DESC:DESCRIPTION
Technical Field of the Invention

This invention pertains to the field of oral hygiene, introducing an advanced oral cleansing film designed to enhance oral cleanliness and fresh breath in a convenient, portable, and environmentally friendly manner.

Background of the Invention

Oral hygiene is a cornerstone of overall health, impacting not just dental health but also contributing to systemic health conditions. Traditional oral care products, predominantly toothpaste and mouthwash, have been the mainstay in oral hygiene practices for decades. These products are designed to clean teeth, reduce the risk of dental caries, gingivitis, and periodontitis, and provide fresh breath. Toothpaste, a semi- viscous formulation, is typically applied to a toothbrush to clean teeth and gums, while mouthwash is a liquid used to rinse the oral cavity, offering a supplementary cleaning and freshening effect.

Despite their widespread use and benefits, conventional toothpaste and mouthwash present several notable disadvantages that have increasingly come under scrutiny. One primary concern is their composition, which often includes chemicals and substances that may pose risks to human health and the environment.

Mouthwashes, on the other hand, may contain high levels of alcohol (ethanol), leading to a drying effect on the oral mucosa, which can be uncomfortable for users, particularly those with sensitive mouths or oral conditions.

Parabens and triclosan, used as preservatives, have been linked to hormonal disruptions and antibiotic resistance, respectively. Microbeads, tiny plastic particles found in some toothpaste formulations, contribute to environmental pollution, posing a significant threat to aquatic life and ecosystems.

The environmental impact of oral care products extends beyond their composition to their packaging. The majority of toothpaste tubes are made from a combination of plastic and aluminum, making them difficult to recycle and contributing to the growing problem of plastic waste. Similarly, mouthwash bottles, typically made of plastic, exacerbate the issue of plastic pollution. The environmental footprint of these products is a growing concern for eco-conscious consumers seeking sustainable alternatives.

In light of these concerns, there is a growing demand for innovative oral care solutions that address the limitations of traditional products while maintaining or enhancing the effectiveness of oral hygiene practices. The ideal solution would be one that offers the convenience and benefits of conventional toothpaste and mouthwash without the associated health and environmental risks.

Enter the oral cleansing film, a modern advancement in oral care technology that promises to revolutionize the way we maintain oral hygiene. This novel formulation is a thin, water-soluble strip that dissolves rapidly upon contact with saliva, releasing active ingredients to clean and freshen the mouth. Unlike traditional toothpaste and mouthwash, oral cleansing films are designed as a convenient option for on-the-go oral care. These thin, dissolvable films are placed on a moistened toothbrush, and used for brushing, eliminating many of the drawbacks of traditional oral care products. Additionally, they can be placed directly on the tongue to dissolve, followed by brushing providing an instant freshening and antibacterial effect.

The composition of oral cleansing films is meticulously formulated to include safe, effective ingredients that provide the desired cleaning and freshening effects without harmful chemicals. Key components typically include water-soluble polymers such as pullulan or hydroxypropyl methylcellulose (HPMC), which serve as the film's base, allowing for rapid dissolution in the mouth. Active ingredients may include antimicrobial agents to reduce bacterial load, breath fresheners to combat halitosis, and potentially whitening agents to address surface stains on teeth.

Moreover, the manufacturing process of oral cleansing films is designed to ensure uniform dispersion of ingredients, optimal film thickness, and ease of use. The solvent casting method, commonly employed in the production of these films, involves dissolving the polymer and active ingredients in a solvent, casting the solution onto a substrate, and then drying to form a thin film. This film is subsequently cut into individual strips, which are packaged for single use, ensuring hygiene and convenience.

The introduction of oral cleansing films represents a significant step forward in oral care, offering a novel, convenient, and environmentally friendly alternative to traditional toothpaste and mouthwash. By addressing the health and environmental concerns associated with conventional oral care products, oral cleansing films have the potential to redefine oral hygiene practices, catering to the needs of the modern, health- conscious, and eco-aware consumer.

