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Oral Fast Dissolving Films Comprising Novel Natural Polymer And Method Of Preparation Thereof

Abstract: The present invention relates to an oral fast dissolving film and a method of preparation thereof. Specifically, the present invention relates to an oral fast dissolving film comprising novel natural polymer and a method of preparation thereof. More particularly, the present invention relates to an oral fast dissolving film comprising natural polymer chlorophytum. The present invention provides a method for preparation of an oral fast dissolving film for therapeutic purpose, said method comprising the steps of: obtaining chlorophytum powder from Chlorophytum borivilianum; dispersing the obtained chlorophytum powder in water to obtain a first solution; filtering said first solution to obtain a filtrate; centrifuging said filtrate to obtain a supernatant liquid; and mixing a plasticizer to said supernatant liquid to obtain a homogenous solution, said homogenous solution being dried and casted into said fast dissolving film.

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Patent Information

Application #
Filing Date
10 January 2019
Publication Number
29/2020
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
info@khuranaandkhurana.com
Parent Application

Applicants

Chitkara Innovation Incubator Foundation
SCO: 160-161, Sector -9c, Madhya Marg, Chandigarh- 160009, India.

Inventors

1. RAJNIBALA
Chitkara University, Chandigarh Patiala National Highway (NH-64), Tehsil - Rajpura, District Patiala-140401, Punjab, India.
2. MADAAN, Reecha
Chitkara University, Chandigarh Patiala National Highway (NH-64), Tehsil - Rajpura, District Patiala-140401, Punjab, India.
3. SHARMA, Ritima
Chitkara University, Chandigarh Patiala National Highway (NH-64), Tehsil - Rajpura, District Patiala-140401, Punjab, India.
4. GARG, Shivali
Chitkara University, Chandigarh Patiala National Highway (NH-64), Tehsil - Rajpura, District Patiala-140401, Punjab, India.
5. ARORA, Sandeep
Chitkara University, Chandigarh Patiala National Highway (NH-64), Tehsil - Rajpura, District Patiala-140401, Punjab, India.

Specification

[0001] The present invention relates to an oral fast dissolving film and a method of preparation thereof. Specifically, the present invention relates to an oral fast dissolving film comprising novel natural polymer and a method of preparation thereof. More particularly, the present invention relates to an oral fast dissolving film comprising natural polymer chlorophytum.
BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Oral administration of active substances in the form of tablets or capsules is extensively applied in the pharmaceutical and nutritional supplements industry. Conventional oral dosage forms such as tablets and capsules are meant to be swallowed whole or chewed with sufficient amounts of liquid to deliver the medication into the gastro-intestinal tract which is generally regarded as inconvenient. Liquids syrups and suspensions are an alternative to solid dosage forms, however in these dosage forms dosing accuracy cannot be ensured. Tablets may be formulated so as to be quick dissolving (orally disintegrating tablets) such that when placed on tongue they disintegrate rapidly in the oral cavity. Generally quick dissolving tablets are formed using complex multi-step manufacturing processes, thus making it cumbersome to manufacture.
[0004] Oral Mouth dissolving films, a new drug delivery system was developed based on the technology of the transdermal patch. This delivery system consists of a very thin oral strip, which is simply placed on the patients tongue or any oral mucosal tissue, instantly wet by saliva, film rapidly hydrates and then disintegrates and/or dissolve to release the medication. Using films for administration of active substances has several advantages over conventional forms.

