Description:DESCRIPTION
Technical Field of the Invention

The present invention relates to the field of edible films containing active ingredients, more specifically to a film composition provided in a disintegrating film dosage form for oral consumption, with green coffee as one of the main ingredients.

Background of the Invention

Green coffee with combinations like Ashwagandha, Shilajit, and Q-actin, which have been linked to antioxidant properties. Antioxidants serve multiple functions in promoting health and preventing disease by combating oxidative stress and supporting various bodily functions.

Green coffee extract, from unroasted coffee beans, is increasingly recognized for its health benefits and distinctive flavor profile. The global market for green coffee is experiencing significant growth. This growth is largely attributed to rising consumer awareness of its health benefits, particularly its high content of chlorogenic acid, which aids in weight management, regulates blood sugar levels, and supports heart health by lowering blood pressure and cholesterol.

Ashwagandha, an adaptogenic herb, is known for its stress-reducing properties and ability to enhance mental clarity and focus. Together with green coffee, they may help reduce anxiety and improve mood while supporting metabolic health and promoting overall well-being. This combination can be particularly beneficial for those looking to manage stress and maintain energy levels throughout the day.

Shilajit is a natural substance found in the Himalayas, formed from decomposed plant or animal material over centuries. It is rich in fulvic acid and minerals, making it a powerful health supplement. When combined with green coffee, shilajit enhances energy levels and overall health. Shilajit helps reduce stress and improve cognitive function, while green coffee contains chlorogenic acid, an antioxidant that aids weight management and regulates blood sugar. Together, they provide a balanced and sustained energy boost.

Q-actin is a dietary supplement derived from cucumber (Cucumis sativus L.) that is often marketed for its potential benefits in enhancing physical performance, supporting weight management, and improving metabolic health. The mechanism behind Q-actin's efficacy appears to be its ability to inhibit pro-inflammatory cytokines, particularly tumor necrosis factor alpha (TNF-α), which is associated with joint degeneration. This anti-inflammatory action contributes to its potential as a therapeutic agent for joint health.

Combination of chlorogenic acids present in green coffee and Q-actin could potentially lead to improved energy levels and exercise performance while also supporting weight management through enhanced metabolic processes.

A few patents and non-patent literature on coffee and disintegrating films have been discussed below:
The patent application “Functional coffee tea bag (KR102497503B1)” describes a coffee teabag that contains Robusta coffee beans sourced from India. The preparation process for these coffee beans involves rapid cooling of the roasted green beans at a temperature range of -30 to -40 °C. The coffee beans are then ground into a powder with a particle size of 1.0 to 1.2 mm. Finally, the coffee powder is packaged in an eco-friendly teabag that includes a KR102497503B1 biodegradable filter.

The patent application “Functional formulation in chewing gum (US2012121520A1)” describes a nutritional composition that combines Ashwagandha herb and an L-Theanine sublingual formulation. It outlines a method for reducing stress by administering an effective amount of nutritional gum composition to an individual in need. This composition includes Ashwagandha extract in quantities ranging from approximately 80 mg to 150 mg and L-Theanine in amounts between about 50 mg and 125 mg.

Another patent application “Health drink and method of manufacture and/or use thereof (GB2627538A)” describes a health drink that contains Shilajit that is palatable and pleasant tasting, thereby improving the regular consumption of the health drink and providing the health benefits of the shilajit to the consumer. Preferably, the drink comprises 0.2-0.3% w/v Shilajit, 0.5-0.6% w/v aniseed, 0.1-0.2% w/v dried dates, 0.5-0.6% w/v fennel seeds, 2.5-2.6% w/v honey, 27-30% v/v of water and 70-74% v/v of milk and/or non-dairy milk.

In general, the roasting process leads to the destruction of Chlorogenic acids, and when it comes to green coffee the roasting step is excluded which makes it deliver more antioxidant properties compared to that of roasted coffee beans (Paper: Ground green coffee beans as a functional food supplement – Preliminary study). Apart from the above benefits, green coffee beans also have anti-obesity effects by decreasing fat accumulation, by regulating adipogenesis and lipid metabolism-related genes and proteins in adipose tissue and the liver (paper: Green coffee bean extract improves obesity by decreasing body fat in high-fat diet-induced obese mice).

Large varieties of green coffee products are commercially available. But these have some disadvantages, to overcome these disadvantages, the present article focuses on manufacturing green coffee products in the form of disintegrating films which have more advantages compared to commercially available green coffee products.

The major disadvantage over green coffee powder is more steeping and brewing time. Conventional green coffee powder is more prone to microbial contamination because, water content is certainly the most critical quality parameter of green coffee beans, during storage and transport, as given in the study “Water content determination in green coffee – Method comparison to study specificity and accuracy”.

To prevent deterioration during transportation, a special hermetic packaging technique is used which is very expensive, as given in the paper “Storage of green coffee in hermetic packaging injected with CO2”.

A single plastic coffee bag steeped at 95 ℃ for 5 min could release more than 10,000 microplastic particles into a cup of coffee, as given in the study “Pouring hot water through drip bags releases thousands of microplastics into coffee”.

