Description:FIELD OF INVENTION

The present invention relates to the field of drug delivery systems, specifically to the preparation of unilamellar liposomal zinc using a green, scalable, and cost-effective process. More particularly, it pertains to the use of maltodextrin as a capping agent in synthesizing stable liposomal zinc vesicles without the use of organic solvents.

BACKGROUND OF INVENTION

Zinc is a vital mineral that plays a crucial role in body functions such as immune system support, cell growth and division, potent antioxidant defense. It also contributes to DNA and protein synthesis. Zinc oxide contributes to the body's zinc intake, supporting various body functions.
Traditional zinc supplement has low bioavailability because of poor solubility and degradation, only a small fraction of the zinc in traditional supplements is absorbed into the bloodstream, limiting its effectiveness. Due to low absorption of traditional zinc supplemental causes Gastrointestinal Side Effects because high doses of the traditional zinc supplemental are required to compensate for poor absorption, which lead to issues like nausea, stomach upset, and constipation.
Due to low selective distribution, fast elimination, the poor solubility and damage to the adjacent health tissue (especially for cancer therapy) of traditional drug administration, drug delivery systems (DDS) which could delivery drug to target site have been less effective and unable to reduce the side effect. It is widely accepted that encapsulated Zinc Oxide (ZnO) are able to enter cells rapidly through intracellular endocytic pathways and release drugs effectively at target site. Therefore, the development of more biocompatible, less expensive and newer drug delivery systems (DDS) is required area of research.
Zinc oxide (ZnO) can be modified to become nanocomposites with excellent properties, is considered to be one of the five metal oxides that is generally recognized as safe and approved by the US Food and Drug Administration. In addition, ZnO has an outsized exciton-binding energy (about 60 mV) and on the spot wide gap (about 3.37 eV) that can be the favorable metal oxide containing a huge list of fascinating properties. In view of those characteristics and its low-cost, ZnO and/or ZnO-based nanomaterials have attracted tremendous interest in biomedical applications. Moreover, the good biodegradability, high drug loading capacity and various prepared methods of ZnO nanomaterials make them reasonable choices for drug delivery.
Liposomal is a drug delivery system. Liposomes are bilayer vesicles constructed from phospholipids and serve as promising carriers in drug delivery systems due to their biocompatibility and ability to encapsulate both hydrophilic and hydrophobic drugs. They are recognized for their capability to enhance the controlled release of active ingredients at the target site.
Encapsulated Zinc in liposomal form is a novel advancement in management of medical technology. Liposome technology is a special kind of microencapsulation technique, which has been extensively investigated and developed in the biomedical field as a drug delivery system. An important aspect of this application is the protection afforded by encapsulation, against potentially damaging conditions in the extracapsular environment.
In liposomes, drugs are enveloped with these polymeric devices, drugs get protected from degradation, leakage of API, odd diffusion and get released only in the receptor site in a controlled manner to reduce the dose. This fulfills the need of effective delivery of biomolecules.
For proper operation of biological system on cellular level, the Greasy lipid membrane serves as gate to separate the outside part of the cell from that of inside part. This membrane allows the selective transport of ions and/or organic/inorganic molecule into the cell.
A physical approach to reduce/prevent the premature metabolism by means of metabolic enzymes in the bloodstream and the steady, slow release of the drug substances is to encapsulate the active drug within a small vesicle called Liposomes. One of the major applications of liposomes zinc in the food and nutraceutical industries as their property to dissolve in water and lipid-soluble molecules at the same time.
It is reported in the literature about the usefulness of unilamellar vesicles (ULV) as an immune potentiating carrier. The literature results indicate that large ULV (240 +50 nm) are much more effective than MLV (330 + 70 nm) of the same lipid composition in potentiating the PFC (plaque-forming cell) response to the entrapped BSA antigen. (Ref: P. N. SHEK, B. Y. K. YUNG & N. Z. STANACEV, Immunology, 1983, 49, 37-44 and references cited therein).
Importance of Unilammelar liposomal zinc
• Liposomes fuse with the cell membrane.
• Encapsulated zinc is released into the cell.
• This represents a form of drug delivery or cellular uptake.
• The lymphatic system is a vast network that extends throughout the body, ensuring that nutrient absorption is not limited to a specific region.
• Liposomes drain into lymphatic vessels along with interstitial fluid.
The Prior art EP3043872 titled “Solid compositions based on minerals and orally disintegrating formulations containing the same” wherein the claimed composition was of zinc salt, sucrose esters or sucresters E473 and lecithin. In the prior art they did not disclose about unilamellar liposome and also did not disclose the encapsulation efficiency, particle size, polydispersity index and zeta potential of claimed composition. The Claimed composition not having maltodextrin as capping agent and neither their use in the synthesis of the composition. The prior art also silent on emulsification process of lecithin.
The Prior art CN117653600 tiled “Zinc liposome formulation for liver delivery and treatment of liver diseases” wherein the formulation includes phospholipid, cholesterol and zinc compound. The method disclosed in the prior art to prepare the zinc liposome where it used ethanol as solvent which is an organic solvent and also used chloroform to prepare the zinc liposome. The prior art is silent on the capping technology and use of starch and maltodextrin. The prior art also did not disclose the emulsification technique in process of preparation of zinc liposome.
The existing prior art and conventional preparation techniques rely on complex processes involving toxic organic solvents such as chloroform, methanol, or ethanol, and require high-end instrumentation like ultracentrifuges, lyophilizes or rotavapors. These methods are not scalable or environmentally sustainable.
