutes the major part of diet. In many countries milk is supplied by government or nonprofit organization to school, so that health of the school children can be taken care of. But milk itself has many limitations that creates hurdle in its storage, supply and distribution. Milk has short shelf life hence its stability is poor. Milk requires significantly large storage space and refrigeration and thus it is often difficult to transport or store in its liquid form due to the weight and its highly perishable nature. The physical delivery of milk to schools, dairy and distributors requires stocking milk in refrigerators. And, schools are also required to have the provision for refrigerators/ chilled vending for storage of fresh milk. All these practices increase the cost of milk distribution.

Milk in liquid form that is supplied to nutrition intervention programs or applied nutrition programs is also very much prone for adulteration and its unauthorized clandestine diversion for unintended uses such as for drinking or for usual milk applications such as making tea, coffee, sweets, yogurts, cheese etc. This pilferage or/and wastage/ or spoilage of liquid milk in a school feeding program is a great practical problem difficult to solve. Convenient distribution of liquid milk amongst the beneficiaries every day is also very difficult to manage. Unauthorized use mentioned above includes use for household purposes or for commercial purposes to make milk containing beverages like tea/coffee, or milk containing sweets etc.

Thus, liquid milk is prone for pilferage.

Further, being liquid, distribution of fixed dose of milk is cumbersome. Liquid milk is highly susceptible to microbial growth on storage. Milk contains most of the nutrients that are required for the growth of children but many children do not like taste of liquid milk. In case of liquid milk, continuous periodic testing and vigilance is required for maintaining its quality. This testing and vigilance require infrastructure which is difficult to maintain and create. Lack of testing and vigilance affect viability of distribution of liquid milk in Nutrition Intervention programs or applied Nutrition programs seriously.

It is very difficult to convert liquid milk and milk powder into a convenient and viable unit dosage form. Though the milk is good source of calcium, proteins and fats, it contains lower level of these nutrients and does not contain other essential nutrients like vitamin D₃, iron etc. Fortified food preparations and essential nutrient supplements are in the market since a very long time. However, they have several shortcomings which need to be overcome. Milk is a food most suitable, the fortification of which will be useful to most of the population of India as well as world. Mitsuho et al. (US 2009/0175998 A1) provided solid milk having suitable solubility and strength. This invention was based on the knowledge that solid milk with sufficient solubility and strength can be obtained basically by compacting and molding only powdered milk as an ingredient under a condition where porosity and free fat content thereof are controlled within fixed ranges and then humidifying and drying. This, however, needs to be reconstituted with water by weighing known quantity of solid milk and b adding water to it.

Mayurachat et al (2007) (Mayurachat Natvaratat, Penkwan chompreeda, Vichai Haruthaithanasan and Hathairat rimkeeree Kasetsart J. (Nat. Sci.), 41: 733-739, 2007) formulated milk tablet under Royal Chitralada Projects to encourage more dairy consumption for Thai children. In this project, milk tablets with high nutritive value were formulated for rural school children. The tablets were formulated to minimize cost and maximize protein and energy. These tablets, although they were called milk tablets, however, were a mixture of whole milk powder and dried egg yolk powder that contained 35% rice flour and sugar. The compressed product is consumed like any solid food products. Since these tablets contain nutrient sources other than milk, such as eggs and rice, these tables are not useful for a milk feeding program since their nutritive value will not be equivalent to milk feeding and these tablets cannot be a substitute for liquid milk in a Nutritional Intervention program.

Henry Secher Brochner (GB894001 A ) formulated milk tablets readily soluble in coffee and tea. It contained 10-19 %butter fat, 7-15% milk protein, 15-65% milk carbohydrates and minor amounts of inorganic milk constituents and water, and is enriched with respect to one or more of the butter fat, protein or carbohydrate. For compression of tablets condensed milk was evaporated to at least 6% of fat content to powder, and powder was mixed with milk proteins and lactose in requisite proportion. But being readily soluble in coffee and tea makes it pilferage prone and unsuitable for a Nutritional Intervention program since the product cannot be prevented from use for an unauthorized / un-intended purposes.

There are many fortified milk preparations available in the market that are in liquid form. Tablets have also been produced out of powdered milk. U.S. Pat. No. 3,241 ,975 and European Patent Application 1 048 216 describe dry powders or milk tablets but all of them are meant for dissolving in water for use and consumption. None of the prior art milk tablets or powders can prevent their use for purposes other than nutritional intervention programs in schools.

All prior art solid milk products that contain only milk as source of nutrients can be reconstituted to liquid milk or can be used to make traditional milk solids based sweets and, hence, they are also vulnerable to pilferage/unauthorized diversion for making milk based sweets, liquid milk or milk based beverages and unsuitable for a Nutrition Intervention program having an objective of providing milk to the children.