Disintegrating Films are single-use products that do not require any special storage conditions. They are convenient and ready to use, reducing steeping and brewing time.
These films are manufactured with a biocompatible polymer. Disintegrating Films provide faster elution of active ingredients.

Each film contains a standard dosage of green coffee extract, ensuring the necessary quantity of bioactive compounds to deliver health benefits. Additionally, Disintegrating Films are simple and easy to carry, in contrast to commercial coffee products that often require special packaging.

Brief Summary of the Invention

OBJECTS OF THE INVENTION
The primary objective of this invention is to create a disintegrating film composed of green coffee. These disintegrating films offer new opportunities to enhance the convenience and overall consumption experience of green coffee, serving as an alternative to traditional brewing methods.

The second objective of the present invention is to develop a disintegrating film that combines Green coffee, Ashwagandha, Shilajit & Q-actin as active components and pharmaceutically acceptable excipients for increased antioxidant properties and many other health benefits.

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.

In an aspect of the present invention, the disintegrating film which comprises of Green coffee extract, Ashwagandha, Shilajit and Q-actin combination as active components along with pharmaceutically acceptable excipients.

In another aspect of our present invention, the disintegrating films are processed to a wet slurry which was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns with temperature as Temperature 95±3°C. Then the films are slitted into required dimensions for achieving the final dose.

In another aspect of our present invention, the stability factors of different embodiments present greater stability values than the reference tested products and provide better absorption of the said ingredients of our composition.

Brief Description of the Drawings

The manner in which the present invention is formulated is given a more particular description below, briefly summarized above, may be had by reference to the components, some of which is illustrated in the appended drawing It is to be noted; however, that the appended drawing illustrates only typical embodiments of this invention and are therefore should not be considered limiting of its scope, for the system may admit to other equally effective embodiments.

Throughout the drawings, the same drawing reference numerals will be understood to refer to the same elements and features. The features and advantages of the present invention will become more apparent from the following detailed description a long with the accompanying figures, which forms a part of this application and in which:

Fig 1 illustrates the Block diagram describing the method of preparation of one embodiment in accordance with our present invention.

Fig 2 illustrates the Diagram showing the In-vitro release of polyphenols, in accordance with our present invention;

Fig 3 illustrates the Diagram showing the DPPH radical scavenging activity, in accordance with our present invention;

Fig 4 illustrates the Diagram showing the ABTS radical scavenging activity, in accordance with our present invention;

Fig 5 illustrates the Diagram showing the FRAP Assay, in accordance with our present invention;

Fig 6 illustrates the Diagram showing Nitric Oxide (NO) Scavenging Activity, in accordance with our present invention;

Fig 7 illustrates the Diagram showing the Superoxide Anion Scavenging Activity, in accordance with our present invention;

Fig 8 illustrates the Diagram showing the Cell assay by Oxidative stress cell method, in accordance with our present invention;

REFERENCE NUMERALS
100 – Step-1: Weighed quantity of purified water was taken in an SS container and kept under stirring at 350 RPM

101 – Step -2: Weighed quantity of Green Coffee Extract was added to above step-1 under stirring at 350 RPM for 5 min

102 – Step -3: Weighed quantity of Polysorbate 80 was added to the above step-2 under stirring at 400 RPM for 15 min

103 – Step-4: Weighed quantity of Roasted coffee flavor was added to above step-3 under stirring at 500 RPM for 20 min

104 – Step -5: Weighed quantity of Polyethylene oxide was added to the above step-4 under stirring at 500 RPM for 3 min

105 – Step -6: Weighed quantity of Chocolate brown colour was added to above step-5 under stirring at 500 RPM for 15 min

106 – Step -7: Weighed quantity of Dibasic Calcium phosphate was added to above step-6 under stirring at 500 RPM for 10 min

107 – Step -8: Weighed quantity of Xanthan gum was added to above step-7 under stirring at 500 RPM for 5min

108 – Step -9: Weighed quantity of Pullulan was added to above step-8 under stirring at 500 RPM for 10min

109 – Step -10: Finally, above step- 9 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution

110 – Step -11: Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry

111 – Step -12: The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns; Temperature 95±3°C; and In-direct drying

112 – Step -13: The dried casted film was slitted into required dimensions for achieving the final dose

Detailed Description of the Invention
It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. In addition, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

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.

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, which are intended to define the spirit and scope of this invention.

The present invention relates to disintegrating films that make green coffee consumption more convenient than traditional methods, which in general take a long time to prepare. When compared to conventional products like coffee powder and coffee dips these films offer more advantages in terms of preparation, handling, and storage.

Green coffee, derived from unroasted coffee beans, offers a variety of health benefits primarily attributed to its high content of chlorogenic acids and antioxidants.
Here are some key benefits:
Weight Management: Green coffee is often associated with weight loss due to chlorogenic acid, which may help reduce carbohydrate absorption and improve metabolism. Studies suggest that it can aid in fat burning and appetite regulation, making it a popular choice for those looking to manage their weight effectively.

Blood Sugar Regulation: The chlorogenic acids in green coffee can enhance insulin sensitivity and regulate blood sugar levels by slowing glucose absorption in the intestines. This property makes it beneficial for individuals at risk of type 2 diabetes or those managing their blood sugar levels.