Brief Summary of the Invention

The present invention unveils an innovative oral cleansing film, aiming to revolutionize the realm of oral hygiene with a cutting-edge alternative to traditional toothpaste and mouthwash. This novel product takes the form of a thin, water-soluble strip that dissolves swiftly in the mouth, liberating active ingredients that cleanse and refresh the oral cavity. Crafted from a water-soluble polymer matrix, the film encapsulates a carefully selected blend of active components designed to meet oral hygiene needs, including antimicrobial agents for bacterial reduction, breath fresheners to combat halitosis, and, potentially, agents that target tooth stains for a whitening effect.

The invention sets out to offer unparalleled convenience, ensuring oral hygiene can be maintained effortlessly at any time and place. making it an indispensable tool for individuals on the move. Despite its innovative form, the film does not compromise on effectiveness; it is engineered to deliver its active constituents directly to the oral cavity, ensuring immediate and potent cleaning and freshening actions akin to those provided by traditional oral care products.

A significant emphasis is placed on safety and environmental consciousness within this invention. The formulation is meticulously designed to avoid harmful chemicals, alcohol, and micro plastics, which are often critiqued in traditional oral care formulations for their potential health risks and environmental impact. This conscious exclusion not only safeguards user health but also aligns with increasing environmental awareness and the demand for sustainable products.

Moreover, the oral cleansing film boasts a minimalistic and biodegradable packaging approach, significantly reducing plastic waste and environmental footprint, a stark contrast to the often non-recyclable and environmentally taxing packaging associated with conventional toothpaste tubes and mouthwash bottles.

In essence, this invention not only aims to refine the efficacy and convenience of oral hygiene practices but also endeavors to address the growing environmental concerns and health consciousness among consumers, heralding a new era in oral care that is safe, effective, convenient, and sustainable.

OBJECTS OF THE INVENTION

The invention of the oral cleansing film is rooted in a commitment to enhance the convenience and effectiveness of oral hygiene practices while prioritizing user safety and environmental sustainability. This innovative product is designed to seamlessly integrate into the fast-paced lifestyle of modern users, offering a practical solution for maintaining oral hygiene on the go. Unlike traditional oral care products these thin, dissolvable films are placed on a moistened toothbrush, and used for brushing, eliminating many of the drawbacks of traditional oral care products. The slim, lightweight design of the film ensures portability, allowing users to easily carry it in a pocket or purse, ready for use at any moment.

Central to the invention is the focus on safety and inclusivity. The formulation of the oral cleansing film is carefully crafted to exclude harmful chemicals, alcohol, and micro plastics, common in these oral care products, thereby minimizing potential health risks. This health-conscious approach makes the film suitable for a broad audience, including those with sensitivities or allergies to traditional oral care ingredients. Furthermore, the product offers an alternative for situations where conventional oral hygiene practices are impractical, such as during travel, at work, or in outdoor activities, ensuring that users can maintain oral hygiene effortlessly and effectively, regardless of their circumstances.

An additional advantage of this invention lies in its reduced environmental footprint. The commitment to eco-friendly packaging and the use of biodegradable materials address the growing concern over plastic waste generated by traditional toothpaste tubes and mouthwash bottles. This not only aligns with the values of eco-conscious consumers but also contributes to the broader effort to mitigate environmental impact. The simplicity and cleanliness of using the film, which dissolves without creating mess or requiring disposal of additional materials, further enhance its appeal as an environmentally responsible oral care solution.

In essence, the oral cleansing film represents a leap forward in oral care, merging practicality with innovation to offer a product that is not only effective and convenient but also safe and sustainable. By redefining the approach to oral hygiene, this invention caters to the evolving needs and values of consumers, promising an improved oral care experience that aligns with the priorities of health, convenience, and environmental stewardship.