The existing prior art also silent on the composition of liposomal zinc using starch and maltodextrin. The prior art also silent on the capped technology used in the preparation of liposomal zinc which ensure the stability and encapsulation efficiency.
The present invention has novel composition of liposomal zinc which includes zinc oxide, maltodextrin, starch and emulsified lecithin having stability and high encapsulation efficiency and nano-particle size.
The present invention having process that is based on green chemistry principles, eliminates the need for harmful organic solvents, and introduces a novel capping technology using maltodextrin to produce highly stable unilamellar liposomal zinc particles. The present invention is safe, scalable, and cost-effective production of unilamellar liposomal zinc.
Advantages over Prior Arts:
• No use of organic solvents (ethanol, methanol, chloroform, etc.).
• Use of break through capping technology for unilamellar liposomal zinc and use of maltodextrin. This introduction of capping technology is a milestone in the preparation of unilamellar liposomal zinc.
• No need for lyophilization or ultracentrifugation.
• Lower energy input compared to traditional reverse-phase evaporation or thin-film hydration.
• Excellent atom economy and negligible byproduct formation using green chemistry principle.
WHY CAPPING TECHNOLOGY IS A MILESTONE FOR THE PREPARATION OF LIPOSOMAL ZINC
The capping technology is widely used in the field of preparation of nanoparticle. In this patent, the innovators used this capping concept with maltodextrin for the first time in the preparation liposomal zinc. The maltodextrin is a large unit having multiple number of hydroxy groups. Apart from usual hydrophobic and hydrophilic interaction in liposome, the added advantage of capping agent (maltodextrin) is the formation of hydrogen bond between hydroxy groups of maltodextrin with the metal. This hydrogen bonding provides extra rigidity, protected degradation, high percentage of encapsulation efficiency, and prevents the odd diffusion which triggers the controlled release property.
The added advantage of use of capping agent (in this patent it is maltodextrin) is its function as an end capped or terminating agent to prevent the formation of Multilamellar liposomes (MLLs), also known as multilamellar vesicles (MLVs). Therefore, in this specification, the innovators have described the process for the preparation of exclusive unilamellar liposomal zinc which is a milestone in this field.
SUMMARY OF INVENTION
The invention presents a novel process for the preparation of unilamellar liposomal zinc using zinc oxide, maize starch, lecithin, and maltodextrin as a capping agent in water as the sole solvent. The process employs emulsification at a specified RPM using a Pitch Blade Turbine Impeller (PBTI), followed by spray drying. This green method and use of maltodextrin as capping agent ensures high encapsulation efficiency (>87%), PDI less than 0.4, zeta potential for stability (~ -31 mV).
Summary of Figures
Figure 1: Molecular structure of phosphatidylcholine showing various residues
Figure 2: Representative arrangement of a phospholipid bilayer
Figure 3: Composition of Lecithin using HPLC
Figure 4: Encapsulation efficiency of Liposomal Zinc
Figure 5: Particle size and Encapsulation efficiency
Figure 6: Particle size of zinc v. liposomal zinc
Figure 7: Polydispersity index of zinc. Liposomal zinc
Figure 8: Zeta potential of liposomal zinc
Figure 9: SEM of liposomal zinc
DETAILED DESCRIPTION OF INVENTION
Liposomes are emerging era for New Drug Delivery System (NDDS) consist of bilayer vesicles built by molecules such as phospholipids and one of promising carriers for drug delivery. They are nontoxic, biodegradable, biocompatible and capable of accommodating both hydrophilic drugs in inner water cavity and hydrophobic agent in bilayer.
In liposomes, drugs are enveloped with these polymeric devices, drugs get protected from degradation, leakage of API, odd diffusion and get released only in the receptor site in a controlled manner to reduce the dose. This fulfills the need of effective delivery of biomolecules.
The present invention includes the composition of liposomal zinc and their process to prepare.
1. Materials Used:
• Zinc oxide: USP grade, generally recognized as safe (GRAS).
• Maize starch: Used for structure modification and dispersion.
• Maltodextrin: Serves as the capping agent to improve encapsulation efficiency and stability.
• Lecithin: Serves as the primary phospholipid for liposome formation.
• Process water: The only solvent used in the synthesis.
Zinc oxide (ZnO):
Zinc oxide (ZnO) is generally recognized as safe and approved by the US FDA which overcomes the clinical obstacles, so it is widely used in biomedical application.
Zinc oxide easily be modified to become nanocomposites with excellent properties, is considered to be one of the five metal oxides that is generally recognized as safe (GRAS) and approved by the US Food and Drug Administration. In addition, ZnO has an outsized exciton-binding energy (about 60 mV) and on the spot wide gap (about 3.37 eV) that can be the favorable metal oxide containing a huge list of fascinating properties. In view of those characteristics and its low-cost, ZnO and/or ZnO-based nanomaterials have attracted tremendous interest in biomedical applications. Moreover, the good biodegradability, high drug loading capacity and various prepared methods of ZnO nanomaterials make them reasonable choices for drug delivery.
Maize starch:
Easily accessible and cost-efficient raw material in the present invention.
Maltodextrin:
S.N. Properties Explanation
1 Steric Stabilizer Maltodextrin forms a steric barrier around particles, preventing aggregation by physically blocking contact between particles.
2 Surface Adsorption Hydroxyl groups in maltodextrin can adsorb onto the surface of nanoparticles (e.g. zinc oxide), creating a stabilizing coating.
3 Hydrogen Bonding Its polysaccharide structure allows hydrogen bonding with functional groups of other molecules, aiding in stabilization.
4 Biocompatibility It is non-toxic, water-soluble, and biodegradable — ideal for pharmaceutical, cosmetic, and food applications.
5 Controlled Release Acts as a matrix or shell in encapsulation systems, offering slow and controlled release of active ingredients.