Using film strips to deliver drugs enhances patient compliance since it eliminates the need for
water and the necessity to swallow a bulky pill. Such films are highly portable and excellent for
use on-the-go. Importantly oral films can achieve fast onset of action since the drugs that
dissolve rapidly in the mouth can give the perception that the drug acts faster than a traditional
pill swallowed in the traditional way.
[0005] Oral films, such as those found in Listerine PocketPacks™, are known in the art.
Other examples of products including such films are Neo Citran® Thin Strips™ for cough (with
25 mg of diphenhydramine hydrochloride), Theraflu® Thin Strips™ (with 25 mg of
diphenhydramine hydrochloride) and Gas-X® Thin Strips™ (with 62.5 mg of simethicone)
useful for the relief of multiple gas symptoms.
[0006] Formulation of fast dissolving oral film involves material such as film forming
polymers, plasticizers, active pharmaceutical ingredient, sweetening agents, saliva stimulating
agent, flavoring agents, coloring agents, stabilizing and thickening agents, permeation enhancers,
etc.
[0007] The use of film forming polymers in oral films has attracted considerable attention in
medical and nutraceutical applications. The selection of film forming polymers, is one of the
most important and critical parameter for the successful development of film formulation. The
polymers can be used alone or in combination to provide desired film properties. Presently, both
natural and synthetic polymers are used for preparation of fast dissolving oral film. Natural
polymers are materials of large molecular weights obtained from natural origins such as plants,
micro-organisms and animals. In comparison to synthetic, natural polymers are preferable due to
low toxicity, renewability, flexibility to modification, biodegradability and low cost.
[0008] Natural Polymers generally used for film formation are pullulan, starch, gelatin,
pectin, sodium alginate, maltodextrins, polymerized rosin, dextrin, chitin, chitosan, levan,
elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and
mixtures thereof. Synthetic Polymers used as film forming polymers include hydroxy propyl
methylcellulose, sodium carboxymethyl cellulose, polyethylene oxide, hydroxypropyl cellulose,
polyvinylpyrrolidone, polyvinylalcohol and mixtures thereof.
[0009] With the increasing interest in polymers of natural origin, the pharmaceutical world
has compliance to use most of them in their formulations. Moreover, the tremendous orientation
of pharma world towards these naturally derived polymers has become a subject of increasing

interest to discover, extract and purify such compounds from the reported origin. Most natural polymers are generally regarded as safe for oral consumption and so find applications in the food and pharmaceutical industries. The use of natural polymers has increased in recent times; also due to the advocacy of "green" materials from "green" chemistry and technologies. Natural polymers are biogenic and their biological properties such as cell recognition and interactions, enzymatic degradability, semblance to the extracellular matrix and their chemical flexibility make them materials of choice for drug delivery. Natural gums are preferred as film former because of their safety, good mouth feel, better mechanical properties and water solubility. [0010] There is, therefore, a need to develop better and efficient natural polymers that can be used for oral film formation, which are easily available, cheap, safe, non-toxic and can overcome deficiencies associated with the known arts. The current invention discloses a novel natural polymer that can be used for thin film formation.
OBJECTS OF THE INVENTION
[0011] An object of the present invention is to provide an oral fast dissolving film.
[0012] Yet another object of the present invention is to provide an oral fast dissolving film
comprising novel natural polymer.
[0013] Another object of the present invention is to provide an oral fast dissolving film
comprising natural polymer chlorophytum.
[0014] Another object of the present invention is to provide an oral fast dissolving film
comprising natural polymer chlorophytum, which is easily available and cheap.
[0015] Yet another object of the present invention is to provide an oral fast dissolving film
comprising natural polymer chlorophytum, which is safe and non-toxic.
[0016] Another object of the present invention is to provide a method for preparation of oral
fast dissolving film comprising novel natural polymer.
SUMMARY OF THE INVENTION
[0017] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in detailed description section. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0018] The present invention relates to an oral fast dissolving film and a method of
preparation thereof. Specifically, the present invention relates to an oral fast dissolving film
comprising novel natural polymer and a method of preparation thereof.
[0019] In another aspect, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum.
[0020] In another aspect, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum wherein chlorophytum is Chlorophytum borivilianum,
derived from the roots of Chlorophytum borivilianum.
[0021] In one embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum wherein the concentration of chlorophytum is in the
range of 5% to 30%.
[0022] In one embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum wherein the concentration of chlorophytum is 10%.
[0023] In one aspect, the present invention relates to an oral fast dissolving film comprising
natural polymer chlorophytum and one or more ingredient selected from the group consisting of
plasticizing, saliva stimulation, stabilizing, emulsifying, fillers, thickening, binding, coloring, or
acting as a surfactant.
[0024] In another aspect, the present invention relates to an oral fast dissolving film
comprising natural polymer and plasticizers, wherein the plasticizer can be selected from any or
a combination of sorbitol, mannitol, maltitol, glycerine, propylene glycol, ethanolamine and the
like. In a preferred embodiment, the plasticizer is glycerine.
[0025] In another aspect, the present invention relates to an oral fast dissolving film
comprising natural polymer, wherein film is instantly wettable and rapidly dissolving. Thus, the
film adheres to the roof of one's mouth or tongue, quickly and totally dissolves.
[0026] It should be appreciated by those skilled in the art, that other edible water-soluble
film forming agents which exhibit desirable properties may be utilized in combination with
chlorophytum.
[0027] In an aspect, the present disclosure relates to a method for preparation of a fast
dissolving film, said method comprising the steps of: obtaining chlorophytum powder from
Chlorophytum borivilianum; dispersing the obtained chlorophytum powder in water to obtain a
first solution; filtering said first solution to obtain a filtrate; centrifuging said filtrate to obtain a