Detailed Description of the Invention

The oral cleansing film is composed of key ingredients such as menthol, Sodium Lauryl Sulfate (SLS), calcium carbonate, flavorings, sorbitol, silica, colorants, Hydroxypropyl Methylcellulose (HPMC), sucralose, and xanthan gum, combined with water as the vehicle. The meticulous manufacturing process ensures a homogeneous mixture, resulting in films that provide an immediate cleaning effect upon dissolution in the oral cavity.

The process begins with the preparation of a homogeneous mixture of the ingredients in water, followed by the casting of this mixture onto a substrate. The coated substrate is then subjected to a controlled drying process, after which the film is cut into individual strips and packaged for single-use applications, ensuring convenience and hygiene.

Upon placement in the mouth, the film rapidly dissolves, releasing its active ingredients to effectively clean the oral cavity and freshen breath. This innovative delivery mechanism of the present invention is the use of the film which dissolve upon contact with saliva or when wetted with toothbrush.

The present invention relates to a unit dose oral cleansing film for use in mouth cleaning applications, wherein the film comprises a cellulosic polymer and a natural copolymer, plasticizer, colour, flavour, wherein the unit dose Oral cleansing film contains less than 15 wt. % of water.

The following examples illustrate the present invention.
Formulation 1:
Sl.
No
Name of the
Material

Concentration range
(%w/w)

Functional category
1 Menthol 6.7 - 14.6 Soothing agent
2 SLS 0.5 – 5.3 Cleansing agent
3 Calcium carbonate 8.4 – 18.3 Abrasive agent
4 Flavour 1.6 – 3.6 Flavoring agent
5 Sorbitol 33. 7 – 51.2 Humectant
6 Silica 3.3 – 7.3 Scrubbing agent
7 FDC blue 0.16 – 0.36 Colour
8 HPMC 10.1 – 21.9 Base polymer
9 Sucralose 1.6 – 3.6 Sweetener
10 Xanthan gum 0.67 – 1.4 Co-polymer
11 Water Quantity sufficient Vehicle
Table 1 showing the ingredients with % values for Formulation 1
Manufacturing Process for Formulation 1:
The manufacturing process of Oral cleansing films involves several steps:

Step

no.
Details of the Manufacturing procedure

Step 1 Weighed quantity of Water was taken in a container and kept under

stirring at 350 RPM

Step 2 Weighed quantity of Menthol 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 350 RPM for 5 min

Step 4 Weighed quantity of Sorbitol was added to above step-3 under stirring at

400 RPM for 5 min

Step 5 Weighed quantity of Sucralose was added to above step-4 under stirring

at 400 RPM for 20 min

Step 6 Weighed quantity of Silica was added to above step-5 under stirring at

400 RPM for 5 min

Step 7 Weighed quantity of SLS was added to above step-6 under stirring at 400

RPM for 5 min

Step 8 Weighed quantity of HPMC was added to above step-7 under stirring at

500 RPM for 5 min

Step 9 Weighed quantity of Xanthan gum was added to above step-8 under

stirring at 500 RPM for 5 min

Step 10 Weighed quantity of FD&C Blue was added to above step-9 under

stirring at 500 RPM for 5min

Step 11 Weighed quantity of Flavour was added to above step-10 under stirring at

500 RPM for 5 min

Step 12 Finally, above step- 11 Wet slurry was stirred at 500 RPM for 20 min to

get a 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 300 to 1000 microns; Temperature 95±3°C; and In-direct drying

Step 15 The dried casted film was slitted into the required dimensions to achieve

the final required weight.

Step 16 The pre-measured cut films were individually wrapped for convenient
single-use packaging.