Role of Capping Agent – Maltodextrin:
• Prevents agglomeration of liposomal particles.
• Enhances encapsulation efficiency (EE) by electrostatic interaction with Zn²⁺.
• Provides structural rigidity to liposomes.
• Creates a synergistic effect between organic (lecithin) and inorganic (ZnO) components.
• Reduces leakage rate by stabilizing the membrane structure.
Lecithin:
Lecithin is a generic term to designate any group of fatty substances occurring in animal and plant tissues which are amphiphilic – they attract both water and fatty substances (and so are both hydrophilic and lipophilic), and are used for smoothing food textures, emulsifying, homogenizing liquid mixtures, and repelling sticking materials. Lecithin is generally recognized as safe (GRAS) by the FDA.
Lecithins are mixtures of glycerophospholipids including phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine, and phosphatidic acid.

Figure 1 : An example of a phosphatidylcholine, a type of phospholipid in lecithin. Shown in red – choline residue and phosphate group; black – glycerol residue; green – monounsaturated fatty acid residue; blue – saturated fatty acid residue.

Figure 2: Representative arrangement of phospholipid bilayer
The most favored structure for most of the phospholipid bilayer in aqueous media is a bimolecular sheet. The steric hindrance of bulky fatty acyl groups prevents it to fit into interior. The formation of bilayer plays a critical biological importance. The formation of lipid bilayer from phospholipid is spontaneous and rapid process in water, hydrophobic interaction is a major driving force behind it. Moreover, van der Waals attractive forces between the hydrocarbon tails make the close packing. At last, but not the least, electrostatic and hydrogen bonding attraction between the polar head groups and water molecule make the bilayers stabilized.
Water:
The present invention did not use organic solvent like methanol, ethanol, isopropyl alcohol or chloroform. has been used. Process water is the only media and this process affords Exclusively Unilamellar Liposomal Zinc (ULZ).
2. Process Steps:
• Process water is charged into a clean reactor 1.
• Zinc oxide is added under stirring at room temperature.
• Maltodextrin (0.2% w/w of ZnO) as capping agent is added.
• Maize starch is added lot-wise under stirring.
• Separately, process water is heated to 60°C and 6 kg and lecithin is added and Emulsification is carried out at 2830–2850 RPM for 30–40 minutes in reactor 2.
• The emulsified lecithin is added to the previous reactor 1 and stirred at 30–40 RPM for 1–2 hours.
• The final product is isolated via spray drying to Unilammelar Liposomal Zinc.
Liposomal is a drug delivery system. Encapsulated Zinc in liposomal form is a novel advancement in management of medical technology. Liposome technology is a special kind of microencapsulation technique, which has been extensively investigated and developed in the biomedical field as a drug delivery system. An important aspect of this application is the protection afforded by encapsulation, against potentially damaging conditions in the extracapsular environment.
The Preparation of liposomal Zinc is tricky and faces challenges in scale up. It generally requires fridge drying or repeated cooling at very low temperature or centrifugation with high RPM or Thin-film hydration (TFH) or Thin-film and sonication (TFS) or Freeze-thawing (FT) or Reverse-phase evaporation (REV). But the present invention does not involve any such complicated and expensive technique. These techniques are also time consuming leading to the higher occupancy of infrastructures. In the present invention an Emulsification is a critical step which can be achieved by simple reactor design.
The present invention does not involve the use of any kind of organic solvent like alcohol or ether or chloroform.
In the present invention, the final product (unilammelar liposomal zinc) is isolated by spray drying.
At last, but not the least, in this patent the innovator has used the Capped technology using capping agent namely Maltodextrin.
