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Edible Pouch

Abstract: The present invention relates to water soluble or dispersible, rapidly dissolving or dispersing edible films and pouches prepared employing such films. The edible pouches are preferably completely soluble in water or significantly soluble in water. They serve as primary packaging materials for food, nutraceuticals, pharmaceuticals etc. Because of complete or significant solubility, they release contents faster in the aqueous medium. They additionally provide stability to the contents and advantageously unit dosing.

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Patent Information

Application #
Filing Date
07 July 2022
Publication Number
02/2024
Publication Type
INA
Invention Field
POLYMER TECHNOLOGY
Status
Email
Parent Application

Applicants

INTELLISCEND NDDR PRIVATE LIMITED
Plot #A111, Road #18, Wagle Industrial Estate, Thane (W) - 400604, Maharashtra, India.

Inventors

1. ROY, Shashank
3/203, Garden Enclave, Pokhran Road No 2 Thane - 400607, Maharashtra, India
2. ROY, Sunilendu. B
3/203, Garden Enclave, Pokhran Road No 2 Thane - 400607, Maharashtra, India
3. ROY, Soubin
B704, Shree Prastha, G B road Thane - 400615, Maharashtra, India
4. NAVALE, Santosh
At-kanchangaon, P.O.: Khairagao, Kanchangaon -422402, Maharashtra, India
5. SETHI, Prafulla Kumar
61, Goudsahi, Dihasahi Jagatsinghpur, Odisha, India -754138

Specification

F O R M 2
THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
1. TITLE OF THE INVENTION: “Edible Pouch”

2. APPLICANT:
a) NAME
b) NATIONALITY
c) ADDRESS : INTELLISCEND NDDR PRIVATE LIMITED : Indian Company
: Plot #A111, Road #18, Wagle Industrial Estate, Thane (W), Maharashtra, India 400604.
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which
it is to be performed.

Edible Pouch
Field of The Invention
The present invention relates to water soluble or dispersible, rapidly dissolving or dispersing edible films and edible pouches prepared from such films. The films dissolve or disperse forming a fine dispersion in around 60 seconds in water or aqueous media. Preferably, the pouches along with the contents dissolve completely or form fine dispersion in less than 2-3 minutes. The edible pouches are preferably completely soluble in water or significantly soluble in water. They serve as primary packaging materials for food, nutraceuticals, pharmaceuticals etc. Because of complete or significant solubility, they release contents faster in the aqueous medium. They additionally provide stability to the contents and advantageously unit dosing.
Objects of the Invention
A first object of the invention is to prepare an edible, water soluble transparent film
which can be employed to produce edible pouch that can pack any suitable food,
nutraceutical or pharmaceutical product.
A second object of the present invention is to produce an edible pouch which is
preferably transparent and water soluble or dispersible which can pack suitable
food, nutraceutical or pharmaceutical product which can be added to water to
prepare ready to drink solution of the product enclosed.
Yet another object is to provide stability imparting primary edible packaging
material for suitable food, nutraceutical or pharmaceutical product
One more object of the present invention is to provide edible, water soluble pouch which can pack suitable food, nutraceutical or pharmaceutical product such that it can dispense unit dose with ease and the said product can be in a simple form such as powder, granules, pellets etc. without requiring to compress or encapsulate the same. This takes away need to employ heavy tabletting or encapsulating machines and avoids occupying a lot of space due to such processing machines.

