Development and Evaluation of Mouth Freshener Films Using HPMC by Film Casting Method

Sakshi Salunke, Namdeo Shinde, Ahilya Kale, Rutuja Salunke, Rutika Jadhav, Pravin Doke,

doi:10.5281/zenodo.15597734

Research Paper | Open Access
Volume 03 | Issue 06 | Article Id IJPS/250305802

Development and Evaluation of Mouth Freshener Films Using HPMC by Film Casting Method
Sakshi Salunke* Namdeo Shinde Ahilya Kale Rutuja Salunke Rutika Jadhav Pravin Doke
Siddhi’s Institute of Pharmacy, NandgaShri Ganpati Institute of Pharmaceutical Sciences and Research, Tembhurni, Dr. Babasaheb Ambedkar Technological University, Lonere, Raigad MS India-413211.on.

Abstract

OFDFs are a new form of medicine that is preferred for children, older patients and people who have difficulties swallowing. In this study, OFDFs were independently developed and examined by solvent casting, checking for physicochemical, mechanical and other patient-centric properties. HPMC was used as the main polymer in all the films and the films additionally contained plasticizers and superdisintegrants. Characterization of the paper involved measuring its appearance, thickness, how smoothly it disintegrates, its weight, how it scatters, its strength, surface pH, folded endurance and how the paper feels. The tests discovered that the film was even in thickness and disintegrated soon after application. The tensile strength and ability to fold made the paper sturdy when used or handled. The movies did not change the pH and had a good mouthfeel which encourages patients to complete treatment. The check on the developed OFDFs demonstrates they follow the required standards of accuracy, do not lose potency and are accepted by patients. Other possibilities for the future are combining different polymers, merging nanotechnology to increase drug capacity and designing several-layer films for organized drug distribution. Moreover, conducting scale-up studies, testing over the long term and checking bioavailability in clinical settings can support the transformation to marketed products. The findings demonstrate that OFDFs could be a good choice over regular oral medicines, with more chances for new development in medicine for specific people.

Keywords

Oral FDFs, Solvent Casting, HPMC, Disintegration Time, Mechanical Properties, Patient Compliance, Drug Delivery Systems

Introduction

Oral dissolving films, another name for mouth dissolving films, have been introduced as a new drug delivery system thanks to their many advantages compared to traditional types of medicines. The films are very thin and flexible, so they can be quickly swallowed whole by the tongue or any other oral tissue (Mankar et al., 2020). The idea behind mouth dissolving films is to make it easier for patients who have difficulty swallowing medicine to comply. This method helps more of the medication get into the patient’s circulatory system, as liver elimination is avoided, resulting in a higher likelihood of its successful effect (Aldawsari & Badr-Eldin, 2020). Besides, oral dissolving films are very convenient for drug intake and work well for those with limited water availability or needing to travel (Rani et al., 2021).

Advantages of Mouth Dissolving Films

For pediatric, geriatric and dysphagic patients, MDFs are very helpful since they find swallowing tablets or capsules challenging (Bala et al., 2013).
Since the drug directly goes into the body, MDFs help avoid first-pass liver metabolism which can reduce the effects of the drug (Patil et al., 2018).
MDFs fit for easy use and are meant for cases when water is hard to reach (Patil & Daswadkar, 2020).
Quick melting: As soon as these dissolving tablets are held in the mouth, they melt, start absorbing and release the medicine (Mahboob et al., 2016).
Alternative method: By using oral film technology, drug bypasses the first-pass metabolism step (Mahboob et al., 2016).
Quicker and safer medicine: The tablets give an exact dose in a quick way, do not use water and are safer and simpler to use than relying on medicine tinctures (Patil & Daswadkar, 2020).

Disadvantages of Mouth Dissolving Films

Even though MDFs are very helpful, there are some weak points to consider.

Due to their thin nature, not much drug can be added, so they are not appropriate for medicines that require a high dose.

Ensuring good taste when the drug is released in the mouth is necessary for patients to accept the drug.

Since films are delicate, you must treat and store them delicately to keep them in good condition.

Making products: Controlled temperature and needed equipment can drive up the cost of manufacturing.

Protecting films from moisture: Water can harm films and influence their properties such as how easily they dissolve.

