DESC:FORM 2
THE PATENTS ACT 1970
39 of 1970
&
The Patent Rules 2003
COMPLETE SPECIFICATION
(See sections 10 & rule 13)

AN ENCAPSULATED OIL IN WATER NANOEMULSION AND PREPARATION METHOD THEREOF

1. APPLICANTS (S)
(a) NAME (b) NATIONALITY (c) ADDRESS(d)

SRI KRISHNA PHARMACEUTICALS LIMITED

INDIAN C-4, INDUSTRIAL AREA, UPPAL, HYDERABAD – 500 039, TELANGANA, INDIA

2. PREAMBLE TO THE DESCRIPTION
COMPLETE SPECIFICATION

The following specification particularly describes the invention and the manner in which it is to be performed.

AN ENCAPSULATED OIL IN WATER NANOEMULSION AND PREPARATION METHOD THEREOF

FIELD OF THE INVENTION:
The present invention relates to emulsion technology where the present invention specifically relates to encapsulated oil in water emulsions and their preparation methods. The encapsulated oil in water emulsions encapsulate an active ingredient and assist in delivering the active ingredient in food, Nutracosmetics, dietary supplements, pharmaceuticals, flavour &fragrance.

BACKGROUND OF THE INVENTION:
Nanoemulsions are kinetically stable liquid-in-liquid dispersions with small droplet sizes. Their small size leads to useful properties such as high surface area per unit volume, robust stability, optically transparent appearance, and tuneable rheology. Nanoemulsions are increasingly investigated for the delivery of hydrophobic active compounds to improve their bioavailability or make their administration possible. Active compound/ active ingredient cored Nano emulsions are finding its applications in diverse areas such as drug delivery, food, Nutracosmetics, pharmaceuticals and dietary supplements.
One such important active ingredient is Pigment White 6 (TiO2) which is authorised both as a colorant and as a UV-filter. TiO2 is also used as a filler in Nutracosmetics products and dietary supplements. The titanium ore, refines it to produce pigments using either the sulfate process (with sulfuric acid) or the chloride process (with chlorine) and grinds it into a fine, uniform powder for optimum technical performance. Pigment White 6 is the world’s primary pigment for providing whiteness, brightness and opacity. Pigment White 6 is a naturally occurring oxide of titanium. It has the highest refractive index of any material known to man, even the diamond, and is one of the whitest materials on earth. When ground into a fine powder, it transforms into a pigment that provides maximum whiteness and opacity. TiO2 pigments are used in paints and coatings, plastics, paper, building materials, Nutracosmetics, pharmaceuticals, foods, dietary supplements and many other commercial products. However, nature does not yield Pigment White 6 in a usable form. It must be carefully mined in one of its pure forms, such as rutile beach sand, and refined into a fine uniform particle size.
Several patent applications discussed metal oxide encapsulated nanoemulsions like the patent application KR20130051705 A titled as “O/W Nano-emulsion with high emulsion stability, preparation method thereof, and cosmetic composition comprising the same” discusses an oil-in-water type nanoemulsion contains an oil phase part in which an aqueous phase part is dispersed and contains an oil sphere with an average size of 150nm or less. The nanoemulsion contains a vegetable emulsifier containing polyglyceryl-3-methyl glucose distearate, cetearyl glucoside, and methyl glucose sequestrate. The vegetable emulsifier contains 1 part by weight of methyl glucose sequestrate, 3.3-5.5 parts by weight of polyglyceryl-3-methyl glucose distearate, and 0.5-1 parts by weight of cetearyl glucoside. A cosmetic composition contains the oil-in-water type nanoemulsion.
Another patent application numbered as US2017143627 A1 and titled as “A pharmaceutical oil-in-water Nano-emulsion” discusses a pharmaceutical oil-in-water Nano-emulsion, with a pharmaceutically active substance. The selected pharmaceutically active substance is encased in monounsaturated fatty acid droplets with the droplets having an average particle size in the range of 60 to 200 nm. The Nano-emulsion is also provided with a non-ionic surfactant system, which is a mixture of polyethers, macrogolglycerides and polysaccharides, along with pharmaceutically acceptable adjuvants. The present invention also provides a process for the preparation of pharmaceutical oil-in-water Nano-emulsion.
Yet another patent application numbered as US2004258644 A1 and titled as “finely divided photo protective oil-in-water emulsions comprising 4,4-diarylbutadiene UV-A sunscreens” discusses a UV-Photo protective oil-in-water emulsions well suited for photo protecting the skin, lips and/or hair against the damaging effects of UV-radiation, the oil globules of which having an average size of at most 500 nm and containing particles of at least one ionic polymer and at least one UV-radiation-screening system, such screening system comprising at least one 4,4-diarylbutadiene UV-A-screening agent.
However, none of the prior arts discuss an active ingredient cored nanoemulsions and specifically relating to Pigment White 6 encapsulated nanoemulsions with improved the solubility and dissolution of encapsulated spherical pellets by This innovative platform of Encapsulation Nano Emulsion and Spray Congealing methods of solid dispersion (ENE-SC) which is most innovative platform not existing in prior art. The present invention discusses a novel process where it modified the active state from Crystalline to Amorphous without any alteration in Chemical structure & Physical property by this innovative platform of Encapsulation, Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC). Where the entire process provides a greener option prepared using green technology without using any synthetic process or Carcinogenic organic media which harmful for society and human. The invention focusses on improving physicochemical property of BCS Class -2 active’s and their various applications in a safe and environmentally friendly manner.