One more object is to provide a simple process to prepare edible, water soluble or dispersible pouches.
Yet another object is to provide suitable dosage form packed in suitable edible water soluble pouches that can dissolve in water or form very fine dispersion providing ease to paediatric and geriatric patients for consumption.
Background Of The Invention
Hydroxypropyl methyl cellulose (HPMC) produces a strong film and is a preferred film former. Its linear structure and nonionic nature are ideal for micelle formation or for film structure development, except that the larger hydroxypropyl groups keep polymer chains farther apart due to steric hindrance. When a 3% solution of HPMC is cast at a thickness of 20 mils (0.02 in.), a clear film is produced. This film is strong enough to peel off the casting surface in one with a tensile strength of ~ 1,100 g and a puncture strength of ~ 590 g. (Kerry C Huber, Milda Embuscado, 2009). However, cellulose derivative films are poor water vapor barriers because of the inherent hydrophilic nature of polysaccharides and they possess poor mechanical properties.
Poly vinyl alcohol (PVA) is a synthetic water-soluble polymer with good film forming property, which offers good tensile strength (TS), flexibility and barrier properties to oxygen and aroma. (Schellekens, R., & Bastiansen, C. J. , 1991). Miscibility studies conducted on blends of HPMC/PVA in water concluded that in order to be soluble, blend must contain at least 60 % HPMC (Chandralekha Fadnis, 2009).
WO 2013/015545 A1 provides an edible film containing drugs such as paracetamol. Edible film is consisting of hyroxypropyl methylcellulose and polyvinyl alcohol-polyethylene glycol graft copolymer, PVA-PEG copolymer. The drug is present in the film structure. The same patent application has shown how the film produced therein is better than a film having a film former and a plasticizer. However, such films are not employed in pouch making.
Summary Of The Invention

The present invention relates to water soluble or dispersible, rapidly dissolving or dispersing edible films and edible pouches prepared from such films. The edible pouches are preferably completely soluble in water or significantly soluble in water. The films dissolve or disperse forming a fine dispersion in around 60 seconds in water or aqueous media. Preferably, the pouches along with the contents dissolve completely or form fine dispersion in less than 2-3 minutes. They serve as primary packaging materials for food, nutraceuticals, pharmaceuticals etc. Because of complete or significant solubility, they release contents faster in the medium. They provide additionally stability to the contents and advantageously unit dosing. The edible pouches of the present invention provide ready to use solutions or fine dispersions when added to water or aqueous media and contents thereof can be easily consumed.
The edible pouches of the present invention are made up of water soluble or dispersible polymeric films employing water soluble and compatible polymers, plasticizer and other excipients to facilitate an easy to process and formation of rugged and stable pouches.
The present invention relates to water soluble or dispersible, edible, rapidly dissolving or dispersing edible pouches. Preferably, The present invention relates to water soluble, edible, rapidly dissolving oral primary packaging materials namely edible pouches which can provide for ready to use aqueous solutions or dispersions of the items wherein the edible film forming the pouch has an optimal composition of water soluble and compatible polymers, plasticizer and other excipients to facilitate an easy to process, rugged and stable pouch , offering the advantage of enclosing unit/fixed amount, an ease of delivery of wide array of therapeutic, nutraceutical and food items.
More particularly, such food, nutraceutical or pharmaceutical product can be in a simple form such as powder, granules, pellets etc. without requiring to compress or encapsulate the same. This takes away need to employ heavy tabletting or encapsulating machines and avoids occupying a lot of space due to such processing machines and avoids occupying a lot of space due to such processing machines.

The invention specifically covers edible film-based pouch formed from polymers namely Hydroxypropyl methylcellulose (HPMC), PVA and plasticizer PEG 400. The invention specifically covers edible film-based pouch formed from polymers namely Hydroxypropyl methylcellulose (HPMC), PVA and plasticizer PEG 400. Single polymer amount is preferably from 5 % – 75 %, more preferably from 7 % – 60 % and most preferably from 10 % – 50 % and total polymer amount is preferably from 40 % – 90 %, more preferably from 50 % – 85 % and most preferably from 60 % to 80 %. Another essential ingredient is a plasticizer. Preferably plasticizers include plasticizers from a group consisting of polyhydric alcohols, acetate esters, phthalate esters, glycerides etc. More preferably, polyhydric alcohols such as polyethylene glycol, glycerol, propylene glycols are employed. Most preferably, polyethylene glycol is employed as a plasticizer. The amount of plasticizer preferably varies from 5 % – 50 %, more preferably from 10 % – 45 % and most preferably from 12 % – 45 %.
Brief Description Of The Drawings
Figure 1: Solution containing Hydroxy propyl methyl cellulose, polyvinyl alcohol
and polyethylene glycol.
Figure 2: Casting of liquid solution shown in figure 1 on glass surface.
Figure 3: Film formed on glass surface after drying.
Figure 4A: Film formed is added to water and is in a partially solubilized state.
Figure 4B: Film added to water in figure 4A is completely solubilized in water
Figure 5: Edible water soluble transparent film cut to desired length.
Figure 6: Edible pouch filled with mannitol and sealed.
Figure 7A: Edible pouch filled with mannitol is added to a container containing
water.
Figure 7B: Edible pouch filled with mannitol which is added to a container
containing water as shown in figure 7A has partially dissolved exposing contents
to the water wherein contents are also partially dissolved.

