WO2025079114A1

WO2025079114A1 - A self-nano emulsifying drug formulation for cholecalciferol

Info

Publication number: WO2025079114A1
Application number: PCT/IN2024/052053
Authority: WO
Inventors: Dr. Iqbal AHMAD
Original assignee: Vytals Wellbeing India Pvt Ltd
Current assignee: Vytals Wellbeing India Pvt Ltd
Priority date: 2023-10-13
Filing date: 2024-10-11
Publication date: 2025-04-17
Anticipated expiration: 2026-04-13

Abstract

A self-nano emulsifying drug formulation for cholecalciferol by a method of spontaneous emulsification and spray drying, the self-nano 5 emulsifying drug formulation for cholecalciferol comprising of one active ingredient cholecalciferol, powder substrates, oil phases, surfactants and co-surfactants, wherein, the active ingredient having a loading capacity range from 100 IU/g to 10,00,000 IU/g and has an increased rate of dissolution, increased rate of permeability and increased bioavailability of the at least one active ingredient, wherein, the method for adsorption of the self-nano emulsifying drug on the substrate to obtain a powder formulation is spontaneous emulsification and spray drying method (SESDM) where the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared and atomized into fine droplets and kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

Description

A SELF-NANO EMULSIFYING DRUG FORMULATION FOR CHOLECALCIFEROL

FIELD OF THE INVENTION

The present invention relates to a self-nano emulsifying drug delivery system for a high loading formulation for cholecalciferol. More specifically, the invention relates to self-nano emulsifying drug delivery system adsorbed on a powder substrate for increased rate of dissolution, increased permeability and increased bio availability and stability.

BACKGROUND OF THE INVENTION

Cholecalciferol, commonly known as Vitamin D3, is an essential nutrient vital for the proper functioning of the human body. It plays a crucial role in calcium absorption, bone health, reabsorption of calcium and phosphate in kidney immune system modulation, and various other physiological processes. As such, it is a widely recognized and utilized supplement in healthcare and nutraceutical applications. Cholecalciferol is a fat-soluble vitamin and one of the primary challenges associated with Cholecalciferol is its inherently low aqueous solubility. This limited solubility poses significant hurdles in achieving optimal bio availability when administered orally. Traditional dosage forms often struggle to deliver sufficient quantities of Cholecalciferol to meet therapeutic requirements due to its poor dissolution properties.

The self-nanoemulsifying drug formulation for Cholecalciferol not only underscores the paramount importance of this essential vitamin in human health but also represents a groundbreaking innovation that has the potential to transform

the landscape of Cholecalciferol supplementation. By addressing the challenges of solubility and bioavailability, this formulation holds the promise of improving health outcomes, reducing the burden of deficiency-related diseases, and enhancing the overall quality of life for individuals worldwide. To address these issues and enhance the therapeutic potential of Cholecalciferol, there is a growing need for innovative pharmaceutical formulations. These formulations should not only improve the loading capacity of Cholecalciferol but also enhance its overall solubility and bioavailability, thereby maximizing its clinical benefits.

EP4009815A2 discloses a composition including a dispersion medium including: an aqueous solution; a first active ingredient; a flavor agent; and a first type of polymer; and a dispersed phase including: a population of particles, each particle including: a core including: a second active ingredient a second type of polymer; and an aqueous solution; a shell, substantially surrounding the core, the shell including: a third type of polymer; a plurality of lipophilic carriers; and a third active ingredient; and a plurality of emulsifying agents.

EA038458B1 discloses an invention relating to the field of pharmaceutical nano formulations, namely, to an aqueous nano dispersion of a lipophilic and hydrophobic bioactive compound with physical stability during at least 1 year at room temperature, comprising an aqueous dispersion medium, a dispersed phase and a surface-active agent, wherein the dispersed phase comprises a bioactive compound and the dispersion medium comprises water and a nano dispersion stabilizer in minimum concentration of 30% w/v, wherein said nano dispersion stabilizer ranges in concentration from 15 to 70% w/v and consists of a monosaccharide, a disaccharide, at least one oligosaccharide selected from

gentianose, a malto tiro se and a raffinose, a polysaccharide, at least one glycol selected from a propylene glycol or a polyethylene glycol, a polyol or combinations thereof. The invention also relates to a method for preparing such stable nano dispersion.