Heart Health: Regular consumption of green coffee may support cardiovascular health by lowering blood pressure and improving cholesterol profiles. It has been shown to help reduce LDL cholesterol levels while increasing HDL cholesterol, contributing to better heart health.

Antioxidant Effects: Green coffee is rich in antioxidants, particularly chlorogenic acids, which combat oxidative stress and free radical damage in the body. This antioxidant activity can help reduce the risk of chronic diseases and promote overall health.

Cognitive Enhancement: The caffeine content in green coffee can improve cognitive function, increase alertness, and enhance mood. It is believed to stimulate neurotransmitters that promote mental clarity and focus without the jitters commonly associated with regular coffee.

Anti-Aging Properties: The antioxidant properties of green coffee may also provide anti-aging benefits by promoting skin health, reducing inflammation, and protecting against UV damage. This can lead to improved skin elasticity and a reduction in wrinkles.

Detoxification: Green coffee acts as a natural detoxifier, helping to eliminate toxins from the body and support overall health by bolstering the immune system.

In one embodiment of the present invention, green coffee extract in the present formulation is provided in a disintegrating film dosage form for oral consumption is disclosed.

In one embodiment of the present invention, green coffee is supplemented with Shilajit and/or Ashwagandha and /or Q-actin and is presented in the form of a disintegrating film dosage form for oral consumption is disclosed.

In one embodiment of the present invention, the benefits provided by the green coffee disintegrating film can include but are not limited to weight management, regulates blood sugar levels, and supports heart health by lowering blood pressure and cholesterol.

In one embodiment of the present invention, the disintegrating film will protect the body from stress and maintain energy levels throughout the day thus providing a balanced and sustained energy boost.

In one embodiment of the present invention, the disintegrating film will support the anti-inflammatory action that contributes to its potential as a therapeutic agent for joint health, while also supporting weight management through enhanced metabolic processes.

The working examples of the present embodiment with the combination of the ingredients and the manufacturing procedure are tabulated below:
Example 1
S No. Ingredients Function Range
% w/w
1 Green Coffee Extract Active 30 - 40
2 Pullulan Polymer 15 - 20
3 Polyethylene oxide Polymer 5.0 - 7.13
4 Xanthan gum Viscosity enhancer 1 - 2
5 Chocolate brown Color 0.1 – 0.5
6 Dibasic Calcium phosphate Anti adherent 0.05 – 2.9
7 Roasted coffee flavor Flavoring agent 5 - 10
8 Polysorbate 80 Plasticizer 15 - 25
9 Purified Water Vehicle Qs

Example 1
A method of preparation of the said disintegrating films comprises of the following steps:
Step no. Details of the Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in an SS container and kept under stirring at 350 RPM (100)
Step 2 Weighed quantity of Green Coffee Extract was added to above step-1 under stirring at 350 RPM for 5 min (101)
Step 3 Weighed quantity of Polysorbate 80 was added to the above step-2 under stirring at 400 RPM for 15 min (102)
Step 4 Weighed quantity of Roasted coffee flavor was added to above step-3 under stirring at 500 RPM for 20 min (103)
Step 5 Weighed quantity of Polyethylene oxide was added to the above step-4 under stirring at 500 RPM for 3 min (104)
Step 6 Weighed quantity of Chocolate brown was added to above step-5 under stirring at 500 RPM for 15 min (105)
Step 7 Weighed quantity of Dibasic Calcium phosphate was added to above step-6 under stirring at 500 RPM for 10 min (106)
Step 8 Weighed quantity of Xanthan gum was added to above step-7 under stirring at 500 RPM for 5min (107)
Step 9 Weighed quantity of Pullulan was added to above step-8 under stirring at 500 RPM for 10min (108)
Step 10 Finally, above step- 9 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution (109)
Step 11 Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry (110)
Step 12 The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns; Temperature 95±3°C; and In-direct drying (111)
Step 13 The dried casted film was slitted into required dimensions for achieving the final dose (112)

The stability of the dissolving film is studied, and the results are tabulated below. Several trial-and-error experiments have been conducted to develop the stable product.
Example - 1 Stability data
Tests Initial 40°C± 2°C/75% ± 5%RH 30°C± 2°C/65% ± 5%RH 25°C± 2°C/60% ± 5%RH
1M 3M 6M 1M 3M 6M 1M 3M 6M
Description Dark brown coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content (%) 12.66 12.31 11.26 11.09 12.78 12.77 12.32 12.74 12.12 12.28
Disintegration Time (Sec) 24 23 24 26 24 21 2 26 27 26
Folding Endurance (no.s) >150 >150 >150 >150 >150 >151 >150 >149 >150 >150
Assay of chlorogenic acid (%) 102.4 101.7 99.9 97.7 101.7 100.5 98.6 102.5 100.3 99.8

