Buccal Films as an Advanced Drug Delivery System: A Review of Formulation, Manufacturing, Evaluation and Therapeutic Applications

Mucoadhesive buccal films are thin, flexible, transparent drug-loaded films designed to adhere to the buccal mucosa for localized or systemic drug delivery. Their mucoadhesive nature prolongs the residence time of the formulation, allowing controlled drug release and improved drug absorption. Compared with conventional dosage forms, buccal films offer greater flexibility, comfort, ease of administration, and improved patient compliance, making them a promising platform for effective drug delivery.^[1]

Various mucoadhesive buccal dosage forms, including tablets, gels, ointments, and films, have been developed to improve drug delivery through the oral mucosa. Among these, mucoadhesive buccal films are preferred because of their flexibility, comfort, and prolonged residence time at the site of application. Unlike gels and ointments, which can be easily removed by saliva, buccal films remain adhered to the mucosal surface for longer periods, ensuring accurate drug dosing, sustained drug release, and improved patient compliance.^[2]

     

Figure 1. Buccal Film

Figure 2. Mucosal region of Oral cavity.

Figure 3. Image of Buccal absorption pathways.

Figure 4. Classification and drug release direction of Buccal films.

Figure 5. Solvent casting method.

Figure 6. Diagram of a Film Extrusion System.

3. Semisolid Casting Method

First, prepare a solution of water-soluble film-forming polymer by a semi-solid casting method. The resulting solution is then added to insoluble polymers, such as cellulose acetate butyrate, cellulose acetate phthalate, etc., which are made with sodium hydroxide or ammonium hydroxide. Then add the correct amount of plasticizer to make a gel. Finally, a temperature-controlled barrel is used to shape the gel mass into a film. The thickness of the film is about 0.015- 0.05 mm. ^[34]

4. Rolling Method

A pre-mix of the film-forming polymer, polar solvent, and other excipients was prepared without the drug and transferred to the master batch feed tank. The pre-mix was pumped into the mixer, where the required amount of drug was added and mixed until a homogeneous matrix was obtained. The uniform matrix was then transferred to the casting pan through a metering pump and formed into a film over the base material using a support roller. Finally, the wet film was dried under controlled bottom-drying conditions until complete dehydration. ^[35,36]

Figure 7. Three rolling coating units.

5. Electrospinning Method

The electrospinning process is facilitated using a high-voltage direct-current power supply generator with a maximum voltage of 10 kV.  The drug-polymer solutions were filled into 10 mL plastic disposable syringes fitted with a 22G tip, which was connected to flat needles mounted on a horizontally positioned syringe pump; the distance between the needle and collector was 12 cm, and the flow rate was 1 mL/min. The fibers were deposited on aluminium foil covering the rotating drum collector at 200 rpm. The temperature and relative humidity were set at 25 ± 2 °C and 35 ± 1%, respectively.^[37]

Evaluation parameters of Buccal Film

1. Organoleptic properties

Buccal films should have pleasant taste, flavour, odour, and an attractive, uniform colour to improve patient acceptability. Colour can be evaluated by visual inspection, while suitable flavouring agents can mask the unpleasant taste and odour of the drug, polymer, and excipients. Attractive formulations are particularly important for pediatric use.^[38]

2. Folding Endurance

The folding endurance of the oral thin films was determined by repeatedly folding a 2 × 2 cm² strip at the same location until it broke. Folding endurance was expressed as the number of times the film could be folded at the same point without breaking. The test was performed in triplicate, and the results were reported as the mean ± standard deviation.^[39]

3. Thickness of Film

Film thickness was measured using a calibrated digital micrometer or micrometer screw gauge at five points on the film, including the center and four corners. At least five films from each formulation were tested, and results were expressed as mean ± SD. Thickness uniformity is important for consistent drug distribution. Oral thin films generally range from 5–200 µm, while buccal films may range from 50–1000 µm.^[40]

4. Weight variation

The weight variation of the oral thin films was determined by weighing each film individually, followed by the calculation of the average weight of all the films. The individual weight of each film was then compared with the average weight to assess weight variation. Significant variation in the weight of the films indicates inconsistency in the manufacturing process and may suggest non-uniform distribution of the drug within the formulation.^[41]

5. Tack test

Tack refers to the adhesive property of the film, which is determined by its ability to adhere to a surface, such as a piece of paper, upon contact. Dryness is a measure of the residual solvent or water content present in the film. The drying process of oral films is generally classified into eight stages: set-to-touch, dust-free, tack-free, dry-to-touch, dry-hard, dry-through, dry-to-recoat, and dry print-free. These characteristics can be evaluated using various instruments; at the laboratory scale, tackiness was evaluated by pressing the strip between layers of aluminum foil. The observations were recorded as tack-free, slightly tacky, tacky, or very tacky based on the degree of adhesion of the strip to the aluminum foil.^[42]