The use of capping agent like maltodextrin for the synthesis of liposomal zinc is a breakthrough technology. The use of capping agent stabilizes the liposome structure enhance the % of EE and reduces the leakage rate. The another key benefit of capping agent, its ability to control the rate of crystallization and to promote the uniform growth of crystal by self-adjustment of surrounding chemical environment. The capping agent maltodextrin creates a synergistic effect between organic and inorganic component. The capping agent prevents the aggregation during preparation of liposomal zinc. The use of capping agent is a breakthrough approach and make the rigid structure by means of its electrostatic interaction with Zn+2 and maltodextrin in aqueous medium.
The capped technology makes the liposomal Zinc very site specific prevents the odd diffusion.
The capped technology is a greener technology, cost effective, energy efficient which avoid the requirement of high temperature extensive grinding and widely used the nanotechnology.
Critical process parameters:
• Emulsification speed: 2830-2850 RPM.
• Stirring time: about 30 to 40 min during emulsion formation.
• Reactor impeller design: Preferably Pitch Blade Turbine Impeller (PBTI) for large-scale production.
The present invention is a novel process to synthesis of the Exclusive Unilamellar Liposomal Zinc and the step of emulsification is the critical process parameter. The RPM has to be 2000 to 4000 more specifically 2500 to 3000 and precisely 2830 to 2850 for the period of about 30 to 40 min.
A limited colloidal stability is a potential problem of all emulsions. A prerequisite of good emulsion stability is that small droplets and a narrow droplet size distribution are obtained in the emulsification process. If these requirements are attained, the stability will depend on the ability of the emulsifier to prevent coalescence and flocculation of the droplets. The higher the stirring speed and the longer the stirring time, the density and viscosity values will decrease. The stability of the emulsion is increasing, where the higher the emulsifier concentration of lecithin, the greater the stability obtained. Similarly, density and viscosity increase as solid concentrations increase. The optimum results obtained in this study for the homogenization process of emulsions was at a speed of 2830-2850 RPM and stirring time of 30 to 40 min.
For the preparation of Liposomal Zinc, the below specific design needs to be followed i.e., Pitch Blade Turbine Impeller (PBTI) or Flat Blade Impeller (FBI) or Vertical Impeller (VI) or Spiral Impeller (SI) for up to 1000 kg, preferably Pitch Blade Turbine Impeller (PBTI) and Impeller for up to 50 to 100 kg of production is must.
The present invention followed the green chemistry in the process of preparation of liposomal zinc especially atom economy which signify no by-product in the present process and final product which is liposomal zinc contain all the ingredients used in the process like zinc oxide, starch, maltodextrin, lecithin and water. The present invention also complies other principles of green chemistry; other than atom economy, through no use of organic solvent and no hazardous chemical as the by product after the synthetic process. The present invention complies all 12 principles of green chemistry.
The Twelve (12) principles of Green Chemistry (Anastas & Warner)
1 Prevention- No waste, do not need have to clean it up or purification.
2 Atom economy- The final product contains all the ingredients used in the process.
3 Less hazardous chemical synthesis- The process designed to make substances that are less toxic or no toxic to people or the environment.
4 Designing safer chemicals- Chemical products (liposomal zinc) designed to do their job with minimum harm/no harm to people or the environment.
5 Safer Solvents- Only water used as solvent do not use any organic solvent.
6 Design for energy efficiency- The emulsification in the present process is energy efficient. The processes carried out at ambient temperatures.
7 Use of renewable feed stocks- The raw material used in the process is renewable like maize starch, lecithin, maltodextrin, water.
8 Reduce derivatives- No more reagent required in the process. No byproduct.
9 Catalysis- Maltodextrin act as capping agent which enhance the encapsulation efficiency and stability.
10 Design for degradation- No by-product in the process.
11 Real-time analysis for pollution prevention- No harmful products are detected in the process.
12 Inherently safer chemistry for accident prevention-Substances used in a chemical process chosen to minimise the risk of chemical accidents, including explosions and fire.

