Clove Infused Mucoadhesive Orobuccal Film for the Management of Tooth Ache and Dental caries
Mamatha A1*, Anjan BH2, Hemalatha KV2, Bhoomika2, Ritika K2, Smitha Shree3,
Pavithra Chandrashekar4
1Professor & HoD, Department of Pharmacognosy, KLE College of Pharmacy, Rajajinagar,
Bengaluru – 560010.
2B.Pharm Students, Department of Pharmacognosy, KLE College of Pharmacy, Rajajinagar, Bengaluru 560010, A Constituent Unit of KLE Academy of Higher Education and Research, Belagavi 590010, Karnataka, India.
4Professor and HOD, Dept. of Pathology, KLE Society’s Institute of Dental Sciences, Bangalore, India.
*Corresponding Author E-mail: mamathasmitha@gmail.com
ABSTRACT:
The present research explores the formulation of a mucoadhesive orobuccal film containing clove (Syzygium aromaticum) powder for effective local delivery in dental pain management. This approach stems from the need to reduce the systemic side effects associated with conventional pain medications, especially when used frequently or over long durations. Clove, known for its natural analgesic, antibacterial and antimicrobial properties primarily due to the presence of eugenol offers a plant-based therapeutic alternative that is both effective and biocompatible. The films were prepared using the solvent casting method, employing hydroxypropyl methylcellulose (HPMC) E-15 and E-50 as film-forming polymers. Suitable plasticizers and permeation enhancers were incorporated to improve flexibility, adhesion and drug diffusion. A total of seven formulations were developed by varying polymer concentrations and compositions to optimize the film’s physicochemical characteristics and therapeutic performance. The primary objective was to formulate a stable, effective and patient-friendly buccal film capable of adhering to the mucosal lining close to painful or caries affected tooth and delivering the clove actives. The formulations were subjected to a series of evaluation parameters to assess their suitability for buccal application. Among the tested variants, one formulation exhibited superior mucoadhesive and therapeutic performance. Microbial studies confirmed the antimicrobial efficacy of the selected film against common oral pathogens like Streptococcus mutans, Lactobacillus acidophilus and Candida albicans, supporting its use as a promising alternative in the treatment of dental infections and pain. The incorporation of clove in a mucoadhesive film offers a novel, natural and site-specific drug delivery system, potentially improving patient compliance, minimizing gastrointestinal side effects and reducing the need for systemic analgesics. This study opens avenues for further research into herbal-based buccal drug delivery systems for various oral health conditions.
KEYWORDS: Syzygium aromaticum, Herbal Drug Delivery, Buccal Film, Clove Powder, Mucoadhesive, Dental caries, Oral pathogens.
INTRODUCTION:
Toothache is among the most prevalent and distressing oral health issues, often driving the demand for effective pain-relieving medications. These include various classes of drugs such as analgesics, local anesthetics, vasoconstrictors and fixed-dose medicinal combinations aimed at alleviating discomfort. However, the long-term and repeated use of these conventional medications is often associated with a range of undesirable side effects. These adverse reactions may include headache, nausea, dizziness, drowsiness, gastrointestinal irritation and psychological disturbances such as anxiety and nervousness. The accumulation of such complications over prolonged usage periods is well-documented and presents a significant concern in routine dental pain management1.
Recent advancements in pharmaceutical technology have led to the development of more acceptable oral dosage forms, particularly tailored for populations such as pediatric, geriatric, bedridden, nauseated or otherwise non- compliant patients. Among these innovations, the buccal route of drug administration has gained notable prominence. Unlike conventional oral tablets or capsules, which require swallowing and systemic processing, buccal drug delivery systems offer direct absorption through the oral mucosa, bypassing the gastrointestinal tract. As a result, various bioadhesive mucosal dosage forms have been introduced to improve drug efficacy and patient convenience2-7. These include adhesive films, ointments, gels, buccal tablets and more recently, polymeric films also known as mouth-dissolving films8.