5. Percentage Elongation

Percentage elongation indicates the flexibility and elasticity of an oral thin film when subjected to tensile force. It is commonly measured using a texture analyzer or tensile testing instrument. During the test, the increase in the film's length before breaking is measured and expressed as a percentage of its original length. It is calculated using the following equation:

Percent Elongation=L-L0L0×100

Where:

L0 = Initial length of the film

L  = Final length of the film after stretching.^[43]

7. pH Determination

The pH of the film formulation is determined to ensure compatibility with the physiological environment of the oral cavity and to minimize the risk of mucosal irritation. The film was dissolved in a suitable volume of distilled water, and the pH was measured using a calibrated digital pH meter. Alternatively, pH indicator paper may also be used for preliminary assessment. A pH close to that of the oral mucosa is generally considered suitable for buccal application.^[44]

8. Content Uniformity

Drug content uniformity is evaluated by analyzing multiple film samples using suitable spectrophotometric or chromatographic methods. The measured drug content is compared with the intended drug content of the formulation. This test helps to ensure uniform drug distribution among individual film units and provides consistent dosing and product quality. The acceptance limits may vary depending on the applicable pharmacopoeial or regulatory requirements.^[45]

9. Swelling Index

The swelling index of the buccal films is determined by measuring the increase in film weight after hydration. The weight and diameter of the films were recorded. The films are then placed on the surface of an agar plate and incubated at 37 ± 0.2°C to simulate physiological conditions. At predetermined time intervals (1–5 h), the swollen films (n = 3) are carefully removed, gently blotted to remove excess surface moisture, and weighed. The percentage swelling (%S) is calculated using the following equation:

S. I=Wt-W0W0×100

where:

(W_t)= Weight of the swollen film at time t

(Wo) = Initial weight of the film at time zero

All measurements were performed in triplicate, and the mean values were calculated.^[46]

10. Percentage Moisture Loss

The percentage moisture loss of the films is determined to evaluate the stability of buccal films under dry storage conditions. The film samples measuring 2 × 2 cm² are accurately weighed and placed in a desiccator containing anhydrous calcium chloride as a desiccant. After 3 days, the films are removed and reweighed. The percentage moisture loss is calculated using the following equation ^[47]

Percent moisture loss =Initial weight - Final weightInitial weight x 100

11. Percentage Moisture Uptake

Moisture uptake capacity of the films is evaluated by exposing them to a humid environment. Pre-weighed film samples (2 × 2 cm²) are placed in a desiccator containing a saturated potassium chloride (KCl) solution, which maintains a relative humidity of approximately 84%, at room temperature. After 24 h, the films were removed and reweighed. The percentage moisture uptake is calculated using the following equation:

Percent moisture uptake =Final weight - Initial weightInitial weight  X 100

All measurements were performed in triplicate, and the results were expressed as mean ± standard deviation.^[48]

12. Tensile Strength

The tensile strength of the oral thin film is defined as the maximum force required to cause deformation and break the film. Film strips of a specified size are secured between two clamps separated by a fixed distance, and a tensile load is applied until the film ruptures. The tensile strength is calculated by dividing the breaking force by the cross-sectional area of the film using the following equation:

Tensile Strength (N/mm2)=Breaking Force (N)Cross-sectional Area (mm2)

Where:

Breaking force = force required to break the film (N)

Cross-sectional area = width × thickness of the film (mm²)

It is expressed in N/mm².^[49]

13. In Vitro Disintegration Time

In vitro disintegration time is determined by placing the film in a Petri dish containing distilled water and gently swirling it at regular intervals. The time required for the film to disintegrate or break is recorded as the in vitro disintegration time.^[50]

14. In Vitro Drug Release

In vitro drug release studies are carried out using a Franz diffusion cell assembly consisting of donor and receptor compartments separated by a suitable membrane. The receptor compartment contains an appropriate buffer medium, while the drug-loaded film is placed in the donor compartment. The membrane is pre-treated with the receptor medium before use, and care is taken to avoid air bubbles between the membrane and the liquid surface. The system is maintained at a controlled temperature, and samples are withdrawn from the receptor compartment at predetermined time intervals and replaced with fresh buffer. The amount of drug released is determined using a suitable analytical method, and the drug release flux is calculated.^[51]

15. Ex Vivo Mucoadhesion Time

Ex vivo mucoadhesive strength is evaluated using a modified physical balance method with fresh chicken pouch mucosa. The mucosa is rinsed with phosphate buffer (pH 6.8), mounted in a Petri dish, and kept hydrated with the same buffer. A 2 × 2 cm film is attached to a glass stopper and brought into contact with the mucosa under a 10-min preload. Water is gradually added to the opposite side of the balance until the film detaches. The required weight is recorded, and adhesion force and bond strength are calculated using the respective formulas. The test was performed in triplicate (n = 3).^[52]

F=W×g1000

Where:

F = Mucoadhesive force (N)

W = Weight required for detachment (g)

g = Acceleration due to gravity (9.81 m/s²

16. Young’s modulus

It is a measure of the stiffness of a film. It is defined as the ratio of applied stress to strain within the elastic limit.