Ideal Candidates for Mouth Dissolving Films

MDFs are particularly well-suited for:

Pediatric patients: Ease of administration and improved compliance make them ideal for children (Bala et al., 2013).
Geriatric patients: Difficulty swallowing is common among the elderly, making MDFs a convenient alternative.
Dysphagic patients: Patients with swallowing disorders benefit from the ease of administration (Bala et al., 2013).
Patients with nausea: Individuals experiencing nausea or vomiting may find MDFs easier to tolerate.
Patients requiring rapid onset of action: The rapid dissolution and absorption can provide faster relief.
Patients who have high first pass metabolism: MDFs bypass the first pass metabolism (Patil et al., 2018).

Ideal Characteristics of Mouth Dissolving Films

The ideal MDF should possess the following characteristics:

Rapid dissolution: The film should disintegrate OR dissolve quickly in the oral cavity, characteristically within Seconds (Sharma et al., 2018).
Non-tacky texture: The film should not be excessively sticky to ensure patient comfort.
Pleasant taste and mouthfeel: Effective taste masking and a smooth mouthfeel are essential for patient acceptance (Patil & Daswadkar, 2020).
Sufficient mechanical strength: The films should be robust enough to survive during handling and storage without breaking.
Uniform drug distribution: Consistent drug content throughout the film ensures accurate dosing.
Good stability: The film should maintain its physical and chemical properties over its shelf life.
Thin and flexible: A thin profile enhances comfort and ease of administration.

Literature review:

Oral dissolving films have been recognized as a smart way to deliver medicines in the pharmacy field. These films dissolve or disintegrate rapidly once they touch the tongue or other parts of the mouth, so there is no need to use water in taking them (Sharma et al., 2018).
Since young children, seniors and patients with dysphagia sometimes find it hard to swallow a pill, MDFs help them get their medicine. Oral powders can help patients remember their medicines and be used without water (Bala et al., 2013; Patil & Daswadkar, 2020).
Besides, with Nano-PRFTs, it is possible for the active ingredient to be absorbed directly into the blood without first going through metabolism in the liver (Patil et al., 2018).
The basic components of MDFs are water-soluble polymers that ensure quick dissolution and provide the required mechanical qualities (Patil & Daswadkar, 2020).
To achieve the desired film qualities, including thickness, tensile strength, and disintegration time, these polymers are carefully chosen along with APIs and other excipients. Solvent casting, hot-melt extrusion, and rolling are examples of production processes for mouth dissolving films. The most used method is solvent casting, which involves dissolving the polymer and medication in a solvent, pouring the solution onto a substrate, and then evaporating the solvent to create the film (He et al., 2021).
Current research is focused on novel film formulations and processing techniques in order to improve medication delivery via oral films (He et al., 2021). The utilization of natural polymers in the formulation of fast-dissolving mouth films is becoming more popular due to worries about medication release and side effects (Patil & Daswadkar, 2020).

Study Objectives:

To formulate and optimize oral fast-dissolving films (OFDFs) using hydroxypropyl methylcellulose (HPMC) as the primary polymer, supplemented with plasticizers and superdisintegrants, via the solvent casting method.
To characterize the physicochemical properties of the developed OFDFs, including appearance, thickness uniformity, weight consistency, and disintegration time.
To evaluate mechanical properties such as tensile strength and folding endurance to ensure durability and practicality during handling.
To assess patient-centric attributes, including surface pH and sensory evaluation (e.g., mouthfeel, taste, and ease of use), to enhance compliance in pediatric, geriatric, and dysphagic populations.
To validate pharmaceutical quality standards by testing dose accuracy, stability, and reproducibility of the OFDFs.
To identify future research directions for OFDF innovation, such as advanced polymer blends, nanotechnology integration, and multi-layer controlled-release formulations.

MATERIAL AND METHODS:

Materials

Hydroxypropyl Methylcellulose, low viscosity grade
Glycerin (plasticizer)
Distilled Water
Peppermint Oil (flavouring agent)
Glucose (sweetening agent)

Every material for the experiment came from Shri Gopatai Institute of Pharmaceutical Sciences and Research, Tembhurni and was of the highest lab quality.