Oral disintegrating films (ODFs), also referred to as oral strips, are defined as thin dosage units formulated using water-soluble polymers. These films are designed to rapidly hydrate upon contact with saliva, adhere to the mucosal surface and disintegrate within seconds. This process facilitates the immediate release of the incorporated drug, allowing for rapid absorption through the oral mucosa when placed on the tongue or within the oral cavity. The sublingual mucosa, in particular, is highly permeable due to its thin epithelial layer and rich blood supply, enhancing the bioavailability of drugs administered through this route9.
Controlled and sustained release drug delivery systems have increasingly become popular and well-accepted across various therapeutic areas. The oral mucosal route serves as an excellent alternative to both injectable and conventional oral dosage forms, offering several distinct advantages. These include the avoidance of first-pass metabolism, rapid onset of action, improved patient compliance and a non-invasive mode of delivery that is especially beneficial in acute conditions like dental pain10.
One of the key anatomical advantages of the sublingual route is its epithelial layer thickness, which ranges between 100 to 200 micrometers. This thin mucosal barrier allows for higher permeability and faster rate of drug absorption as compared to other oral routes. In the present study, hydroxypropyl methylcellulose (HPMC) was selected as the film-forming polymer due to its desirable characteristics, including being biodegradable, non-hygroscopic, chemically non-reactive and having excellent mucoadhesive properties. These attributes make HPMC an ideal polymer for developing buccal drug delivery systems. Additionally, HPMC allows for quick drug release, contributing to the immediate onset of therapeutic action while effectively bypassing hepatic first-pass metabolism11. Also other natural plant ingredients like badam gum12, tamarind gum, xanthan gum etc have been researched upon to contribute as natural polymer.
Clove consists of dried flower buds of Syzygium aromaticum L. Family – Myrtaceae13, a common household spice, has long been recognized for its medicinal properties, particularly in dental care. The essential oil extracted from clove contains a high concentration of eugenol, a bioactive compound with potent analgesic, anti-inflammatory and antimicrobial activities. Eugenol has been shown to inhibit bacterial enzyme activity, interfere with bacterial adhesion and disrupt biofilm formation. These mechanisms contribute to the reduction of dental plaque, thereby lowering the risk of dental caries and other oral infections14.
Hence, the primary objective of the present study was to formulate and evaluate a clove powder-based mucoadhesive buccal films using Syzygium aromaticum. The intention was to investigate its potential in providing dual benefits analgesic and antimicrobial effect through a controlled release mechanism. This approach aims to offer a natural, site-specific and effective alternative for the management of dental pain, potentially minimizing the side effects associated with conventional systemic therapies and also to exert antimicrobial activity on oral pathogens.
Clove powder, HPMC E-15, HPMC E-50, Glycerin, Tartaric acid, Sodium Lauryl Sulphate, PEG-400 all the ingredients were obtained from KLE college of Pharmacy, Bengaluru. Remi lab world Magnetic stirrer was used to carry out uniform mixing of ingredients.
Crude clove was obtained from the Amruth Kesari Depot, Bangalore. Authentication was done by Botany department of KLE Society’s S.Nijalingappa College, Bangalore. It was then ground into a fine powder using a mechanical grinder. The powdered clove was passed through a sieve no.100 to obtain uniform particle size.
The solvent casting method was used to produce films with varying quantities of polymers and plasticizers. For 2 hours, HPMC was dissolved in Distilled water, stirring occasionally in beaker 1. Beaker 2 containing fine powder of clove, SLS, Tartaric acid were mixed separately with distilled water. To enhance film permeation and release, adjuvants such as SLS, Tartaric acid were introduced. Beaker 2 was added to the Beaker 1 solution while constantly stirring. To Beaker 1 plasticizer, Glycerin, PEG 400 was added to the solution with continuous stirring. The viscous solution was kept at room temperature for about 3hrs to get a clear, bubble-free solution. Then poured into the glycerin coated petri plate and then allowed to settle for 24hrs. Then films were cut into 2×2 cm size. The composition of the films is reported in Table.1.
a) Physicochemical evaluation:
The formulated buccal films were evaluated for their color, odor and taste through visual and organoleptic inspection to ensure acceptability and uniformity. The pH of the films was determined by dissolving the film in distilled water and measuring with a calibrated digital pH meter to ensure compatibility with the buccal mucosa and avoid irritation.