SUMMARY OF THE INVENTION

This invention comprises a solid dosage form of milk that is essentially substantially water insoluble in water and does not contain rice flour or any other staple food source that is used as food in daily diet by a human being or dried egg yolk powder. The milk powder includes one or more of, without limitation, whole milk powder, partly skimmed milk powder, skimmed milk powder, and colostrum powder.

In one embodiment, the solid dosage form of milk comprises milk powder and at least one binder.

In another embodiment, the solid dosage form of milk of this invention further comprising other ingredients also. The other ingredients may comprise permitted food additives and permitted pharmaceutical ingredients and excipients.

In one embodiment, the solid dosage form of milk is a chewable tablet or other chewable compressed formulation. The chewable tablet of milk comprises a predetermined shape and size. The shape and size of the chewable tablet of milk is chosen such that the product is easy to handle during transportation and easier for distribution. The chewable tablet of milk may be biscuit shaped. The chewable tablet of milk conveniently weights 5.50 g to 7.50 g. The chewable tablet of milk powder may comprise an accurate desired dose of all the nutrients corresponding to a certain quantity of liquid whole milk or a milk powder.

In another embodiment, the solid dosage form of milk according to this invention comprises an essentially water insoluble granulated milk powder. In yet another embodiment, this invention comprises a process of making a solid dosage form of milk that is essentially substantially water insoluble in water and does not contain rice flour or dried egg yolk powder, or any other staple food source that is used as food in daily diet by a human being, the process comprising steps of: (a) mixing the milk powder with at least one binder and optionally other ingredients; wherein the binder is such that upon binding, the solubility of milk powder in water decreases, (b) granulation, (c) drying and milling the granules, if required, (d) optionally adding flavor, and (e) either (i) packing the resulting an essentially water insoluble granulated milk powder in sachets, or (ii) adding glident s and pressing into chewable

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tablets or a chewable compressed formulation.

The step of granulation is either wet granulation, hot melt granulation or moisture activated dry granulation.

In one embodiment the process of making a solid dosage form of milk of this invention results is an essentially water insoluble granulated milk powder when the final granulated powder resulting form the process is not pressed to result into a chewable tablet or other chewable compressed formulation. In another embodiment, the process of making a solid dosage form of milk of this invention results into a chewable tablet or other chewable compressed formulation when the final granulated powder is mixed with glidents and pressed.

DETAILED DESCRIPTION OF THE INVENTION

In view of the above problem that pilferage of conventional liquid milk or ny form of milk such as milk tablets or milk powders that can be dissolved in water to reconstitute into milk is difficult to be prevented in nutrition intervention programs since they can be unauthorizedly diverted to be used by unintended end users who can make tea, coffee or traditional food recipes that require milk as one ingredient from the milk meant for beneficiaries of the nutrition intervention programs. First objective of this work is to make such dosage forms from milk powders which shall be solid, so that they are shelf stable, and substantially insoluble in water so that there is no incentive to divert them to food uses. Such solid forms of milk shall have solubility in water that is so less than whole milk powder or skim milk powder that they can be described as substantially or essentially water insoluble solid forms of milk. The wording "substantially" and "essentially" indicates that although a small portion of these solid forma may dissolve n water, most of the part remains insoluble and reconstitution of the same by diluting with water to milk is not possible. Further, such forms could be used to further enrich them with other nutrients that are needed to be provided to the beneficiaries of nutrition intervention programs. Further objective is to make their packing such that transportation and consumption is convenient and, if possible, nutrient content in the servings can be accurately controlled.

In one embodiment this invention comprises a solid unit dosage form of whole milk or skimmed milk, with or without fortification by one or more of essential nutrients, colors, flavors and excipients; wherein the solid unit dosage form cannot be re-constituted as liquid milk. The compositions of this invention differ from prior art in that they are formulated to be very close to the composition of whole milk or to the composition of whole milk supplemented with one or more of specific isolates of nutrients. Thus the compositions of this invention cannot have any staple food item such as rice flour or egg yolk or any such staple food items etc. as supplementing / fortifying ingredients in order to avoid significant deviation from the composition of milk. For the purpose of this specification, "staple food", sometimes simply referred to as a "staple" is a food, as defined by the link http://en.wikipedia.org/wiki/Staple_food that is eaten routinely and in such quantities that it constitutes a dominant portion of a standard diet in a given population, supplying a large fraction of the needs for energy-rich materials and generally a significant proportion of the intake of other nutrients as well. Above link further explains that "Staple foods vary from place to place, but typically they are inexpensive or readily available foods that supply one or more of the three organic macronutrients needed for survival and health: carbohydrates, proteins, and fats." Still further, the link notes that "Most staple plant foods are derived either from cereals such as wheat, barley, rye, maize, or rice, or starchy tubers or root vegetables such as potatoes, yams, taro, and cassava. Other staple foods include pulses (dried legumes), sago (derived from the pith of the sago palm tree), and fruits such as breadfruit and plantains. Staple foods may also contain, depending on the region, sorghum, olive oil, coconut oil and sugar. Most staples are plant materials, but in some communities fishing is the primary source of nutrition."