OBJECTIVE OF THE INVENTION
The present invention provides an innovative platform of Encapsulation Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC) through green process for preparation of an encapsulated oil in water nanoemulsions and Beadlets of BCS Class-2 Active’s.
The present invention provides a nanoemulsion encapsulating the active ingredient comprising oil phase and encapsulation matrix layer wherein the core oil phase includes the active ingredient to be delivered.
The present invention provides a process of obtaining an active ingredient encapsulated nanoemulsion whose spherical pellets produced by the combination of encapsulation Nano emulsion techniques and spray congealing methods of solid dispersion (ENE-SC).
The present invention provides novel process where it modifies the active state from Crystalline to Amorphous without any alteration in Chemical structure & Physical property, to improve solubility and permeability for application.

SUMMARY OF INVENTION
The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.
The present invention relates to the method of preparation of encapsulated oil in water nanoemulsion comprising a core oil phase including emulsifier, nonionic surfactant along with active compound embedded within; an encapsulation matrix having wetting agent, encapsulating agent, coloring agent and an adsorbing agent, wherein the nanoemulsion comprises the oil phase encapsulated by the encapsulating agent in water phase and the emulsion is adsorbed on the adsorbing agent to yield a spherical uniform pellets.
The present invention also discusses a unique process or method for the preparation of the nanoemulsion where the method includes important steps of:
1. Oil phase preparation: Preparation of oil phase embedding active compound comprising active ingredient, Emulsifier, and non-ionic surfactant under steady slow stirring under heating at 60°C for 30 minutes & stir manually.
2. Preparation of water phase or aqueous phase comprising Purified water, Maltodextrin, Maize starchand Red No.3 under steady slow stirring to avoid foam & lumps formation at 25°C
a) Preparation of encapsulated Nano emulsion using Nano emulsion techniques by way of emulsification and Micronization: Add oil phase into water phase for Oil in water emulsions (O/W) by Nano emulsion technique. The particle size of the (O/W) emulsion was 90% less than 300 Nanometre & viscosity less than 300 cps at 75 rpm.Wherein the emulsification is performed with the help of by help of high speed homogenizer at 8000-12000rpm for 20 minutes.
3. Encapsulated Nano Emulsion heat at 60°Cand spray onchilled (0°C to 8°C) Powder catch media in spray chamber under rotation to form fine encapsulated spherical pellets by adsorbing phenomenon which is called spray congealing.
4. Separation after curing, fines and encapsulated spherical pellets by sieving techniques.
5. Drying: Encapsulated spherical pellets further drying to achieve desirable moisture content by using fluid bed dryer for uniform drying. by using fluid bed dryer for uniform drying at 45±2°C to achieve moisture content below 5%.
6. Packing: Dry free flow & stain free Encapsulated spherical pellets obtained which is packed in suitable packing material like LDPE bag.
The present invention provides a green process for preparation of encapsulated oil in water nanoemulsions using this innovative platform of Encapsulation, Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC) where the produced nanoemulsions demonstrate improved physicochemical properties in terms of solubility and dissolution. The process is inventive and novel as has modified active state from Crystalline to Amorphous without any alteration in Chemical structure & Physical property by this innovative platform of Encapsulation Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC).
BRIEF DESCRIPTION OF DRAWINGS
Figure 1: Illustrates the process flowchart of preparation of encapsulated nanoemulsion.
Figure 2: Illustrates the schematic structure of nanoemulsion.
Figure 3: Illustrates the encapsulated nanoemulsion particle size graph of Titanium Dioxide made by ENE-SC Technology. (Graph obtained by Malvern).
Figure 4: Illustrates the overlay FTIR graph of Encapsulated spherical beadlets of Titanium Dioxide made by ENE-SC Technology and Active of Titanium Dioxide.
Figure 5: Illustrates the overlay XRD graph of Encapsulated spherical beadlets of Titanium Dioxide made by ENE-SC Technology and Active of Titanium Dioxide.
Figure 6: Illustrates the encapsulated spherical beadlets Images obtained by Scanning Electron microscopy of Titanium Dioxide made by ENE-SC Technology.

