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A Thin Particle Delivery System For Fish Oil Encapsulation

Abstract: The present invention is a formulation for a thin particle delivery system of oily phase, specifically, omega-3 fatty acid, and/or other oil-soluble drugs. The formulation of the thin particle delivery includes an active ingredient, e.g. fish oil (containing omega-3 fatty acid), one phospholipid, a surfactant one, a surfactant two and one co-surfactant, herein, the formulation efficiently encapsulates hydrophobic or oily liquids, and the shelf life of the active ingredient is effectively increased. Herein, the structure of the formulation creates an environment suitable for a stable entrapment of the active ingredient while preventing separation or degradation of the formulation.

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Patent Information

Application #
Filing Date
19 October 2023
Publication Number
19/2025
Publication Type
INA
Invention Field
BIO-CHEMISTRY
Status
Email
Parent Application

Applicants

Vytals Wellbeing India Pvt. Ltd.
Block A, Building 5, 16th Floor, DLF Cyber City, Gurugram, Haryana

Inventors

1. Dr. Iqbal Ahmad
Vytals Wellbeing India Pvt. Ltd., Block A, Building 5, 16th Floor, DLF Cyber City, Gurugram, Haryana, 122002

Specification

DESC:FIELD OF THE INVENTION
The present invention relates to a formulation of thin particle delivery for oil phase encapsulation, specifically fish oil, for the delivery of omega-3 fatty acids. More specifically, the invention relates to the spontaneous self-assembly of fish oil formulation in an aqueous medium to form a thin particle delivery system to efficiently encapsulate hydrophobic or oily liquids.

BACKGROUND OF THE INVENTION
Omega-3 fatty acids, particularly those derived from fish oil, have garnered significant attention in the fields of nutrition, health, and pharmaceuticals due to their proven benefits on human well-being. The efficacy of these fatty acids, including eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), in promoting cardiovascular health, cognitive function, and overall inflammation management has led to an increased demand for efficient delivery systems.
Fish oil, a rich source of omega-3 fatty acids, is inherently hydrophobic, which poses substantial challenges for its delivery in an aqueous environment, such as the human gastrointestinal tract. Traditional oral dosage forms often struggle to effectively deliver the desired amount of fish oil due to poor solubility and bioavailability issues.
Recognizing the crucial importance of optimizing the delivery of fish oil, the present invention introduces a novel formulation of a liquid-encapsulated thin particle delivery system specifically designed for efficient fish oil delivery. The groundbreaking aspect of this invention lies in the concept of spontaneous self-assembly, where fish oil undergoes a unique self-assembly process in an aqueous medium, leading to the efficient encapsulation of hydrophobic or oily liquids.
The thin particle delivery encompasses the benefits of both nano-liposomes and nano emulsion and imparts high encapsulation efficiency, stability as well as biocompatibility. The specific feature of the thin particle delivery system is that the oil phase is perfectly encapsulated in the rigid phospholipid bilayer by self-assembly when introduced to an aqueous environment.
US11672760B2 discloses an oil-in-water micro-emulsion for formulating pharmaceutically active compounds. The micro-emulsion contain oils, surfactants, water, and the pharmaceutical compounds, and are produced by mixing an aqueous phase and a lipid phase in which each phase contains at least one surfactant in a defined ratio whereby the resulting micro-emulsion has very small, dispersed particles and is thermodynamically very stable.
AU2018204190B2 discloses the compositions disclosed herein employed to improve the bioavailability of poorly soluble or poorly bioavailable lipophilic bioactive substances. The bioactive substances are encapsulated in fenugreek fiber compositions to form hydrophilic powder compositions. The special grade fenugreek fiber has high lipophilic holding capacity and also ensures the consistent release of bioactive substances. The present invention further provides process for the preparation of powder lipophilic bioactive substances
To overcome these challenges, the present invention introduces a thin particle delivery system for fish oil delivery. This innovative formulation represents a significant advancement in the field of pharmaceuticals and nutraceuticals by offering a comprehensive solution to the limitations associated with fish oil delivery.