The link http://www.thefreedictionary.com/staple gives several meanings of the word "Staple" of which the meaning most applicable in present context is: "A basic dietary item, such as flour, rice, or corn".

For removal of any doubt, the expression "Staple food" as is used here is intended to exclude nutrients or selective class of nutrients that are in the form of essentially pure isolated compositions made either chemically or from their natural raw material sources. Thus, for example, whereas wheat flour or corn flour are included in the term "Staple food", wheat germ oil or corn oil, being nutrients isolated form their raw material, are excluded from the term "Staple food" and, being oils, would be considered as "nutrient". Similarly, an antioxidant extracted from its raw material in an isolate form, such as alpha- tocopherol, would be excluded form the term "Staple food" or "Staple" and would come in the category of "anti-oxidants" that can be added to the compositions of this invention.

The invention also comprises a method of making a solid unit dosage form of whole milk or skimmed milk, with or without fortification by one or more of essential nutrients, colours, flavors and excipients; wherein the solid unit dosage form cannot be re-constituted as liquid milk and none of the fortification ingredients are naturally grown and naturally available food items that are consumed traditionally/conventionally.

The "nutrients", for the purpose of this specification, are defined to comprise, without limitation, one or more of vitamins, minerals and anti-oxidants and probiotics. The probiotics that can be added includes, without limitation, the bacteria Lactobacillus sp. With the changing demographic profile we expect to have more share of elderly people in the population. This set of population has its own set of nutritional requirements. Addition of probiotic in the milk formulations will meet nutritional requirement of geriatric population and menopausal women.

In one aspect, the unit dosage form of milk of this invention lacks at least one organoleptic property of milk in such a way that the product or its diluted form cannot be used for food applications for which liquid milk or condensed (boiled down or concentrated) milk or milk powder is used in the past. In such an embodiment of this invention, the unit dosage form of milk of this invention cannot be used for applications in which liquid milk or condensed milk or milk powder needs to be used for their organoleptic properties. Thus, the product of this invention cannot either (a) be reconstituted into liquid milk by dissolving in water for making tea, coffee, curd or for drinking, flavored milk or (b) be used for adding in sweets that need liquid milk, condensed milk or a milk powder as an ingredient; examples of such sweets include, without limitation, Indian recipes Pedha, Gulab Jamun, Barfi, Kala-kand, Ras-gulla etc.

In one embodiment, this invention comprises solid compressed dosage forms of milk. Most preferred form is tablets. The tablets may be biscuit shaped. However, the compressed form may be other than a tablet also.

In another embodiment, the solid dosage form of milk of this invention further comprises other ingredients also besides milk. The ether ingredients may comprise permitted food additives and permitted pharmaceutical ingredients and excipients. The food additives and permitted pharmaceutical ingredients and excipients may comprise, without limitation, one or more of nutrients, colours, flavors, pharmaceutically acceptable carriers, sweeteners, antioxidents, other excipients not mentioned here and ingredients. The pharmaceutically acceptable carrier may include, without limitation, one or more of lactose, mannitol, dicalcium phosphate, microcrystalline cellulose, dextrose, maltose and the like. Sweetener may comprise without limitation, one or more of sucralose, aspartame, neotame, sodium saccharin, potassium acesulfame and sucrose. Nutrients may comprises, without limitation, one or more of vitamins proteins .minerals and probiotics and the like. Vitamins added to the composition of this invention may include, without limitation, one or more of thaimine, riboflavin, Nicinamide, folic acid, pyridoxine, cynocobalamine, vitamin C and Vitamin D and the like. The "Vitamin D" includes all of its different forms, including Vitamin D3. Minerals may include, without limitation, one or more of iron as ferrous sulfate, calcium as calcium carbonate, zinc as zinc sulpahte and magnesium as magnesium trisilicate and the like,

A recommended unit dose of the solid dosage form of milk of this invention may range from 5.5 gram to 7.5 gram.

The solid dosage form of milk according to this invention may have, per unit dose that weights 5.50 g to 7.50 g: (a) vitamins added to it, essentially comprising thaimine 1 to 4.5 mg, riboflavin 1 to 5 mg, Nicinamide 1 to 40 mg, folic acid 100 meg to 500 meg, pyridoxine 1 mg to 3 mg, cynocobalamine 1 to 5 meg, vitamin C 30 mg to 80 mg, Vitamin D3 100 IU to 400 IU; (b) minerals added to it essentially comprising 10 to 200 mg of calcium as calcium carbonate, 2- to 10 mg of zinc as zinc sulpahte and 25 to 100 mg of magnesium as magnesium trisilicate, 5 to 525 mg of ferrous sulfate, (c) sweeteners added to it essentially comprising essentially of 1.0 mg to 10.0 mg of sucralose, 10.0 mg to 100.0 mg of sugar, 1.0 mg to 50.0 mg of aspartame, 0.5 mg to 5 mg of neotame, 1.0 mg to 100.0 mg of sodium saccharin, and 1.0 mg to 100.0 mg of potassium acesulfame and (d) flavoring agents added to it essentially comprising of 0.1.0 mg to 10.0 mg of the flavoring agents.