DETAILED DESCRIPTION
The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.
The embodiments will be described in detail with corresponding marked references to the drawings, in which the illustrative components of the invention are outlined. The embodiments disclosed herein can be expressed in different forms and should not be considered as limited to the listed embodiments in the disclosed invention. The various embodiments outlined in the subsequent sections are construed such that it provides a complete and a thorough understanding of the disclosed invention, by clearly describing the scope of the invention, for those skilled in the art.
The present invention relates to the method of preparation of encapsulated oil in water nanoemulsion comprising a core oil phase including emulsifier, nonionic surfactant along with active compound embedded within; an encapsulation matrix having wetting agent, encapsulating agent, coloring agent and an adsorbing agent, wherein the nanoemulsion comprises the oil phase encapsulated by the encapsulating agent in water phase and the emulsion is adsorbed on the adsorbing agent to yield a spherical uniform pellet. The embodiments of the invention include encapsulating any active compound including metal oxides and BCS class 2 actives as well.
In one of the embodiments of the said nanoemulsions produced. The invention focused on producing active compound including various metal oxide and BCS class 2 actives molecules embedded in the oil core of the nanoemulsion.

EXPERIMENT 1
TIO2 ENCAPSULATED NANOEMULSION
Pigment White 6 (TiO2) is authorized both as a colorant and as a UV-filter. TiO2 is also used as a filler in cosmetic products. The titanium ore, refines it to produce pigments using either the sulfate process (with sulfuric acid) or the chloride process (with chlorine) and grinds it into a fine, uniform powder for optimum technical performance. Pigment White 6 is the world’s primary pigment for providing whiteness, brightness and opacity.
Pigment White 6 is a naturally occurring oxide of titanium. It has the highest refractive index of any material known to man, even the diamond, and is one of the whitest materials on earth. When ground into a fine powder, it transforms into a pigment that provides maximum whiteness and opacity. TiO2 pigments are used in paints and coatings, plastics, paper, building materials, Nutracosmetics, pharmaceuticals, foods, dietary supplements and many other commercial products. However, nature does not yield Pigment White 6 in a usable form. It must be carefully mined in one of its pure forms, such as rutile beach sand, and refined into a fine uniform particle size.
In one of the embodiments of the invention where an encapsulate oil in water nanoemulsion is produced, which comprises:
(i) a core oil phase comprising emulsifier, non-ionic surfactant and active compound embedded within where the emulsifier in the present embodiment is MCT oil, non-ionic surfactant is Polysorbate, and the said oil phase is embedded with metal oxide and in the present case Pigment White 6 (active compound)
(ii) An encapsulation matrix comprising wetting agent, and where the wetting agent in the present nanoemulsion is Maltodextrin, encapsulating agent is Maize starch and coloring agent which is Red No. 3.
(iii) An adsorbing agent which is powder starch media. The nanoemulsion comprises the oil phase encapsulated by the encapsulating agent in water phase and the emulsion is adsorbed on the adsorbing agent to yield a spherical uniform pellet.