OBJECTIVE OF THE INVENTION
The main objective of the present invention is to provide a novel formulation for omega-3 fatty acids delivery by facilitating the spontaneous self-assembly of fish oil in an aqueous medium to improve the solubility and absorption of fish oil's hydrophobic components.
Yet another objective of the present invention is to enhance its bioavailability by significantly improving the solubility and absorption of fish oil.
Yet another objective of the present invention is to provide a stable and reliable delivery system for fish oil, extending its shelf-life and minimizing issues related to oxidation and degradation.
Yet another objective of the present invention is to provide a steady release of omega-3 fatty acids over time, reducing the dosage frequency.
Yet another objective of the present invention is to encapsulate the oil phase with additional loading of any other oil-soluble drugs/nutrients other than fish oil to achieve sustained release, controlled release, or enhancement of bioavailability.
Yet another objective of the present invention is to encapsulate the oil phase to achieve a particle size range of 50 to 5000 nm and a zeta potential ranging from -30 mV to -50mV when dispersed in an aqueous phase.
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 formulation for a thin particle delivery of oily phase, having the formulation of the liquid-encapsulated system includes an active ingredient(s) e.g. fish oil having a concentration range from 30% to 85%, a phospholipid composition having a concentration range from 5% to 20%, a surfactant one having a concentration range from 0.5% to 30%, a surfactant two having a concentration range from 0.5% to 15% and a co-surfactant having a concentration range from 0.5% to 5%. Herein, the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium to form a novel thin particle delivery system. Herein, the present invention is characterized in that the formulation of the thin particle delivery efficiently encapsulates hydrophobic or oily liquids. Herein, the shelf life of the active ingredient is effectively increased to not less than 18 months and the therapeutic and nutritional effects of the formulation of the thin particle delivery system are varied to form multiple compositions. Herein, the present invention is characterized in that the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium to form particles ranging from 50-5000nm and zeta potential -30mV to -50 mV. Herein, the structure of the formulation creates an environment suitable for a stable entrapment of the active ingredient while preventing separation or degradation of the formulation.
The main advantage of the present invention is that it provides a novel formulation for omega-3 fatty acids delivery by facilitating the spontaneous self-assembly of fish oil in an aqueous medium to improve the solubility and absorption of fish oil and/or additionally some lipophilic drugs.
Yet another advantage of the present invention is that it enhances its bioavailability by significantly improving the solubility and absorption of fish oil.
Yet another advantage of the present invention is that it provides a stable and reliable delivery system for fish oil, extending its shelf-life and minimizing issues related to oxidation and degradation.
Yet another advantage of the present invention is that it provides steady release of omega-3 fatty acids over time, reducing the dosage frequency.
Yet another advantage of the present invention is that the thin particle delivery system encompasses the benefits of both nano-liposomes and nano emulsion and imparts high encapsulation efficiency, stability as well as biocompatibility. The specific feature of the thin particle delivery system is that the oil phase is perfectly encapsulated in the rigid phospholipid bilayer by self-assembly when introduced to an aqueous environment.
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.

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. shows comparison of the said formulation, Liposome and Nanoemulsion
FIG 2. represents the structure of the fish oil formulation
FIG 3. Shows solubility data of surfactant and co-surfactants
FIG 4. is an example composition of fish oil formulation
FIG 5. shows phase contrast microscopic image (40X) of Fish oil formulation
FIG 6. shows particle size analysis as per DLS measurement
FIG 7. Shows transmission electron microscopic image of dispersed fish oil formulation in aqueous buffer
FIG 8. is a graphical representation of DHA - AUC and DHA - plasma concentration vs time profile.
FIG 9. is a graphical representation of EPA - AUC and EPA - plasma concentration vs time profile.

