DESC:Technical Field of the Invention

The present invention relates to the field of films containing therapeutic active ingredients, more specifically to an oral film composition provided in a dissolving film dosage form for oral consumption.

Background of the Invention

The skin, joints, and eyes contain large amounts of Hyaluronic acid, a polysaccharide (a type of carbohydrate) that lubricates and maintains the moisture of tissues. As age progresses, the body produces less hyaluronic acid. Hyaluronic acid supplements could thus aid in the treatment or prevention of illnesses linked to ageing. Hyaluronic acid taken orally has been shown to have antiaging qualities that enhance skin tone and lessen fine lines and wrinkles. Additionally, Hyaluronic acid improves skin elasticity, texture, wrinkle depth, and hydration. Hyaluronic acid helps skin flex and stretch while also minimising lines and wrinkles. Also, Hyaluronic acid has been shown to promote wound healing and lessen scarring.

A 2017 study published in Clinical, Cosmetic, and Investigational Dermatology found that after 12 weeks of oral hyaluronan therapy, the depth and volume of 60 people's crow's feet (wrinkles around the corner of the eyes) decreased. Additionally, they exhibited more suppleness and shine to their skin.

Hyaluronic acid is a component of cartilage, the flexible tissue that covers the ends of bones in joints. Some research suggests that HA supplementation could support cartilage health by providing essential nutrients for its maintenance and possibly helping to delay its breakdown. Maintaining the health of synovial fluid and cartilage can potentially enhance joint function and mobility.

It is said that vitamin C is the most effective treatment for all skin issues. When combined with Vitamin-C in a skincare program, Hyaluronic acid can deliver far better anti-aging outcomes than using either one alone. Hyaluronic acid and Vitamin-C work marvelously together to produce effects that are significantly superior to those of utilizing either substance alone. Since Hyaluronic acid is hydrophilic by nature, it improves vitamin-C absorption, leading to more direct Vitamin-C being available in the epidermal layers. Since both substances have potent anti-aging qualities, they work well together as a powerful anti-aging pair to improve the appearance of the skin and fight against the earliest indications of age.

With continued use, incorporating these two substances into your skincare regimen can improve the health and appearance of your skin, reducing fine lines and wrinkles, fading hyperpigmentation and dark spots, and hydrating your skin.

Collagen is a major structural protein in bones, providing strength and flexibility. Vitamin C is essential for collagen synthesis, as it plays a crucial role in the hydroxylation of proline and lysine amino acids, which are important for collagen stability. Hyaluronic acid, on the other hand, is a component of the extracellular matrix in bones and contributes to the organization and stability of collagen fibers. Both Hyaluronic acid and vitamin C have antioxidant properties and have been linked to reducing inflammation in the body. By helping to manage inflammation, these compounds may indirectly support bone and joint health.

In general, the dosage forms are tablets, capsules, and oral liquids. Therefore, this oral dissolving film dosage form is beneficial and practical.

The patent application KR20160062152A discloses a composition comprising substantially pure sericin-free, pure silk fibroin-based protein fragments, wherein the composition has an average weight average molecular weight ranging from about 17 kDa to about 38 kDa, wherein the composition comprises from about 1.5 to about 3.0 Wherein the composition is substantially uniform, wherein the composition comprises from 0 ppm to about 500 ppm of inorganic residues, wherein the composition comprises from 0 ppm to about 500 ppm of organic residues.

Another patent US9855206B2 claims hyaluronic acid gel sheet comprising hyaluronic acid alcogel containing 100 parts by weight of a hyaluronic acid having a molecular weight of from 5×104 to 5×106 daltons, 10 to 100 parts by weight of polycarboxylic acid or oxycarbonic acid, and 100 to 8000 parts by weight of polyhydric alcohol, wherein a thickness of the sheet is in a range of 30 µm to 1 mm, the polyhydric alcohol is selected from the group consisting of glycerin, propylene glycol, ethylene glycol, polyethylene glycol, 1,3-butylene glycol, dipropylene glycol and sorbitol, and wherein the hyaluronic acid alcogel is formed by drying an aqueous solution containing the hyaluronic acid, the polycarboxylic acid or oxycarbonic acid, and the polyhydric alcohol to remove water therefrom.

While Hyaluronic acid (HA) and ascorbic acid (AA) are generally safe and well-tolerated, their formulations as tablets, gummies, and syrups may have some disadvantages. These disadvantages can vary based on the specific formulation and individual patient characteristics. Some potential disadvantages include:

Variable Absorption: In tablet and gummy formulations, the bioavailability of HA and AA may vary between individuals due to differences in gastrointestinal pH, gastric emptying rate, and interactions with other substances in the digestive system. This variability may lead to inconsistent therapeutic effects.

