Developing mucoadhesive buccal films: How AdhexPharma supports your project

Following an initial paper-based feasibility that indicates potential suitability, development proceeds to laboratory-scale investigations to experimentally verify key assumptions. In this context, the evaluation of API permeability across the buccal mucosa can represent an important component of laboratory feasibility, providing valuable evidence to support further formulation development and enabling the early identification of potential limitations before scale-dependent costs arise.

Early prototype films may be prepared to evaluate excipient compatibility, API solubility and stability within the film matrix. At this stage, the objective is to move from theoretical feasibility into practical formulation evidence while identifying potential limitations before scale-dependent costs are incurred.

When appropriate, preliminary in vitro permeation studies using buccal tissue models may also be conducted to assess absorption potential and provide early insight into transmucosal performance. These investigations can help guide formulation strategy and support the definition of the most suitable development pathway for subsequent stages.

Building on laboratory feasibility results, development progresses to the prototyping and optimization phase, where scientific findings are translated into a robust and patient-acceptable lead prototype product.

Formulation parameters are systematically refined to ensure stability, assay and purity, drug release performance, water content, usability, applicability and manufacturability. Addressing these parameters early helps avoid late-stage reformulation and ensures that the formulation is reproducible and ready for scale-up.

Key activities include:

• Film design options: Evaluation of single-layer versus multilayer systems, unidirectional versus bidirectional release and fast versus controlled release, enabling directional or controlled drug delivery depending on therapeutic objectives
• Polymer and excipient screening: Optimization of composition and disintegration rate to ensure patient acceptability while maintaining effective mucoadhesion and API release
• Analytical method development: Supporting accurate API quantification, stability studies and reliable performance assessment throughout development
• Confirmatory API permeation checks: When relevant, targeted in vitro permeation studies may be conducted to verify that the lead prototype maintains the API permeability established during laboratory feasibility, ensuring that formulation optimization does not compromise transmucosal absorption

The methodical optimization of these parameters is essential to select a lead prototype ready to be evaluated in Phase I clinical studies.

Once the formulation has been optimized, AdhexPharma supports process development and pilot-scale manufacturing using industrially relevant processes such as solvent casting, controlled drying and precision punching.

Semi-automated pilot-scale production reproduces key parameters of commercial equipment, enabling validation of process robustness while reducing risks associated with industrial scale-up.

Pilot batches can be used to generate to generate preclinical supply for pharmacokinetic, toxicology or proof-of-concept studies while confirming process robustness and scalability.

This stage plays a critical role in for securing industrialization and preparing the project for clinical development.

For clinical studies, our teams provide full GMP manufacturing supported by established quality systems and regulatory expertise.

Services include:

• GMP manufacturing of clinical trial batches and batch release
• Packaging and quality control in accordance with regulatory requirements
• Regulatory support for clinical trial applications and submissions

This integrated capability ensures continuity between development and clinical supply, avoiding delays often associated with technology transfer between multiple partners.

Additional scientific and analytical support

To address complex or highly specific development needs, AdhexPharma offers complementary services that can be integrated at any stage of a mucoadhesive oral film project.

These services include advanced permeation studies, such as in vitro diffusion analyses, to better characterize API transport across the buccal mucosa, support formulation optimization and strategic decision-making, while relying on comprehensive analytical services, including stability testing, API quantification, and formulation characterization, to ensure robust data generation throughout development. 

Together, these capabilities strengthen the scientific foundation of each project and support confident progression toward industrial readiness.

Discover how AdhexPharma can support your project, from idea to market.
Explore the full range of our services here: Services 

Why integrated development accelerates success

One of the main challenges in buccal film development lies in the transition between formulation development and industrial manufacturing. Fragmented development models can lead to reformulation, delays, or complex technical transfers.

By combining early development expertise at Labtec with industrial manufacturing capabilities at AdhexPharma, projects benefit from continuity of knowledge, aligned process design, and smoother scale-up. This integrated approach reduces technical risk while accelerating timelines toward clinical and commercial milestones.