Figure 7C: Edible pouch filled with mannitol which is added to a container
containing water as shown in figure 7A has almost completely dissolved exposing
contents to the water wherein contents are also partially dissolved.
Figure 7D: Edible pouch filled with mannitol which is added to a container
containing water as shown in figure 7A has completely dissolved and the contents
are also completely dissolved when stirred.
Figure 7E: Edible pouch filled with mannitol which is added to a container
containing water as shown in figure 7A has completely dissolved and the contents
are also completely dissolved.

Detailed Description Of The Present Invention
Water-soluble films are well known in the art. Water-soluble films have many applications, including non-edible forms, such as packaging materials, and edible forms, wherein the film itself is or makes up an edible article.
Edible films are known for uses such as delivery of therapeutic agents, nutraceuticals and food items. The edible polymers can be comprised in any of the four categories: (1) hydrocolloids, (2) polypeptides, (3) lipids, (4) synthetic and composite edible polymers. (Subhas C. Shit, Pathik M. Shah, 2014).
An advantage of this type of delivery from packaging perspective is ease in handling and intake of the consumer as in a traditional packaged state, the package must be torn or otherwise opened to remove the contents prior to consuming. This is not only a hassle, but also has the disadvantage that the contents can tend to be spilled at the time of opening the packages, especially when they are in powder or liquid form. One solution is to package such contents with an edible film. If the packaging material is soluble in water, the package can be dissolved simply by pouring water over it or immersing it in the water, thus making it unnecessary to tear the package. Accordingly, it is highly desirable to package food contents with such a film.
Another advantage is the stability wherein the item to be enclosed is easily subject to degradation or unfavourable interaction. Many formulations which cannot be marketed as aqueous dispersions or solutions due to shelf-life issues can with this type of individualized and segregated packaging can be administered to the consumer or patient at the time of intake in a solubilized or dispersed form thus avoiding shelf-life issues, greater potency and safety due to minimal degradation.
The efficiency of preservation can be improved by using primary edible packaging together with nonedible packaging as secondary packaging to add additional protection from the atmosphere and prevent contamination from microorganisms or foreign particles. The utilization of edible packaging can reduce the complexity of overall packaging requirements by allowing conversion from multilayer or

multilevel packaging to a single-component package, resulting in source reduction and improved recyclability of the simplified packaging system without compromising protective functions.
Edible packaging materials can also be used for nonedible packaging as an O2- or grease barrier layer to improve protective functions and biodegradability of multilayer packaging. The unique advantages and versatility of edible packaging materials are envisioned to create green, innovative packaging for reducing waste and/or for improving product stability, quality, safety, variety, and convenience for consumers. From perspective of environment these edible, biodegradable pouches or packaging materials are extremely suitable.
Also, the film opaqueness/transparency is another area of importance. It is in this background that the present invention covers an edible film-based pouch for enclosing a wide array of orally consumable products inclusive of food, medicines and nutraceuticals wherein the composition of the film and the process of making the pouch ensures a rugged, transparent, primary package of the desired item meant to be dispersed or solubilized at the time of consumption giving a distinct and unique advantage over existing prior art and products.
The present invention relates to water soluble or dispersible, edible, rapidly dissolving or dispersing edible pouches made from water soluble or dispersible films. The films dissolve or disperse forming a fine dispersion in around 60 seconds in water or aqueous media. Preferably, the pouches along with the contents dissolve completely or form fine dispersion in less than 2-3 minutes. The edible pouches are preferably completely soluble in water or significantly soluble in water. They serve as primary packaging materials for food, nutraceuticals, pharmaceuticals etc. Because of complete or significant solubility of the said edible pouch in water or aqueous media, they dissolve and release contents faster in the medium.
The edible pouches provide additionally stability to the contents and advantageously provide unit dosing.