To overcome these challenges, the present invention introduces a self- nanoemulsifying drug formulation for Cholecalciferol. This innovative formulation represents a significant advancement in the field of pharmaceuticals and nutraceuticals by offering a comprehensive solution to the limitations associated with Cholecalciferol delivery.

OBJECTIVE OF THE INVENTION

The main objective of the present invention is to provide a self-nanoemulsifying drug formulation for Cholecalciferol to enhance its solubility in water, since it is a fat-soluble vitamin and is poorly soluble in water.

Another objective of the present invention is that aqueous dispersion of the system provides a particle size range of 40 nm-1500 nm.

Yet another objective of the present invention is to accommodate a significantly high loading of Cholecalciferol in comparison to traditional dosage forms to ensure a therapeutically effective dose in a smaller volume.

Yet another objective of the present invention is to provide steady release of cholecalciferol over time, reducing the dosage frequency.

Yet another objective of the present invention is to provide a versatile delivery system and not being restricted to a single form of dosage, to provide delivery in

the form of capsules, tablets, liquids, or any other suitable form as per the patient preferences.

Yet another objective of the present invention is to provide a formulation with enhanced bioavailability.

Further objectives, advantages, and features of the present invention will become apparent from the detailed description provided herein below, in which various embodiments of the disclosed invention are illustrated by way of example.

SUMMARY OF THE INVENTION

A self-nano emulsifying drug formulation for cholecalciferol by a method of spontaneous emulsification and spray drying, the self-nano emulsifying drug formulation for cholecalciferol includes one active ingredient cholecalciferol, having a concentration range from 0.30% to 2.6%, one powder 5 substrate having a concentration range from 80.00% to 99.00%, one oil phase having a concentration range from 0.1% to 5.0%, a surfactant one having a concentration range from 0.2% to 0.9%, a surfactant two having a concentration range from 0.2% to 10.0% and a cosurfactant having a concentration range from 0.1% to 5.%, herein, the at least one active ingredient having a loading capacity range from 100 lU/g to 10,00,000 lU/g and herein, the composition has an increased rate of dissolution, increased rate of permeability and increased bioavailability of the at least one active ingredient. Herein, the particle size of formulations has a nano globule of 40 nm to 1500 nm in aqueous environment. Herein, the method for adsorption of the self-nano emulsifying drug on the substrate to obtain a powder formulation is spontaneous emulsification and spray drying method (SESDM)

where the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared and atomized into fine droplets and kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

The main advantage of the present invention is that it provides a self- nanoemulsifying drug formulation for Cholecalciferol to enhance its solubility in water, since it is a fat-soluble vitamin and is poorly soluble in water.

Yet another advantage is that aqueous dispersion of the system provides a particle size range of 40 nm-1500 nm.

Yet another advantage of the present invention is that it accommodates a significantly high loading of Cholecalciferol in comparison to traditional dosage forms to ensure a therapeutically effective dose in a smaller volume.

Yet another advantage of the present invention is that it provides steady release of cholecalciferol over time, reducing the dosage frequency.

Yet another advantage of the present invention is that it provides a versatile delivery system and not being restricted to a single form of dosage, to provide delivery in the form of capsules, tablets, liquids, or any other suitable form as per the patient preferences.

Yet another advantage of the present invention is that it provides a formulation with enhanced bio availability.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings are incorporated in and constitute a part of this specification to provide a further understanding of the invention. The drawings illustrate one embodiment of the invention and together with the description, serve to explain the principles of the invention.

FIG. 1 and FIG. 2 describes solubility data chart

FIG. 3 is graphical representation of peak of vitamin D

FIG. 4 describes triplicate injections of each concentration of Vitamin D reference standard

FIG. 5 is graphical representation of particle size

FIG. 6 shows Cholecalciferol crystals (40X Phase contrast) FIG. 7 shows transmission of redispersed NAV-D

FIG. 8 is graphical representation of release of NAV-D

FIG. 9 shows (A) NAV-D powder (B) NAV-D nano-adsorbed Cholecalciferol under microscope (40X phase contrast)

DETAILED DESCRIPTION OF THE INVENTION

Definition

The term “a” or “an”, as used herein, is defined as one. The term “plurality”, as used herein, is defined as two as or more than one. The term “another”, as used

herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language).