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 2. represents the structure of a formulation showing the oil phase encapsulated in lipid bilayer.
FIG 4. is an example composition of fish oil formulation prepared by Sonication assisted homogenization method.
FIG 5. Phase contrast microscopic image (40X) of Fish oil formulation revealing the encapsulation of fish oil (yellow regions) in the bilayer (Avg. particle size by optical microscopy =1.35 ± 0.45µm)
FIG 7. Shows transmission electron microscopic image of dispersed fish oil formulation in aqueous buffer, Negative staining of fish oil formulation revealed dark bilayer implying oil phase distribution.
FIG 8. represents the clear that base-line corrected DHA (AUC 0.5 – 24) value was significantly (5 fold) higher in the FO-TPT group (n=5) in comparison to the FO-P (n=5) group with a t (28.98) = 5.415 (P>0.05). All data is represented as Mean ± SEM, with significance (****P<0.05) tested using the unpaired t-test with Welch’s correction.
FIG 9. represents the clear base line corrected EPA (AUC 0.5 – 24) value was significantly (10 fold) higher in FO-TPT group (n=5) in comparison to the FO-P (n=5) group with a t (29.12) = 8.983 (P>0.05). All data is represented as Mean ± SEM, with significance (****P<0.05) tested using unpaired t-test with Welch’s correction.
The present invention relates to a thin particle delivery formulation of omega-3 fatty acid. The formulation of a thin particle delivery includes active ingredient fish oil, a phospholipid, a surfactant one, a surfactant two and a co-surfactant. The active ingredient has a concentration range from 30% to 85%. In an embodiment the active ingredient is fish oil (omega-3 fatty acid). In the preferred embodiment, the fish oil includes but is not limited to Salmon, Mackerel, Sardines, Anchovies, Tuna, Herring, Krill, and Codfish. In the preferred embodiment, source of oil includes but is not limited to algal oil, Flaxseed oil, Canola oil, Chia seeds, Walnuts, Soybeans. The phospholipid has a concentration range from 5% to 20%. In an embodiment, the phospholipid includes but is not limited to lecithin. The surfactant one has a concentration range from 0.5% to 30%. In an embodiment, the surfactant includes but is not limited to sorbitan monooleate, caprylic/capric triglycerides and lauroyl polyoxyl-6 glycerides, Caprylocaproyl Polyoxyl-8 glycerides/ Polyoxylglycerides, Glyceryl Behenate, Glyceryl Distearate, Lauroyl Polyoxyl-32 glycerides, PEG-8 Caprylic/Capric Glycerides, PEG-32 Stearate / Polyoxyl-32 stearate, Polyethylene Glycol Palmitostearate, Polyethylene Glycol Stearate, Polyglyceryl-3 oleate, Polyoxyl 32 stearate, Polyoxyl 35 castor oil, Polyoxylglycerides, Propylene glycol monolaurate, Sorbitans, Stearoyl polyoxyl-32 glycerides, Polysorbates, Lecithin. The surfactant two has a concentration range from 0.5% to 15%. In an embodiment, the surfactant two includes but is not limited to sorbitan sesquioleate, polysorbate 80 and oleoyl polyoxyl-6 glycerides. The co-surfactant has a concentration range from 0.5% to 5%. In an embodiment, the co-surfactant includes but is not limited to polyethylene glycol 200, diethylene glycol monoethyl ether and polyglyceryl-3 dioleate, Diisopropyl Adipate, Diisopropyl Dimer Dilinoleate, Ethylhexylglycerin Octyldodecanol, Fatty Alcohols, Cetyl Alcohol, Stearyl Alcohol, Glycol Esters (e.g., Glycol Stearate), Glyceryl Stearate, , Isopropyl Myristate, Isopropyl Palmitate, Isostearyl Isostearate, Medium-Chain Triglycerides (MCTs), Polyglyceryl Esters, Polyglyceryl-3 Diisostearate, Polyglyceryl Polyricinoleate, Triethyl Citrate. Herein, in the present invention the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium. Herein, in the present invention the formulation efficiently encapsulates hydrophobic or oily liquids. Herein, in the present invention the shelf life of the active ingredient is effectively increased, i.e., not less than 18 months. Herein, the therapeutic and nutritional effects of the formulation are varied to form multiple compositions. Herein, in the present invention that the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium to form particles ranging from 50-5000nm and zeta potential -30mV to -50 mV.
Herein, the present invention includes a structure of the formulation which creates an environment suitable for a stable entrapment of the active ingredient while preventing separation or degradation of the formulation.
In an embodiment, a method of thin film dissolution is for preparing the thin particle delivery. The method includes:
the phospholipid is dissolved in an organic solvent;
the solution is transferred in a round-bottom flask;
the organic solvent is evaporated under reduced pressure till a thin phospholipid film is formed in the flask;
in another container, the active ingredient is combined with the surfactant one, the surfactant two and the co-surfactant to form an oil phase;
the oil phase is transferred to the phospholipid film and the flask is sealed to prevent degradation of the formulation; and
a reduced pressure is applied to the flask till fusion of the phospholipid film and oil phase.