3. Examples:
Preparation of Liposomal Zinc:
i. Charged process water (400 Lit) in a clean reactor 1 with suitable stirring arrangement.
ii. Added 56 kg of Zinc oxide into the above reactor under stirring at RT. Charged (0.2% maltodextrin wrt zinc oxide).
iii. Added maize starch (136 Kg) in lot wise to the above mixture at RT under stirring.
iv. In a separate reactor 2, added 30 Lit of process water and heated up to about 60 deg. C. In this warm water, sunflower lecithin (6 Kg) was added in a lot wise manner. The resulting solution was emulsified at about 2830 to 2850 RPM for about 30 to 40 min.
v. The emulsified solution obtained from step (iv) was added in to the solution of step (iii) and stirring continued at RPM about 30 to 40 for about 1 to 2 h. As zinc in +2 oxidation state has less coagulation properties hence above RPM is sufficient to make the liposomal zinc API.
vi. After in process test, the final Liposomal Zinc was isolated through spray drying which afforded 175 Kg of final API.
4. Characterization
Composition of Lecithin using HPLC:


Figure 3: Composition of Lecithin using HPLC

Encapsulation Efficiency (% of EE):

Figure 4: Encapsulation efficiency of Liposomal zinc
The results indicate successful production of Liposomal zinc that meets quality standards. Encapsulation efficiency reached 94.51%, exceeding the minimum acceptable level. An elemental assay confirmed NLT 20.0% of zinc in the final product, which falls within the acceptable range. The high encapsulation efficiency suggests most zinc oxide particles are trapped within the liposomes.