Slower Onset of Action: Tablets and gummies usually take longer to disintegrate, and dissolve compared to oral disintegrating films or liquids. This slower onset of action may delay the desired therapeutic effects, especially when immediate action is needed.

Swallowing Difficulties: Tablets, especially larger ones, can be difficult for some individuals, particularly children and elderly patients, to swallow. This can lead to non-compliance or a risk of choking if not taken properly.

Lower Bioavailability: Some oral tablets and gummies may contain preservatives, stabilizers, and other excipients that could interact with HA and AA, potentially reducing their bioavailability or stability.

Stability Issues: HA and AA in tablet and gummy formulations may be sensitive to environmental conditions, leading to degradation and reduced potency over time if not stored properly.

Sugar Content in Syrups and Gummies: Some formulations of syrups and gummies may contain added sugars or sweeteners to enhance taste. Excessive sugar consumption can have negative health effects, especially for individuals with diabetes or those trying to reduce sugar intake.

Reduced Mohaddessin: Tablets and gummies may lack the mucoadhesive properties that are present in oral disintegrating films, potentially reducing the drug's residence time in the oral cavity and affecting bioavailability.

Potential Interactions: HA and AA may interact with other drugs or supplements taken simultaneously, leading to reduced effectiveness or adverse effects. It is essential for patients to consult their healthcare providers to avoid potential interactions.

Flavor and Taste Issues: Some individuals may find the taste of HA and AA formulations in tablets, unpleasant, leading to poor compliance, especially in children.

Overconsumption Risk with Gummies: Gummy formulations, due to their palatable taste and appearance, may be perceived as candies and inadvertently lead to overconsumption, resulting in excessive intake of HA and AA.

There are many other patents/applications and scientific literatures which provide different types of formulations for orally, topically administration to improve skin care. However, Hyaluronic acid and Vitamin-C combined in the present formulation and provided in a dissolving film dosage form for oral consumption is not studied or reported till date. The prior-arts addresses some of the benefits of skin care but none of the documents till date report the oral dissolving film for skin care comprising the researched ingredients in the specified combination.

The present invention has studied the effects and advantages of the oral dissolving film and the efficacy is proved and is evident that the present invention is effective for skin care.
Objectives of the Invention

The main objective of the present invention is to develop an oral dissolving film composition for skin care and bone health with greater stability.

The second objective of the present invention is to develop a dissolving film that combines hyaluronic acid and vitamin C as active components and pharmaceutically acceptable excipients.

Further objective of the present invention is developing an oral formulation in a dissolving film dosage for skincare routine, bone, and joint health.
Brief 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 oral dissolution film which comprises of Hyaluronic acid and Vitamin C combination as active components along with pharmaceutically acceptable excipients.

In another aspect of our present invention, the oral dissolving films are processed to a wet slurry which was casted at process parameters of Dr. Knife thickness of 500 to 900 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.

Further objects, features, and advantages of the invention will be readily apparent from the following description of the preferred embodiments thereof, taken in conjunction with the accompanying drawings.

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.

REFERENCE NUMERALS:

100 - Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM
101 - Weighed quantity of Vitamin-C (L-Ascorbic acid) was added to above step-1 under stirring at 350 RPM for 5 min
102 - Weighed quantity of Calcium carbonate was added to above step-2 under stirring at 400 RPM for 15 min
103 - Weighed quantity of Sodium Hyaluronate was added to above step-3 under stirring at 500 RPM for 20 min
104 - Weighed quantity of Sucralose was added to above step-4 under stirring at 500 RPM for 3 min
105 - Weighed quantity of Pullulan was added to above step-5 under stirring at 500 RPM for 15 min
106 - Weighed quantity of Polyvinyl alcohol was added to above step-6 under stirring at 500 RPM for 10 min
107 - Weighed quantity of Microcrystalline cellulose was added to above step-7 under stirring at 500 RPM for 5min
108 - Weighed quantity of Propylene glycol was added to above step-8 under stirring at 500 RPM for 10min
109 - Weighed quantity of Peppermint flavour was added to above step-9 under stirring at 500 RPM for 10min
110 - Weighed quantity of Lemon Flavour was added to above step-10 under stirring at 500 RPM for 3 min
111 - Weighed quantity of sunset yellow was added to above step-11 under stirring at 500 RPM for 3 min
112 - Finally, above step- 12 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution
113 - Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
114 - 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
115 - The dried casted film was slitted into required dimensions for achieving the final dose.
116 -
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 use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

According to an exemplary embodiment of the present invention, relates to an oral dissolving film composition for routine skin care and bone and joint health.