The solid dosage form of milk may contain supplement of (a) the mineral in the form of enteric release iron, (b) one or more of the vitamin selected from the group consisting of folic acid and Vitamin D3, and (c) the protein as milk protein.

Thus, an illustrative chewable tablet of milk may comprise Iron consisting essentially of 5 to 575 mg ferrous as ferrous sulphate, 100 meg to 500 meg of Folic acid, 1 mg to 100 mg of sweetener, 0.1.0 mg to 10.0 mg of flavoring agents and a pharmaceutically acceptable carrier, wherein the complete dosage unit weighting 5.50 g to 7.50 g.

Another illustrative chewable tablet of milk according to this invention may comprise Vitamin D3 essentially 100 IU to 400 IU, Calcium carbonate essentially 10 mg to 200 mg, sweetener 1.0 mg to 100.0, and flavoring agents 0.11 to 10 mg and weighing round 5.50 g to 7.50 g.

The chewable tablet of milk according to this invention may comprise the sweetener 1.0 mg to 10.0 mg of sucralose and/or 10.0 mg to 100.0 mg sugar,

In one embodiment, this invention comprises a chewable milk tablet or an essentially water insoluble milk powder, that does not reconstitute into liquid milk on adding water to the same.

In another embodiment of this invention, the chewable milk tablet is made in predetermined shape and size. The shape and size is chosen such that the product is easy to handle during transportation and hence easier for distribution and does not have the disadvantage of large storage space and refrigeration required for use of liquid milk for nutritional intervention programs.

In another embodiment, the chewable milk tablet is made to provide an accurate desired dose of all the nutrients corresponding to a certain quantity of liquid milk or a milk powder.

In a further embodiment, the chewable milk tablet or the water insoluble milk powder is fortified with essential nutrients that can be added in an accurate and desired quantity in each tablet. The said essential nutrients may, without limitation, be one or more of vitamins, minerals. This will overcome the need of additional vitamins and minerals supplements that are usually required to be given separately to the beneficiaries of Applied Nutrition Programs such as for school children, women and elderly population.

Throughout this specification, the terms "Nutrition Intervention Programs" or "Applied Nutrition Programs" shall be used interchangeably, which are usually Government run or an Institution-run programs undertaken to supplement a vulnerable population with nutrient found deficient in the consumption of such population leading to development of health related problems/disorders/diseases.

In one aspect of a method of making a solid unit dosage form of whole milk or skimmed milk of this invention comprises granulation for developing solid compressed milk formulation without the use of water or with use of a quantity of water that does not give a scope for microbial growth in the dosage form.

In another aspect, milk based formulations of this invention are made with the use of different colors and flavors to make them children friendly.

This invention comprises a milk based formulation with standardized composition prepared on large scale that cannot be adulterated and requires no further analysis at various locations once produced and packaged. Invention is also embodied wherein the compressed milk tablets are fortified with probiotics that offer several health benefits.

In present invention, the term milk powder means and includes any one selected from the group of whole milk powder, skimmed milk powder, partly skimmed milk powder or colostrum powder. Perishability of milk was overcome by using solid milk powder instead of liquid milk, thus resulting in chewable milk tablets with greater shelf life. The present invention also comprises a unique composition of chewable milk tablets and method of manufacturing thereof.

In present invention, attempt has been made to compress milk powder with sufficient hardness and also easily chewable.

In one embodiment, the essentially sunstantial reduction of the milk powder in water is achieved by use of binders, the binder being a food additive that shall bind the particles of the milk powder composition together when bound with ingredients of the milk powder and shall essentially retard or prevent solubilization/dissolution of the components held by it when contacted with water. The binder comprises, one or more, without limitation, povidone, starch, maltodextrin, polyvinyl alcohol, xanthan gum, Sugar esters, gelucire, polyethylene glycols, stearic acid, cetyl alcohol, carnauba wax, paraffin wax, cetostearyl alcohol, hydrogenated castor oil, gyceryl monostearate, xylitol, pearlitol, beeswax, cetyl palmitate, glyceryl behenate, and the like. this invention comprises use of wet granulation for making milk tablets. It is also another embodiment of this invention wherein Hot Melt Granulation is used for making milk tablets. It is still another embodiment of this invention wherein Moisture Activated Dry Granulation (MADG) is used to make milk tablets.

