DESC:DESCRIPTION

TECHNICAL FIELD OF INVENTION

The present invention relates to the field of oral disintegrating film. More particularly it relates to the process of preparing amla oral disintegrating film.

BACKGROUND OF THE INVENTION

Over the past few decades, tendency toward innovative drug delivery systems has majorly increased attempts to ensure efficacy, safety and patient acceptability. As discovery and development of new chemical agents is a complex, expensive and time-consuming process, so recent trends are shifting toward designing and developing innovative drug delivery systems for food and nutraceuticals.

These fast-disintegrating films have superiority over fast disintegrating tablets as the latter are associated with the risks of choking and friability. This delivery system has numerous advantages over conventional fast disintegrating tablets as they can be used for dysphasic patients and are taken without water due to their ability to disintegrate within a few seconds releasing medication in mouth. Various approaches are employed for formulating ODFs and among which solvent casting and spraying methods are frequently used. Generally, hydrophilic polymers along with other excipients are used for preparing ODFs which allow films to disintegrate quickly releasing incorporated active ingredient within seconds.

Amla is a powerhouse of vitamin C thus making it an amazing immune booster. It is also loaded with Vitamin A, polyphenols, alkaloids and flavonoids – quercetin and kaempferol. Studies reveal that amla increases the number of white blood cells, the body’s defence mechanism to fight allergies, infections and to flush out toxins. Eating gooseberry daily shields body against harmful bacteria and inflammation.

Amla possesses good amounts of phytochemicals like quercetin, gallic acid, corilagin and ellagic acids that aid body in detoxification and in fighting free radicals. This improves liver function, boosts vitality, and provides energy.

Indian gooseberry possesses various plant compounds, vitamins and minerals that aid in growth of healthy hair. Vitamin C in amla increases the collagen that adds length and volume to the hair. It also replaces dead hair cells on the scalp and regenerates the new ones.

Amla might be useful to manage a number of eye disorders like lacrimation (tear formation), redness, burning, itching of the eye and in improvement of the eyesight. Tannins in Amla help to manage diabetic cataract and prevent loss of vision by reducing the fluid pressure in the eye. Due to its antimicrobial, antioxidant, and anti-inflammatory properties, Amla is known as a natural eye tonic.

There are several other patents that have developed an oral disintegrating film. JP5551361B2 tilted “A rapidly disintegrating oral disintegrating film for neuroleptics” disclose a film that cannot be exhaled, comprising a neuroleptic agent, in particular olanzapine. The film should be suitable for oral administration of neuroleptic drugs. After contact with liquid or saliva, the film should adhere to the mouth and in the mouth the film should disintegrate rapidly, for example it should dissolve or break down under the action of saliva. The active ingredient-containing film should be both chemically and physically stable.

Another patent No.RU2436565C2 tilted “Disintegrating oral films” disclose a water-soluble film which disintegrates in a mouth for active agent delivery. The disintegrating film contains at least one water-soluble polymer and one active agent. The present invention also offers methods for making the disintegrating oral film and applying the disintegrating film for oral of an effective dose of the active agent for absorption through an oral mucosa. According to certain versions, the disintegrating film contains at least one water-soluble polymer and one active nicotine.

JP5784878B2 tilted “Orally administrable film” a film forming agent, an orally disintegrating film comprising a polymer selected from the group consisting of croscarmellose sodium, corn starch or mixtures thereof; and (c) a layer comprising an alkaline substance. The orally disintegrating film without any further pharmaceutically active substance is, for example, after eating an acidic food such as fruit (e.g. apple) or after eating a food containing sugar that is broken down by oral bacteria into acid. It can be useful by adhering to the buccal mucosa and neutralizing saliva, for example, for several minutes. If dental erosion can be caused by the acid, an orally disintegrating film containing an alkaline substance is beneficial for neutralizing the absorbed or formed acid.

The present invention implements a process of preparing amla source oral disintegrating film to improve overall immunity. Hence this ready to dissolve film is convenient to consume and presents to be a good immunity booster.

SUMMARY OF THE INVENTION

The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.

The main objective of the present invention is a process to prepare amla oral disintegrating film.

Another objective of the present invention is amla oral disintegrating film helps to manage diabetic cataract and prevent loss of vision by reducing the fluid pressure in the eye.

Further objective of the present invention is by in taking amla oral disintegrating film increases the collagen that adds length and volume to the hair. It also replaces dead hair cells on the scalp and regenerates the new ones.