supernatant liquid; and mixing a plasticizer to said supernatant liquid to obtain a homogenous
solution, said homogenous solution being dried and casted into said fast dissolving film.
[0028] In an aspect, the chlorophytum powder can be obtained from roots of Chlorophytum
borivilianum.
5 [0029] In another aspect, the water can be distilled water, and the first solution can be boiled
before the step of filtering.
[0030] In another aspect, the step of filtering can be performed using a defined number of
folds of a muslin cloth.
[0031] In another aspect, the step of centrifuging can be performed at an RPM ranging from
10 1000-2000 rpm and for duration of 10-40 minutes.
[0032] In another aspect, the plasticizer can be selected from any or a combination of
sorbitol, mannitol, maltitol, glycerine, propylene glycol, ethanolamine and the like. In a preferred
embodiment, the plasticizer is glycerine.
[0033] In another aspect, w/v ratio of chlorophytum and water can range from 1:5 to 1: 100.
15 [0034] In another aspect, the plasticizer can be mixed with the supernatant liquid using a
magnetic stirrer, and wherein post mixing, the homogenous solution can be kept undisturbed for
a defined period of time for removal of air bubbles, post which the homogenous solution can be
casted into a Petri plate.
[0035] In another aspect, the casted homogenous solution can be removed using a blade and
20 kept in a dessicator for a second defined period of time before being cut into said fast dissolving
film.
[0036] In another aspect, the present disclosure relates an oral fast dissolving film
comprising natural polymer chlorophytum, prepared using the above-defined method.
[0037] Other aspects of the invention will be set forth in the description which follows, and
25 in part will be apparent from the description, or may be learnt by the practice of the invention.
BRIEF DESCRIPTION OF DRAWINGS THE INVENTION
[0038] The following drawings form part of the present specification and are included to
further illustrate aspects of the present disclosure. The disclosure may be better understood by
30 reference to the drawings in combination with the detailed description of the specific
embodiments presented herein.
- 6 -

Figure 1 illustrates the prepared oral thin film.
Figure 2 represents SEM images of 10% Chlorophytum film
DETAILED DESCRIPTION
5 [0039] The following is a detailed description of embodiments of the disclosure. The
embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
10 [0040] All publications herein are incorporated by reference to the same extent as if each
individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
15 [0041] Reference throughout this specification to “one embodiment” or “an embodiment”
means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures,
20 or characteristics may be combined in any suitable manner in one or more embodiments.
[0042] In some embodiments, the numbers expressing quantities of ingredients, properties
such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the
25 written description and attached claims are approximations that can vary depending upon the
desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are
30 approximations, the numerical values set forth in the specific examples are reported as precisely
as practicable. The numerical values presented in some embodiments of the invention may
- 7 -

contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0043] As used in the description herein and throughout the claims that follow, the meaning
of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise.
5 Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the
context clearly dictates otherwise.
[0044] Unless the context requires otherwise, throughout the specification which follow, the
word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”
10 [0045] The recitation of ranges of values herein is merely intended to serve as a shorthand
method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any
15 and all examples, or exemplary language (e.g. “such as”) provided with respect to certain
embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
20 [0046] Groupings of alternative elements or embodiments of the invention disclosed herein
are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the
25 specification is herein deemed to contain the group as modified thus fulfilling the written
description of all Markush groups used in the appended claims.
[0047] The description that follows, and the embodiments described therein, is provided by
way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation,
30 and not of limitation, of those principles and of the disclosure.
- 8 -

[0048] It should also be appreciated that the present disclosure can be implemented in
numerous ways, including as a system, a method or a device. In this specification, these
implementations, or any other form that the invention may take, may be referred to as processes.
In general, the order of the steps of the disclosed processes may be altered within the scope of
5 the invention.
[0049] The headings and abstract of the invention provided herein are for convenience only
and do not interpret the scope or meaning of the embodiments.
[0050] The following discussion provides many example embodiments of the inventive
subject matter. Although each embodiment represents a single combination of inventive
10 elements, the inventive subject matter is considered to include all possible combinations of the
disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second
embodiment comprises elements B and D, then the inventive subject matter is also considered to
include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[0051] Various terms as used herein are shown below. To the extent a term used in a claim
15 is not defined below, it should be given the broadest definition persons in the pertinent art have
given that term as reflected in printed publications and issued patents at the time of filing..
[0052] The present invention relates to an oral fast dissolving film and a method of
preparation thereof. Specifically, the present invention relates to an oral fast dissolving film
comprising novel natural polymer and a method of preparation thereof.
20 [0053] In one embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum.
[0054] In another embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum wherein chlorophytum is Chlorophytum
borivilianum, derived from the roots of Chlorophytum borivilianum.
25 [0055] Orally dissolvable films can include many ingredients. The base ingredients for
forming a film may include water (which can be later dried out of the film) and a film
forming agent. Many other additives can be used as well for purposes of plasticizing, saliva
stimulation, stabilizing, emulsifying, fillers, thickening, binding, coloring, or acting as a
surfactant.
30 [0056] In one embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum and one or more ingredient selected from the
- 9 -

group consisting of plasticizing, saliva stimulation, stabilizing, emulsifying, fillers,
thickening, binding, coloring, or acting as a surfactant.
[0057] In one embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum wherein the concentration of chlorophytum is in
5 the range of 5% to 30%.
[0058] In one embodiment, the present invention relates to an oral fast dissolving film
comprising natural polymer chlorophytum wherein the concentration of chlorophytum is
10%.
[0059] The natural polymer chlorophytum, is easily available, cheap, safe and non-toxic
10 compound.
[0060] In yet another embodiment, the present invention relates to an oral fast dissolving
film comprising natural polymer and plasticizers, wherein the plasticizer can be selected
from any or a combination of sorbitol, mannitol, maltitol, glycerine, propylene glycol,
ethanolamine and the like. In a preferred embodiment, the plasticizer is glycerine.
15 [0061] Plasticizers are preferred for making a flexible film. As less plasticizer is used, the
film becomes more brittle; whereas as more plasticizer is used the film loses tensile strength.
[0062] Saliva stimulating agents can also be added to the oral films according to the
present invention. Any number of saliva enhancing agents can be used in the formation of
orally dissolvable thin films. These agents are well known in the art, which include common
20 food-grade sweeteners such as glucose, dextrose, fructose, lactose, maltose, xylose, sucrose,
corn sugar syrup, and other sweet mono- or di-saccharides. Saliva stimulating agents also
include food acids such as citric, lactic, malic, succinic, ascorbic, adipic, fumaric and tartaric
acids.
[0063] In still another embodiment, the present invention relates to an oral fast dissolving
25 film comprising natural polymer, wherein film is instantly wettable and rapidly dissolving.
Thus, the film adheres to the roof of one's mouth or tongue, quickly and totally dissolves.
[0064] It should be appreciated by those skilled in the art, that other edible water-soluble
film forming agents which exhibit desirable properties may be utilized in combination with
chlorophytum.
30 [0065] In one embodiment, the present disclosure relates to a method for preparation of a
fast dissolving film, said method comprising the steps of: obtaining chlorophytum powder from
- 10 -