It is said that vitamin C is the most effective treatment for all skin issues. When combined with Vitamin-C in a skincare programmed, Hyaluronic acid can deliver far better anti-aging outcomes than using either one alone. Hyaluronic acid and Vitamin-C work marvelously together to produce effects that are significantly superior to those of utilizing either substance alone. Since Hyaluronic acid is hydrophilic by nature, it improves vitamin-C absorption, leading to more direct Vitamin-C being available in the epidermal layers. Since both substances have potent anti-aging qualities, they work well together as a powerful anti-aging pair to improve the appearance of the skin and fight against the earliest indications of age.

Vitamin C is essential for collagen synthesis, as it plays a crucial role in the hydroxylation of proline and lysine amino acids, which are important for collagen stability. Hyaluronic acid, on the other hand, is a component of the extracellular matrix in bones and contributes to the organization and stability of collagen fibers. While they have distinct functions, they can complement each other to support overall bone health in several ways.

In one embodiment of the present invention the Hyaluronic acid and Vitamin-C combined in the present formulation and provided in a dissolving film dosage form for oral consumption is disclosed.

In one embodiment of the present invention, the skin care benefits provided by the oral dissolving film can include but not limited to healthier and younger skin, anti-aging properties, reduce visible pores, wrinkles, and under eye circles, prevent sun damage, blemishes, and hyper-pigmentation, can restore firmness and even texture to the skin.

In one embodiment of the present invention, the oral dissolving film will protect from harmful bacteria and infections, leaving the individual feeling and looking healthier.

In one embodiment of the present invention, the oral dissolving film will help in synthesizing and stabilizing collagen thereby protecting cells, including those in bones, from oxidative stress and damage leading to improved bone and joint health.

The working examples of the present embodiment with the combination of the ingredients and the manufacturing procedure is tabulated below:

Example 1
S No. Ingredients Function Range
% w/w
1 Hyaluronic acid (as Sodium Hyaluronate) API 2 - 20
2 Vitamin-C (as L-Ascorbic acid) API 5 - 32
3 Calcium carbonate pH modifier 3.1 - 7.13
4 Sucralose Sweetener 1.05 - 3.05
5 Microcrystalline cellulose Diluent 6.55 - 15.35
6 Pullulan Polymer 22 - 54
7 Polyvinyl alcohol Polymer 2.1 - 6.4
8 Propylene glycol Plasticizer 0.25 - 1.1
9 Lemon flavour Flavourant 0.5 - 3.2
10 Peppermint flavour Flavourant 0.2 - 1.2
11 Sunset yellow Colourant 0.05 - 0.5
12 Purified water Vehicle Qs

Example 1
A method of preparation of the said oral disintegrating films comprises of the following steps as shown in fig 1:
Step no. Details of the Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM (100)
Step 2 Weighed quantity of Vitamin-C (L-Ascorbic acid) was added to above step-1 under stirring at 350 RPM for 5 min (101)
Step 3 Weighed quantity of Calcium carbonate was added to above step-2 under stirring at 400 RPM for 15 min (102)
Step 4 Weighed quantity of Sodium Hyaluronate was added to above step-3 under stirring at 500 RPM for 20 min (103)
Step 5 Weighed quantity of Sucralose was added to above step-4 under stirring at 500 RPM for 3 min (104)
Step 6 Weighed quantity of Pullulan was added to above step-5 under stirring at 500 RPM for 15 min (105)
Step 7 Weighed quantity of Polyvinyl alcohol was added to above step-6 under stirring at 500 RPM for 10 min (106)
Step 8 Weighed quantity of Microcrystalline cellulose was added to above step-7 under stirring at 500 RPM for 5min (107)
Step 9 Weighed quantity of Propylene glycol was added to above step-8 under stirring at 500 RPM for 10min (108)
Step 10 Weighed quantity of Peppermint flavour was added to above step-9 under stirring at 500 RPM for 10min (109)
Step 11 Weighed quantity of Lemon Flavour was added to above step-10 under stirring at 500 RPM for 3 min (110)
Step 12 Weighed quantity of sunset yellow was added to above step-11 under stirring at 500 RPM for 3 min (111)
Step 13 Finally, above step- 12 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution (112)
Step 14 Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry (113)
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 (114)
Step 16 The dried casted film was slitted into required dimensions for achieving the final dose (115)

The stability of the dissolving film is studied and the results are tabulated below. Several trial-and-error experimentations have been conducted to develop the stable product.