In an embodiment, a method of co-solvent evaporation method is for preparing the thin particle delivery system. The method includes:
an oil phase is formed from the active ingredient and the surfactant one and the surfactant two;
the phospholipid, the oil phase and the co-surfactant were taken in separate containers;
the organic solvent is mixed with the phospholipid;
the co-solvent is added to the phospholipid solution; and
the oil phase is gradually added to phospholipid solution and stirred continuously in a stirrer till the solvent mixture of chloroform and the co-solvent is slowly evaporated, and the thin particle delivery system is obtained.
In an embodiment, a method of sonication assisted homogenization method is for preparing the thin particle delivery system. The method includes:
the active ingredient, the phospholipid, the surfactant one, the surfactant two and the co-surfactant are blended in a blender;
nitrogen is added to the mixture to the continuously blend mixture;
the temperature of the container is kept below 10? and sound waves are introduced to the particles to agitate them till a homogenous mixture is obtained;
vacuum is introduced at a low temperature

In an embodiment, the present invention relates to a thin particle delivery formulation of omega-3 fatty acid. The formulation of a thin particle delivery includes one or more active ingredients fish oils, one or more phospholipids, one or more surfactants one, one or more surfactants two and one or more co-surfactants. The one or more have a concentration range from 30% to 85%. In an embodiment the one or more active ingredient is fish oil. In the preferred embodiment, the one or more fish oil includes but are not limited to Salmon, Mackerel, Sardines, Anchovies, Tuna, Herring, Krill, and Codfish. In the preferred embodiment, one or more source of oil includes but are not limited to algal oil, Flaxseed oil, Canola oil, Chia seeds, Walnuts, Soybeans. The one or more phospholipids have a concentration range from 5% to 20%. In an embodiment, the one or more phospholipids includes but are not limited to lecithin. The one or more surfactants one have a concentration range from 0.5% to 30%. In an embodiment, the one or more surfactants one includes but are not limited to sorbitan monooleate, caprylic/capric triglycerides and lauroyl polyoxyl-6 glycerides, Caprylocaproyl Polyoxyl-8 glycerides/Polyoxylglycerides, Glyceryl Behenate, Glyceryl Distearate, Lauroyl Polyoxyl-32 glycerides, PEG-8 Caprylic/Capric Glycerides, PEG-32 Stearate / Polyoxyl-32 stearate, Polyethylene Glycol Palmitostearate, Polyethylene Glycol Stearate, Polyglyceryl-3 oleate, Polyoxyl 32 stearate, Polyoxyl 35 castor oil, Polyoxylglycerides, Propylene glycol monolaurate, Sorbitans, Stearoyl polyoxyl-32 glycerides, Polysorbates, Lecithin. The one or more surfactants two have a concentration range from 0.5% to 15%. In an embodiment, the one or more surfactants two phospholipids includes but are not limited to sorbitan sesquioleate, polysorbate 80 and oleoyl polyoxyl-6 glycerides. The one or more co-surfactants have a concentration range from 0.5% to 5%. In an embodiment, the one or more co-surfactants includes but are not limited to polyethylene glycol 200, diethylene glycol monoethyl ether and polyglyceryl-3 dioleate, Diisopropyl Adipate, Diisopropyl Dimer Dilinoleate, Ethylhexylglycerin Octyldodecanol, Fatty Alcohols, Cetyl Alcohol, Stearyl Alcohol, Glycol Esters (e.g., Glycol Stearate), Glyceryl Stearate, , Isopropyl Myristate, Isopropyl Palmitate, Isostearyl Isostearate, Medium-Chain Triglycerides (MCTs), Polyglyceryl Esters, Polyglyceryl-3 Diisostearate, Polyglyceryl Polyricinoleate, Triethyl Citrate. Herein, in the present invention the formulation efficiently encapsulates hydrophobic or oily liquids. Herein, in the present invention the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium. Herein, in the present invention the shelf life of the active ingredient is effectively increased to not less than 18 months. Herein, the therapeutic and nutritional effects of the formulation are varied to form multiple compositions. Herein, the present invention includes a structure of the formulation which creates an environment suitable for a stable entrapment of the active ingredient while preventing separation or degradation of the formulation.
In an embodiment, a method of thin film dissolution is for preparing the thin particle delivery. The method includes:
the one or more phospholipids are dissolved in one or more organic solvents;
the solution is transferred in a round-bottom flask;
the one or more organic solvents are evaporated under reduced pressure till a thin phospholipid film is formed in the flask;
in another container, the one or more active ingredients is combined with the one or more surfactants one, the one or more surfactants two and the one or more co-surfactants to form an oil phase;
the oil phase is transferred to the phospholipid film and the flask is sealed to prevent degradation of the formulation; and