In MADG, moisture is used to activate granule formation, without the need to apply heat to dry the granules. During this process, the generation of moist agglomerates is followed by the stepwise addition and blending of common pharmaceutical ingredients that absorb and distribute the moisture, which results in a uniform, free-flowing and compactable granulation. The said common pharmaceutical ingredients comprise one or more selected from a group consisting Microcrystalline cellulose, avicel PH 200 LM, Aeroperl 300, crospovidone, Avicel PH 101 , PH102, Aerosil, spress B. In another embodiment, this invention comprises a process of manufacturing of the compressed milk wherein in the drying process and sifting is avoided by using moisture activated/aided dry granulation process.

Following are the generalized advantages of MADG and Hot Melt Granulation Advantages of wet granulation:

• Improving uniformity, flow and compactaility of granules.

Advantages of MADG over conventional granulation/ wet granulation process

• The MADG method produces granules with excellent flow-ability.

· The tablets prepared using the MADG method have better content uniformity.

• MADG is a simple, economical, clean, lean and robust process that creates granulation with very good physical properties and finished products with satisfactory quality attributes. In the MADG process, only a small amount of water is used to create agglomeration. Moisture distribution and absorption steps follow, and neither heat drying nor milling is needed.

In Hot Melt Granulation, drying step can be avoided, and hence it is time saving, cost effective and economic process.

In yet another aspect this invention, solid milk chewable tablets are provided without any addition of external moisture and method of manufacturing thereof. In this embodiment, the method of manufacture uses Hot Melt Granulation process. In this embodiment, this was achieved by using binders that melt at higher temperature and bring about granulation upon cooling. The hot melt binders that can be used in present invention include, without limitation, one or more of or a mixture of one or more of polyethylene glycol 6000, polyethylene glycol 4000, carnauba wax, stearic acid, sugar esters, cetostearyl alcohol, hydrogenated castor oil, gelucire 55/18, gelucire 50/02, glyceryl monostearate, xylitol, pearlitol, beeswax, cetyl palmitate, glyceryl behenate, paraffin wax, and stearic alcohol.

For making tablets form the granulated mix, in the illustrative examples, the glidants used are talcum and magnesium stearate. However, any other glident known to a person skilled in the art can be used.

In a further aspect of this invention, chewable tablets are made that are fortified with vitamin D3 and calcium carbonate by wet granulation. The tablets of this invention may contain Vitamin D3 essentially 100 IU to 400 IU, Calcium carbonate essentially 200 mg to 500 mg, a mixture of sweeteners and flavoring agents consisting essentially 1.0 mg to 10.0 mg of sucralose, 10.0 mg to 100.0 mg Pharma grade sugar, 10.0 mg to 100.0 mg of flavoring agents, a pharmaceutically acceptable carrier, wherein the complete dosage unit, which resembles like a biscuit in shape, weighs around 5.50 g to 7.50 g. In a further embodiment, this invention comprises a method for manufacturing solid milk fortified with additional nutritional components and a method for manufacturing thereof.

In yet another embodiment, this invention comprises chewable tablets fortified with milk protein, folic acid and enteric release iron using moisture activated dry granulation process. Iron consisting essentially of 100 to 300 mg ferrous as ferrous sulphate, Folic acid consisting essentially of folic acid 100 meg to 500 meg. A mixture of sweeteners and flavoring agents consisting essentially 1.0 mg to 10.0 mg of sucralose, 10.0 mg to 100.0 mg Pharma grade sugar, 10.0 mg to 100.0 mg of flavoring agents, a pharmaceutically acceptable carrier, wherein the complete dosage unit weights 5.50 g to 7.50 g.

In yet another embodiment of this invention comprises coating of iron which leads to improved patient compliance, with no gastric irritation, no vomiting and no need for extra antacids.

In yet another embodiment, this invention comprises chewable milk tablets fortified with trace minerals and vitamins using hot melt granulation.

In yet another embodiment, this invention comprises a granulated water insoluble milk powder formulation.

In yet another embodiment of this invention impurity profile of vitamins and minerals is minimized in tablets/powder as the process is one pot. Moisture activated dry granulation process, for example, is a "one pot" process, as all the steps involves during granulation are carried out in single pot. Avoiding use of multiple equipments for moisture activated dry granulation procedure lead to less chances of impurity, since impurity is generated where multiple steps and multiple equipments are involved.

The ranges of amounts of ingredients given herein below relate to the amount of said ingredients in the compositions of this invention and include appropriate overages:

1. Weight of complete dosage unit: 5.50 g to 7.50 g,

2. A mixture of vitamins consisting essentially of thaimine 1 to 4.5 mg, riboflavin 1 to 5 mg, Nicinamide 10 to 40 mg, folic acid 100 meg to 500 meg, pyridoxine 1 mg to 3 mg, c y; nocobalamine 1 to 5 meg, vitamin C 30 mg to 80 mg, Vitamin D3 100 IU to 400 IU.