Formulation 2:
Sl. No. Name of the Material Concentration range (%w/w) Functional category
1 Spearmint 13.6 – 25.3 Soothing agent
2 SLS 6.8 – 12.6 Cleansing agent
3 Silica 17.0 – 31.7 Abrasive agent
4 Sodium Flouride 0.01 – 0.5 Anti-cavity agent
5 Activated Charcoal 0.34 – 5.63 Tooth Whitening agent
6 HPMC 20.4 – 38.0 Base polymer
7 Sucralose 3.4 – 6.3 Sweetener
8 Pullulan 1.36 – 2.53 Co-polymer
9 Glycerin 21.2 – 40.5 Humectant
10 Water Quantity sufficient Vehicle

Table 2 showing the ingredients with % values for Formulation 2

Manufacturing Process for Formulation 2:

The manufacturing process of Oral cleansing films involves several steps:
Step no. Details of the Manufacturing procedure – Example-2
Step 1 Weighed quantity of Water was taken in a container and kept under stirring at 350 RPM
Step 2 Weighed quantity of Spearmint was added to above step-1 under stirring at 350 RPM for 5 min
Step 3 Weighed quantity of Silica was added to above step-2 under stirring at 350 RPM for 5 min
Step 4 Weighed quantity of Sucralose was added to above step-3 under stirring at 400 RPM for 20 min
Step 5 Weighed quantity of Sodium Flouride was added to above step-4 under stirring at 400 RPM for 5 min
Step 6 Weighed quantity of SLS was added to above step-5 under stirring at 400 RPM for 5 min
Step 7 Weighed quantity of HPMC was added to above step-6 under stirring at 500 RPM for 5 min
Step 8 Weighed quantity of Pullulan was added to above step-7 under stirring at 500 RPM for 5 min
Step 9 Weighed quantity of Activated charcoal was added to above step-8 under stirring at 500 RPM for 5min
Step 10 Weighed quantity of Glycerin was added to above step-9 under stirring at 500 RPM for 5min
Step 11 Finally, above step- 10 Wet slurry was stirred at 500 RPM for 20 min to get a 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 300 to 1000 microns; Temperature 95±3°C; and In-direct drying
Step 14 The dried casted film was slitted into the required dimensions to achieve the final required weight.
Step 15 The pre-measured cut films were individually wrapped for convenient single-use packaging.

EVALUATION TESTS
To ensure the efficacy and stability of the oral cleansing film, the following evaluation tests were conducted:
1. Physical and Chemical Tests
Principle: Physical and chemical characteristics of the film, such as pH, appearance, and dissolution time, determine its suitability and effectiveness.
Methodology:
? pH Measurement: The pH of the film was determined using a calibrated pH meter by dissolving the film in distilled water.
? Disintegration Time: The time taken for the film to dissolve completely in water was recorded.
? Moisture Content: Measured using a Karl Fisher Titrator to ensure proper stability and shelf life.
? Film Thickness Uniformity: The film thickness was measured at different points using a calibrated instrument to ensure consistency.

Test Results:

Test Parameter Example -1 Example -2 Reference Toothpaste Reference Mouthwash
Appearance Uniform, flexible Uniform, flexible Paste, semi-solid Liquid
pH Measurement 7.21 7.27 7.41 4.29
Disintegration Time 10 sec 13 sec N/A N/A
Thickness Uniformity Consistent Consistent N/A N/A
Moisture Content 11% 8% N/A N/A

The film exhibited uniform appearance, optimal pH, and rapid dissolution during brushing.
Foaming Test Report for Oral cleansing film
Objective: To evaluate and compare the foaming properties (foam height and stability) of In-House oral cleansing film, Marketed toothpaste and Marketed mouthwash using Shake Flask Method.
Rationale: To simulate manual agitation and assess foam generation and decay in a simple setup.
Apparatus: Stoppered flask (250 mL), stopwatch, graduated cylinder.
Procedure:
1. Prepare a sample solution by dissolving the 100 mg dose of product in 10 mL of sterile distilled water.
2. A 50 mL sample solution was placed in a 250 mL stoppered flask.
3. The flask was shaken vigorously for 25 strokes.
4. The initial foam height was measured immediately after shaking.
5. The foam height was measured again after 5 minutes to assess stability.
Test Results:
Product Form Initial Foam Height (cm) Foam Height after 5 min (cm) Foam Stability Observation
In-House Film 9.5 8.6 Very Good Consistent foam with slight decay
Marketed Toothpaste 8.5 7.3 Good Moderate foam production, gradually decayed
Marketed Mouthwash 6.3 3.2 Moderate Foam dissipated more quickly than solution

Oral cleansing Films showed superior foaming capability and foam stability. Marketed Toothpaste was next, with good stability followed by Marketed mouthwash that had the least stable foam, with significant reduction in foam height after 5 minutes.