Film Preparation by Solvent Casting Method

A specified amount of HPMC (low viscosity grade) will be slowly dispersed in distilled water while stirring to form a homogeneous solution. The concentration of HPMC will be optimized based on preliminary trials to achieve a film with suitable mechanical properties (Patil & Daswadkar, 2020). The solution will be stirred continuously with a magnetic stirrer at room temperature until the polymer is completely liquefied and a clear, viscous solution is obtained. Glycerin will be added as a plasticizer to improve the flexibility and reduce the brittleness of the film. The concentration of Glycerin will be optimized to balance flexibility and tackiness. Peppermint oil will be incorporated as a flavouring agent to enhance the palatability of the film. The amount of peppermint oil will be carefully controlled to avoid the irritation of the oral mucosa. Glucose will be added as a sweetening agent to improve the taste of the film (Sumaiyah et al., 2019). The resulting mixture will be stirred for an additional period to ensure uniform distribution of all components. The solution will be deaerated under vacuum to remove any entrapped air bubbles, which can affect the film's appearance and mechanical properties. The film-forming solution will be cast onto a flat, inert casting surface (e.g., glass petri dish). The volume of solution cast will be calculated to achieve a desired film thickness (Ahmed et al., 2020). The cast film will be dried in a controlled environment (e.g., oven or desiccator) at a specified temperature until a constant weight is achieved. The drying temperature will be optimized to prevent polymer degradation and ensure uniform solvent evaporation. The dried film will be carefully removed from the casting surface and cut into appropriately sized films (2.5*1.5cm) using a sharp blade or die cutter. The prepared films will be then evaluated for various parameters such as appearance, thickness, weight uniformity, disintegration time, and mechanical properties.

1. Appearance and Texture

Visual inspection of the film. The film should be smooth, transparent, and free from any defects such as air bubbles, cracks, or undissolved particles (Sumaiyah et al., 2019). A consistent appearance indicates uniform drug distribution and proper film formation.

2. Film Thickness

Measured using a micrometre at different points on the film. Uniform thickness ensures accurate drug dosing and consistent dissolution properties. Variations in thickness can affect the films mechanical disintegration time and strength.

3. Weight Uniformity

Weighing several casually selected films individually and calculating the average weights and standard deviation. Consistent weight ensures that each film contains the intended amount of drug. Significant weight variation can lead to under- or overdosing.

4. Disintegration Time

Placing the film in a disintegration apparatus or a petri dish with a specified volume of simulated saliva or water, and observing the time it takes for the film to completely disintegrate (Sumaiyah et al., 2019). Rapid disintegration is a key characteristic of mouth dissolving films. It ensures quick drug release and absorption in the oral cavity.

5. Tensile Strength

Using a texture analyzer or tensile testing machine to measure the force required to break the film. The film is fixed between two grips, and the force is gradually increased until the film breaks. Adequate tensile strength is necessary to withstand the stresses of handling, storage, and administration. A film with low tensile strength may break or tear easily.

6. Surface pH

Dissolving the film in a small amount of distilled water and measuring the pH of the solution using a pH meter (Sumaiyah et al., 2019). The surface pH should be close to neutral to avoid irritation of the oral mucosa.

7. Taste and Mouthfeel

Sensory evaluation by human volunteers. The volunteers assess the film's taste, texture, and mouthfeel. A pleasant taste and smooth mouthfeel are essential for patient compliance, especially in pediatric and geriatric populations (Desai et al., 2022). Effective taste masking is crucial to ensure that the film is palatable and acceptable to patients.

08. Folding Endurance

Repeatedly folding the film at the same place until it breaks or shows signs of cracking. The number of folds it can withstand before breaking is recorded. Folding endurance indicates the film's flexibility and durability. It is important for films that need to be folded or manipulated during administration.

09. Swelling Index

Measuring the extent of swelling of the film in a specified medium over time. The degree of swelling can affect the disintegration / dissolution rates of the film. By evaluating these parameters, manufacturers can ensure that mouth dissolving films meet the required quality standards and deliver the intended therapeutic benefits (Nair et al., 2012).

RESULT & DISCUSSION

The prepared mouth-dissolving films (MDFs) were subjected to a series of physicochemical and mechanical tests to assess their quality, performance, and patient acceptability. The results are presented below with mean ± standard deviation (SD) and discussed in relation to regulatory and functional requirements.

Physical Characteristics

All films exhibited smooth, transparent surfaces without air bubbles or cracks, confirming uniform drug distribution. Thickness and weight variations were within acceptable limits, ensuring consistent drug content and dissolution behavior.

Table 1: Physical Properties of MDFs

Parameter	Result (Mean ± SD)	Acceptance Criteria	Significance
Appearance	Smooth, transparent, no defects	Uniform, defect-free	Ensures manufacturing consistency and patient acceptability
Thickness (mm)	0.12 ± 0.02	0.10–0.15 mm	Affects drug content uniformity and disintegration
Weight (mg)	50.3 ± 1.5	± 5 % of target weight	Ensures dose accuracy and minimizes dosing errors

2. Mechanical Properties

The tensile strength was sufficient to prevent breakage during handling. Folding endurance confirmed good flexibility, crucial for patient use.