The second embodiment of our present invention is given below:
Example 2
S No. Ingredients Function Range
% w/w
1 Green Coffee Extract Active 30 - 40
2 Ashwagandha Active 2 - 25
3 Pullulan Polymer 10 - 35
4 Maltodextrin Diluent 3.0 – 7.3
5 Xanthan gum Viscosity enhancer 0.3 – 4.3
6 Chocolate brown Color 0.05 – 0.3
7 Dibasic Calcium phosphate Anti adherent 0.05 – 2.9
8 Roasted coffee flavor Flavoring agent 3 – 8.8
9 Glycerin Plasticizer 5 - 17
10 Purified Water Vehicle Qs
Example 2
A method of preparation of the said disintegrating films comprises of the following steps:
Step no. Details of the Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in an SS container and kept under stirring at 350 RPM
Step 2 Weighed quantity of Green Coffee Extract was added to above step-1 under stirring at 350 RPM for 5 min
Step 3 Weighed quantity of Ashwagandha was added to the above step-2 under stirring at 400 RPM for 15 min
Step 4 Weighed quantity of Roasted coffee flavor was added to above step-3 under stirring at 500 RPM for 20 min
Step 5 Weighed quantity of Glycerin was added to above step-4 under stirring at 500 RPM for 20 min
Step 6 Weighed quantity of Maltodextrin was added to the above step-5 under stirring at 500 RPM for 3 min
Step 7 Weighed quantity of Chocolate brown was added to above step-6 under stirring at 500 RPM for 15 min
Step 8 Weighed quantity of Dibasic Calcium phosphate was added to above step-7 under stirring at 500 RPM for 10 min
Step 9 Weighed quantity of Xanthan gum was added to above step-8 under stirring at 500 RPM for 5min
Step 10 Weighed quantity of Pullulan was added to above step-9 under stirring at 500 RPM for 10min
Step 11 Finally, above step- 10 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution
Step 12 Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
Step 13 The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns; Temperature 95±3°C; and In-direct drying
Step 14 The dried casted film was slitted into required dimensions for achieving the final dose

The stability of the dissolving film is studied, and the results are tabulated below. Several trial-and-error experiments have been conducted to develop a stable product.
Example - 2 Stability data
Tests Initial 40°C± 2°C/75% ± 5%RH 30°C± 2°C/65% ± 5%RH 25°C± 2°C/60% ± 5%RH
1M 3M 6M 1M 3M 6M 1M 3M 6M
Description Dark brown coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content (%) 10.45 11.23 11.81 10.12 9.45 11.34 12.45 10.65 11.76 10.43
Disintegration Time (Sec) 22 21 25 25 21 21 27 22 25 27
Folding Endurance (no.s) >150 >150 >150 >150 >150 >151 >150 >149 >150 >150
Assay of chlorogenic acid (%) 101.4 100.4 98.1 96.2 100.3 99.2 97.6 101.3 99.7 99.1

In yet another embodiment of the present invention the ingredients and its combination are tabulated below:
Example 3
S No. Ingredients Function Range
% w/w
1 Green Coffee Extract Active 30 - 40
2 Ashwagandha Active 2 - 25
3 Shilajit Active 1 - 30
4 Pullulan Polymer 15 - 34
5 Maltodextrin Diluent 2.6 – 6.1
6 Xanthan gum Viscosity enhancer 0.5 – 5.9
7 Chocolate brown Color 0.05 – 0.3
8 Dibasic Calcium phosphate Anti adherent 0.05 – 2.9
9 Roasted coffee flavor Flavoring agent 2 – 5.9
10 Polysorbate 80 Plasticizer 3 - 12
11 Purified Water Vehicle Qs

Example 3
A method of preparation of the said disintegrating films comprises of the following steps:
Step no. Details of the Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in an SS container and kept under stirring at 350 RPM
Step 2 Weighed quantity of Green Coffee Extract was added to above step-1 under stirring at 350 RPM for 5 min
Step 3 Weighed quantity of Ashwagandha was added to the above step-2 under stirring at 400 RPM for 15 min
Step 4 Weighed quantity of Shilajit was added to the above step-3 under stirring at 400 RPM for 15 min
Step 5 Weighed quantity of Roasted coffee flavor was added to above step-4 under stirring at 500 RPM for 20 min
Step 6 Weighed quantity of Polysorbate 80 was added to above step-5 under stirring at 500 RPM for 20 min
Step 7 Weighed quantity of Maltodextrin was added to the above step-6 under stirring at 500 RPM for 3 min
Step 8 Weighed quantity of Chocolate brown was added to above step-7 under stirring at 500 RPM for 15 min
Step 9 Weighed quantity of Dibasic Calcium phosphate was added to above step-8 under stirring at 500 RPM for 10 min
Step 10 Weighed quantity of Xanthan gum was added to above step-9 under stirring at 500 RPM for 5min
Step 11 Weighed quantity of Pullulan was added to above step-10 under stirring at 500 RPM for 10min
Step 12 Finally, above step- 11 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution
Step 13 Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
Step 14 The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns; Temperature 95±3°C; and In-direct drying
Step 15 The dried casted film was slitted into required dimensions for achieving the final dose

The stability data for this embodiment of our present invention is given below:
Example - 3 Stability data
Tests Initial 40°C± 2°C/75% ± 5%RH 30°C± 2°C/65% ± 5%RH 25°C± 2°C/60% ± 5%RH
1M 3M 6M 1M 3M 6M 1M 3M 6M
Description Dark brown coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content (%) 9.56 9.89 8.87 9.32 9.87 10.19 9.31 10.83 10.16 10.11
Disintegration Time (Sec) 35 36 29 33 38 39 36 38 41 39
Folding Endurance (no.s) >150 >150 >150 >150 >150 >151 >150 >149 >150 >150
Assay of chlorogenic acid (%) 99.2 97.1 96.1 96.4 100.1 98.5 96.9 100.1 99.3 97.5

