SOFTs - Structured orodispersible film templates.

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Orodispersible films (ODFs) are promising for personalized medicine, allowing drug-free templates to be printed with active pharmaceutical ingredients (APIs).
• Current ODFs require enhanced loading capacity and suitable structures to meet the demands of precise, patient-specific dosing.

Purpose of the Study:

• To develop and characterize structured orodispersible film templates (SOFTs) with high drug loading capacity.
• To investigate the influence of film formulation on porosity, disintegration, and mechanical properties.

Main Methods:

• SOFTs were fabricated using a solvent casting method with water-soluble cellulose derivatives.
• The formulation of the casting mass was systematically varied to control pore size and number.
• API loading capacity, mechanical properties, and handling safety were evaluated.

Main Results:

• SOFTs exhibited a porous structure enabling high API mass loads of up to 6.1 mg/cm².
• Formulation adjustments significantly impacted film porosity and disintegration time.
• Incorporation of matrix material improved mechanical properties and nanoparticle dissolution, while a protection layer enhanced handling safety.

Conclusions:

• SOFTs represent a novel template for high-capacity, individualized drug delivery via printing.
• The developed SOFTs address limitations of current ODFs, offering improved drug loading and handling.
• Further optimization holds potential for advanced personalized medication systems.