Chlorophytum borivilianum; dispersing the obtained chlorophytum powder in water to obtain a
first solution; filtering said first solution to obtain a filtrate; centrifuging said filtrate to obtain a
supernatant liquid; and mixing a plasticizer to said supernatant liquid to obtain a homogenous
solution, said homogenous solution being dried and casted into said fast dissolving film.
5 [0066] In another embodiment, the chlorophytum powder can be obtained from roots of
Chlorophytum borivilianum.
[0067] In still another embodiment, the water can be distilled water, and the first solution
can be boiled before the step of filtering.
[0068] In one embodiment, the step of filtering can be performed using a defined number
10 of folds of a muslin cloth.
[0069] In one embodiment, the step of centrifuging can be performed at an RPM ranging
from 1000-2000 rpm and for duration of 10-40 minutes.
[0070] In one embodiment, the plasticizer can be selected from any or a combination of
sorbitol, mannitol, maltitol, glycerine, propylene glycol, ethanolamine and the like. In a
15 preferred embodiment, the plasticizer is glycerine.
[0071] In one embodiment, w/v ratio of chlorophytum and water can range from 1:5 to 1:
100.
[0072] In another embodiment, the plasticizer can be mixed with the supernatant liquid
using a magnetic stirrer, and wherein post mixing, the homogenous solution can be kept
20 undisturbed for a defined period of time for removal of air bubbles, post which the homogenous
solution can be casted into a Petri plate.
[0073] In one embodiment, the casted homogenous solution can be removed using a blade
and kept in a dessicator for a second defined period of time before being cut into said fast
dissolving film.
25 [0074] The oral films according to the invention may have one or more layers and typically
have a thickness of from 5-3000, preferably 10-1000, more preferably 20-500 and in particular
30-300 micrometers.
[0075] In still another embodiment, the present disclosure relates an oral fast dissolving
film comprising natural polymer chlorophytum, prepared using the above-defined method.
30 [0076] There is no particular limitation on the drugs used in the invention, as long as they
can be orally administered.
- 11 -

[0077] The fast dissolving film may include at least one physiologically acceptable,
pharmaceutically active agent. The expression “physiologically acceptable' as used herein is
intended to encompass compounds, which upon administration to a patient, are adequately
tolerated without causing undue negative side effects. The expression encompasses edible
5 compounds.
[0078] The films of the present invention may be mucoadhesive, whose advantage resides
in their ability to bypass the gastrointestinal tract, and barriers in the gastrointestinal tract to drug absorption such as first pass metabolism and decomposition of the active ingredient in the stomach. Alternatively the films of the present invention may be non-mucoadhesive which
10 mimics the pharmacokinetic profile conventional immediate release solid oral dosage forms and
are bioequivalent to and interchangeable with existing orally administered drug products.
[0079] The films of the present invention must be formed into a sheet or film prior to
drying. After the desired components are combined to form a multi-component matrix, including the polymer, water, and active or other components as desired, the combination is formed into a
15 sheet or film, by any method known in the art such as extrusion, coating, spreading, casting or
drawing the multi-component matrix.
[0080] In another aspect the present invention may be practiced using a simple casting
method, by moulding the polymeric solution on a simple Petri dish, or on a glass plate using a path wet film applicator or casting equipment (to obtain a more homogenous film thickness), or
20 by more sophisticated extrusion machines, and by allowing it to dry at room temperature, or in
an oven or in a ventilated oven, or in a vacuum chamber.
[0081] The oral film composition may be dried by a process not limited to drying oven,
drying tunnel, vacuum drier, or other such drying equipment.
[0082] While the foregoing describes various embodiments of the disclosure, other and
25 further embodiments of the disclosure may be devised without departing from the basic scope
thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
30
- 12 -