In yet another embodiment of the present invention the ingredients and its combination are tabulated below:
Example 4
S No. Ingredients Function Range
% w/w
1 Green Coffee Extract Active 30 - 40
2 Ashwagandha Active 2 - 25
3 Shilajit Active 1 - 30
4 Q-actin Active 0.1 - 15
5 Pullulan Polymer 11 - 40
6 Polyethylene oxide Polymer 1.2 – 7.2
7 Xanthan gum Viscosity enhancer 0.3 – 3.9
8 Chocolate brown Color 0.05 – 0.43
9 Dibasic Calcium phosphate Anti adherent 0.05 – 2.9
10 Roasted coffee flavor Flavoring agent 1.4 – 4.4
11 PEG 400 Plasticizer 2.1 – 10.7
12 Purified Water Vehicle Qs

Example 4
A method of preparation of the said disintegrating films comprises of the following steps:
Step no. Details of the Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in an SS container and kept under stirring at 350 RPM
Step 2 Weighed quantity of Green Coffee Extract was added to above step-1 under stirring at 350 RPM for 5 min
Step 3 Weighed quantity of Ashwagandha was added to the above step-2 under stirring at 400 RPM for 15 min
Step 4 Weighed quantity of Shilajit was added to the above step-3 under stirring at 400 RPM for 15 min
Step 5 Weighed quantity of Q-actin was added to the above step-4 under stirring at 400 RPM for 15 min
Step 6 Weighed quantity of Roasted coffee flavor was added to above step-5 under stirring at 500 RPM for 20 min
Step 7 Weighed quantity of PEG 400 was added to above step-6 under stirring at 500 RPM for 20 min
Step 8 Weighed quantity of Polyethylene oxide was added to the above step-7 under stirring at 500 RPM for 3 min
Step 9 Weighed quantity of Chocolate brown was added to above step-8 under stirring at 500 RPM for 15 min
Step 10 Weighed quantity of Dibasic Calcium phosphate was added to above step-9 under stirring at 500 RPM for 10 min
Step 11 Weighed quantity of Xanthan gum was added to above step-10 under stirring at 500 RPM for 5min
Step 12 Weighed quantity of Pullulan was added to above step-11 under stirring at 500 RPM for 10min
Step 13 Finally, above step- 12 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution
Step 14 Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
Step 15 The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns; Temperature 95±3°C; and In-direct drying
Step 16 The dried casted film was slitted into required dimensions for achieving the final dose

The stability data for this embodiment of our present invention is given below:
Example - 4 Stability data
Tests Initial 40°C± 2°C/75% ± 5%RH 30°C± 2°C/65% ± 5%RH 25°C± 2°C/60% ± 5%RH
1M 3M 6M 1M 3M 6M 1M 3M 6M
Description Dark brown coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content (%) 11.50 10.89 11.87 10.42 10.56 10.98 9.83 11.73 10.45 10.29
Disintegration Time (Sec) 43 39 39 34 38 43 46 34 45 49
Folding Endurance (no.s) >150 >150 >150 >150 >150 >151 >150 >149 >150 >150
Assay of chlorogenic acid (%) 100.2 97.4 94.5 95.8 100.8 97.9 96.1 100.4 99.6 97.1

The above-mentioned formulations are non-limiting examples of suitable disintegrating film compositions. In particular embodiments of the subject invention have been described, it will be obvious to those skilled in the art that various changes and modifications to the subject invention can be made without departing from the scope of the invention.

The present invention is compared with the existing standard marketed products. The efficacy is tabulated on the table below.

Determination of Total Polyphenol Content in Green Coffee samples:
The total polyphenol content of the green coffee extract was determined using the Folin-Ciocalteu method. A 20 μL aliquot of the extract was diluted with 1580 μL of distilled water. From this, 160 μL of the diluted extract was mixed with 10 μL of Folin-Ciocalteu’s phenol reagent and allowed to react for 8 minutes at room temperature. Subsequently, 30 μL of a 20% sodium carbonate (Na₂CO₃) solution was added to the mixture, which was then incubated in the dark for 2 hours to allow for color development. Distilled water was used as a control, and a standard curve was generated using gallic acid solutions (0–1 mg/mL) with a correlation coefficient (r2 = 0.997). The absorbance of the reaction mixtures was measured at 765 nm using a UV-visible spectrophotometer. The polyphenol content of the extract was expressed as milligrams of gallic acid equivalents per millilitre (mg GAE/g), ensuring an accurate quantification of the phenolic compounds.