10 samples of each formulation were individually and collectively weighed to establish their weight variation using a Digital balance. 10 samples of each formulation were measured for thickness using a micrometer screw gauge at three separate positions. The mean thicknesses were calculated10.
Three films of formulation F1 to F7 (2 × 2cm) were cut using a sharp blade. Folding endurance was tested by repeatedly folding a short piece of film at the same location till it broke. Repeatedly, a film is folded several times at the same place till it breaks and folding endurance is measured. The mean value of three readings and standard deviation are shown in Table 211.
The buccal films were thoroughly weighed and stored in desiccator containing anhydrous calcium chloride. After three days, the films were weighed again. Moisture loss was calculated by using the following formula12.
Initial weight − Final weight
Moisture loss(%) = ------------------------------------ × 100
Initial weight
e) In vitro disintegration time:
The in vitro disintegration test was followed as per Bala and Sharma (2018), Hussain et al. (2018) and Mashru et al. (2005) guidelines with slight modifications. The in-vitro disintegration was tested in a phosphate buffer. The phosphate buffer consisted of 72.38g Na2HPO4, 0.19g KH2PO4 and 8.00g NaCl per liter of distilled water, adjusted with phosphoric acid to a pH of 6.8. A 2×2cm film was cut into strips and put on a petri-plate with 25mL of phosphate buffer (pH 6.8), then agitated. The film began to shatter at a specific moment. The test was repeated thrice and the average value was recorded.
Based on the results obtained for formulation F1 to F7, F7 was found to be ideal for further studies.
After cutting into small pieces, each film was dissolved in 10ml of methanol. A 1ml aliquot was collected and diluted with methanol to 50ml. The solution's absorbance was measured spectrophotometrically at 280nm using a Shimadzu UV spectrophotometer with methanol as a blank to calculate drug concentration and uniformity of dose units.
The total phenolic content (TPC) of clove was evaluated using the Folin-Ciocalteu reagent.
0.5mL of Folin-Ciocalteau (10% v/v) was mixed with 0.1 mL of clove extract sample. After stirring the mixture for 6 minutes, 1 mL of 7.5% (w/v) sodium carbonate (Na2CO3) was added and mixed with the samples. After 2 hours at room temperature, the absorbance was measured using a spectrophotometer at 765 nm wavelength. The data were represented as gallic acid equivalents per 100 g of sample (mg GAE/100 g of dry weight).
Table 1: Formulation of Orobuccal films.
|
Ingredients |
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
|
Clove |
0.15g |
0.30g |
0.30g |
0.30g |
0.30g |
0.30g |
0.30g |
|
HPMC E-15 |
1 g |
1.5g |
2g |
- |
- |
- |
- |
|
HPMC E-50 |
- |
- |
- |
1g |
1g |
1g |
1g |
|
Glycerin |
2ml |
3ml |
3ml |
2ml |
1ml |
0.5ml |
0.5ml |
|
PEG 400 |
- |
- |
- |
- |
1ml |
1.5ml |
2ml |
|
SLS |
0.1g |
0.1g |
0.1g |
0.1g |
0.1g |
0.1g |
0.1g |
|
Tartaric acid |
0.1g |
0.1g |
0.1g |
0.1g |
0.1g |
0.1g |
0.1g |
|
Distilled Water |
Q.s 20ml |
Q.s 20ml |
Q.s 20ml |
Q.s 20ml |
Q.s 20ml |
Q.s 20ml |
Q.s 20ml |
The antibacterial and antifungal efficacy of the clove film was evaluated using the well diffusion technique, a standard qualitative method widely used in microbiology to assess the inhibition potential of natural and synthetic agents against various microbial strains. The test organisms included Streptococcus mutans, Lactobacillus acidophilus and Candida albicans, which are common oral pathogens associated with dental caries and oral candidiasis. Fresh bacterial and fungal cultures were prepared and standardized to a concentration of 1–2 × 10⁵ colony-forming units per milliliter (CFU/mL) using McFarland’s turbidity standards to ensure consistency across all experimental groups.