Particle Size and % of Encapsulation Efficiency (EE):

Figure 5: Particle size and Encapsulation efficiency of Liposomal zinc
Liposomes smaller than or about 200 nm usually consist of one bilayer (reservoir type), and are known as unilamellar liposomes, as shown in below figure of particle size. Larger liposomes often are comprised of several unilamellar vesicles that form one inside the other in diminishing size, creating a multilamellar structure of concentric phospholipid spheres separated by layers of water. Multilamellar liposomes (matrix type) have been described as looking like an onion.
Particle Size of Liposomal Zinc:

Figure 6: Particle size of Zinc Vs. Liposomal Zinc
In this patent, the inventors of WBCIL have developed a unique process to develop the industrial scale preparative method to develop exclusively unilamellar liposomal zinc oxide which is novel in this research field.
(Ref: A.G. Gaonkar, N. Vasisht, A.R. Khare, R. Sobel (Eds): Microencapsulation in the Food Industry. Chapter 13. DOI: http://dx.doi.org/10.1016/B978-0-12-404568-2.00013-3.© 2014 Elsevier Inc).
Table 1: Particle size with encapsulation efficiency of Liposomal zinc
This study investigated to establish the relationship between particle size and encapsulation efficiency (EE) of zinc liposome. EE, expressed as a percentage, reflects the amount of zinc oxide successfully encapsulated. Particle size was categorized by mesh size, with lower numbers indicating larger particles. A consistent trend in EE was observed with decreasing particle size. This indicates the robustness of the manufacturing process along with very low leakage rate.
Polydispersity Index (PDI):

Figure 7: Polydispersity index of Zinc vs. Liposomal zinc
Polydispersity Index (PDI), a measure of size distribution, was also assessed. Ideally, PDI values closer to 1 indicate a more uniform population. The zinc oxide liposome exhibited a PDI of 0.3344 suggesting moderate poly dispersity.
Zeta Potential:

Figure 8: Zeta potential of Liposomal zinc
The electrical charge (zeta potential) on the surface of liposomal zinc particles were measured to assess their stability in suspension. Established guidelines suggest higher absolute zeta potential (positive or negative) indicates greater stability, with values exceeding +/- 30 mV considered ideal. The liposomal Zinc manufactured by WBCIL exceeds the recommended threshold. This zeta potential of -31.08 mV indicates sufficient surface charge for stability in suspension. This improved stability is essential for maintaining product quality during storage and potentially improving its effectiveness within the body.
Zeta Potential Values and Stability:
Zeta Potential (mV) Colloidal Stability
> +30 or < -30 Highly stable (good repulsion).
Between +10 and -10 Unstable (prone to aggregation).
Between +10 and +30 / -10 and -30 Moderately stable.
Table 1: Colloidal stability with zeta potential
Scanning Electron Microscopy (SEM):

