Journal of Applied Pharmacy
Open Access

Development and Clinical Evaluation of Mucoadhesive Buccal Films for Rapid Pain Relief

Camila Rodríguez Torres^{* *}Correspondence: Camila Rodríguez Torres, Department of Pharmaceutics and Drug Delivery Systems, National Institute of Pharmaceutical Innovation, Guadalajara, Mexico, Email:

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About the Study

The increasing demand for patient-friendly drug delivery systems has catalyzed the development of novel pharmaceutical formulations that ensure both therapeutic efficiency and enhanced patient compliance. Among these innovations, mucoadhesive buccal films have garnered significant attention for their ability to provide rapid and localized pain relief. These thin, flexible films are designed to adhere to the buccal mucosa, facilitating the direct absorption of drugs into the systemic circulation while bypassing first-pass hepatic metabolism. This delivery route not only accelerates onset of action but also reduces dosing frequency and gastrointestinal side effects, making it particularly suitable for acute pain management. In Mexico, where pain management remains a clinical priority in both outpatient and emergency care, the implementation of mucoadhesive buccal films offers a promising alternative to conventional oral and parenteral routes.

The development of buccal films involves careful selection of mucoadhesive polymers, plasticizers, and drug molecules to ensure optimal mechanical strength, flexibility, and drug release profiles. Polymers such as Hydroxypropyl Methylcellulose (HPMC), sodium alginate, and carbopol are frequently employed for their biocompatibility and strong adhesion properties. Plasticizers like glycerol or polyethylene glycol are added to improve film elasticity and comfort. During formulation, various techniques including solvent casting or hot melt extrusion are used to ensure homogenous distribution of the drug and reproducibility of film properties. In our laboratory, lidocaine hydrochloride was selected as the model drug due to its rapid analgesic effect, well-known safety profile, and suitability for mucosal absorption. The formulation process involved optimizing drug-polymer ratios and evaluating the physicochemical properties such as thickness, tensile strength, folding endurance, surface pH, and moisture content.

The in vitro evaluation of the mucoadhesive films included drug content uniformity, swelling behavior, disintegration time, and mucoadhesion strength using porcine buccal tissue. The results demonstrated that the films maintained structural integrity upon application, adhered effectively to mucosal surfaces, and released the drug within 5 to10 minutes. Drug diffusion studies using Franz diffusion cells showed a controlled yet rapid release profile that matched the desired pharmacokinetics for acute pain relief. Moreover, the films were stable under accelerated storage conditions, retaining their physical and chemical properties over time, which is essential for commercial viability and patient safety.

Following successful laboratory testing, a Phase I/II clinical evaluation was conducted among a group of 60 adult patients suffering from mild to moderate dental pain. The trial was performed in collaboration with the Guadalajara University Hospital and followed ethical approval and informed consent procedures. Patients were randomized into two groups one receiving the mucoadhesive buccal film and the other receiving a standard oral tablet of the same drug. Pain intensity was measured using the Visual Analogue Scale (VAS) at baseline and multiple intervals post-administration. The buccal film group reported a significantly faster reduction in pain scores, with most patients experiencing relief within 10 minutes compared to 25 minutes in the oral tablet group. Additionally, patients preferred the film due to ease of use, absence of swallowing difficulty, and lack of gastrointestinal discomfort.

Patient feedback revealed high acceptability and satisfaction with the buccal film, particularly among elderly individuals and those with swallowing difficulties. There were no reports of significant adverse events, and the films were well tolerated across all participants. The clinical results affirm the film's potential as a first-line treatment for acute or breakthrough pain episodes in dental, post-surgical, or musculoskeletal conditions. Moreover, the non-invasive nature of the film and its potential for selfadministration make it an ideal choice for home-based or emergency use, especially in rural or resource-limited settings prevalent in parts of Mexico.

The success of this study highlights the importance of integrating pharmaceutical technology with clinical practice to enhance drug delivery and patient outcomes. Mucoadhesive buccal films are not merely a technological advancement but also a patient-centered solution that addresses common barriers in pain management, including delayed onset, side effects, and non-compliance. Their application can be extended to other therapeutic areas such as anti-emetics, anxiolytics, and cardiovascular agents, where rapid onset is critical. Furthermore, the scalability of the production process and the potential for customization open doors for industrial development and commercialization within the national pharmaceutical sector.

In conclusion, the development and clinical evaluation of mucoadhesive buccal films for rapid pain relief demonstrate a significant step forward in novel drug delivery systems. These films offer a practical, efficient, and user-friendly alternative to traditional formulations, particularly for patients requiring quick relief and non-invasive treatment. In the context of Mexico’s healthcare challenges, such innovations provide both clinical and economic value. By investing in further research, regulatory support, and industrial collaboration, mucoadhesive buccal films can become a mainstay in modern pain management protocols.