Anti-bacterial activity Test Report for Oral cleansing film
The antibacterial activities of different formulations were determined by agar well diffusion method. In this method, nutrient agar plates were seeded with 100 µL of 24 h broth culture of Streptococcus mutans from a microbial culture collection. The agar plates were allowed to solidify. A sterile 6 mm borer was used to cut wells of equidistance in each of the plates solution of 50 µL solution (as prepared in above foaming test) of prepared oral cleansing film solution and marketed toothpaste and marketed mouthwash were introduced into the wells. The plates were incubated at 37ºC for 24 hours. The antibacterial activities were evaluated by measuring the zones of inhibition (in mm).
Test Results:
Product Form Zone of Inhibition (mm)
In-House Film (Example -1) 14.5
In-House Film (Example -2) 13.9
Marketed Toothpaste 11.2
Marketed Mouthwash 17.8

The oral cleansing film demonstrated significant antibacterial activity, with a mean zone of inhibitions of 14.5 and 13.9 mm against S. mutans, comparable to marketed mouthwash (17.8 mm) and marketed toothpaste (11.2 mm).
,CLAIMS:. CLAIMS
I/We claim
1. A oral dispersible film (ODF) composition comprising:
Menthol 6.7 - 14.6(%w/w)
SLS 0.5 – 5.3(%w/w)
Calcium carbonate 8.4 – 18.3(%w/w)
Flavour 1.6 – 3.6(%w/w)
Sorbitol 33. 7 – 51.2(%w/w)
Silica 3.3 – 7.3(%w/w)
FDC blue 0.16 – 0.36(%w/w)
HPMC 10.1 – 21.9(%w/w)
Sucralose 1.6 – 3.6(%w/w)
Xanthan gum 0.67 – 1.4(%w/w)
Water Quantity sufficient Vehicle

2. The method manufacturing the ODF as claimed in Claim 1 comprising of the following steps:

Weighed quantity of Water was taken in a container and kept under stirring at 350 RPM
Weighed quantity of Menthol was added to above under stirring at 350 RPM for 5 min
Weighed quantity of Calcium carbonate was added to above under stirring at 350 RPM for 5 min
Weighed quantity of Sorbitol was added to above under stirring at 400 RPM for 5 min
Weighed quantity of Sucralose was added to above under stirring at 400 RPM for 20 min

Weighed quantity of Silica was added to above under stirring at 400 RPM for 5 min
Weighed quantity of SLS was added to above under stirring at 400 RPM for 5 min
Weighed quantity of HPMC was added to above under stirring at 500 RPM for 5 min
Weighed quantity of Xanthan gum was added to above under stirring at 500 RPM for 5 min
Weighed quantity of FD&C Blue was added to above under stirring at 500 RPM for 5min
Weighed quantity of Flavour was added to above under stirring at 500 RPM for 5 min

Wet slurry was stirred at 500 RPM for 20 min to get a uniform viscous solution

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

The Wet slurry was casted at process parameters of Dr. Knife thickness of 300 to 1000 microns; Temperature 95±3°C; and In-direct drying

The dried casted film was slitted into the required dimensions to achieve the final required weight.

The pre-measured cut films were individually wrapped for convenient single-use packaging.

6. DATE AND SIGNATURE
Dated this on 14th April 2025

Signature

(Mr. Srinivas Maddipati)
IN/PA 3124
Agent for Applicant.