Each strain was spread evenly across the surface of their respective selective media using the spread plate technique. Brain Heart Infusion (BHI) agar was used for Streptococcus mutans under aerobic conditions, de Man, Rogosa and Sharpe (MRS) agar was used for Lactobacillus acidophilus under facultative anaerobic conditions and Potato Dextrose Agar (PDA) was used for Candida albicans, incubated aerobically. After solidification of the agar, 5 mm diameter wells were bored into the media using a sterile cork borer. The clove film was prepared and cut to provide a dose equivalent to 2 mg, which was then placed into each well under aseptic conditions.
Positive controls included ciprofloxacin at 1 µg/well for bacterial strains and itraconazole24 at 200 µg/well for fungal strains, while sterile distilled water served as the negative control. All Petri plates inoculated with bacterial strains were incubated at 37°C for 48 hours and those containing fungal strains were kept at room temperature for the same duration. Following incubation, zones of inhibition surrounding the wells were observed and measured in millimeters using a digital vernier caliper. The presence of a clear zone indicated susceptibility of the microorganism to the test agent. Each experiment was carried out in duplicates to verify the reliability and reproducibility of the results.
This methodology was adapted and performed in accordance with previously published protocols for agar well diffusion testing, which is a validated approach to measure antimicrobial potential of herbal extracts and formulations16.
The aim of this study was to formulate a drug-loaded buccal film using clove powder and evaluate its antimicrobial activity against Streptococcus mutans, Lactobacillus acidophilus and Candida albicans. The developed buccal films are intended as a therapeutic approach to address dental problems and prevent periodontal diseases.
Clove powder was incorporated into the buccal films due to its potent analgesic, anti-inflammatory and antimicrobial properties, which are highly beneficial for managing oral pain and infections. Incorporating clove into the film allows localized and sustained drug delivery, directly at the site of action, enhancing therapeutic efficacy. Moreover, the use of natural clove powder contributes to reduced side effects, better patient acceptability and supports the trend toward herbal and cost-effective alternatives in dental care.
Each film was designed to contain the equivalent of one clove's worth of approximately 1.5gm to ensure adequate therapeutic action against dental caries. In Formulation 1, the drug content was only 0.15 g, which was below the intended dose. This resulted in a rubbery texture that was unsuitable for buccal administration and exhibited a rapid disintegration time of approximately 4 minutes. Based on these findings, Formulation 2 was modified by increasing the concentrations of the drug, polymer and plasticizer. Although this batch achieved the desired clove content, it lacked sufficient folding endurance, making it inappropriate for clinical use.
To address the issue of folding endurance, Formulation 3 was developed by increasing the polymer concentration, which in turn increased the viscosity. However, this led to undesirable air bubble entrapment in the film. Consequently, the polymer was changed to HPMC E50, a higher-viscosity variant, resulting in Formulation 4. Although this formulation showed an extended disintegration time, it still had a rubbery texture and inadequate folding endurance.