Total polyphenols content:
Sample Total polyphenols
(mg GAE/g)

Marketed formulation (Green coffee powder) 234.76
Green Coffee Films (GCF) 356.23
Green Coffee + Ashwagandha (GCAF) 454.38
GC + Ashwagandha + Shilajit (GCASF) 509.22
GC + Ashwagandha + Shilajit + Q-actin (GCASFQ) 505.26

In-vitro release of Polyphenol in various green coffee formulations:
The in-vitro release of polyphenols was evaluated using a paddle-type dissolution apparatus in a purified water maintained at 37 ± 0.5°C. Samples, including Marketed Coffee Powder, Green Coffee Films (GCF), and their combinations with Ashwagandha, Shilajit, and Q-actin, were placed in separate vessels containing 900 mL of dissolution medium and stirred at 50 rpm. Aliquots of 5 mL were withdrawn at predefined intervals (1, 2, 3, 5, and 10 minutes), filtered using a 0.45 µm syringe filter, and analyzed spectrophotometrically for polyphenol content using Folin-Ciocalteu reagent at 765 nm. The percentage cumulative release was calculated based on a standard calibration curve.

The results highlighted a significant improvement in the dissolution rate of polyphenols for the film formulations compared to the Marketed Coffee Powder. At 10 minutes, the cumulative release for the Marketed Coffee Powder was 62.23%, whereas the film formulations exhibited superior dissolution rates, with Green Coffee Films (GCF) achieving 99.99%. The addition of other components in the different film formulations showed comparable release profiles, with all formulations achieving over 100% release by 10 minutes. The rapid disintegration and increased surface area of the film dosage forms accounted for their faster dissolution when compared to the Marketed Coffee Powder, which dissolved more slowly due to its particulate nature. The study clearly demonstrates the advantage of film dosage forms in enhancing the dissolution rate of polyphenols, as shown in fig 2. The rapid release profiles of the films make them an efficient delivery system, offering significant benefits over conventional powder formulations.

In an embodiment of the present invention, the disintegrating film has a faster onset of action. The Green coffee disintegrating films dissolve quickly upon contact with water, allowing for faster absorption of the active ingredients compared to marketed green coffee product. Additionally, this quick dissolution facilitates the rapid release of bioactive polyphenols, enhancing the potential health benefits of green coffee.

There is no need for brewing or steeping in the present invention. The Green coffee disintegrating films can be easily carried, making them a convenient option for people during traveling.

The disintegrating films are thin, lightweight, and individually packaged, which makes them highly portable and easy to carry. Each film is manufactured to high standards, ensuring accurate and consistent delivery of the active ingredients in less time.

The Green coffee disintegrating films typically have better shelf stability and resistance to temperature fluctuations compared to conventional coffee products, which may be susceptible to microbial contamination or deterioration during improper storage.
Sample Preparation
Five sample groups were tested and are represented below:
A. Marketed coffee powder.
B. Green coffee disintegrating films (GCF).
C. Green coffee + ashwagandha films (GCAF).
D. Green coffee + ashwagandha + shilajit films (GCASF).
E. Green coffee + ashwagandha + shilajit + Q-actin films (GCASFQ).

Methods for measuring antioxidant capacity
1. DPPH Radical Scavenging Activity
● Procedure: The DPPH radical scavenging activity was determined using a modified method of Gülçin et al, as shown in fig3. Reaction mixtures contained 50 µl of coffee extract (20–100 µg/ml) and 2.95 ml of 0.1 mM DPPH in methanol. After thorough mixing, the samples were incubated in the dark at room temperature for 30 minutes. Absorbance was measured at 517 nm. Ascorbic acid was used as the standard. The percentage of DPPH radical scavenging activity was calculated using the equation:
% Radical Scavenging=[(Abscontrol−Abssample) / Abscontrol]×100

2. ABTS Radical Scavenging Activity (fig.4)
● Procedure: ABTS radical scavenging activity was evaluated using the method of Re et al. The ABTS working solution was prepared by reacting 7 mM ABTS with 2.4 mM potassium persulfate in equal amounts and incubating in the dark for 12 hours. The ABTS+ solution was diluted with methanol to an absorbance of 0.76 at 734 nm. Coffee extracts (20–100 µg/ml) were reacted with ABTS+ solution for 7 minutes, and absorbance was recorded at 734 nm. Ascorbic acid was used as the standard. The percentage of ABTS radical scavenging activity was calculated using the equation:
% Radical Scavenging=[(Abscontrol−Abssample) / Abscontrol]×100

3. Ferric Reducing Antioxidant Potential (FRAP) (fig.5)
● Procedure: FRAP reagent was freshly prepared by mixing 300 mM acetate buffer (pH 3.6), 10 mM TPTZ in 40 mM HCl, and 20 mM ferric chloride in a ratio of 10:1:1. Coffee extracts (16 µl, 20 µg/ml) were mixed with 500 µl FRAP reagent and 50 µl distilled water, incubated for 4 minutes, and absorbance was measured at 593 nm. Activity was expressed as µmol Fe²⁺/g using a FeSO₄ standard curve.