The edible pouches of the present invention provide ready to use solutions or fine dispersions when added to water or aqueous media and contents thereof are released faster and can be easily consumed.
The edible pouches of the present invention are made up of water soluble or dispersible polymeric films employing water soluble and compatible polymers, plasticizer and other excipients to facilitate an easy to process and formation of rugged and stable pouches. Other excipients include surfactants, emulsifiers, antioxidants, preservatives and texture modifiers etc.
It is necessary that the ingredients used for the manufacture of the film that make edible pouch have no influence on enclosed product contained in the pouch, both during packing and also at the time of dissolution in water, namely on its colour, its odour and taste and its texture.
Water soluble polymers include, natural as well as synthetic polymers such as one or more of gums including xanthan gum and guar gum, pectin, chitosan, dextran, carrageenan, cellulose ethers, Hyaluronic acid, albumin, starch, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylic acid, polyacrylamide, N-(2-Hydroxypropyl) methacrylamide (HPMA), Divinyl Ether-Maleic Anhydride (DIVEMA), Polyoxazoline, Polyphosphates, Polyphosphazenes etc.
Amongst cellulose ethers, most preferred ones are Hydroxypropylmethyl cellulose (HPMC), Hydroxypropyl cellulose (HPC), Hydroxyethyl cellulose (HEC) and Sodium carboxy methyl cellulose (Na-CMC).
Preferably, the edible pouch of the present invention is made from a film formed from two polymers. In an embodiment, polymer includes one or more cellulose ethers and polyvinyl pyrrolidone. In another embodiment, polymers include one or more cellulose ethers and one or more gums or pectin or carrageenan. In yet another embodiment, polymers include one or more cellulose ethers and polyvinyl alcohol.
The present invention relates to water soluble or dispersible, edible, rapidly dissolving or dispersing edible pouches made up of film formed from one or more,

preferably two polymers In a preferred embodiment, the polymers employed
include hydroxy propyl methyl cellulose and polyvinyl alcohol.
Hydroxypropyl Methyl Cellulose (HPMC) is a water-soluble cellulose ether
hydrocolloid with good film forming properties. It is GRAS listed and safe for oral
consumption.
The invention specifically covers edible film-based pouch formed from polymers namely Hydroxypropyl methylcellulose (HPMC), PVA and plasticizer PEG 400. Single polymer amount is preferably from 5 % – 75 %, more preferably from 7 % – 60 % and most preferably from 10 % – 50 % and total polymer amount is preferably from 40 % – 90 % or 45 – 90 %, more preferably from 50 % – 85 % and most preferably from 60 % to 80 %.
Films produced from polymers have the rigid nature and lack of elasticity. To overcome rigid structure and for imparting elasticity, it is necessary to add plasticizer. Plasticizers weaken polymer chain cohesion forces, increasing chain mobility and improving polymeric matrix flexibility contributing to film formulation process in general. The edible pouch of the present invention contains at least one plasticizer apart from polymers. Thus, another essential ingredient of water soluble or dispersible, edible, rapidly dissolving or dispersing edible pouches is a plasticizer. Preferably plasticizers include plasticizers from a group consisting of polyhydric alcohols, acetate esters, phthalate esters, glycerides etc. The plasticizer is thus selected from the group consisting of polyethylene glycol, glycerol, propylene glycols, glyceryl triacetate, triethyl citrate,
More preferably, polyhydric alcohols such as polyethylene glycol, glycerol, propylene glycols are employed. Most preferably, polyethylene glycol is employed as a plasticizer. Polyethylene Glycol (PEG) is a water soluble plasticizer and a biocompatible, hydrophilic, and anti-fouling compound. The addition of PEG has functions to improve compatibility, mechanical properties (tensile and elongation strength), and thermal stability. Polyethylene glycol can make edible film strong and elastic. Besides, the addition of PEG can make the films solubilize quickly in water because of its hydrophilic nature.