Example-1 Stability data
Tests Initial 40°C / 75% RH 30°C / 65% RH 25°C / 40% RH
1M 2M 3M 6M 1M 2M 3M 6M 1M 2M 3M 6M
Description Orange coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content 13.56% 12.67% 11.37% 11.88% 10.47% 13.00% 13.91% 13.91% 12.17% 13.29% 13.69% 13.58% 12.52%
Disintegration Time 25 sec 20 sec 20 sec 25 sec 29 sec 23 sec 23 sec 27 sec 31 sec 27 sec 27 sec 30 sec 28 sec
Folding Endurance >150 >150 >150 >150 >150 >150 >150 >151 >150 >150 >150 >150 >150
Assay of L-Ascorbic acid 101.40% 98.70% 96.20% 94.90% 90.41% 100.10% 98.10% 95.60% 91.58% 100.90% 98.90% 95.20% 91.61%
Assay of Sodium Hyaluronate 102.60% 100.80% 99.30% 98.90% 97.65% 101.30% 99.90% 98.50% 97.79% 102.50% 100.50% 99.50% 98.58%

The second embodiment of our present invention is given below:

Example 2
S No. Ingredients Function Range
% w/w
1 Hyaluronic acid (as Sodium Hyaluronate) API 15 – 45
2 Vitamin-C (as L-Ascorbic acid) API 2 – 28
3 Calcium carbonate pH modifier 0.5 - 2.5
4 Sucralose Sweetener 1.2 - 3.6
5 Pullulan Polymer 8.1 – 34
6 Polyethylene Oxide N-10 Polymer 0.8 - 3.4
7 Maltodextrin Diluent 0.6 - 3.1
8 Polyvinyl alcohol Polymer 7.8 – 32
9 Propylene glycol Plasticizer 1.9 - 4.3
10 Lemon flavour Flavourant 0.1 - 2.2
11 Sunset yellow Colourant 0.02 - 0.5
12 Purified water Vehicle Qs

Example 2
A method of preparation of the said oral disintegrating films comprises of the following steps as shown in fig 2:
Step no. Details of Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM
Step 2 Weighed quantity of Vitamin-C (L-Ascorbic acid) was added to above step-1 under stirring at 350 RPM for 5 min
Step 3 Weighed quantity of Calcium carbonate was added to above step-2 under stirring at 400 RPM for 15 min
Step 4 Weighed quantity of Sodium Hyaluronate was added to above step-3 under stirring at 500 RPM for 20 min
Step 5 Weighed quantity of Sucralose was added to above step-4 under stirring at 500 RPM for 3 min
Step 6 Weighed quantity of Pullulan was added to above step-5 under stirring at 500 RPM for 15 min
Step 7 Weighed quantity of Polyethylene oxide N-10 was added to above step-6 under stirring at 500 RPM for 10 min
Step 8 Weighed quantity of Maltodextrin was added to above step-7 under stirring at 500 RPM for 5min
Step 9 Weighed quantity of Polyvinyl alcohol was added to above step-8 under stirring at 500 RPM for 10min
Step 10 Weighed quantity of Propylene glycol was added to above step-9 under stirring at 500 RPM for 10min
Step 11 Weighed quantity of Lemon Flavour was added to above step-10 under stirring at 500 RPM for 3 min
Step 12 Weighed quantity of Sunset yellow colour was added to above step-11 under stirring at 500 RPM for 3 min
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 of the dissolving film is studied and the results are tabulated below. Several trial-and-error experimentations have been conducted to develop the stable product.