Table 2: Various Evaluation outcomes of Clove Mucoadhesive films
|
Evaluation |
F1 |
F2 |
F3 |
F4 |
F5 |
F6 |
F7 |
|
Colour |
Light brown |
Light brown |
Light brown |
Light brown |
Light brown |
Light brown |
Light brown |
|
Odour |
Slightly Aromatic |
Aromatic |
Aromatic |
Aromatic |
Aromatic |
Aromatic |
Aromatic |
|
Taste |
Slightlysweet |
Slightlysweet |
Slightly sweet |
Slightly sweet |
Slightly sweet |
Slightly sweet |
Slightly sweet |
|
pH |
6.9 |
7 |
7 |
6.9 |
7 |
7 |
7 |
|
Weight |
0.36g |
0.35g |
0.34g |
0.36g |
0.36g |
0.34g |
0.37g |
|
Thickness |
0.98mm |
1mm |
0.98mm |
0.99mm |
1mm |
1mm |
1mm |
|
Folding endurance |
96 |
13 |
128 |
25 |
224 |
148 |
180 |
|
Moisture loss |
17.6% |
18.2% |
19.8% |
16.4% |
19.2% |
18% |
15.4% |
|
Disintegration Time |
4min |
6min |
8min |
15min |
16min |
19min |
21min |
In an effort to improve the mechanical properties, Formulation 5 employed a combination of glycerin and PEG-400 as plasticizers. This modification enhanced the folding endurance, but the value exceeded optimal levels for a buccal film. To resolve this, Formulation 6 was developed by reducing the glycerin concentration while increasing PEG 400. This adjustment improved folding endurance slightly, but the rubbery texture persisted. Finally, in Formulation 7, the glycerin content was further reduced while PEG-400 was increased. This formulation demonstrated a balanced profile, with acceptable disintegration time, folding endurance and a desirable slow drug release, suitable for sustained buccal delivery.
Evaluation of Formulation 7 yielded promising results. The films exhibited uniform thickness (approximately 1 mm) and the average weight of ten films was 0.37 g, meeting the standard specifications for buccal films as per standard. The formulation showed excellent folding endurance, withstanding more than 180 folds without breaking, indicating its suitability for buccal application. Moisture loss, measured by the desiccator method, was 15.4%, which is within the acceptable range to minimize microbial contamination while maintaining adequate hydration.
The disintegration time was recorded at approximately 21 minutes, making it ideal for sustained-release applications. The drug content, determined by UV spectrophotometry at 280 nm, showed an absorbance of 0.667, corresponding to a drug content of 93%, which is within the acceptable range for dosage uniformity. The swelling index was calculated to be 1.07 g, indicating adequate water absorption, essential for facilitating controlled drug release. The surface pH of the film was found to be 7, aligning well with the pH of saliva, thereby ensuring compatibility with the buccal mucosa. Stability studies conducted over 47 days revealed no significant changes in physical appearance, drug content or microbial contamination, confirming the formulation's stability.
Formulation 7 incorporated hydroxypropyl methylcellulose polymers (HPMC E50) along with essential excipients including glycerin and polyethylene glycol-400 (PEG-400) as plasticizers, sodium lauryl sulfate (SLS) as a surfactant and permeation enhancer and tartaric acid as a saliva- stimulating agent. Distilled water was used as the solvent for preparing the films. On subjecting to evaluation, Formulation 7(fig.1) gave all acceptable values and thus was found satisfactory.
Fig. 1: Formulation 7 – Clove Mucoadhesive Orobuccal film.
The drug content was determined by UV spectrophotometry at 280 nm, showed an absorbance of 0.667, corresponding to a drug content of 93%, which is within the acceptable range for dosage uniformity. Total Phenolic Content of clove infused mucoadhesive orobuccal film was found to be 173.7mg GAE/g.
Formulation 7 was further subjected to antimicrobial studies. It was tested on oral pathogens - Streptococcus mutans, Lactobacillus acidophilus and Candida albicans. The results are as shown below in Table 3:
Table 3: Inhibitory activity of test compounds against Streptococcus mutans
|
Sample |
Concentration |
Zone of inhibition (mm) |
|
Control (Water) |
20µl |
NA |
|
Standard (Ciprofloxacin) |
1µg/well |
16.5± 0.5 |
|
Clove(Film Dissolved) |
2mg/well |
6.2± 0.5 |
|
Clove |
2mg/well |
6.0± 0.5 |
Fig-2: Streptococcus mutans: A-Standard (Ciprofloxacin; 1µg/well), B-Control(water). C- Clove (Film Dissolved) (2mg/well), D- Clove (2mg/well).