The amount of plasticizer preferably varies from 5 % – 50 %, more preferably from 10 % – 45 % and most preferably from 12 % – 45 %.
Few preferred embodiments of edible pouch contain Hydroxypropyl methylcellulose (HPMC), PVA and plasticizer PEG 400 wherein Hydroxypropyl methylcellulose (HPMC) is from 10 % - 40 %, polyvinyl alcohol is from 30 % – 60 % and polyethylene glycol is from 15 – 45 %. Some of these embodiments are provided under examples 1 – 5.
Preferably, The present invention relates to water soluble, edible, rapidly dissolving oral primary packaging materials namely edible pouches which can provide for ready to use aqueous solutions or dispersions of the items wherein the edible film forming the pouch has an optimal composition of water soluble and compatible polymers, plasticizer and other excipients to facilitate an easy to process, rugged and stable pouch, offering the advantage of enclosing unit/fixed amount, an ease of delivery of wide array of therapeutic, nutraceutical and food items.
Preferably both the pouch and its contents are soluble in water or aqueous media. Alternatively, pouch is soluble and contents are water dispersible. Yet alternatively, pouch disintegrates readily forming a fine dispersion wherein significant portion of the pouch has already dissolved.
The contents of the pouch readily dissolve or disperse in water or aqueous media such as milk, tea, coffee, juices etc. More particularly, contents such as food, nutraceutical or pharmaceutical product can be in a simple form in the edible pouch such as powder, granules, pellets etc. without requiring to compress or encapsulate the same. This takes away need to employ heavy tabletting or encapsulating machineries.
In yet another aspect, the invention provides a process to prepare edible pouch comprising first preparing an edible film and converting edible film into a ready to use pouch. Any suitable Bag filling and sealing machine can be employed having an inline or rotary layout. The machine may be modified according to the contents to be filled and nature of film.

The solvent chosen is either water or preferably hydroalcoholic containing from 1:1 to 1:0.05 water and alcohol. Preferred alcohol is ethanol or isopropyl alcohol. Most preferably, alcohol is ethanol. Water-ethanol mixture help in producing smooth films. In an embodiment, solvent is 1 part of water and 0.5 part of alcohol. In another embodiment, solvent is 1 part of water and 0.1 part of alcohol. In yet another embodiment, solvent is 1 part of water and 0.2 parts of alcohol.
The process of preparing edible pouch comprises,
A) Preparing film
i) dissolving a first and a second polymer in a hydroalcoholic solvent by
stirring to prepare a first solution;
ii) Adding plasticizer to the first solution in required amounts and stirring
to prepare a second solution.
iii) Casting second solution on a non-adhesive surface, preferably a glass
surface.
iv) Drying the casted preparation at 40-60°C in an oven for 12 – 36 hrs to
dry casted preparation completely and peeling film;
v) Cutting film in desired dimensions as per the weight / volume of the
contents to be filled;
B) Preparing edible pouch filled with the content
vi) Preparing content such as food, nutraceutical, pharmaceutical
preparation;
vii) Sealing two cut films, preferably of same size cut in step A, from the
three sides using a heal sealing machine to form an open pouch;
viii) Holding the open pouch in a gripper and filling the contents in the pouch
and sealing the pouch.
Alternatively, inline bag filler machines can be employed which are normally used for sachet filling after modifying them to fill pouch of the present invention.
Alternatively, step B comprises preparing film as described above, preparing content selected from food, nutraceutical or pharmaceutical preparation, arranging two cut films of about same size and sealing together from at least one side, filling