a reduced pressure is applied to the flask till fusion of the phospholipid film and oil phase.
In an embodiment, a method of co-solvent evaporation method is for preparing the thin particle delivery. The method includes:
an oil phase is formed from the one or more active ingredients and the one or more surfactants one and the one or more surfactant two;
the one or more phospholipids, the one or more oil phase and the one or more co-surfactants were taken in separate containers;
one or more organic solvents are mixed with the phospholipid;
the one or more co-solvents are added to the phospholipid solution; and
the oil phase is gradually added to phospholipid solution and stirred continuously in a stirrer till the solvent mixture of chloroform and the one or more co-solvents are slowly evaporated and the thin particle delivery is obtained.
In an embodiment, a method of sonication assisted homogenization method is for preparing the thin particle delivery. The method includes:
the one or more active ingredients, the one or more phospholipids, the one or more surfactants one, the one or more surfactants two and the one or more co-surfactants are blended in a blender;
nitrogen is added to the mixture to the continuously blending mixture;
the temperature of the container is kept below 10? and sound waves are introduced to the particles to agitate them till a homogenous mixture is obtained;
vacuum is introduced at a low temperature.
In the embodiment, the formulation is suitable for the encapsulation of fish oil, other oily phase, or oil soluble drugs, actives or herbal extracts and combination thereof to enhance solubility, modify the release behaviour, and enhance bioavailability.
EXAMPLE: Enhanced Bioavailability by the thin particle delivery system
Two test items were selected for this study: plain fish oil (FO-P) and fish oil formulated with thin particle technology (FO-TPT). Chlorzoxazone was used as LC-MS internal standard (CAS No. 95-25-0), procured from Tokyo Chemical Industry Co., Ltd. The plain fish oil (Test Item I) had the batch number P-40617, supplied by the vendor and used as such. The chemical constituents were eicosapentaenoic acid – ethyl ester (EPA-EE) and docosahexaenoic acid – ethyl ester (DHA-EE). The FO-TPT formulation (Test Item II) had the batch number 075_1601_1. The constituents were measured as EPA-EE = 518.4 mg/g and DHA-EE = 274.6 mg/g.
An equivalent dose of EPA – 400 mg/kg and DHA ~ 200 mg/kg was administered by oral route in animals through both test items I and II. All animals received a single dose of the test sample according to the calculated amounts. Blood was collected through the retro-orbital plexus under mild anesthesia into microtubes containing a 10% solution of K2EDTA as an anticoagulant. Plasma was separated by centrifuging the blood samples at 5000 rpm for 5 minutes. The plasma samples were immediately transferred to microtubes and stored at -80°C until analysis.
Bioanalysis was performed using an in-house developed bioanalytical method for determining test compounds' concentration in rat plasma. The instrument used was a SCIEX QTRAP-6500+ LC-MS/MS System, with a Shim-pack Velox C18 (1.8µm, 2.1 x 50 mm) column. The mobile phase consisted of a 10mM ammonium acetate buffer in 0.1% formic acid in water and 0.1% formic acid in acetonitrile. The flow rate was 0.400 mL/min, the column oven temperature was set to 40°C, and the injection volume was 1.0 µL with an autosampler temperature of 10°C.
RESULTS:
Pharmacokinetic (PK) parameters in plasma were calculated using the non-compartmental analysis tool of the Phoenix WinNonlin® software (Version 8.3) using plasma as the data type (model 200-202) with extravascular as the dose type for oral administration. For graphing and statistical analysis, GraphPad PRISM version 10 was used. The area under the plasma concentration-time curve (AUC0.5-24) was calculated by the linear trapezoidal method after baseline correction with time-0 (0 hr) data. The maximum concentration (Cmax) and the time for the peak plasma concentration (Tmax) were observed values.
The AUC of DHA following oral administration of the FO-TPT formulation at a dose of 200 mg/kg was found to be 4.7 times greater than that of the FO-P. The AUC of EPA following oral administration of the Fish oil FO-TPT formulation at a dose of 400 mg/kg was found to be 13.2 times greater than that of the plain fish oil. FO-TPT has shown significantly better absorption of EPA and DHA compared to plain fish oil. ,CLAIMS:1. A formulation for a thin particle delivery of omega-3 fatty acid, the formulation of the thin particle delivery comprising of:
an at least one active ingredient having a concentration range from 30% to 85%;
an at least one phospholipid having a concentration range from 5% to 20%;
an at least a surfactant one having a concentration range from 0.5% to 30%;
an at least a surfactant two having a concentration range from 0.5% to 15%; and
an at least one co-surfactant having a concentration range from 0.5% to 5%;