A mixture of minerals consisting essentially of 100 to 200 mg of calcium as calcium carbonate, 2-10 mg of zinc as zinc sulpahte, 25 to 100 mg of magnesium as magnesium trisilicate. A mixture of sweeteners and flavoring agents consisting essentially 1.0 mg to 10.0 mg of sucralose, 10.0 mg to 100.0 mg Pharma grade sugar, 10.0 mg to 100.0 mg of flavoring agents.

A pharmaceutically acceptable carrier.

The invention is illustrated by following examples which are merely illustrative of the invention without limiting it in any manner. Unless the context does not permit, a singular also includes the pleural, for example, a polymer also includes "polymers" and all equivalents and variants obvious to a person skilled in the art are considered to be included in this disclosure.

Example 1: chewable compressed milk formulation using wet granulation process for milk powder

Following ingredients are used to make a chewable milk tablet

Process:

1. First milk powder, sucralose, erythrosine color and pharma Grade sugar was sifted through mesh #40.

2. Then, the above sifted blend was transferred to the RMG (Rapid Mixer Granulator) for dry mixing for about 20 minutes at 3 rpm (revolutions per minute).

3. Distilled water was boiled on heating pan and then xanthan gum was dissolved with continuous stirring to obtain uniform dispersion and then PG (Phrma grade) sugar was added.

4. The dry mixed blend was granulated with above prepared binder solution in the RMG for about 20 min. 5. The granules obtained from above process were dried in fluid bed dryer for 20 min.

6. Milling of the above obtained granules was done and sifted through • #25.

7. Flavor was added and mixing was done in blender for 5 minutes resulting into water insoluble granulated milk powder.

8. Either the resulting water insoluble granulated milk powder was (a) packed in small packing or bulk packing or (b)talcum and magnesium stearate were added to the same, mixed for 10 min. and compression of the resulting blend was done by using 35 mm, circular, flat, D tooling punches to result into chewable tablets or chewable tablet.

Example 2: chewable compressed milk formulation using Moisture

Activated Dry Granulation process for milk powder.

1. Firstly milk powder, sucralose, erythrosine color and pharma grade sugar was sifted through mesh #40.

2. Then, the above sifted blend was transferred to the RMG for dry mixing for about 20 minutes at 3 rpm. 3. During mixing, 2% water was sprayed onto the powder blend, thus moistening the binder Povidone and making it tacky.

4. Flavor was added and mixing was done in blender for 5 minutes resulting into water insoluble granulated milk powder.

9. Either the resulting water insoluble granulated milk powder was (a) packed in small packing or bulk packing or (b)talcum and magnesium stearate were added to the same, mixed for 10 mih. and compression of the resulting blend was done by using 35 mm, circular, flat, D tooling punches to result into chewable tablets.

Example 3: chewable compressed milk formulation using hot melt granulation process for milk powder.

1. Firstly milk powder, sucralose, meltable binder (Sugar esters/PEG 6000) and PG sugar was sifted through Mesh #40.

2. Then, the above sifted blend was transferred to the jacketed planetary mixer, missing was done for about 20 minutes at 3 rpm.

3. Planetary mixer was heated at 80°C for 30 min.

4. The granules were cooled at room temperature. After cooling, milling was done and granules were sifted through mesh #25.

5. Flavor was added and mixing was done in planetary mixer for 5 minutes resulting into water insoluble granulated milk powder. 10. Either the resulting water insoluble granulated milk powder was (a) packed in small packing or bulk packing or (b)talcum and magnesium stearate were added to the same, mixed for 0 min. and compression of the resulting blend was done by using 35 mm, circular, flat, D tooling punches to result into chewable tablets.

Example 4: chewable compressed milk formulation fortified with calcium carbonate (200 mg) and vitamin D3 (100 IU) by wet granulation

1. Firstly milk powder, calcium carbonate, sucralose, erythrosine color and pharma grade sugar was sifted through mesh #40.

2. Then, the above sifted blend was transferred to the Rapid Mixer Granulator for dry mixing for about 20 minutes at 3 rpm.

3. Distilled water was boiled on heating pan and then xanthan gum was dissolved with continuous stirring to obtain uniform dispersion and then pharma grade sugar was added.

4. The dry mixed blend was granulated with above prepared binder solution in the rapid mixture granulator for about 20 min. 5. The granules obtained from above process were dried in fluid bed dryer for 20 min.

6. Milling of the above obtained granules was done and sifted through #25.

7. Flavor was added and mixing was done in blender for 5 minutes, resulting into water insoluble granulated milk powder.

11. Either the resulting water insoluble granulated milk powder was (a) packed in small packing or bulk packing or (b)talcum and magnesium stearate were added to the same, mixed for 0 min. and compression of the resulting blend was done by using 35 mm, circular, flat, D tooling punches to result into chewable tablets.