EXPERIMENT 2
FLAVOURS ENCAPSULATED NANOEMULSION
Menthol/ Citric Acid / Ginger/ Orange/ Mango etc. is authorized as a Flavour. Flavour is used as a taste masking and taste enhancing in Food, Nutraceutical & Pharmaceutical products. In one of the embodiments of the invention where an encapsulate oil in water nanoemulsion is produced, which comprises:
(i) A core oil phase comprising emulsifier, non-ionic surfactant and active compound embedded within where the emulsifier in the present embodiment is MCT oil, non-ionic surfactant is Polysorbate, and the said oil phase is embedded with Flavour and in the present case prefer Menthol.
(ii) An encapsulation matrix comprising wetting agent, and where the wetting agent in the present nanoemulsion is Maltodextrin, encapsulating agent is Maize starch.
(iii) An adsorbing agent which is powder starch media. The nanoemulsion comprises the oil phase encapsulated by the encapsulating agent in water phase and the emulsion is adsorbed on the adsorbing agent to yield a spherical uniform pellet.

EXPERIMENT 3
FRAGRANCE ENCAPSULATED NANOEMULSION
Lavender/ Lemongrass/ Eucalyptus / Sandalwood / Cedar wood etc. is authorized as a Fragrance. Fragrance is used provide a pleasant odor and make the products more distinct, as well as help mask the smell of some ingredients in Food, Nutraceutical & Pharmaceutical products. In one of the embodiments of the invention where an encapsulate oil in water nanoemulsion is produced, which comprises:
(i) A core oil phase comprising emulsifier, non-ionic surfactant and active compound embedded within where the emulsifier in the present embodiment is MCT oil, non-ionic surfactant is Polysorbate, and the said oil phase is embedded with Fragrance and in the present case preferLavender.
(ii) An encapsulation matrix comprising wetting agent, and where the wetting agent in the present nanoemulsion is Maltodextrin, encapsulating agent is Maize starch.
(iii) An adsorbing agent which is powder starch media. The nanoemulsion comprises the oil phase encapsulated by the encapsulating agent in water phase and the emulsion is adsorbed on the adsorbing agent to yield a spherical uniform pellet.
THE PROCESS OF PREPARATION OF THE TIO2 ENCAPSULATED NANOEMULSIONS
The process of preparation of the TiO2 encapsulated nanoemulsions is as below:
b) Preparation of oil phase including active compound and water phase, where the oil phase includes active compound which is metal oxide / TiO2 in the present embodiment, emulsifier and non-ionic surfactant which are mixed and stirred manually
c) Preparation of water phase or aqueous phase using wetting agent, encapsulating agent and coloring agent where the said components are slow stirred avoiding foam and lumps. Preparing encapsulated Nano emulsion using Nano emulsion techniques;
d) Emulsification &Micronization: Add oil phase into water phase for Oil in water emulsions (O/W) by Nano emulsion technique. The particle size of the (O/W) emulsion was 90% less than 300 Nanometer & viscosity less than 300 cps at 75 rpm. Wherein the emulsification is performed with the help of by help of high speed homogenizer at 8000-12000rpm for 20 minutes
e) Spray congealing, where the prepared nanoemulsion under low temperatures along with adsorbing agent is subjected to spray chamber to form encapsulated spherical uniform pellet;
f) Separation by sieving, and
g) drying to yield a dry free flowing and stain free encapsulated spherical pellets to achieve desirable moisture content by using fluid bed dryer for uniform drying by using fluid bed dryer for uniform drying at 45±2°C to achieve moisture content below 5% to obtain dry free flowing stain-free pellets
h) Packing: dry free flow & stain free encapsulated spherical pellets obtained.
The structure of the prepared encapsulated oil in water emulsion mentioned below in Table 1.
Table 1. Ingredient details with rational use.
S.No. Ingredients Rational use
1 Pigment White 6/ Menthol/ Lavender Active Compound
2 MCT Oil Emulsifier
3 Polysorbate Nonionic Surfactant
4 Maltodextrin Wetting agent
5 Maize Starch Encapsulating agent
6 Red No. 3 Coloring agent
7 Powder catch starch media Adsorbing agent