characterized in that, the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium;
characterized in that, the formulation of the thin particle delivery efficiently encapsulates hydrophobic or oily liquids;
characterized in that, the shelf life of the active ingredient is effectively increased to not less than 18 months;
characterized in that, the formulation of fish oil undergoes spontaneous self-assembly in aqueous medium to form particles ranging from 50-5000 nm and zeta potential -30mV to -50 mV;

wherein, the therapeutic and nutritional effects of the formulation of the liquid-encapsulated system is varied to form multiple compositions;

wherein, the structure of the formulation creates an environment suitable for a stable entrapment of the active ingredient while preventing separation or degradation of the formulation.

2. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, wherein the active ingredient is fish oil and is selected from algal oil, Salmon, Mackerel, Sardines, Anchovies, Tuna, Herring, Krill, and Codfish.
3. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, the at least one phospholipid is lecithin.

4. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, the at least a surfactant one is selected from sorbitan monooleate, caprylic/capric triglycerides and lauroyl polyoxyl-6 glycerides, Caprylocaproyl Polyoxyl-8 glycerides/Polyoxylglycerides, Glyceryl Behenate, Glyceryl Distearate, Lauroyl Polyoxyl-32 glycerides, PEG-8 Caprylic/Capric Glycerides, PEG-32 Stearate / Polyoxyl-32 stearate, Polyethylene Glycol Palmitostearate, Polyethylene Glycol Stearate, Polyglyceryl-3 oleate, Polyoxyl 32 stearate, Polyoxyl 35 castor oil, Polyoxylglycerides, Propylene glycol monolaurate, Sorbitans, Stearoyl polyoxyl-32 glycerides, Polysorbates, Lecithin.

5. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, the at least a surfactant two is selected from sorbitan sesquioleate, polysorbate 80 and oleoyl polyoxyl-6 glycerides.

6. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, the at least a co-surfactant is selected from polyethylene glycol 200, diethylene glycol monoethyl ether and polyglyceryl-3 dioleate, Diisopropyl Adipate, Diisopropyl Dimer Dilinoleate, Ethylhexylglycerin Octyldodecanol, Fatty Alcohols, Cetyl Alcohol, Stearyl Alcohol, Glycol Esters (e.g., Glycol Stearate), Glyceryl Stearate, , Isopropyl Myristate, Isopropyl Palmitate, Isostearyl Isostearate, Medium-Chain Triglycerides (MCTs), Polyglyceryl Esters, Polyglyceryl-3 Diisostearate, Polyglyceryl Polyricinoleate, Triethyl Citrate.

7. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, a method for preparing the thin particle delivery is thin film dissolution, the method comprising:

the at least one phospholipid is dissolved in an organic solvent;
the solution is transferred in a round-bottom flask;
the organic solvent is evaporated under reduced pressure till a thin phospholipid film is formed in the flask;
in another container, the active ingredient is combined with the at least a surfactant one, the at least a surfactant two and the at least one co-surfactant to form an oil phase;
the oil phase is transferred to the phospholipid film and the flask is sealed to prevent degradation of the formulation; and
a reduced pressure is applied to the flask till fusion of the phospholipid film and oil phase.

8. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, a method for preparing the thin particle delivery is co-solvent evaporation method, the method comprising:
an oil phase is formed from the active ingredient and the at least a surfactant one and the at least a surfactant two;
the at least one phospholipid, the oil phase and the at least one co-surfactant were taken in separate containers;
an organic solvent is mixed with the phospholipid;
an at least one co-solvent is added to the phospholipid solution; and
the oil phase is gradually added to phospholipid solution and stirred continuously in a stirrer till the solvent mixture of chloroform and the at least one co-solvent is slowly evaporated, and the thin particle delivery is obtained.

9. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, a method for preparing the thin particle delivery is sonication assisted homogenization method, the method comprising:
the active ingredient, the at least one phospholipid, the at lease a surfactant one, the at least a surfactant two and the at least one co-surfactant are blended in a blender;
nitrogen is added to the mixture to the continuously blending mixture;
the temperature of the container is kept below 10? and sound waves are introduced to the particles to agitate them till a homogenous mixture is obtained;
vacuum is introduced at a low temperature.

10. The formulation for a thin particle delivery of omega-3 fatty acid as claimed in claim 1, the formulation is suitable for the encapsulation of fish oil, other oily phase, or oil soluble drugs, actives or herbal extracts and combination thereof to enhance solubility, modify the release behaviour, and enhance bioavailability.

Documents

Application Documents

# Name Date
1 202311071407-STATEMENT OF UNDERTAKING (FORM 3) [19-10-2023(online)].pdf 2023-10-19
2 202311071407-PROVISIONAL SPECIFICATION [19-10-2023(online)].pdf 2023-10-19
3 202311071407-PROOF OF RIGHT [19-10-2023(online)].pdf 2023-10-19
4 202311071407-POWER OF AUTHORITY [19-10-2023(online)].pdf 2023-10-19
5 202311071407-FORM FOR SMALL ENTITY(FORM-28) [19-10-2023(online)].pdf 2023-10-19
6 202311071407-FORM FOR SMALL ENTITY [19-10-2023(online)].pdf 2023-10-19
7 202311071407-FORM 1 [19-10-2023(online)].pdf 2023-10-19
8 202311071407-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [19-10-2023(online)].pdf 2023-10-19
9 202311071407-EVIDENCE FOR REGISTRATION UNDER SSI [19-10-2023(online)].pdf 2023-10-19
10 202311071407-DECLARATION OF INVENTORSHIP (FORM 5) [19-10-2023(online)].pdf 2023-10-19
11 202311071407-DRAWING [02-07-2024(online)].pdf 2024-07-02
12 202311071407-COMPLETE SPECIFICATION [02-07-2024(online)].pdf 2024-07-02
13 202311071407-FORM 3 [16-10-2024(online)].pdf 2024-10-16
14 202311071407-Request Letter-Correspondence [18-11-2024(online)].pdf 2024-11-18
15 202311071407-Power of Attorney [18-11-2024(online)].pdf 2024-11-18
16 202311071407-FORM28 [18-11-2024(online)].pdf 2024-11-18
17 202311071407-Form 1 (Submitted on date of filing) [18-11-2024(online)].pdf 2024-11-18
18 202311071407-Covering Letter [18-11-2024(online)].pdf 2024-11-18
19 202311071407-MSME CERTIFICATE [14-01-2025(online)].pdf 2025-01-14
20 202311071407-FORM28 [14-01-2025(online)].pdf 2025-01-14
21 202311071407-FORM-9 [14-01-2025(online)].pdf 2025-01-14
22 202311071407-FORM 18A [14-01-2025(online)].pdf 2025-01-14
23 202311071407-FER.pdf 2025-07-11
24 202311071407-FORM 3 [31-07-2025(online)].pdf 2025-07-31
25 202311071407-RELEVANT DOCUMENTS [23-09-2025(online)].pdf 2025-09-23
26 202311071407-PETITION UNDER RULE 137 [23-09-2025(online)].pdf 2025-09-23
27 202311071407-FORM-5 [23-09-2025(online)].pdf 2025-09-23
28 202311071407-OTHERS [25-09-2025(online)].pdf 2025-09-25
29 202311071407-FER_SER_REPLY [25-09-2025(online)].pdf 2025-09-25
30 202311071407-COMPLETE SPECIFICATION [25-09-2025(online)].pdf 2025-09-25
31 202311071407-NBA Approval Submission [10-10-2025(online)].pdf 2025-10-10

Search Strategy

1 202311071407_SearchStrategyNew_E_SearchHistoryE_09-07-2025.pdf