An Updated Overview of the Emerging Role of Patch and Film-Based Buccal Delivery Systems

Abstract

Buccal mucosal membrane offers an attractive drug-delivery route to enhance both systemic and local therapy. This review discusses the benefits and drawbacks of buccal drug delivery, anatomical and physiological aspects of oral mucosa, and various in vitro techniques frequently used for examining buccal drug-delivery systems. The role of mucoadhesive polymers, penetration enhancers, and enzyme inhibitors to circumvent the formulation challenges particularly due to salivary renovation cycle, masticatory effect, and limited absorption area are summarized. Biocompatible mucoadhesive films and patches are favored dosage forms for buccal administration because of flexibility, comfort, lightness, acceptability, capacity to withstand mechanical stress, and customized size. Preparation methods, scale-up process and manufacturing of buccal films are briefed. Ongoing and completed clinical trials of buccal film formulations designed for systemic delivery are tabulated. Polymeric or lipid nanocarriers incorporated in buccal film to resolve potential formulation and drug-delivery issues are reviewed. Vaccine-enabled buccal films have the potential ability to produce both antibodies mediated and cell mediated immunity. Advent of novel 3D printing technologies with built-in flexibility would allow multiple drug combinations as well as compartmentalization to separate incompatible drugs. Exploring new functional excipients with potential capacity for permeation enhancement of particularly large-molecular-weight hydrophilic drugs and unstable proteins, oligonucleotides are the need of the hour for rapid advancement in the exciting field of buccal drug delivery.

Keywords: buccal delivery; buccal film; buccal patch; clinical trials; evaluation; manufacturing; mucoadhesive polymers; nanoparticles; penetration enhancers.

Figure 1

A schematic diagram depicting the key regions of the buccal area.

Figure 2

Development of rizatriptan loaded hydrogel-based mucoadhesive buccal film and enhanced buccal permeation displayed by the film compared to oral solution containing equivalent dose (adapted from [25], published by MDPI, 2021). *, Statistically different at p < 0.005.

Figure 3

Possible designs of multilayered vaccine comprised buccal film with different functions for unidirectional release of antigen.

Figure 4

A schematic diagram showing the transport process of diverse nanocarriers through the buccal epithelium.

Figure 5

Development of acyclovir loaded nanospheres embedded buccal film and comparison of the plasma profiles of acyclovir following buccal application of buccal film and oral solution in rabbits (adapted with permission from [146], published by Elsevier, 2015).

Figure 6

Flow chart illustrating the various processes typically involved in buccal film manufacturing based on solvent casting technique.