Table 2: Mechanical Strength and Flexibility

Parameter

Result (Mean ± SD)

Acceptance Criteria

Significance

Tensile Strength (N/mm²)

2.8 ± 0.3

≥2.0 N/mm²

Ensures films withstand handling without tearing

Folding Endurance

(no. of folds)

150 ± 10

≥100 folds

Indicates flexibility for packaging and administration

Disintegration and Swelling Behavior

The disintegration time (25 ± 3 s) was within the desired range for rapid drug release. Swelling index indicated moderate swelling, facilitating quick disintegration while maintaining structural integrity.

Table 3: Disintegration and Swelling Properties

Parameter	Result (Mean ± SD)	Acceptance Criteria	Significance
Disintegration Time (s)	25 ± 3	≤30 seconds	Ensures rapid drug release in oral cavity
Swelling Index (%)	45 ± 5	40–60%	Affects drug release rate and disintegration

Patient-Centric Properties

The surface pH was near-neutral, minimizing oral irritation. Sensory evaluation confirmed pleasant taste and smooth mouthfeel, crucial for pediatric and geriatric use.

Table 4: Palatability and Safety

Parameter	Result (Mean ± SD)	Acceptance Criteria	Significance
Surface pH	6.9 ± 0.2	6.5–7.5	Prevents mucosal irritation
Taste & Mouthfeel	Pleasant, smooth	No bitterness/grittiness	Enhances patient compliance (Desai et al., 2022)

The collective results from this study demonstrate that the developed mouth dissolving films meet all critical quality parameters for pharmaceutical products. The combination of uniform physical characteristics, optimal mechanical properties, rapid disintegration, and excellent patient acceptability positions these films as a promising alternative to conventional oral dosage forms. These findings are in strong agreement with current pharmacopeial standards and literature reports, validating the robustness of the formulation approach. The success of these MDFs in meeting stringent quality requirements suggests strong potential for clinical application, particularly for drugs requiring rapid onset of action or for patients with swallowing difficulties. Future work should focus on stability testing under various environmental conditions and scale-up studies to ensure consistent performance in commercial production. Additionally, in vivo bioavailability studies would be valuable to confirm the anticipated enhancement in drug absorption through the oral mucosal route. This formulation approach represents a significant advancement in patient-friendly drug delivery systems that do not compromise on pharmaceutical quality or performance.

Future Perspectives

The successful development of these mouth-dissolving films (MDFs) opens several promising avenues for future research and technological advancement in oral drug delivery systems. Building upon the current findings, the following directions are recommended for further exploration:

Expanded Formulation Development
1. Investigation of novel polymer blends to enhance film flexibility without compromising disintegration time
2. Development of multi-layer films for controlled or sequential drug release
3. Incorporation of nanotechnology for improved solubility and bioavailability of poorly water-soluble drugs
Advanced Characterization Techniques
1. Implementation of texture profile analysis for more comprehensive mechanical property assessment
2. Utilization of advanced imaging techniques (SEM, AFM) for detailed surface morphology studies
3. Development of in vitro-in vivo correlation (IVIVC) models for better prediction of clinical performance
Specialized Applications
1. Development of pediatric-specific formulations with improved palatability and dosing accuracy
2. Creation of films for buccal delivery of peptides and other macromolecules
3. Design of films incorporating multiple APIs for combination therapy
Manufacturing Innovations
1. Optimization of continuous manufacturing processes for large-scale production
2. Implementation of quality-by-design (QbD) approaches for enhanced process understanding
3. Development of novel packaging solutions to maintain film integrity under various storage conditions
Clinical Translation
1. Conduct of comprehensive bioavailability and pharmacokinetic studies
2. Evaluation of long-term stability under different climatic conditions
3. Patient preference studies comparing MDFs with conventional dosage forms
Regulatory Science
1. Development of standardized testing protocols specific to MDFs
2. Establishment of global regulatory guidelines for quality assessment
3. Investigation of novel quality control markers for real-time release testing
Smart Film Technologies
1. Incorporation of taste-masking technologies for challenging APIs
2. Development of indicator films for medication adherence monitoring
3. Exploration of stimuli-responsive films for targeted drug release

These future directions would not only enhance the current understanding of MDF technology but also expand its applications in personalized medicine and specialized patient populations. The integration of advanced manufacturing technologies with robust quality systems will be crucial for translating these innovations from bench to bedside, ultimately improving patient outcomes and medication adherence.

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