The term “comprising” is not intended to limit the present invention with such terminology rather is used in a wider sense. Any invention using the term comprising could be separated into one or more claims using “consisting” or “consisting of’. The term “comprising” may be used interchangeably with the terms “having” or “containing”.

Reference in this document to “one embodiment”, “certain embodiments”, “an embodiment”, “another embodiment”, and “yet another embodiment” or similar terms, throughout the document means that a specific feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases in various places, this specification throughout are not necessarily all referring to the same embodiment. Furthermore, the specific features, structures, or characteristics are combined in any suitable manner in one or more embodiments without limitation.

The term “or” as used herein is to be interpreted as inclusive or meaning any one or more combinations. Therefore, “A, B or C” means any of the following: “A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps, or acts are in mutually exclusive, inherently.

As used herein, the term "one or more" generally refers to, but is not limited to, singular as well as the plural form of the term.

FIG. 1 and FIG. 2 describes solubility of lipids, surfactant and co- surfactant used.

FIG. 3 is graphical representation of analytical method development in different matrix, an HPLC method was developed for the determination of vitamin D content, compatibility, and stability studies.

FIG. 4 describes quantification details of Vitamin D3 (DADIA) at different calibration points

FIG. 5 is graphical representation of particle size as per DLS measurement

FIG. 8 is graphical representation of In vitro release profile of NAV-D vs plain vitamin D

The present invention relates to a self-nano emulsifying drug formulation of cholecalciferol by a method of spontaneous emulsification and spray drying. The self-nano emulsifying drug formulation for cholecalciferol includes an active ingredient, a powder substrate, an oil phase, a surfactant and a co -surfactant. The active ingredient has a concentration range from 0.30% to 2.6%. The powder substrate has a concentration range from 80.00% to 99.00%. In an embodiment, the powder substrate includes but is not limited to, calcium carbonate, corn starch, dicalcium phosphate, lactose monohydrate, microcrystalline cellulose, rice starch, tapioca starch, maltodextrin, Sorbitol, trehalose, mannitol, polyvinyl alcohol, cyclodextrins and combinations thereof. The oil phase has a concentration range from 0.1% to 5.0%. In an embodiment, the oil phase includes, but is not limited to, olive oil, soybean oil, sunflower oil, hempseed oil, castor oil, castor oil,

flaxseed oil, medium chain triglycerides, palm oil, Glyceryl palmito stearate, glyceryl monolinoleate, canola oil, cotton seed oil, hazelnut oil, oleic acid 65.0%, rice bran oil, sweet almond oil. The surfactant one has a concentration range from 0.2% to 10.0%. The surfactant one includes but is not limited to, Lauroyl polyoxyl-6 glyceride, caprylic/capric triglycerides, polyoxyl 35 castor oil, polyethylene glycol palmito stearate, glyceryl behenate, sorbitan monolaurate, polyoxylglycerides/ oleoyl polyoxyl-6 glycerides and polyethylene glycol peg-32 stearate/polyoxyl-32 stearate, caprylocaproyl polyoxyl- 8 glycerides/ polyoxyglycerides, propylene glycol monolaurate, polyglyceryl-3 oleate, stearoyl polyoxyl-32 glycerides, Lauroyl polyoxyl-32 glycerides, polysorbates, sorbitans, glyceryl behenate, Glyceryl distearate, PEG-8 caprylic/capric glycerides. The surfactant two has a concentration range from 0.1% to 5.0%. The surfactant two includes but is not limited to, polyoxylglycerides/ oleoyl polyoxyl-6 glycerides, polyoxyl-32 stearate, caprylic/capric triglyceride and lauroyl polyoxyl-6 glycerides. The co-surfactant has a concentration range from 0.1% to 5.0%. The co-surfactant includes but is not limited to, ethylhexylglycerin, isostearyl isostearate, polyvinyl alcohol, diethylhexyl carbonate, isopropyl myristate and caprylic acid Polyethylene glycols, ethanol, Isopropyl palmitate, Sorbitan esters (e.g. Sorbitan Oleate), Polysorbates (e.g., Polysorbate 20, Polysorbate 80), Glycol Esters (e.g., Glycol Stearate), Fatty Alcohols (e.g., Cetyl alcohol, Stearyl alcohol), Lecithin, Caprylic/Capric Triglycerides, Medium- Chain Triglycerides (MCTs), Diisopropyl Adipate, Diisopropyl Dimer Dilinoleate, Castor oil and Derivatives, Ethylhexylglycerin Octydodecanol, Polyglyceryl Esters (e.g., polyglyceryl-3 Diisostearate), Glyceryl Stearate, Caprylyl Glycol, Isostearyl Neopentanoate, Polyglyceryl Polyricinoleate, Coco-Caprylate/Caprate, Sucrose Esters (e.g., Sucrose Stearate), Triethyl Citrate, Hydrogenated Castor Oil and Diethylene