The composition of the prepared TiO2 encapsulated Nano emulsion of is mentioned in table 2
S.No. Ingredients Composition % (w/w) Rational use
1 Pigment White 6 28 - 32 Active Compound
2 MCT Oil 5 - 10 Emulsifier
3 Polysorbate 1 - 3 Nonionic Surfactant
4 Maltodextrin 4 - 6 Wetting agent
5 Maize Starch 35 - 40 Encapsulating agent
6 Red No. 3 0.1 - 1 Coloring agent
7 Powder catch starch media 15 - 20 Adsorbing agent

The composition of the prepared Flavours encapsulated Nano emulsion of is mentioned in table 3
S.No. Ingredients Composition % (w/w) Rational use
1 Menthol 28 - 32 Active Compound
2 MCT Oil 5 - 10 Emulsifier
3 Polysorbate 1 - 3 Nonionic Surfactant
4 Maltodextrin 4 - 6 Wetting agent
5 Maize Starch 35 - 41 Encapsulating agent
6 Powder catch starch media 15 - 20 Adsorbing agent

The composition of the prepared Fragrance encapsulated Nano emulsion of is mentioned in table 4
S.No. Ingredients Composition % (w/w) Rational use
1 Lavender 28 - 32 Active Compound
2 MCT Oil 5 - 10 Emulsifier
3 Polysorbate 1 - 3 Nonionic Surfactant
4 Maltodextrin 4 - 6 Wetting agent
5 Maize Starch 35 - 41 Encapsulating agent
6 Powder catch starch media 15 - 20 Adsorbing agent