Hard and brittle films generally exhibit high tensile strength and high Young’s modulus but show low elongation before breaking.^[53]

^{Young's modulus=Slope×100Stripthickness×Crossheadspace}

17. Permeation Studies

Permeation studies evaluate drug movement across the mucosal membrane. The mucosal surface is placed in contact with the film and moistened with a few drops of simulated saliva fluid to study the interaction between the film and the mucosa. Simulated saliva fluid (1 ml, pH 6.8) is placed in the donor compartment. Samples are withdrawn at predetermined time intervals and replaced with an equal volume of fresh medium. The amount or percentage of drug permeated is then determined using a suitable analytical method.^[54]

18. Stability Studies

Stability studies are performed to evaluate the ability of the formulation to withstand storage conditions and environmental stresses over time. These studies are generally carried out under controlled temperature and humidity conditions according to relevant regulatory guidelines to

assess product shelf-life. Additional evaluations may be conducted to confirm the physical stability, uniformity, and integrity of the formulation during storage.^[55]

Factors Affecting Buccal Film Performance

1. Polymer Type and Concentration – Influences film thickness, hardness, flexibility, and mucoadhesive strength.
2. Plasticizer Concentration – Improves film flexibility and folding endurance, but excess may cause stickiness.^[56]
3. Film Thickness – Affects drug content and comfort during application. Suitable thickness is important for proper film performance.
4. Drug Properties – Molecular weight, pKa, solubility, lipophilicity, and ionization affect drug release and absorption.^[57]
5. Saliva Flow – High saliva flow can dilute the drug and reduce film residence time and absorption.^[58]
6. pH – Influences drug solubility, dissolution, ionization, release, and permeation through the buccal mucosa.^[59]

Applications of Mucoadhesive Buccal Drug Delivery Systems

1. Oral Ulcer Treatment

Fast-dissolving oral films have been investigated as a localized drug-delivery approach for the management of oral ulcers. In one study, oral films containing extracts of Ocimum sanctum and Glycyrrhiza glabra were developed for the treatment of mouth ulcers. The herbal extracts were incorporated into fast-dissolving films prepared by the solvent-casting method using HPMC E5, HPMC E15, sodium alginate and PVA as film-forming polymers. The developed films demonstrated satisfactory physical characteristics, rapid disintegration and drug release. The study indicated that incorporating these herbal extracts into an oral film may provide a convenient localized dosage form for the management of mouth-ulcer conditions and their associated inflammation and discomfort.^[60]

2. Analgesic Therapy

Buccal films provide an effective route for systemic pain management, particularly with buprenorphine. The mucoadhesive film allows prolonged residence and direct absorption through the buccal mucosa, while avoiding first-pass metabolism. Buprenorphine buccal films have been used for persistent chronic pain, including cancer-related, musculoskeletal, and neuropathic pain. They also offer rapid absorption, improved compliance, and convenience for patients with swallowing difficulties.^[61]

3. Anti-inflammatory Therapy

Inflammation is a common factor associated with several oral diseases. Mucoadhesive buccal systems can provide prolonged local delivery of anti-inflammatory drugs such as flurbiprofen, flufenamic acid, and ibuprofen. Sustained-release bilayered buccal tablets containing flurbiprofen have been developed using mucoadhesive polymers and hydrotalcite. An optimized formulation containing 20 mg of flurbiprofen provided sustained anti-inflammatory activity for approximately 12 hours, while potentially reducing the required daily dose.

4. Antiemetic Therapy

Buccal films have potential application in the management of nausea and vomiting, particularly when swallowing conventional tablets is difficult. Rapid hydration and dissolution of the film in the oral cavity facilitates drug release and mucosal absorption, while buccal administration can reduce gastrointestinal exposure and first-pass metabolism. Antiemetic drugs such as metoclopramide, palonosetron hydrochloride, prochlorperazine maleate, domperidone, aprepitant, granisetron hydrochloride and dimenhydrinate have been investigated in fast-dissolving film formulations, demonstrating the potential of film-based delivery as a convenient alternative to conventional oral dosage forms.^[62]

5. Hormone Delivery

Mucoadhesive buccal films have been explored for estradiol delivery in hormone replacement therapy for menopausal symptoms. Buccal administration can bypass first-pass metabolism and improve estradiol bioavailability. A nano-emulsion-based estradiol film showed about 80% drug release within 6 min and 15% buccal mucosal permeation over 10 h. These findings indicate its potential as an alternative system for hormonal therapy.^[63]