Example-2 Stability data
Tests Initial 40°C / 75% RH 30°C / 65% RH 25°C / 40% RH
1M 2M 3M 6M 1M 2M 3M 6M 1M 2M 3M 6M
Description Orange coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content 10.88% 9.67% 9.37% 8.88% 8.89% 11.00% 10.91% 9.94% 9.46% 11.29% 10.69% 10.58% 9.98%
Disintegration Time 37 sec 30 sec 30 sec 35 sec 38 sec 33 sec 33 sec 37 sec 39 sec 37 sec 37 sec 40 sec 40 sec
Folding Endurance >150 >150 134 101 90 >150 146 115 98 >150 >150 133 107
Assay of L-Ascorbic acid 102.10% 98.74% 93.22% 89.90% 86.20% 96.40% 92.20% 91.50% 88.71% 97.70% 93.10% 91.30% 89.89%
Assay of Sodium Hyaluronate 100.50% 99.18% 92.30% 89.70% 88.19% 99.83% 94.90% 98.50% 91.47% 98.10% 95.40% 93.80% 91.56%

In yet another embodiment of the present invention the ingredients and its combination are tabulated below:

Example 3
S No. Ingredients Function Range
% w/v
1 Hyaluronic acid (as Sodium Hyaluronate) API 2 - 50
2 Vitamin-C (as L-Ascorbic acid) API 0.5 - 8
3 Vitamin-C (as Sodium ascorbate) API 3 - 30
4 Calcium carbonate pH modifier 0.5 - 2.6
5 Sucralose Sweetener 1.5 - 2.6
6 Pullulan Polymer 22.1 - 73.9
7 Polyethylene Oxide N-10 Polymer 0.9 - 3.1
8 Maltodextrin Diluent 0.9 - 3.1
9 Polyvinyl alcohol Polymer 1.3 - 2.6
10 Propylene glycol Plasticizer 0.25 - 1.2
11 Lemon flavour Flavourant 1 - 3.1
12 Sunset yellow Colourant 0.05 - 1.2
13 Purified water Vehicle Qs

Example 3
A method of preparation of the said oral disintegrating films comprises of the following steps:
Step no. Details of the Manufacturing procedure
Step 1 Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM
Step 2 Weighed quantity of Vitamin-C (L-Ascorbic acid) was added to above step-1 under stirring at 350 RPM for 5 min
Step 3 Weighed quantity of Calcium carbonate was added to above step-2 under stirring at 400 RPM for 15 min
Step 4 Weighed quantity of Vitamin-C (Sodium ascorbate) was added to above step-3 under stirring at 400 RPM for 15 min
Step 5 Weighed quantity of Sodium Hyaluronate was added to above step-4 under stirring at 500 RPM for 20 min
Step 6 Weighed quantity of Sucralose was added to above step-5 under stirring at 500 RPM for 3 min
Step 7 Weighed quantity of Pullulan was added to above step-6 under stirring at 500 RPM for 15 min
Step 8 Weighed quantity of Polyethylene oxide N-10 was added to above step-7 under stirring at 500 RPM for 10 min
Step 9 Weighed quantity of Maltodextrin was added to above step-8 under stirring at 500 RPM for 5min
Step 10 Weighed quantity of Polyvinyl alcohol was added to above step-9 under stirring at 500 RPM for 10min
Step 11 Weighed quantity of Propylene glycol was added to above step-10 under stirring at 500 RPM for 10min
Step 12 Weighed quantity of Lemon Flavour was added to above step-11 under stirring at 500 RPM for 3 min
Step 13 Weighed quantity of Sunset yellow was added to above step-12 under stirring at 500 RPM for 3 min
Step 14 Finally, above step- 13 Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution
Step 15 Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry
Step 16 The Wet slurry was casted at process parameters of Dr. Knife thickness of 500 to 900 microns; Temperature 95±3°C; and In-direct drying
Step 17 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 / 75% RH 30°C / 65% RH 25°C / 40% RH
1M 2M 3M 6M 1M 2M 3M 6M 1M 2M 3M 6M
Description Orange coloured film Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Identification Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies Complies
Water content 9.88% 9.48% 9.57% 8.98% 8.89% 10.98% 10.89% 9.84% 9.66% 11.54% 10.63% 10.54% 10.87%
Disintegration Time 32 sec 32 sec 30 sec 37 sec 35 sec 32 sec 36 sec 35 sec 32 sec 33 sec 38 sec 41 sec 38 sec
Folding Endurance >150 >150 124 109 96 >150 >150 129 102 >150 >150 148 118
Assay of L-Ascorbic acid 100.10% 99.74% 93.02% 91.90% 89.10% 96.50% 93.22% 92.50% 89.61% 97.80% 94.20% 92.83% 91.01%
Assay of Sodium Hyaluronate 102.10% 99.21% 93.14% 90.37% 90.19% 99.63% 95.12% 98.65% 91.81% 98.12% 96.44% 93.18% 91.37%

The above-mentioned formulations are non-limiting examples of suitable oral dissolving 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. Examples 1-3 are formula compositions that have the benefit of enhanced anti-ageing benefits and improved bone health.