4. Nitric Oxide (NO) Scavenging Activity
● Procedure: Sodium nitroprusside (2 ml) in phosphate-buffered saline was incubated with coffee extracts (20–100 µg/ml) at 25°C for 150 minutes. The reaction mixture was mixed with Griess reagent, incubated for 30 minutes, and absorbance was recorded at 540 nm. Quercetin was used as the standard. The percentage of NO radical scavenging activity was calculated using the equation:
% Radical Scavenging=[(Abscontrol−Abssample) / Abscontrol]×100

5. Superoxide Anion Scavenging Activity (fig. 7)
● Procedure: Coffee extracts (20–100 µg/ml) were reacted with 1 ml of PMS (60 µM) and 1 ml of NADH in phosphate buffer (pH 7.4) at 25°C for 5 minutes. Absorbance was measured at 230 nm. Quercetin served as the standard for comparison. The percentage of NO radical scavenging activity was calculated using the equation:
% Radical Scavenging=[(Abscontrol−Abssample) / Abscontrol]×100

6. Cell assay by Oxidative stress cell method (fig.8)
● Procedure: The antioxidant potential of marketed coffee powder, green coffee + ashwagandha films, green coffee + ashwagandha + shilajit films, and green coffee + ashwagandha + shilajit + Q-actin films was evaluated using a HepG2 oxidative stress cell model. HepG2 cells were cultured in DMEM supplemented with 10% FBS and antibiotics, seeded in 96-well plates, and treated with 200 µM H₂O₂ for 2 hours to induce oxidative stress. The test samples were prepared in suitable solvents at specific concentrations and incubated with the cells for 24 hours before oxidative stress induction. Intracellular ROS levels were measured using the DCFH-DA fluorescence assay, with fluorescence intensity recorded at excitation/emission wavelengths of 485/535 nm.

Discussion on the Comparative Evaluation of Antioxidant Activity
The antioxidant activities of the tested samples followed the order:
Marketed Coffee Powder < Green Coffee Films (GCF) < Green Coffee + Ashwagandha Films (GCAF) < Green Coffee + Ashwagandha + Shilajit Films (GCASF) = Green Coffee + Ashwagandha + Shilajit + Q-actin Films (GCASFQ).
1. Marketed Coffee Powder:
o The marketed product (powder) demonstrated the lowest antioxidant activity across all assays, reflecting limited polyphenolic content and reduced bioavailability of its active components. Traditional coffee powders are often subjected to thermal processing, which can degrade heat-sensitive bioactives like chlorogenic acid and related polyphenols. This reduction in polyphenol content likely contributed to its lower performance in scavenging free radicals and reducing oxidative intermediates.
2. Green Coffee Films (GCF):
o GCF displayed a significant enhancement in antioxidant activity compared to the marketed powder. This improvement is attributable to the stabilization of chlorogenic acid and other polyphenols within the film matrix, which prevents oxidation and degradation. The disintegration properties of the films further ensure rapid dissolution and bioavailability, leading to enhanced radical scavenging efficiency.

3. Green Coffee + Ashwagandha Films (GCAF):
o Incorporating Ashwagandha boosted antioxidant activity significantly. Ashwagandha root extract contains bioactives like withanolides and withaferin A, known for their free-radical neutralizing and oxidative stress-reducing properties. The synergistic interaction between green coffee polyphenols and Ashwagandha bioactives likely potentiates their combined antioxidant efficacy. Enhanced nitric oxide scavenging and superoxide neutralization in this sample are indicative of its therapeutic potential for conditions involving reactive oxygen and nitrogen species.

4. Green Coffee + Ashwagandha + Shilajit Films (GCASF):
o Adding Shilajit further elevated the antioxidant activity, as evidenced by the highest performance across all assays. Shilajit, a natural resin rich in fulvic acid and trace minerals, functions as a powerful stabilizer for polyphenols and other bioactives. Its chelating properties also enhance ferric ion reduction and mitigate oxidative stress by promoting cellular energy metabolism. Shilajit’s role as a bioavailability enhancer ensures maximal utilization of active components, which explains the superior performance of GCASF.

5. Green Coffee + Ashwagandha + Shilajit + Q-actin Films (GCASFQ):
o The addition of Q-actin, a non-antioxidant bioactive, did not contribute to antioxidant capacity. This result aligns with Q-actin’s mode of action, which is not related to radical scavenging. The combination reduced ROS levels by over 70% while also addressing secondary effects of oxidative stress, such as inflammation. Q-actin's role in modulating inflammation pathways complements the antioxidant action of the other components, resulting in a formulation that not only reduces oxidative damage but also promotes recovery from oxidative stress-induced cellular injury. However, the antioxidant performance of this formulation matched that of GCASF, indicating that the film matrix remains stable, and Q-actin’s inclusion does not compromise the activity of other components.