Table 4: Inhibitory activity of test compounds against Lactobacillus acidophilus
|
Sample |
Concentration |
Zone of inhibition (mm) |
|
Control (Water) |
20µl |
NA |
|
Standard |
1µg/well |
14.8± 0.5 |
|
Clove (Film Dissolved) |
2mg/well |
6.3± 0.5 |
|
Clove |
2mg/well |
6.3± 0.5 |
Fig-3: Lactobacillus acidophilus: A-Standard (Ciprofloxacin; 1µg/well), B-Control (water).C-Clove (Film Dissolved) (2mg/well), D- Clove (2mg/well).
Table 5: Inhibitory activity of test compounds against Candida albicans
|
Sample |
Concentration |
Zone of inhibition (mm) |
|
Control (Water) |
20µl |
NA |
|
Standard |
200µg/well |
15.0± 0.5 |
|
Clove |
2mg/well |
6.0 ± 0.5 |
|
Clove |
2mg/well |
6.2 ± 0.5 |
Fig. 4: Candida albicans: A- Control (water) B-Standard (Itraconazole; 200µg/well),-. C- Clove (2mg/well), D- Clove (2mg/well).
The antimicrobial and antifungal activity of the clove film was assessed using the agar well diffusion method against Streptococcus mutans, Lactobacillus acidophilus and Candida albicans. The clove film demonstrated moderate inhibitory activity against all three microorganisms. In the case of S. mutans (Table 3,Fig 2), inhibition zones of 6.2±0.5mm and 6.0±0.5mm were observed, while the standard antibiotic ciprofloxacin produced a larger inhibition zone of 16.5±0.5mm. Against L. acidophilus (Table 4,Fig 3), only one replicate showed activity, with a zone of 6.3±0.5 mm, compared to 14.8±0.5mm for ciprofloxacin. For C. albicans, the clove film produced zones of 6.0±0.5mm and 6.2±0.5mm, whereas the standard antifungal agent, itraconazole, demonstrated a zone of 15.0±0.5mm (Table 5,Fig 4), No inhibition was observed in the negative control wells containing sterile water, confirming that the observed activity was due solely to the active ingredients in the clove film.
These findings indicate that although the clove film exhibits less antimicrobial efficacy than standard pharmaceutical agents, it still possesses measurable activity that could be beneficial in early-stage or adjunctive therapies. Further studies, including determination of minimum inhibitory concentration (MIC), time-kill kinetics and biofilm inhibition assays, are recommended to explore its full therapeutic potential. Also future research can be done by increasing the concentration of Clove taken in the films followed by assessing their antimicrobial activity.
Clove is a highly valued spice known for its powerful medicinal properties, including analgesic, anti-inflammatory, antimicrobial and antioxidant effects. Widely used in cooking, it adds a rich flavor and aroma to various dishes across global cuisines. For centuries, it has played a key role in traditional medicine for treating numerous health issues. Its main bioactive compound, eugenol, shows great promise for pharmaceutical applications due to its therapeutic potential. Clove’s strong antimicrobial properties also make it a natural choice for food preservation and use in cosmetic products like skincare and oral care. Continued research may lead to new therapeutic discoveries, including solutions to combat antimicrobial resistance and prevent cancer. Additionally, clove’s benefits for oral health further emphasize its broad and growing significance.