EXAMPLES
[0083] The present invention is further explained in the form of following examples.
However, it is to be understood that the following examples are merely illustrative and are not to
be taken as limitations upon the scope of the invention.
5 [0084] Materials: Chlorophytum borivilianum is widely cultivated throughout India.
Major phytochemical components reported from the roots of Chlorophytum borivilianum include mainly steroidal saponins, fructans and fructoligosaccharides (FOS), acetylated mannans, phenolic compounds and proteins.
10 Example 1: Procedure for the preparation of fast dissolving films using chlorophytum
Preparation of the powder: The roots were powdered after washing and air drying. 10 g of chlorophytum powder was dispersed in 100 ml of distilled water, boiled for 1 hour and the resultant solution was filtered through 8 folds muslin cloth. Filtrate was centrifuged at 1500 rpm for 20-30 min. The supernatant liquid was collected and to this
15 glycerine was added as plasticizer and mixed together using magnetic stirrer to obtained
homogenous solution. The solution was kept undisturbed for 2 hours for the removal of air bubbles. Finally the 10 ml solution was taken and casted into plastic Petri plate having area of 40 cm². After drying films were removed with the help of sharp blade and kept in dessicator for
20 24 hrs before cutting into small piece having area of 4cm². Films with air bubbles cut or
imperfections were excluded from study. Figure 1 illustrates the prepared oral thin film. Figure 2 represents SEM images of 10% Chlorophytum film
25 Example 2: Evaluation of different parameters for the oral thin films (prepared following the
procedure in Example 1)
The oral thin films were prepared by solvent casting method using different concentration of chlorophytum powder (4, 6, 8, 10, 12%). HPMC E15 4% was used as standard film forming agent for comparison.
- 13 -

Prepared films were subjected for different evaluation parameters (general appearance, film forming capacity, thickness, pH, tensile strength, folding endurance, % elongation and disintegration time) as shown in Table 1.
Table 1: Films of different conc. of Chlorophytum powder (CP) and their evaluation

Conc. Film
forming
capacity Appearance Thickness
(mm)
n=5 pH Tensile Strengt h
N/mm2 Folding endurance % Elongation Disintegration time (phosphate buffer pH 6.8) sec
CP 4% Poor Transparent 0.05±0.01 7 0.8 156±0.05 50 24±0.12
CP 6% poor Transparent 0.07±0.05 7.1 1.42 140±0.2 54 26±0.11
CP 8% good Transparent 0.10±0.1 7.2 1.53 137±0.08 58 28±0.01
CP 10% Excella nt Transparent 0.11±0.04 7.1 2.13 125±0.1 60 30±0.05
CP 12% Very good Opaque 0.12±0.03 7.3 1.89 100±0.08 45 60±0.06
HPMC
E15 4% Very good Transparent 0.43±0.1 7.1 2.5 160±0.06 30 34±0.12
5
The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention. 10
ADVANTAGES OF THE PRESENT INVENTION
[0085] The present invention provides an oral fast dissolving film comprising novel natural
polymer.
[0086] The present invention provides an oral fast dissolving film comprising natural
15 polymer chlorophytum.
[0087] The present invention provides an oral fast dissolving film comprising natural
polymer chlorophytum, which is easily available and cheap.
[0088] The present invention provides an oral fast dissolving film comprising natural
polymer chlorophytum, which is safe and non-toxic.
- 14 -

[0089] The present invention provides an oral fast dissolving film comprising natural
polymer, wherein film is instantly wettable and rapidly dissolving.