Example 5: chewable compressed milk formulation fortified with milk proteins, folic acid and enteric coated iron by Moisture Activated Dry Granulation process

Excipients Quantity used

Dried Ferrous Sulphate 150

Povidone

Neutral pellets 100

•Cetyl alcohol 2

Acrycoat UOO 30

Diethyl phthalate 100

Milk powder 5000

Sucralose 7

Pharma grade sugar 183

Folic Acid 5

Flavoring agent 114

Magnesium stearate 2

Talcum 4 Process:

1. Firstly milk powder, sucralose and pharma grade sugar was sifted through mesh #40.

2. Then, the above sifted blend was transferred to the rapid mixture granu!ator for dry mixing for about 20 minutes at 3 rpm.

3. During mixing, 2% water was sprayed onto the powder blend, thus moistening the binder povidone and making it tacky.

4. Dried ferrous sulphate was coated on to neutral pellets using powder layering technique and was mixed with above blend.

5. Flavor was added and mixing was done in blender for 5 minutes resulting into water insoluble granulated milk powder.

12. Either the resulting water insoluble granulated milk powder was (a) packed in small packing or bulk packing or (b)talcum and magnesium stearate were added to the same, mixed for 10 min. and compression of the resulting blend was done by using 35 mm, circular, flat, D tooling punches to result into chewabie tablets.

Example 6: Chewabie compressed milk formulation fortified with vitamins, minerals by hot melt granulation process for milk powder

Niacinamide 10.2 calcium carbonate (oyster shell) 1000

Magnesium trisilicate 66.75

Folic acid 0.12 vitamin D3 5

Pyridoxine HCI 1

Vitamin C 31.5

Zinc sulphate 5.75

1. Firstly milk powder, sucralose, meltable binder (Sugar esters/PEG 6000), erythrosine color and pharma grade sugar was sifted through mesh #40.

2. Then, the above sifted blend was transferred to the jacketed planetary mixer for dry mixing for about 20 minutes at 3 rpm.

3. Planetary mixer was heated at 80°C.

4. The granules were cooled at room temperature. After cooling milling was done and sifted through #25. Flavor, vitamins and minerals as mentioned in the table was added and mixing was done in blender for 10 minutes resulting into water insoluble granulated milk powder.

13. Either the resulting water insoluble granulated milk powder was (a) packed in small packing or bulk packing or (b)talcum and magnesium stearate were added to the same, mixed for 10 min. and compression of the resulting blend was done by using 35 mm, circular, flat, D tooling punches to result into chewable tablets.

Claims

1. A solid dosage form , of milk that is essentially substantially water insoluble in water and does not contain rice flour or any other staple food source that is used as food in daily diet by a human being or dried egg yolk powder,.

2. The solid dosage form of milk according to claim 1 wherein the milk powder comprises one or more selected from the group essentially consisting of whole milk powder, partly skimmed milk powder, skimmed milk powder, and colostrum powder.

3. The solid dosage form of milk according to claim 2 comprising milk powder and at least one binder; the binder being a food additive that shall bind the particles of the milk powder composition together when bound with ingredients of the milk powder and shall essentially retard or prevent solubilization/dissolution of the components held by it when contacted with water.

4. The solid dosage form of milk according to claim 3 wherein the binder is selected from one or more from a group consisting essentially of povidone, starch, maltodextrin, polyvinyl alcohol, xanthan gum Sugar esters, gelucire, polyethylene glycols, stearic acid cetyl alcohol, carnauba wax, paraffin wax, cetostearyl alcohol, hydrogenated castor oil, gyceryl monostearate, xylitol, pearlitol, beeswax, cetyl palmitate and glyceryl behenate.

5. The solid dosage form of milk according to claim 4 further comprising other ingredients. .

6. The solid dosage form of milk according to claim 5; wherein the other ingredients comprise one or more selected form the group essentially consisting of nutrients, colours, flavors, pharmaceutically acceptable carrier, sweetener and other excipients.

7. The solid dosage form of milk according to claim 6, wherein:

a. pharmaceutically acceptable carrier comprises one or more selected form the group consisting essentially of lactose, mannitol, dicalcium phosphate, microcrystalline cellulose, dextrose, maltose,

b. Sweetener comprises- one or more selected from the group consisting essentially of sucralose, aspartame, neotame, sodium saccharin, potassium acesulfame and sucrose. c. nutrient comprises one or more selected from the group consisting essentially of vitamins proteins .minerals and probiotics.