In one aspect of the present invention, is to provide amla oral disintegrating film to increases the number of white blood cells, the body’s defense mechanism to fight allergies, infections and to flush out toxins. Eating gooseberry daily shields body against harmful bacteria and inflammation.

In yet another aspect of the present invention, to provide amla oral disintegrating film to improve liver function, boosts vitality, and provides energy.

The features and advantages of the present proposed system will become more apparent from the following detailed description along with the accompanying figures, which forms a part of this application by reference numerals:

REFERENCE NUMERALS
Weigh required quantity of 13% HPMC solution in a container (100).
Add Weighed quantity of Sucralose to step-1 and stir for 2min (101).
Add Weighed quantity of Maltodextrin to step-2 and stir for 5min (102).
Add Weighed quantity of Citric acid monohydrate to step-3 and stir for 2min (103).
Add Weighed quantity of Amla Extract to step-4 and stir for 3min (104).
Add Weighed quantity of Polyethylene oxide to step-5 and stir for 5min (105).
Add Weighed quantity of Pullulan to the step- 6 and stir for 10mins (106).
Add Weighed quantity of glycerol to step- 7 and stir for 2min (107).
Add Weighed quantity of Triethyl citrate to step- 8 and stir for 2min (108).
Weighed quantity of Formulation water was added to step-9 and stir for 3 min (109).
Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion (110).
Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry (111).
Cast the Wet slurry at process parameters of Dr. Knife thickness of 600 to 700 microns; Temperature 98±3°C; In-direct drying for 22 min (112).
Slit the dried casted film into 30mm x 40mm (113).

DETAILED DESCRIPTION OF THE INVENTION

The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.

The embodiments disclosed herein can be expressed in different forms and should not be considered as limited to the listed embodiments in the disclosed invention. The various embodiments outlined in the subsequent sections are constructed such that it provides a complete and a thorough understanding of the disclosed invention, by clearly describing the scope of the invention, for those skilled in the art.

Amla is a powerhouse of vitamin C thus making it an amazing immune booster. It is also loaded with Vitamin A, polyphenols, alkaloids and flavonoids – quercetin and kaempferol. Amla possesses good amounts of phytochemicals like quercetin, gallic acid, corilagin and ellagic acids that aid body in detoxification and in fighting free radicals.

Indian gooseberry possesses various plant compounds, vitamins and minerals that aid in growth of healthy hair. Amla might be useful to manage a number of eye disorders like lacrimation (tear formation), redness, burning, itching of the eye and in improvement of the eyesight. Tannins in Amla help to manage diabetic cataract and prevent loss of vision by reducing the fluid pressure in the eye. Due to its antimicrobial, antioxidant, and anti-inflammatory properties, Amla is known as a natural eye tonic.

The present invention isconvenient touse as Amla disintegrating film makes it a better supplement for immunity booster compared to other forms of oral dosage.

The amla oral disintegrating film is detailed below in the tabular column:
S. No. Ingredients Function
1 Amla Extract Active Agent
2 Maltodextrin Film forming Agent
3 Sucralose Sweetening Agent
4 Citric acid monohydrate Flavour Enhancer
5 Polyethylene oxide Film forming Agent
6 Pullulan Film forming Agent
7 Hydroxypropyl Methylcellulose (HPMC) Film forming Agent
8 Glycerol Plasticizer
9 Triethyl citrate Plasticizer
10 Purified Water* Vehicle

In an embodiment of the present invention is a process of preparing amla oral disintegrating film comprises of the following steps:
1. Weigh required quantity of 13% HPMC solution in a container (100).
2. Add Weighed quantity of Sucralose to step-1 and stir for 2min (101).
3. Add Weighed quantity of Maltodextrin to step-2 and stir for 5min (102).
4. Add Weighed quantity of Citric acid monohydrate to step-3 and stir for 2min (103).
5. Add Weighed quantity of Amla Extract to step-4 and stir for 3min (104).
6. Add Weighed quantity of Polyethylene oxide to step-5 and stir for 5min (105).
7. Add Weighed quantity of Pullulan to the step- 6 and stir for 10mins (106).
8. Add Weighed quantity of glycerol to step- 7 and stir for 2min (107).
9. Add Weighed quantity of Triethyl citrate to step- 8 and stir for 2min (108).
10. Weighed quantity of Formulation water was added to step-9 and stir for 3 min (109).
11. Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion (110).
12. Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry (111).
13. Cast the Wet slurry at process parameters of Dr. Knife thickness of 600 to 700 microns; Temperature 98±3°C; In-direct drying for 22 min (112).
14. Slit the dried casted film into 30mm x 40mm (113).