contents selected from food, nutraceutical or pharmaceutical preparation and sealing pouch from remaining sides.
Edible film pouches carrying premeasured amounts of ingredients can provide the convenience of placing pouch with ingredients into the food formulation.
Edible film pouches have a great potential in the delivery of Therapeutic substances particularly which are given as orally disintegrating preparations, paediatric medicines, nutraceuticals and likes.
Edible film pouches can carry premeasured amounts of ingredients and thus provide the convenience of placing pouch with ingredients into the food formulation. This is of use in intake of unpalatable products that are unstable /prone to decomposition (alone or when mixed with taste masking excipients (food related or otherwise).
The nutraceuticals thus enclosed in the edible pouch of the present invention when added to water / liquid (aqueous media such as water/fruit juice/milk /mil products-buttermilk etc.) will be exposed to other potentially stability threatening excipients only at the time of intake thus facilitating the intake of sensitive and /or unpalatable ingredient in exact measure needed .
Some of the food, nutraceutical or pharmaceutical products / items that can be filled in the edible pouches of the present invention include following without restrictions or without being limited only by the following products / items.
Sodium Bicarbonate which has multiple uses in conditions like poor digestion or hyponatremia mainly in elderly patients. Edible pouch with measured active along with edible formulations (taste masking agents, taste enhancers, food, condiment, etc) to be dispersed in water is an attractive option for those in need.
Vitamin E (fat soluble), Oils –(omega, fish oils ) adsorbed onto solid carriers (many times unpalatable), Water soluble vitamins, Vitamin A, Vitamin B-Complex, Vitamin B6, Vitamin B12, Vitamin D3, Fish Oil, Omega3/6/9, Vit E+ Wheat Germ Oil, Bovine colostrum, Calcium Carbonate+ vitamin D3, Ginseng+ Multivitamin+ Minerals, Multivitamin +Minerals +omega 3 Fish Oil, Cod Liver Oil, Flaxseed Oil,

Evening Primrose Oil, Wheat Germ Oil, Coenzyme Q10, Green Tea Extract, Ferrous Fumarate, ferrous and ferric salts, Thiamine Hydrochloride, Cyanocobalamin, Bovine Colostrum Powder, wherein the oils can be adsorbed onto solid substrate.
Aripiprazole, fentanyl, amphetamine, loratadine, fexofenadine, donepezil,
diphenhydramine, paracetamol, escitalopram, desloratadine, loratadine,
desmopressin, zolpidem, etizolam, clozapine, N-acetylcysteine, acetaminophen, baclofen, clonazepam, clonazepam, lamotrigine, lamotrigine, rizatriptan, meloxicam, alprazolam, desmopressin, hyoscyamine, ibuprofen, prednisolone, carbidopa/levodopa, famotidine, lansoprazole, cisapride, metoclopramide, mirtazapine, risperidone, risperidone, risperidone, tramadol, asenapine, vardenafil, testosterone, Buprenorphine/Naloxone, phentermine, tramadol, diphenhydramine, domperidone, selegiline, ondansetron, zolmitriptan, olanzapine, cetirizine (including levocetirizine).
Amongst therapeutic Ingredients meant for Paediatric category examples (but not
restricted to) which can be provided in edible pouch include Amoxicillin,
Azithromycin, Albuterol, Amoxicillin/Clavunate, Cefdinir, Cephalixin,
Fluticasone, Prednsolone Sodium Sulphate, Ibuprofen, Montelukast Sodium, Trimethoprim/Sulfamethoxazole, codeine phosphate/acetaminophen) is a narcotic pain reliever with acetaminophen, Methylphenidate, dextromethorphan and phenylephrine and chlorpheniramine, Mometasone, Prednisone, Sodium Fluoride, Multivitamins With Fluoride, Amphetamine/Dextroamphetamine, Budesonide, Ciprofloxacin and Dexamethasone, Promethazine, Lisdexamfetamine
Amongst food (but not restricted to) which can be provided in edible pouch include Flavours (solid /adsorbed onto dispersible solid substrate) to be added to Beverages -like tea /coffee, Seasonings -Customisation of the type of seasoning, Sweeteners, juices -wherein the juice is adsorbed to a solid substrate, Caffeine /tea-based substrates, Cocoa based extracts, Condiments and cola based extracts etc.