The present invention has improved the solubility of encapsulated spherical pellets by this innovative platform of Encapsulation Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC). It has modified active state from Crystalline to Amorphous without any alteration in Chemical structure & Physical property by this innovative platform of Encapsulation Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC). Dry free flow & stain free Encapsulated spherical pellets prepared by green technology without using any synthetic or Carcinogenic organic media which harmful for society and human.
The present invention has improved the stability of standalone and application of encapsulated spherical pellets by this innovative platform of Encapsulation Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC) developed unique process which totally green technology to improve physicochemical property of BCS Class-2 actives and their application for human being wellness, health and without harming the environmental.
The said nanoemulsion developed unique process which totally green technology to improve physicochemical property of BCS Class-2 actives by using green excipients which is suitable for food, dietary supplements and Nutracosmetics application.
The characteristic studies conducted on the produced emulsion are discussed in detail below
1. Emulsion results:
a) Emulsion Particle size:
Encapsulated emulsion of Titanium Dioxide made by ENE-SC Technology evaluate for particle size by Malvern in which we obtained Dv [50]: 0.0560µm &Dv [90]: 0.176µm. (as shown in Fig 3)
Its shows we had developed emulsion of formulation in nanoparticle size range and stable.
b) Emulsion Viscosity:
Encapsulated emulsion of Titanium Dioxide made by ENE-SC Technology evaluate for viscosity by Brookfield viscometer. which have 168.4 Cps viscosity at 11.1% torque which shows emulsion is stable and free flow for further drying process.
2. Beadlets results:
a) Partition coefficient (log P):
Titanium Dioxide formulation and active comparative test performed to evaluate Partition coefficient. In which we had observed Formulated Titanium Dioxide LogP value less than 2 in water & Titanium Dioxide Active LogP value more than 3 in water. Which shows Titanium Dioxide formulation more soluble in polar compound like in water as compare to Titanium Dioxide Active.
b) Solubility (mg/ml) in water:
Based on experimental solubility data by HPLC/UV Spectroscopy shows developed Titanium Dioxide formulation more soluble in polar compound like in water as compared to Titanium Dioxide Active.
c) Bulk Density (g/ml) & Tapped Density (g/ml):
Based on experimental bulk density, tapped density and particle size distribution SKPL Titanium Dioxide formulation is more uniform and good density for application like Cosmetic, Dietary supplement, Paint Industry and Food Colorant etc.
3. Spectroscopy results:
a) Fourier Transform Infra-red:
Titanium Dioxide formulation and active comparative test performed to check any changes in structure of active and formulation. Obtained chromatograph showed no change in bond and functional group present naturally. Which show proper Encapsulation of active in matrix of polymer by ENE-SC Technology without alteration in structure of active in water dispersible formulation. (as shown in fig 4)
b) X-Ray Diffraction:
Titanium Dioxide formulation and active comparative test performed to check polymorphism. X-Ray Diffraction (XRD) Spectroscopy shows the present invention has modified Titanium Dioxide state from Crystalline to Amorphous without any alteration in Chemical structure & Physical property by ENE-SC Technology due to this insoluble active successfully converted into water dispersible formulation with same enhanced function for various application. (as shown in fig 5)
c) Scanning Electron microscopy:
Titanium Dioxide formulation performed Scanning Electron microscopy (SEM) to check shape and size of beadlets. After Scanning Electron microscopy obtained images shows proper Encapsulation of active in matrix of polymer and formed spherical beadlets of Titanium Dioxide by ENE-SC Technology. The particles produced by ENE-SC Technology have average particle size of 352.18 µm, high porosity, high density and acceptable colour consistency as illustrated in fig 6. The high porosity and high density provide good wettability and flowbility during application.
The comparative physiochemical study results are shown below in table 3
Table 3
S.No. Test Parameters Comparative Study Remark
Titanium Dioxide Active SKPL Formulation
1 Partition coefficient (log P) 1.38 -0.85 SKPL Formulation Polar Compounds, Good aqueous solubility.
2 Solubility (mg/ml) in water 0.034 0.33 SKPL Formulation 10 Times solubility improved
3 Bulk Density (g/ml) 0.499 0.610 SKPL Formulation 1.22 Times density improved
4 Particle Size (100# pass in %) 79.56 0.10 SKPL Formulation more uniform and good density for application