We Claim:

An oral fast dissolving film comprising natural polymer chlorophytum and one or more ingredient selected from the group consisting of plasticizing, saliva stimulation, stabilizing, emulsifying, fillers, thickening, binding, coloring, or acting as a surfactant.
The oral fast dissolving film as claimed in claim 1, comprising natural polymer chlorophytum and a plasticizer.
The oral fast dissolving film as claimed in claim 1, comprising natural polymer chlorophytum wherein chlorophytum is Chlorophytum borivilianum, derived from the roots of Chlorophytum borivilianum.
The oral fast dissolving film as claimed in claim 1, comprising natural polymer chlorophytum wherein the concentration of chlorophytum is in the range of 5% to 30%.
The oral fast dissolving film as claimed in claim 1, comprising natural polymer chlorophytum wherein the concentration of chlorophytum is 10%.
The oral fast dissolving film as claimed in claim 2, wherein the plasticizer is selected from any or a combination of sorbitol, mannitol, maltitol, glycerine, propylene glycol and ethanolamine.
The oral fast dissolving film as claimed in claim 6, wherein the plasticizer is glycerine.
A method for preparation of a fast dissolving film, as claimed in claim 1, for therapeutic purpose, said method comprising the steps of:
obtaining chlorophytum powder from Chlorophytum borivilianum;
dispersing the obtained chlorophytum powder in water to obtain a first solution;
filtering said first solution to obtain a filtrate;
centrifuging said filtrate to obtain a supernatant liquid; and
mixing a plasticizer to said supernatant liquid to obtain a homogenous solution, said
homogenous solution being dried and casted into said fast dissolving film.
The method as claimed in claim 8, wherein said chlorophytum powder is obtained
from roots of Chlorophytum borivilianum.
i. The method as claimed in claim 8, wherein said water is distilled water, and
wherein said first solution is boiled before the step of filtering.

The method as claimed in claim 8, wherein the step of filtering is performed using a defined number of folds of a muslin cloth.
The method as claimed in claim 8, wherein the step of centrifuging is performed at an RPM ranging from 1000-2000 rpm and for a duration of 10-40 minutes.
The method as claimed in claim 8, wherein said plasticizer is selected from any or a combination of sorbitol, mannitol, maltitol, glycerine, propylene glycol and ethanolamine.
The method as claimed in claim 13 wherein the plasticizer is glycerine.
The method as claimed in claim 8, wherein gram (gm) to milli-liter (ml) ratio of chlorophytum powder and said water respectively ranges from 1:10 to 1:100.
The method as claimed in claim 8, wherein the plasticizer is mixed with the supernatant liquid using a magnetic stirrer, and wherein post mixing, the homogenous solution is kept undisturbed for a defined period of time for removal of air bubbles, post which the homogenous solution is casted into a Petri plate.
The method as claimed in claim 8, wherein the casted homogenous solution is removed using a blade and kept in a dessicator for a second defined period of time before being cut into said fast dissolving film.