6. Antidiabetic Therapy

Mouth-dissolving films offer a convenient approach for diabetes management by rapidly dissolving in the oral cavity and enabling quick drug absorption. They can be administered without water, improving patient compliance, especially in those with swallowing difficulties. Buccal absorption may also reduce first-pass metabolism and enhance drug bioavailability, making these films a promising alternative to conventional oral dosage forms.^[64]

7. Vaccines and Peptides

Buccal mucoadhesive films offer a promising, needle-free approach for mucosal vaccine delivery by providing prolonged contact with the buccal mucosa and avoiding gastrointestinal degradation. A two-layered film containing pullulan, trehalose, sucrose, and an ethyl-cellulose backing layer was developed for delivery of DNA, viral vectors, and mRNA/LNP vaccines. SARS-CoV-2 mRNA/LNP films remained stable and produced immune responses comparable to intramuscular vaccination, with additional mucosal IgA responses, demonstrating their potential for mucosal vaccination.^[65]

Emerging Trends in Buccal Film Technology

• Nanotechnology: Nanocarriers, including liposomes and lipid nanoparticles, are increasingly incorporated into buccal films to improve drug stability, enhance penetration through the buccal mucosa, and protect drugs from enzymatic degradation. These systems are particularly promising for the delivery of complex therapeutic molecules such as peptides and proteins. ^[66-68]
• 3D Printing: 3D printing enables customized buccal films by optimizing printing parameters, film geometry, and polymer composition. Techniques such as pressure-assisted micro syringe, semi-solid extrusion, and fused deposition modelling have been used for drug-loaded films. Post-printing drug loading offers flexible dosing without altering the film structure. Film geometry and infill patterns can significantly affect drug loading, diffusion, and release, allowing drug-release profiles to be tailored through structural design. ^[69-71]
• Smart Polymers/Stimuli-Responsive Buccal Films: The development of novel mucoadhesive materials, such as thiolated polymers and chitosan derivatives, offers stronger and longer-lasting adhesion to the buccal mucosa while potentially protecting drugs from enzymatic degradation. Stimuli-responsive polymers that react to changes in pH, temperature, or ionic strength are being explored to improve mucoadhesion and provide controlled, on-demand drug release. ^[72-74]
• Artificial Intelligence in Formulation Design: AI and machine learning are increasingly being applied to buccal film development to optimize formulation variables, predict pharmacokinetics, drug-release behavior, and drug–polymer interactions. Computational models can reduce trial-and-error during formulation development, saving time and resources while improving efficiency and scalability. These technologies also show potential for designing targeted formulations, including vaccine delivery systems against respiratory pathogens. ^[75,76]
• Targeted Gene and Protein Delivery: Buccal films are being investigated as non-invasive platforms for delivering genes, vaccines, and therapeutic proteins. Improved encapsulation techniques and permeation enhancers may enhance their effectiveness.
• Multilayer Buccal Films: Multilayer films can incorporate different drugs or drug layers to provide simultaneous or sequential drug release, making them useful for combination therapies, particularly in cancer and infectious diseases.^[77]
• Herbal Buccal Films: Green deep eutectic solvents (DESs) have been explored to improve the solubility and localized delivery of herbal bio actives. Curcumin-loaded mucoadhesive buccal films were developed using DES and optimized through Design of Experiments. The optimized films showed good mucoadhesion, swelling, sustained drug release for 24 h, low mucosal permeation, and promising antioxidant, anti-inflammatory, and wound-healing activities, indicating their potential for localized buccal therapy.^[78]

CONCLUSION

Buccal film technology has emerged as a promising and versatile drug delivery approach for both local and systemic therapy. Using suitable polymers, plasticizers, penetration enhancers, surfactants, and other functional excipients allows optimization of mucoadhesion, flexibility, drug release, permeation, stability, and patient acceptability. Different manufacturing techniques, including solvent casting, hot-melt extrusion, rolling, semisolid casting, and electrospinning, further expand their formulation possibilities.

The ability of buccal films to provide prolonged residence, controlled drug release, improved bioavailability, and convenient administration makes them attractive alternatives to conventional oral dosage forms. Their applications extend to oral ulcers, pain management, cardiovascular therapy, antimicrobial treatment, hormones, peptides, proteins, and vaccines. However, challenges such as limited absorption area, mucosal permeability, taste, saliva wash-off, dose limitations, and possible irritation from certain excipients must be carefully addressed. Overall, continued advances in mucoadhesive polymers, nanotechnology, smart formulations, and personalized manufacturing are expected to further improve the therapeutic potential and clinical application of buccal films.

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