glycol monoethyl ether. Herein, the present invention is characterized in that the active ingredient has a loading capacity ranging from 100 lU/g to 10,00,000 lU/g with an increased rate of dissolution, an increased rate of permeability and increased bio availability of the active ingredient. Herein, the particle size of formulations has a nano globule of 40 nm to 1500 nm in aqueous environment.

The present invention herein includes a method for adsorption of the self-nano emulsifying drug on the substrate to obtain a powder formulation is spontaneous emulsification and spray drying method (SESDM) where the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared and atomized into fine droplets and kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

In an embodiment, the method for preparing the self-nano emulsifying formulation includes: the active ingredient was mixed in various oil phases, surfactants and cosurfactants to form self-nano emulsifying drugs; sound waves are used to agitate the particles in the various self-nano emulsifying drugs to further dissolute the particles in the drug; the drugs are placed under a microscope, assessed and tabulated in three categories of solubility; the surfactant one, the surfactant two, the oil phase and the co-surfactant are selected on the basis of solubility data; the powder substrate is selected on the basis of characteristics and compatibility with the self-nano emulsifying drug;

the powder substrate is sifted and extremely dried to enhance adsorption; and the self-nano emulsifying drug is adsorbed on the powder substrate by a method of spontaneous emulsification and spray drying method (SESDM) including: the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared, the mixture is pumped at a fixed rate, the pumped mixture is atomized into fine droplets through a rotary/nozzle atomizer, and the obtained droplets are kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

In the embodiment, the present invention relates to a self-nano emulsifying drug formulation of cholecalciferol by a method of spontaneous emulsification and spray drying. The present invention comprises of one or more active ingredients, one or more powder substrates, one or more oil phases, one or more surfactants and one or more co-surfactants. The one or more active ingredients have a concentration range from 0.30% to 2.6%. The one or more powder substrates have a concentration ranges from 80.00% to 99.00%. In an embodiment, the one or more powder substrates includes but are not limited to, calcium carbonate, corn starch, dicalcium phosphate, lactose monohydrate, microcrystalline cellulose, rice starch, tapioca starch maltodextrin, Sorbitol, trehalose, mannitol, polyvinyl alcohol, cyclodextrins and combinations thereof. The one or more oil phases have a concentration range from 0.1% to 5.0%. In an embodiment, the one or more oil phases includes but are not limited to, olive oil, soybean oil, sunflower oil,