Dental Analgesic Action of Clove could be primarily due to its active compound eugenol, a phenolic compound with local anesthetic and anti-inflammatory properties. Eugenol blocks voltage-gated sodium channels on sensory neurons, thereby inhibiting the propagation of nerve impulses responsible for pain perception. This results in a numbing effect when clove oil is applied topically to the affected dental area. Additionally, eugenol inhibits cyclooxygenase (COX) enzymes, reducing the synthesis of prostaglandins, which are mediators of inflammation and pain. This dual mechanism—nerve conduction blockade and anti-inflammatory action—makes clove particularly effective in relieving toothache and pulpitis-associated pain.
Also its antimicrobial action against oral pathogens like Streptococcus mutans, Lactobacillus acidophillus and Candida albicans is primarily due to eugenol, which disrupts the bacterial cell membrane integrity, leading to leakage of intracellular contents and cell death. Eugenol can also penetrate the lipid bilayer, interfering with enzymatic systems and protein synthesis within microbial cells. Furthermore, clove oil has been shown to inhibit biofilm formation and adhesion of bacteria to tooth surfaces, which are critical steps in the pathogenesis of dental caries and periodontal disease. This broad-spectrum antimicrobial activity makes clove a valuable natural agent in maintaining oral hygiene and controlling infections.
Apart from eugenol, clove contains several other bioactive constituents that significantly contribute to its analgesic and antimicrobial properties, thereby making clove powder a more comprehensive choice than clove oil for formulating oro-buccal films. β-Caryophyllene, a sesquiterpene present in clove, exhibits strong anti-inflammatory and analgesic activity by acting as a CB2 receptor agonist, helping modulate pain and inflammation without central nervous system effects. Tannins, also abundant in clove powder, provide astringent and antimicrobial benefits by precipitating microbial proteins and forming a protective layer over mucosal surfaces. Additionally, flavonoids like kaempferol and rhamnetin offer antioxidant, anti-inflammatory and antimicrobial actions by inhibiting microbial enzymes and reducing tissue oxidative stress. Eugenyl acetate, a minor constituent, further enhances these therapeutic effects by acting synergistically with eugenol. In contrast, clove oil primarily contains eugenol and lacks these additional compounds in significant amounts due to the extraction process. Therefore, incorporating whole clove powder into oro-buccal films ensures a broader spectrum of pharmacological activity, improved local retention and better therapeutic efficacy compared to films formulated with isolated clove oil.
In conclusion, the present study aimed to formulate and evaluate a clove powder-based mucoadhesive orobuccal film for the treatment of dental pain and oral infections. Among the seven formulations developed using the solvent casting method, Formulation 7 exhibited the most desirable properties in terms of drug content, disintegration time, folding endurance and stability. The formulation contained HPMC E-50 as the polymer and an optimized combination of PEG-400 and glycerin as plasticizers, which contributed to the improved mechanical strength and flexibility of the film. The final film demonstrated a disintegration time of 21 minutes, a drug content of 93%, a surface pH of 7 and a swelling index of 1.07 g, all of which are ideal for buccal application. Moisture loss was measured at 15.4%, which is acceptable for maintaining the integrity and microbial safety of the film. Stability studies conducted over 47 days confirmed that the film retained its physical and chemical characteristics without degradation. Furthermore, the incorporation of clove, known for its rich eugenol content, added therapeutic benefits such as antimicrobial and analgesic effects, particularly against Streptococcus mutans, Candida albicans and Lactobacillus acidophilus. Overall, the optimized buccal film proved to be a promising, patient-friendly and effective drug delivery system for managing dental caries and associated pain, with potential for future clinical and commercial application.
The authors have no conflicts of interest regarding this investigation.
We would like to extend our sincere gratitude to Dr.Pavithra, HoD, Dept. of Pathology, KLE Dental College, Bengaluru for providing the necessary facilities and support to conduct the antimicrobial studies.
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Received on 08.07.2025 Revised on 15.11.2025 Accepted on 23.01.2026 Published on 01.07.2026 Available online from July 04, 2026 Research J. Pharmacy and Technology. 2026;19(7):3375-3382. DOI: 10.52711/0974-360X.2026.00479 © RJPT All right reserved
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