ADVANTAGES INCLUDE
1) Pigment White 6 is a food additive, dietary supplements and Nutracosmetics application without any nutritive value and added in processed foods to provide a whitening effect but due to water-insoluble property its shows stain over the period of time.
2) Pigment White 6 has been used as a white pigment due to its very high opacity and brightness, a coloring ingredient of dietary supplements, Nutracosmetics and pharmaceutical film coating but due to water-insoluble property its aggregated due to which uneven coating happened, tedious and need for accuracy for coating process.
3) Pigment White 6 crystalline in nature and fine/fluffy powder due to this very difficult for dispensing during application and found increased lung cancers due to inhalation exposure.In this invention we had developed spherical uniform pellets which is dust
,CLAIMS:WE CLAIM
1. An oil in water Nano emulsion, comprising:
a core oil phase including at least one emulsifier, at least one nonionic surfactant and at least one active ingredient embedded within,
an aqueous phase, comprising encapsulation matrix having at least one wetting agent, at least one encapsulating agent, at least one coloring agent, at least one an adsorbent agent,
wherein the oil phase encapsulated by the encapsulating agent in water phase and the emulsion is adsorbed on the adsorbing agent to yield a spherical pellet, andthe size of Nano emulsion solution 90% of Nano emulsions of size less than 300nm.
2. An oil in water Nano emulsion, comprising:
a core oil phase including at least one emulsifier (5-10% w/w), at least one nonionic surfactant of 1-3% w/w and at least one active ingredient of 28-32% w/w embedded within,
an aqueous phase, comprising encapsulation matrix having at least one wetting agent of 4 - 6% w/w, at least one encapsulating agent of 35-40% w/w, at least one coloring agent of 0.1-1% w/w,an adsorbent agent of 15 - 20% w/w,
wherein the size of Nano emulsion solution 90% of Nano emulsions of size less than 300nm,
wherein the Nano emulsion has viscosity less than 300 cps at 75 rpm, partial co efficient of -0.85, solubility in water of 0.33 mg/ml, with bulk density of 0.610 and particle size of 100# pass in %) is 0.10 which shows Formulation more uniform spheres and good density with flow for application.
3. An oil in water Nano emulsion as claimed in claim 1 & 2 wherein the active ingredient is Metal dioxide and/or Flavour and/or Fragrance
4. An oil in water Nano emulsion as claimed in claim 1& 2 wherein the Metal dioxide is Titanium dioxide, Flavour is Menthol and Fragrance is Lavender.
5. An oil in water Nano emulsion as claimed in claim 1 & 2 wherein the emulsifier as claimed in claim 1 is MCT oil.
6. An oil in water Nano emulsion as claimed in claim 1& 2 wherein the non-ionic surfactant as claimed in claim 1 is Polysorbate.
7. An oil in water Nano emulsion as claimed in claim 1 & 2 wherein the wetting agent as claimed in claim 1 is Maltodextrin.
8. An oil in water Nano emulsion as claimed in claim 1 & 2 wherein the encapsulating agent as claimed in claim 1 is Maize starch.
9. Coloring agent as claimed in claim 1 is Red No 3.
10. An oil in water Nano emulsion as claimed in claim 1 & 2 wherein the adsorbing agent is Powder catch starch media.
11. An oil in water Nano emulsion as claimed in claim 1 & 2 wherein the particle size of 90% of the emulsion is % less than 300 nm.
12. An oil in water emulsion, comprising:
28-32% w/w of active compound;
5-10% w/w of emulsifier;
1-3% w/w of non-ionic surfactant
4-6% w/w of wetting agent
35-40% w/w of encapsulating agent
15 -20% w/w adsorbing agent
and 0.1 to 1 % w/w of colouring agent.
13. A method of preparation of oil in water Nano emulsion comprising steps of:
i) Preparation of oil phase including active compound, where the oil phase includes active compound, emulsifier and non-ionic surfactant which are mixed and stirred manually for 30mins. at 60°C
j) Preparation of aqueous phase with using wetting agent, encapsulating agent and coloring agent where the said components are slow stirred avoiding foam and lumps at 25°C
k) emulsification by addition of oil phase to water phase to yield an oil in water o/w emulsion by help of high-speed homogenizer at 8000-12000rpm for 20 minutes;
l) Spray the o/w Nanoemulsion of temperature 60°C under chilled (0°C to 8°C) Powder catch media in spray chamber under rotation to form fine encapsulated spherical pellets by adsorption; Separation by sieving.
m) Drying until moisture content is below 5 % by using fluid bed dryer for uniform drying at 45±2°C to achieve moisture content below 5%,
To obtain a dry free flowing and stain free encapsulated spherical pellets,
Wherein the said process is green and has modified active state from crystalline to amorphous without any alteration in chemical and physical property using Encapsulation Nano Emulsion and Spray Congealing method of solid dispersion (ENE-SC).
14. The method as claimed in claim 13 wherein the spray congealing includes subjecting Nanoemulsion solution onto adsorption agent under reduced temperatures of 0 to 8°C in a spray chamber.
15. The method as claimed in claim 13 wherein the drying is performed using fluid bed dryer for uniform drying at 45±2°C to achieve moisture content below 5%.
16. The method as claimed in claim 13 wherein the average particle size of the beadlets produced is 352.18µm.

Dated this 25th day of September, 2023

Nalini Kant Pandey
(IN/PA 2187)
Bizrights IP Partners LLP
Agent for applicant(s)