8. The solid dosage form of milk according to claim 7 wherein:

a. vitamins are selected one or more from the group consisting essentially of thaimine, riboflavin, Nicinamide, folic acid, pyridoxine, cynocobalamine, vitamin C and Vitamin D. b. minerals are selected one or more from the group consisting essentially of iron as ferrous sulfate, calcium as calcium carbonate, zinc as zinc sulpahte and magnesium as magnesium trisilicate,

9. The solid dosage form of milk according to claim 8 wherein, per unit dose of 5.50 g to 7.50 g:

a. the range in which the vitamins are added comprises, essentially of, thaimine 1 to 4.5 mg, riboflavin 1 to 5 mg, Nicinamide 1 to 40 mg, folic acid 100 meg to 500 meg, pyridoxine 1 mg to 3 mg, cynocobalamine 1 to 5 meg, vitamin C 30 mg to 80 mg, Vitamin D3 100 IU to 400 III,

b. the range in which the minerals are added comprises, essentially of, 0 to 200 mg of calcium as calcium carbonate, 2- to 10 mg of zinc as zinc sulpahte and 25 to 100 mg of magnesium as magnesium trisilicate, 5 to 525 mg of. ferrous sulfate.

c. the range in which the sweeteners are used comprises, essentially of 1.0 mg to 10.0 mg of sucralose, 10.0 mg to 100.0 mg of sugar, 1.0 mg to 50.0 mg of aspartame, 0.5 mg to 5 mg of neotame, 1.0 mg to 100.0 mg of sodium saccharin, and 1.0 mg to 100.0 mg of potassium acesulfame,

d. the range in which the flavoring agents are used comprises, essentially of 0.1.0 mg to 10.0 mg of the flavoring agents.

10. The solid dosage form of milk according to claim 7, wherein: (a) the mineral is enteric release iron, (b) one or more of the vitamin is selected from the group consisting of folic acid and Vitamin D3, and (c) the protein is milk protein.

11. The solid dosage form of milk according to claim 3, wherein the dosage form is a chewable tablet or other chewable compressed formulation.

12. The chewable tablet of milk according to claim 11 , that comprises a predetermined shape and size.

3. The chewable tablet of milk according to claim 12, wherein the shape and size of the tablet is chosen such that the product is easy to handle during transportation and easier for distribution.

14. The chewable tablet of milk according to claim 13; wherein the tablet is biscuit shaped.

15. The chewable tablet of milk according to claim 12; wherein the complete dosage unit weights 5.50 g to 7.50 g.

16. The chewable tablet of milk or milk powder according to claim 11 ; wherein the chewable milk tablet comprises an accurate desired dose of all the nutrients corresponding to a certain quantity of liquid whole milk or a milk powder.

17. The chewable tablet of milk according to claim 11 comprising Iron consisting essentially of 5 to 575 mg ferrous as ferrous sulphate, 100 meg to 500 meg of Folic acid, 1 mg to 100 mg of sweetener, 0.1.0 mg to 10.0 mg of flavoring agents and a pharmaceutically acceptable carrier, wherein the complete dosage unit weighting 5.50 g to 7.50 g.

18. The chewable tablet of milk according to claim 11 comprising Vitamin D3 essentially 00 I U to 400 IU, Calcium carbonate essentially 10 mg to 200 mg, sweetener 1.0 mg to 100.0, and flavoring agents 0.11 to 10 mg and weighing round 5.50 g to 7.50 g.

19. The chewable tablet of milk according to claim 11 wherein the sweetener comprises 1.0 mg to 10.0 mg of sucralose, 10.0 mg to 100.0 mg sugar,

20. The solid dosage form of milk according to claim 3, wherein the dosage form is an essentially water insoluble granulated milk powder.

21. A process of making a solid dosage form of milk that is essentially substantially water insoluble in water and does not contain rice flour or dried egg yolk powder, or any other staple food source that is used as food in daily diet by a human being, the process comprising steps of: a. mixing the milk powder with at least one binder and optionally other ingredients; wherein the binder is such that upon binding, the solubility of milk powder in water decreases,

b. granulation,

c. drying and milling the granules, if required,

d. optionally adding flavor, and

e. either (i) packing the resulting water insoluble powder, or (ii) adding glident/s and pressing into tablets.

22. The process of making a solid dosage form of milk of claim 21 wherein:

a. the binder is selected one or more from the group essentially consisting of povidone, starch, maltodextrin, polyvinyl alcohol, xanthan gum, Sugar esters, gelucire, polyethylene glycols, stearic acid, cetyle alcohol, carnauba wax, paraffin wax, cetostearyl alcohol, hydrogenated castor oil, gyceryl monostearate, xylitol, pearlitol, beeswax, cetyl palmitate, and glyceryl behenate.

b. other ingredients may comprise one or more selected from the group essentially consisting of nutrients, anti-oxidents, surfactants, colours, pharmaceutically acceptable carrier, sweetener, probiotics, pharmaceutically active ingredient and other excipients,

c. glidants comprise talcum and magnesium stearate.

23. The process of making a solid dosage form of milk of claim 21 , wherein the step of granulation is either wet granulation, hot melt granulation or moisture activated dry granulation.

24. The process of making a solid dosage form of milk of claim 22 wherein the solid dosage form is an essentially water insoluble granulated milk powder.

25. The process of making a solid dosage form of milk of claim 22 wherein the solid dosage form is a a chewable tablet or other chewable compressed formulation.