Following examples illustrate the invention without restricting its scope.
Examples 1-5

Sr. No.
1
2
3 4
5 Ingredients Example Example 1 2 Example 3 Example 4 Example 5


Unit composition Quantity (Mg)

Polyvinyl Alcohol 500.00 300.00 400.00 500.00 300.00

HPMC 15 CPS 500.00 500.00 100.00 100.00 100.00

PEG 400 300.00 250.00 300.00 300.00 300.00

Purified Water ~10000 ~10000 ~10000 ~10000 ~10000

Ethanol ~5000 ~2000 ~2000 ~2000 ~2000
Wei ght (mg) 1300.00 1050.00 800.00 900.00 700.00
Process
The HPMC and PVA were added in mixture of Ethanol and purified water and stirred for suitable time to get clear solution. After that PEG 400 was added to solution mixed well. Entire solution was casted on a non-adhesive surface such as a glass surface and allowed to dry at 40ºC to 60 ºC for 12h -36 hr. They were further peeled, and soluble film was formed.
Example 6: Test for dissolution of film
The film is cut into a suitable size for example, 3 X 3 cm2 square piece and added to 100 ml water. The film dissolves in 45 seconds upon slow stirring.
Figures 1 to 5 provide photographs of actual film produced and dissolved right from preparing solution, casting, drying, producing dried film and dissolving it in water.

Example 7: Test for Dissolution of edible pouch with soluble contents
An edible pouch is prepared and filled with mannitol powder. Approximate dimensions of the edible pouch are 4 X 4 cm2 square and approximate weight of mannitol is 2 g.
The mannitol containing edible pouch is added to 100 ml water and slowly stirred. The film starts dissolving immediately and entire pouch and all contents are completely dissolved in 2 minutes providing ready to drink solution.
Figures 6 to 7E provide photographs of actual edible pouch filled with mannitol powder and dissolved in water with slow stirring in 2 minutes.
References
Subhas C. Shit, Pathik M. Shah, "Edible Polymers: Challenges and Opportunities",
Journal of Polymers, vol. 2014, Article ID 427259, 13 pages, 2014.
https://doi.org/10.1155/2014/427259.
Edible films and Coatings for Food Application -Book 2009, Kerry C Huber, Milda
Embuscado.
Schellekens, R., & Bastiansen, C. J. (1991). A drawing behaviour of polyvinyl
alcohol fibers. Journal of Applied Polymer Science, 43, 2311.
Fadnis, Chandralekha & Iliger, Sudhir & Rao, K.P. & Demappa, Thippaiah. (2009).
Miscibility studies of HPMC/PVA blends in water by viscosity, density, refractive
index and ultrasonic velocity method. Carbohydrate Polymers. 74. 779-782.
10.1016/j.carbpol.2008.04.036.

Claims
We claim
1. A film composition for preparing an edible pouch comprising two polymers and a plasticizer.
2. The film composition as claimed in claim 1 wherein the film is water soluble or dispersible, transparent, edible and dissolves or disperses water in 60 seconds.
3. The film composition as claimed in claim 1 wherein the first polymer is in amounts from 7 – 75 % and total polymer is in amounts from 40 – 90 %.
4. The film composition as claimed in claim 1 wherein the plasticizer is in amounts from 5 – 50%.
5. The film composition as claimed in claim 3 wherein the first and the second polymer is selected from the group consisting of xanthan gum and guar gum, pectin, chitosan, dextran, carrageenan, cellulose ethers, Hyaluronic acid, albumin, starch, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylic acid, polyacrylamide, N-(2-Hydroxypropyl) methacrylamide (HPMA), Divinyl Ether-Maleic Anhydride (DIVEMA), Polyoxazoline, Polyphosphates, Polyphosphazenes etc.
6. The film composition as claimed in claim 5 wherein the plasticizer is selected from one or more of a polyhydric alcohols, acetate esters, phthalate esters and glycerides.
7. The film composition as claimed in claim 5 wherein the plasticizer is selected from one or more of a polyethylene glycol, glycerol, propylene glycols, glyceryl triacetate and triethyl citrate.
8. The film composition as claimed in any of the preceding claims comprising hydroxypropyl methyl cellulose, polyvinyl alcohol and polyethylene glycol wherein a hydroxypropyl methyl cellulose and polyvinyl alcohol together are in amounts from 40 – 90 % or 45 % - 90 % and polyethylene glycol is in amount from 5 – 50 %.