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

Test product vs Reference product:

Study Parameters Reference product (Nyumi Radiant skin gummies) Test product (Oral disintegrating film)
Description Orange-colored round gummies Orange-colored square films
Identification Complies Complies
Water content 3.54% 9.76%
Disintegration Time 38 min 16 sec
28 sec
Assay of L-Ascorbic acid 92.63%
99.82%
Assay of Sodium Hyaluronate 96.16%
100.21%

In an embodiment of the present invention the oral dissolving film has faster onset of action. The Test Product (DFs) dissolve quickly upon contact with saliva, allowing for faster absorption of the active ingredients through the buccal (cheek) and sublingual (under the tongue) mucosa. This rapid dissolution can lead to a faster onset of action compared to oral gummies, which need to be chewed and swallowed before the active ingredients are absorbed in the gastrointestinal tract.

There is no need for chewing or water in the present invention. The test Product (DFs) do not require chewing or water for administration, making them a convenient option for people who have difficulty swallowing pills or those with limited access to water. This is particularly beneficial for children, the elderly, and individuals with certain medical conditions.

The Test Product (DFs) are thin, lightweight, and individually packaged, making them highly portable and easy to carry. Their discreet nature allows for on-the-go use without drawing attention, unlike oral gummies that may resemble candies.

Each Test Product (DFs) is precisely dosed, ensuring accurate and consistent delivery of the active ingredients in every dose. In contrast, oral gummies may vary in dosage due to differences in size and the potential for sticking together.

The Test Product (DFs) typically have better shelf stability and resistance to temperature fluctuations compared to oral gummies, which may be susceptible to melting or degradation in hot environments and the formulation of ODFs allows for better control over the taste, texture, and release profile of the active ingredients, ensuring an optimal product experience.
,CLAIMS:1. An oral dissolving film comprising of:
Hyaluronic acid (as Sodium Hyaluronate) (API) 2 – 20 %w/w
Vitamin-C (as L-Ascorbic acid) (API) 5 – 32 %w/w
Calcium carbonate (pH modifier) 3.1 - 7.13 %w/w
Sucralose (Sweetener )1.05 - 3.05 %w/w
Microcrystalline cellulose (Diluent) 6.55 - 15.35 %w/w
Pullulan (Polymer) 22 – 54 %w/w
Polyvinyl alcohol (Polymer) 2.1 - 6.4 %w/w
Propylene glycol (Plasticizer) 0.25 - 1.1 %w/w
Lemon flavor (Flavourant) 0.5 - 3.2 %w/w
Peppermint flavor (Flavourant) 0.2 - 1.2 %w/w
Sunset yellow (Colorant) 0.05 - 0.5 %w/w
Purified water (Vehicle) Qs
2. An method of processing oral dissolving film comprising the steps of:
Weighed quantity of purified water was taken in a SS container and kept under stirring at 350 RPM (100)
Weighed quantity of Vitamin-C (L-Ascorbic acid) was added to above step-i under stirring at 350 RPM for 5 min (101)
Weighed quantity of Calcium carbonate was added to above step-ii under stirring at 400 RPM for 15 min (102)
Weighed quantity of Sodium Hyaluronate was added to above step-iii under stirring at 500 RPM for 20 min (103)
Weighed quantity of Sucralose was added to above step-iv under stirring at 500 RPM for 3 min (104)
Weighed quantity of Pullulan was added to above step-v under stirring at 500 RPM for 15 min (105)
Weighed quantity of Polyvinyl alcohol was added to above step-vi under stirring at 500 RPM for 10 min (106)
Weighed quantity of Microcrystalline cellulose was added to above step-vii under stirring at 500 RPM for 5min (107)
Weighed quantity of Propylene glycol was added to above step-viii under stirring at 500 RPM for 10min (108)
Weighed quantity of Peppermint flavor was added to above step-ix under stirring at 500 RPM for 10min (109)
Weighed quantity of Lemon Flavor was added to above step-x under stirring at 500 RPM for 3 min (110)
Weighed quantity of sunset yellow was added to above step-xi under stirring at 500 RPM for 3 min (111)
Finally, above step- xii Wet slurry was stirred at 500 RPM for 20 min to get uniform viscous solution (112)
Above step wet slurry after completion of mixing subjected to vacuum degassing for 15 - 30 mins to obtain bubble free slurry (113)
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 (114)
The dried casted film was slitted into required dimensions for achieving the final dose (115).