Figure 9: Scanning Electron Microscopy (SEM) of Liposomal zinc
Cell membranes are built from fatty molecules called phospholipids, one type being lecithin. Liquid state scanning electron microscopy (SEM) analysis as per above figure revealed coated particles appeared with uniform appearance. Due to the proper lecithin coating, the particle shows a near spherical or more specifically near cubic shape. This suggests successful encapsulation of the metal within the lecithin coated liposomes, potentially influencing stability as well.
FTIR Spectra of Zinc Oxide, Empty Liposome & Liposomal Zinc
The infrared (IR) spectrum of Liposomal Zinc Oxide (ZnO) will show characteristic ZnO bands, along with those associated with the liposomal components. The ZnO bands, particularly those around 400-600 cm-1, are attributed to Zn-O stretching and deformation vibrations. The liposome structure will contribute bands related to the phospholipid components, such as C-H stretching (around 2850-3000 cm-1) and C=O stretching (around 1730 cm-1).
Elaboration:
• ZnO Characteristic Bands:
In the infrared spectrum of ZnO nanoparticles, the prominent bands are typically found in the region of 400-600 cm-1. These bands are primarily associated with the stretching and deformation vibrations of the Zn-O bonds within the ZnO structure. The exact position and intensity of these bands can vary slightly depending on the size, shape, and crystallinity of the ZnO nanoparticles. For example, some studies report a band at 570 cm-1 for ZnO nanoparticles.
• Liposomal Component Bands:
Liposomes are primarily composed of phospholipids, which will contribute specific bands to the overall IR spectrum. These include:
• C-H stretching: Bands in the range of 2850-3000 cm-1 are associated with the stretching vibrations of C-H bonds in the fatty acid chains of the phospholipids.
• C=O stretching: The carbonyl group (C=O) of the ester linkages in the phospholipids will exhibit a stretching band around 1730 cm-1.
• Other bands: Depending on the specific liposome formulation, other bands may be observed, such as those associated with phosphate groups .
• Summary of Characterization:
• Encapsulation Efficiency (EE): 94.51%
• Zinc Content: 20.11% w/w (ODB)
• PDI: 0.3344
• Zeta Potential: -31.08 mV
• SEM Analysis: Uniform, near-cubic liposomal structures
5. Chemical Specifications:
Chemical Analysis (as per in house specification):
Test Parameters Specification Results
Description White to off white powder White powder
Apparent Density NLT 0.40 g/mL 0.76 g/mL
Lead NMT 3.0 ppm < 3.0 ppm
Arsenic NMT 1.0 ppm < 1.0 ppm
Mercury NMT 1.0 ppm < 1.0 ppm
Cadmium NMT 1.0 ppm < 1.0 ppm
Zinc Content (ODB) NLT 20.0% w/w 20.11% w/w
Table 3: Analysis report

, Claims:We claim

1. A composition of Exclusive Unilamellar Liposomal Zinc comprising of
- zinc oxide (about 26 to 28%);
- maltodextrin (about 0.05%);
- maize starch (about 64 to 68%);
- lecithin (about 3 to 5%); and
- process water;
wherein the composition having encapsulation efficiency more than 87%, polydisperity index less than 0.4, zeta potential of -31.08 mV, and the maltodextrin act as capping agent.
2. The composition claimed in claim 1, wherein the percentage of input lipid component in liposome having 93% out of which 82.05% Phosphatidylcholine (PC) and 10.82% phosphatidylenthanolamine (PE) and rest is non-lipid component of 7 % which is non-phospholipid.
3. The composition claimed in claim 1, wherein the elemental zinc assay not less than 20%.
4. The composition claimed in claim 1, wherein the Lead not more than 3.0 ppm, Arsenic not more than 1.0 ppm, Mercury not more than 1.0 ppm and Cadmium not more than 1.0 ppm.
5. A process for preparation of the Exclusive Unilamellar Liposomal Zinc claimed in claim 1 by means of capped technology and green chemistry principle comprising of:
a. adding or charged process water in a reactor 1;
b. adding zinc oxide in the reactor 1;
c. stirring at room temperature and adding charged maltodextrin in the amount of 0.2% with respect to zinc oxide;
d. adding maize starch at room temperature under stirring;
e. adding an emulsified solution of lecithin prepared in a separate reactor 2 by a method consisting of:
-adding process water;
-heating up to about 60 0C;
-adding lecithin;
-emulsification at 2830 to 2850 rpm for about 30 to 40 minutes;
f. the above mass from reactor 2 was added in reactor 1 under stirring at 30-40 rpm for 1 to 2 hrs;
g. isolating and spray drying of final product.
6. The process claimed in claim 5, wherein the maltodextrin as capping agent stabilize the liposome structure, enhance the encapsulation efficiency and reduce the leakage rate.
7. The process claimed in claim 5, wherein the green chemistry principle includes atom economy with zero by-product and waste and no use of organic solvent.
8. The process claimed in claim 5, wherein the separate reactor 2 prepared the emulsified solution of lecithin ensuring colloidal stability through emulsification of stirring speed 2830 to 2850 rpm and less stirring time30 to 40 minutes maintaining the density and viscosity of the emulsified lecithin.
9. The process claimed in claim 5, wherein the whole reaction happened at room temperature in the reactor 1.