9. The film composition as claimed in any of the preceding claims comprising hydroxypropyl methyl cellulose, polyvinyl alcohol and polyethylene glycol wherein a hydroxypropyl methyl cellulose and polyvinyl alcohol together are from 50 – 85 % and polyethylene glycol is from 10 – 45 %.
10. The film composition as claimed in any of the preceding claims comprising hydroxypropyl methyl cellulose, polyvinyl alcohol and polyethylene glycol wherein a hydroxypropyl methyl cellulose and polyvinyl alcohol together are from 50 – 85 % or 60 % - 80 % and polyethylene glycol is from 10 – 45 % or 12 % - 45 %.
11. An edible pouch prepared from a film composition of claim 1.
12. An edible pouch as claimed in claim 11 enclosing food, nutraceutical or pharmaceutical product.
13. A process to prepare the film composition of claim 1 comprising
i) dissolving a first and a second polymer in a hydroalcoholic solvent by
stirring to prepare a first solution; ii) adding plasticizer to the first solution in required amounts and stirring
to prepare a second solution. iii) casting second solution on a non-adhesive surface, preferably a glass
surface; iv) drying the casted preparation at 40-60°C in an oven for 12 – 36 hrs to
dry casted preparation completely and peeling film; v) Cutting film in desired dimensions as per the weight / volume of the
contents to be filled.
14. A process to prepare the edible pouch of claim 11 comprising preparing film
in accordance with claim 13, preparing content selected from food,
nutraceutical or pharmaceutical preparation, arranging two cut films of
about same size and sealing together from at least one side, filling contents
selected from food, nutraceutical or pharmaceutical preparation and sealing
pouch from remaining sides.

15. A process to prepare the edible pouch of claim 11 comprising
A) preparing film in accordance with claim 13, and
B) Preparing edible pouch filled with the content comprising
i) Preparing content such as food, nutraceutical, pharmaceutical
preparation;
ii) Sealing two cut films, preferably of same size, from the three
sides using a heal sealing machine to form an open pouch;
iii) Holding the open pouch and filling the contents in the pouch and
sealing the pouch.

Documents

Application Documents

# Name Date
1 202221039168-POWER OF AUTHORITY [07-07-2022(online)].pdf 2022-07-07
2 202221039168-FORM FOR SMALL ENTITY(FORM-28) [07-07-2022(online)].pdf 2022-07-07
3 202221039168-FORM FOR SMALL ENTITY [07-07-2022(online)].pdf 2022-07-07
4 202221039168-FORM 1 [07-07-2022(online)].pdf 2022-07-07
5 202221039168-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [07-07-2022(online)].pdf 2022-07-07
6 202221039168-EVIDENCE FOR REGISTRATION UNDER SSI [07-07-2022(online)].pdf 2022-07-07
7 202221039168-DRAWINGS [07-07-2022(online)].pdf 2022-07-07
8 202221039168-COMPLETE SPECIFICATION [07-07-2022(online)].pdf 2022-07-07
9 202221039168-FORM 3 [11-07-2022(online)].pdf 2022-07-11
10 202221039168-ENDORSEMENT BY INVENTORS [11-07-2022(online)].pdf 2022-07-11
11 Abstract1.jpg 2022-09-21