Documents

Application Documents

# Name Date
1 201911001177-NBA Approval Submission [08-07-2024(online)].pdf 2024-07-08
1 201911001177-STATEMENT OF UNDERTAKING (FORM 3) [10-01-2019(online)].pdf 2019-01-10
2 201911001177-Annexure [12-11-2021(online)].pdf 2021-11-12
2 201911001177-FORM FOR STARTUP [10-01-2019(online)].pdf 2019-01-10
3 201911001177-Written submissions and relevant documents [12-11-2021(online)].pdf 2021-11-12
3 201911001177-FORM FOR SMALL ENTITY(FORM-28) [10-01-2019(online)].pdf 2019-01-10
4 201911001177-FORM 1 [10-01-2019(online)].pdf 2019-01-10
4 201911001177-Correspondence to notify the Controller [27-10-2021(online)].pdf 2021-10-27
5 201911001177-FORM-26 [27-10-2021(online)].pdf 2021-10-27
5 201911001177-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [10-01-2019(online)].pdf 2019-01-10
6 201911001177-FER.pdf 2021-10-18
6 201911001177-EVIDENCE FOR REGISTRATION UNDER SSI [10-01-2019(online)].pdf 2019-01-10
7 201911001177-US(14)-HearingNotice-(HearingDate-28-10-2021).pdf 2021-10-18
7 201911001177-DRAWINGS [10-01-2019(online)].pdf 2019-01-10
8 201911001177-DECLARATION OF INVENTORSHIP (FORM 5) [10-01-2019(online)].pdf 2019-01-10
8 201911001177-CLAIMS [09-06-2021(online)].pdf 2021-06-09
9 201911001177-COMPLETE SPECIFICATION [09-06-2021(online)].pdf 2021-06-09
9 201911001177-COMPLETE SPECIFICATION [10-01-2019(online)].pdf 2019-01-10
10 201911001177-CORRESPONDENCE [09-06-2021(online)].pdf 2021-06-09
10 201911001177-Proof of Right (MANDATORY) [29-01-2019(online)].pdf 2019-01-29
11 201911001177-FER_SER_REPLY [09-06-2021(online)].pdf 2021-06-09
11 201911001177-FORM-26 [29-01-2019(online)].pdf 2019-01-29
12 201911001177-FORM-26 [09-06-2021(online)].pdf 2021-06-09
12 201911001177-Power of Attorney-300119.pdf 2019-02-01
13 201911001177-FORM 18 [03-09-2020(online)].pdf 2020-09-03
13 201911001177-OTHERS-300119.pdf 2019-02-01
14 201911001177-Correspondence-300119.pdf 2019-02-01
14 abstract.jpg 2019-02-25
15 201911001177-Correspondence-300119.pdf 2019-02-01
15 abstract.jpg 2019-02-25
16 201911001177-FORM 18 [03-09-2020(online)].pdf 2020-09-03
16 201911001177-OTHERS-300119.pdf 2019-02-01
17 201911001177-Power of Attorney-300119.pdf 2019-02-01
17 201911001177-FORM-26 [09-06-2021(online)].pdf 2021-06-09
18 201911001177-FER_SER_REPLY [09-06-2021(online)].pdf 2021-06-09
18 201911001177-FORM-26 [29-01-2019(online)].pdf 2019-01-29
19 201911001177-CORRESPONDENCE [09-06-2021(online)].pdf 2021-06-09
19 201911001177-Proof of Right (MANDATORY) [29-01-2019(online)].pdf 2019-01-29
20 201911001177-COMPLETE SPECIFICATION [09-06-2021(online)].pdf 2021-06-09
20 201911001177-COMPLETE SPECIFICATION [10-01-2019(online)].pdf 2019-01-10
21 201911001177-CLAIMS [09-06-2021(online)].pdf 2021-06-09
21 201911001177-DECLARATION OF INVENTORSHIP (FORM 5) [10-01-2019(online)].pdf 2019-01-10
22 201911001177-DRAWINGS [10-01-2019(online)].pdf 2019-01-10
22 201911001177-US(14)-HearingNotice-(HearingDate-28-10-2021).pdf 2021-10-18
23 201911001177-EVIDENCE FOR REGISTRATION UNDER SSI [10-01-2019(online)].pdf 2019-01-10
23 201911001177-FER.pdf 2021-10-18
24 201911001177-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [10-01-2019(online)].pdf 2019-01-10
24 201911001177-FORM-26 [27-10-2021(online)].pdf 2021-10-27
25 201911001177-FORM 1 [10-01-2019(online)].pdf 2019-01-10
25 201911001177-Correspondence to notify the Controller [27-10-2021(online)].pdf 2021-10-27
26 201911001177-Written submissions and relevant documents [12-11-2021(online)].pdf 2021-11-12
26 201911001177-FORM FOR SMALL ENTITY(FORM-28) [10-01-2019(online)].pdf 2019-01-10
27 201911001177-FORM FOR STARTUP [10-01-2019(online)].pdf 2019-01-10
27 201911001177-Annexure [12-11-2021(online)].pdf 2021-11-12
28 201911001177-STATEMENT OF UNDERTAKING (FORM 3) [10-01-2019(online)].pdf 2019-01-10
28 201911001177-NBA Approval Submission [08-07-2024(online)].pdf 2024-07-08

Search Strategy

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