Mechanistic Insights
● DPPH and ABTS Radical Scavenging Assays: These assays measure the ability of bioactives to donate electrons or hydrogen atoms to neutralize free radicals. The progressive increase in scavenging activity from GCF to GCASF indicates that each added component (Ashwagandha, Shilajit) synergistically enhances electron-donating capacity.
● FRAP Assay: This assay quantifies the ability to reduce ferric ions to ferrous ions, reflecting reducing power. The highest values observed in GCASF and GCASFQ suggest a robust electron-donating environment created by the combined polyphenols, fulvic acid, and with anolides.
● Nitric Oxide and Superoxide Scavenging: Enhanced performance in these assays for GCAF and GCASF highlights their efficacy in neutralizing reactive oxygen and nitrogen species, making them particularly relevant for managing oxidative stress-mediated pathologies.
● Oxidative stress cell model: The marketed coffee powder exhibited moderate antioxidant activity, reducing ROS levels by approximately 25% compared to untreated stressed cells. This result underscores its limited efficacy in mitigating oxidative stress when used independently. The green coffee + ashwagandha films displayed significantly enhanced antioxidant capacity, reducing ROS levels by nearly 51%. This improvement is attributed to the complementary antioxidant properties of green coffee and ashwagandha, which are well-documented for their ability to scavenge free radicals effectively. The addition of shilajit in the green coffee + ashwagandha + shilajit films further improved antioxidant activity, achieving an ROS reduction of approximately 76%. The fulvic acid and bioactive compounds in shilajit likely enhanced the formulation's ability to neutralize oxidative stress, providing a more robust protective effect. Interestingly, the Green coffee + Ashwagandha + Shilajit + Q-actin films demonstrated a unique advantage. Although Q-actin does not directly possess antioxidant properties, its inclusion contributed to the formulation’s efficacy by mitigating inflammation caused by oxidative stress.

Stability and Bioavailability
The film-based formulations outperformed marketed powder due to the superior stability of their active ingredients. Films protect polyphenols from environmental degradation (e.g., heat, light, and oxygen) and enhance solubility and absorption through rapid disintegration and release. These advantages position disintegrating films as an innovative delivery platform for bioactives.

Practical Implications
1. Therapeutic Applications: GCASF formulations are highly suited for oxidative stress-related therapeutic conditions due to their potent radical scavenging and reducing capabilities. The inclusion of Ashwagandha and Shilajit in these films could also contribute to stress reduction and improved energy metabolism.
2. Product Differentiation: The marked improvement in antioxidant activity compared to the marketed coffee powder highlights the value addition offered by the film dosage form. GCASFQ, while not superior in antioxidant activity, could cater to specific therapeutic niches through Q-actin’s non-antioxidant benefits, such as anti-inflammatory or cartilage-protective effects.

The results unequivocally demonstrate that Green Coffee + Ashwagandha + Shilajit Films (GCASF) are the most effective antioxidant formulations among the tested embodiments of our present invention. The combination of stabilized polyphenols, Ashwagandha’s bioactives, and Shilajit’s chelating and bioavailability-enhancing properties underpins their superior performance. These findings highlight the importance of combining antioxidants with anti-inflammatory agents to achieve a comprehensive approach to managing oxidative stress and its consequences. The study demonstrates that while the primary antioxidant activity was driven by Green coffee, Ashwagandha, and Shilajit, the addition of Q-actin enhanced the therapeutic potential by addressing inflammation, making the formulation suitable for broader applications in functional foods and nutraceuticals. The advanced disintegrating film format emerges as a promising delivery vehicle, enhancing the stability, bioavailability, and efficacy of natural antioxidants.
, Claims:CLAIMS
We Claim
1. A disintegrating film comprising of:
a. Green Coffee Extract Active 30 – 40 %w/w
b. Pullulan Polymer 15 – 20 %w/w
c. Polyethylene oxide Polymer 5.0 - 7.13 %w/w
d. Xanthan gum Viscosity enhancer 1 – 2 %w/w
e. Chocolate brown Color 0.1 – 0.5 %w/w
f. Dibasic Calcium phosphate Anti adherent 1 – 3 %w/w
g. Roasted coffee flavor Flavoring agent 5 – 10 %w/w
h. Polysorbate 80 Plasticizer 15 – 25 %w/w
i. Purified Water Vehicle Qs
Wherein, the disintegrating film is prepared by a method of forming a wet slurry with the ingredients 1(a)-1(i) added in precise steps and processed, which is then cast at parameters set by a doctor knife, with a thickness ranging from 500 to 1000 microns and a temperature of 95±3°C.

2. The method of processing disintegrating film of green coffee, as claimed in claim 1, comprising the steps of:
a. Weighed quantity of purified water was taken in an SS container and kept under stirring at 350 RPM (100)
b. Weighed quantity of Green Coffee Extract was added to above step-1 under stirring at 350 RPM for 5 min (101)
c. Weighed quantity of Polysorbate 80 was added to the above step-2 under stirring at 400 RPM for 15 min (102)
d. Weighed quantity of Roasted coffee flavor was added to above step-3 under stirring at 500 RPM for 20 min (103)
e. Weighed quantity of Polyethylene oxide was added to the above step-4 under stirring at 500 RPM for 3 min (104)
f. Weighed quantity of Chocolate brown was added to above step-5 under stirring at 500 RPM for 15 min (105)
g. Weighed quantity of Dibasic Calcium phosphate was added to above step-6 under stirring at 500 RPM for 10 min (106)
h. Weighed quantity of Xanthan gum was added to above step-7 under stirring at 500 RPM for 5min (107)
i. Weighed quantity of Pullulan was added to above step-8 under stirring at 500 RPM for 10min (108)
j. Finally, above step- 9 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution (109)
k. Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry (110)
l. The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 1000 microns; Temperature 95±3°C; and In-direct drying (111)
m. The dried casted film was slitted into required dimensions for achieving the final dose (112)