The amla oral disintegrating film and the ingredients is detailed below in the tabular column:
S. No. Ingredients %w/w
1 Amla 25.75
2 Maltodextrin 5.15
3 Sucralose 2.58
4 Citric acid monohydrate 2.14
5 Polyethylene oxide 3.43
6 Pullulan 5.15
7 Hydroxypropyl Methylcellulose (HPMC) 42.92
8 Glycerol 5.15
9 Triethyl citrate 7.73
10 Purified Water* q. s.
Total 100.00

* Water get evaporated during the coating prosses and traces of water content will remain product.
Process:
Manufacturing procedure
1. Weigh required quantity of Purified water in a container.
2. Add Weighed quantity of Sucralose to step-1 and stir for 2min.
3. Add Weighed quantity of Maltodextrin to step-2 and stir for 5min.
4. Add Weighed quantity of Citric acid monohydrate to step-3 and stir for 2min.
5. Add Weighed quantity of Amla Extract to step-4 and stir for 3min.
6. Add Weighed quantity of Polyethylene oxide to step-5 and stir for 5min.
7. Add Weighed quantity of Pullulan to the step- 6 and stir for 10mins.
8. Add Weighed quantity of glycerol to step- 7 and stir for 2min.
9. Add Weighed quantity of Triethyl citrate to step- 8 and stir for 2min.
10. Weighed quantity of Formulation water was added to step-9 and stir for 3 min.
11. Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion.
12. Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry.
13. Cast the Wet slurry at process parameters of Dr. Knife thickness of 600 to 700 microns; Temperature 98±3°C; In-direct drying for 22 min.
14. Slit the dried casted film into 30mm x 40mm.
The films were evaluated for disintegration time, folding endurance, water content Assay. The films were subjected to stability study under 40°C ± 2°C and 75% ± 5% RH condition for six months and evaluated above test parameters and results are tabulated.
When compared to the existing combinations reported till date, the oral disintegrating time is improved and effective. The results are disclosed below:

Example- 1: Results
S. No. Test Parameters Limits Results
Initial 1month 3months 6months
1 Disintegrating time NMT 60sec 45 sec 43 sec 57 sec 52 sec
2 Folding Endurance NLT 10 127 folds 71 folds 84 folds 81 folds
3 Water content NMT 10% 5.62 5.76 5.53 6.99
4 Assay (Tannins) NLT 80% 100.4 99.7 99.2 97.5

Throughout this specification various indications have been given as to preferred and alternative embodiments of the invention. It should be understood that it is the appended claims, including all equivalents that are intended to define the spirit and scope of this invention.

,CLAIMS:5. CLAIMS
I/We Claim
1. An amla oral disintegrating film comprising:
Amla25.75%w/w
Maltodextrin5.15%w/w
Sucralose2.58%w/w
Citric acid monohydrate2.14%w/w
Polyethylene oxide3.43%w/w
Pullulan5.15%w/w
Hydroxypropyl Methylcellulose (HPMC)42.92%w/w
Glycerol5.15%w/w
Triethyl citrate 7.73%w/w
Purified Water wherein the said water gets evaporated during the coating process and traces of water content will remain in the resultant composition.

2. A process to prepare amla oral disintegrating film comprises of the following steps:
i. Weigh required quantity of 13% HPMC solution in a container (100);
ii. Add Weighed quantity of Sucralose to step-1 and stir for 2min (101);
iii. Add Weighed quantity of Maltodextrin to step-2 and stir for 5min (102);
iv. Add Weighed quantity of Citric acid monohydrate to step-3 and stir for 2min (103);
v. Weighed quantity of Amla Extract to step-4 and stir for 3min (104);
vi. Add Weighed quantity of Polyethylene oxide to step-5 and stir for 5min (105);
vii. Add Weighed quantity of Pullulan to the step- 6 and stir for 10mins (106);
viii. Add Weighed quantity of glycerol to step- 7 and stir for 2min (107);
ix. Add Weighed quantity of Triethyl citrate to step- 8 and stir for 2min (108);
x. Weighed quantity of Formulation water was added to step-9 and stir for 3 min (109);
xi. Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion (110);
xii. Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry (111);
xiii. Cast the Wet slurry at process parameters of Dr. Knife thickness of 600 to 700 microns; Temperature 98±3°C; In-direct drying for 22 min (112);
xiv. Slit the dried casted film into 30mm x 40mm (113).

6. DATE AND SIGNATURE

Dated this 5thMay, 2023