hempseed oil, castor oil, castor oil, flaxseed oil, medium chain triglycerides and palm oil, Glyceryl palmito stearate, glyceryl monolinoleate, canola oil, cotton seed oil, hazelnut oil, oleic acid 65.0%, rice bran oil, sweet almond oil. The one or more surfactants one have a concentration range from 0.2% to 10.0%. The one or more surfactants one includes but are not limited to Lauroyl polyoxyl-6 glyceride, caprylic/capric triglycerides, polyoxyl 35 castor oil, polyethylene glycol palmito stearate, glyceryl behenate, sorbitan monolaurate, polyoxylglycerides/ oleoyl polyoxyl-6 glycerides and polyethylene glycol, peg-32 stearate/polyoxyl- 32 stearate, caprylocaproyl polyoxyl- 8 glycerides/ polyoxyglycerides, propylene glycol monolaurate, polyglyceryl-3 oleate, stearoyl polyoxyl-32 glycerides, Lauroyl polyoxyl-32 glycerides, polysorbates, sorbitans, glyceryl behenate, Glyceryl distearate, PEG-8 caprylic/capric glycerides. The one or more surfactants two have a concentration range from 0.1% to 5.0%. The one or more surfactants two includes but are not limited to, polyoxylglycerides/ oleoyl polyoxyl-6 glycerides, polyoxyl-32 stearate, caprylic/capric triglyceride and lauroyl polyoxyl- 6 glycerides. The one or more co-surfactants have a concentration range from 0.1% to 5.0%. The one or more co-surfactants includes but are not limited to, ethylhexylglycerin, isostearyl isostearate, polyvinyl alcohol, diethylhexyl carbonate, isopropyl myristate and caprylic acid, Polyethylene glycols, ethanol, Isopropyl palmitate, Sorbitan esters (e.g. Sorbitan Oleate), Polysorbates (e.g., Polysorbate 20, Polysorbate 80), Glycol Esters (e.g., Glycol Stearate), Fatty Alcohols (e.g., Cetyl alcohol, Stearyl alcohol), Lecithin, Caprylic/Capric Triglycerides, Medium- Chain Triglycerides (MCTs), Diisopropyl Adipate, Diisopropyl Dimer Dilinoleate, Castor oil and Derivatives, Ethylhexylglycerin Octydodecanol, Polyglyceryl Esters (e.g., polyglyceryl-3 Diisostearate), Glyceryl Stearate, Caprylyl Glycol, Isostearyl Neopentane ate, Polyglyceryl Polyricinoleate,

Coco-Caprylate/Caprate, Sucrose Esters (e.g., Sucrose Stearate), Triethyl Citrate, Hydrogenated Castor Oil, Diethylene glycol monoethyl ether and Caprylic acid.

Herein, the one or more active ingredients have a loading capacity ranging from 100 lU/g to 10,00,000 lU/g with an increased rate of dissolution, an increased rate of permeability and increased bio availability of the one or more active ingredients. Herein, the particle size of formulations has a nano globule of 40 nm to 1500 nm in aqueous environment. Herein, in the preferred embodiment, the present invention includes a method for adsorption of the self-nano emulsifying drug on the substrate to obtain a powder formulation comprising of spontaneous emulsification and spray drying method (SESDM) where the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared and atomized into fine droplets and kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

In an embodiment, the method for preparing the self-nano emulsifying formulation includes: the one or more active ingredient was mixed in various oil phases, surfactants and co-surfactants to form self-nano emulsifying drugs; sound waves are used to agitate the particles in the various self-nano emulsifying drugs to further dissolute the particles in the drug; the drugs are placed under a microscope, assessed and tabulated in three categories of solubility; the one or more surfactant one, the one or more surfactant two, the one or more oil phase and the one or more co-surfactant are selected on the basis of solubility data;

the one or more powder substrate is selected on the basis of characteristics and compatibility with the self-nano emulsifying drug; the one or more powder substrate is sifted and extremely dried to enhance adsorption; and the self-nano emulsifying drug is adsorbed on the one or more powder substrate by a method of spontaneous emulsification and spray drying method (SESDM) including: the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared, the mixture is pumped at a fixed rate, the pumped mixture is atomized into fine droplets through a rotary/nozzle atomizer, and the obtained droplets are kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

Claims

1/ WE CLAIM

1. A self-nano emulsifying drug formulation for cholecalciferol by a method of spontaneous emulsification and spray drying, the self-nano emulsifying drug formulation for cholecalciferol comprising of: an at least one active ingredient cholecalciferol, having a concentration range from 0.30% to 1.5%; an at least one powder substrate having a concentration range from 96.20% to 98.10%; an at least one oil phase having a concentration range from 0.1% to 0.4%; an at least a surfactant one having a concentration range from 0.2% to 0.9%; an at least a surfactant two having a concentration range from 0.1% to 0.9%; and an at least one co-surfactant having a concentration range from 0.1% to 0.9%, characterized in that, the at least one active ingredient having a loading capacity range from 100 lU/g to 6,00,000 lU/g; characterised in that, the particle size of formulations has a nano globule of 40 nm to 1500 nm in aqueous environment; characterized in that, increased rate of dissolution, increased rate of permeability and increased bio availability of the at least one active ingredient; wherein, the method for adsorption of the self-nano emulsifying drug on the substrate to obtain a powder formulation is spontaneous

emulsification and spray drying method (SESDM) where the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared and atomized into fine droplets and kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

2. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, wherein, the at least one powder substrate is selected from, calcium carbonate, corn starch, dicalcium phosphate, lactose monohydrate, microcrystalline cellulose, rice starch, tapioca starch, maltodextrin, Sorbitol, trehalose, mannitol, polyvinyl alcohol, cyclodextrins and combinations thereof.

3. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, wherein, the at least one oil phase is selected from olive oil, soybean oil, sunflower oil, hempseed oil, castor oil, flaxseed oil, medium chain triglycerides and palm oil, Glyceryl palmito stearate, glyceryl monolinoleate, canola oil, cotton seed oil, hazelnut oil, oleic acid 65.0%, rice bran oil, sweet almond oil.

4. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, wherein, the at least a surfactant one is selected from Lauroyl polyoxyl - 6 glyceride, caprylic/capric triglycerides, polyoxyl 35 castor oil, polyethylene glycol palmito stearate, glyceryl behenate, sorbitan monolaurate, polyoxylglycerides/ oleoyl polyoxyl-6 glycerides and polyethylene glycol peg- 32 stearate/polyoxyl-32 stearate, caprylocaproyl polyoxyl- 8 glycerides/ polyoxyglycerides, propylene glycol monolaurate, polyglyceryl-3 oleate, stearoyl polyoxyl-32 glycerides, Lauroyl polyoxyl-32 glycerides, polysorbates, sorbitans, glyceryl behenate, Glyceryl distearate, PEG-8 caprylic/capric glycerides.

5. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, wherein, the at least a surfactant two is selected from polyoxylglycerides/ oleoyl polyoxyl-6 glycerides, polyoxyl-32 stearate, caprylic/capric triglyceride and lauroyl polyoxyl-6 glycerides.

6. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, wherein, the at least one co-surfactant is selected from ethylhexylglycerin, isostearyl isostearate, polyvinyl alcohol, diethylhexyl carbonate, isopropyl myristate and caprylic acid, Polyethylene glycols, ethanol, Isopropyl palmitate, Sorbitan esters (e.g. Sorbitan Oleate), Polysorbates (e.g., Polysorbate 20, Polysorbate 80), Glycol Esters (e.g., Glycol Stearate), Fatty Alcohols (e.g., Cetyl alcohol, Stearyl alcohol), Lecithin, Caprylic/Capric Triglycerides, Medium- Chain Triglycerides (MCTs), Diisopropyl Adipate, Diisopropyl Dimer Dilinoleate, Castor oil and Derivatives, Ethylhexylglycerin Octydodecanol, Polyglyceryl Esters (e.g., polyglyceryl-3 Diisostearate), Glyceryl Stearate, Caprylyl Glycol, Isostearyl Neopentanoate, Polyglyceryl Polyricinoleate, Coco- Caprylate/Caprate, Sucrose Esters (e.g., Sucrose Stearate), Triethyl Citrate, Hydrogenated Castor Oil, Diethylene glycol monoethyl ether and Caprylic acid.

7. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, wherein, a method for preparing the self-nano emulsifying formulation comprising: the at least one active ingredient was mixed in various oil phases, surfactants and co-surfactants to form self-nano emulsifying drugs; sound

waves are used to agitate the particles in the various self-nano emulsifying drugs to further dissolute the particles in the drug; the drugs are placed under a microscope, assessed and tabulated in three categories of solubility; the at least a surfactant one, the at least a surfactant two, the at least one oil phase and the at least one co-surfactant are selected on the basis of solubility data; the at least one powder substrate is selected on the basis of characteristics and compatibility with the self-nano emulsifying drug; the at least one powder substrate is sifted and extremely dried to enhance adsorption; and the self-nano emulsifying drug is adsorbed on the at least one powder substrate by a method of spontaneous emulsification and spray drying method (SESDM) including: the homogenous mixture of self-nano emulsifying drug and the aqueous dispersion of solid substrate is prepared, the mixture is pumped at a fixed rate, the pumped mixture is atomized into fine droplets through a rotary/nozzle atomizer, and the obtained droplets are kept in a drying chamber for rapid evaporation of liquid to form a powder formulation.

8. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, that formulation in powder form has better stability with respect to pure vitamin D (cholecalciferol) as well as aqueous emulsion thereof.

9. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of: the at least one active ingredient cholecalciferol, having a concentration of 1.50% the at least one calcium carbonate having a concentration of 96.20%; the at least one olive oil having a concentration of 0.30%; the at least a lauroyl polyoxyl-6 glyceride having a concentration of 0.50%; the at least a polyoxylglycerides/oleoyl polyoxyl-6 glycerides having a concentration range from 0.70%; and the at least one ethylhexylglycerin having a concentration range from 0.80%.

10. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of: the at least one active ingredient cholecalciferol, having a concentration of 0.30%; the at least one corn starch having a concentration of 98.10%; the at least one soybean oil having a concentration of 0.20%; the at least a caprylic/capric triglycerides having a concentration of 0.90%; the at least a polyoxyl-32 stearate having a concentration range from 0.40%; and the at least one isostearyl isostearate having a concentration range from 0.10%.

11. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of:

the at least one active ingredient cholecalciferol, having a concentration of 0.80%; the at least one dicalcium phosphate having a concentration of 97.40%; the at least one sunflower oil having a concentration of 0.40%; the at least a polyoxyl 35 castor oil having a concentration of 0.60%; the at least a caprylic/capric triglyceride having a concentration range from 0.10%; and the at least one polyvinyl alcohol having a concentration range from 0.70%.

12. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of: the at least one active ingredient cholecalciferol, having a concentration of 0.40% the at least one lactose monohydrate having a concentration of 97.80%; the at least one hemp seed oil having a concentration of 0.30%; the at least a polyethylene glycol palmito stearate having a concentration of 0.20%; the at least a lauroyl polyoxyl-6 glycerides having a concentration range from 0.90%; and the at least one diethylhexyl carbonate having a concentration range from 0.40%.

13. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of:

the at least one active ingredient cholecalciferol, having a concentration of 0.60% the at least one microcrystalline cellulose having a concentration of 97.90%; the at least one castor oil having a concentration of 0.10%; the at least a glyceryl behenate having a concentration of 0.70%; the at least a caprylic/capric triglyceride having a concentration range from 0.50%; and the at least one isopropyl myristate having a concentration range from 0.20%.

14. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of: the at least one active ingredient cholecalciferol, having a concentration of 0.70% the at least one rice starch having a concentration of 97.40%; the at least one flaxseed oil having a concentration of 0.20%; the at least a sorbitan mono laurate having a concentration of 0.30%; the at least a polyoxy 1-32 stearate having a concentration range from 0.80%; and the at least one polysorbate 20 having a concentration range from 0.60%.

15. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of: the at least one active ingredient cholecalciferol, having a concentration of 0.20%;

the at least one tapioca starch having a concentration of 97.90%; the at least one medium chain triglycerides having a concentration of 0.40%; the at least a polyoxylglycerides/ oleoyl polyoxyl-6 glycerides having a concentration of 0.50%; the at least a polyoxyl-32 stearate having a concentration range from 0.10%; and the at least one isopropyl myristate having a concentration range from 0.20%.

16. The self-nano emulsifying drug formulation for cholecalciferol as claimed in claim 1, the formulation comprising of: the at least one active ingredient cholecalciferol, having a concentration of 0.90% the at least one maltodextrin having a concentration of 98.0%; the at least one palm oil having a concentration of 0.20%; the at least a caprylic/ capric triglyceride having a concentration of 0.40%; the at least a lauroyl polyoxyl-6 glycerides having a concentration range from 0.30%; and the at least one caprylic acid having a concentration range from 0.20%.