Folded Gastroretentive Bilayer Films Driven by Kollicoat SR 30-D for Sustained Release of Highly Water-Soluble Drugs

This study introduces a bilayer unfoldable oral film for propranolol hydrochloride that combines immediate and sustained release in a single dosage form. The system comprises an immediate-release (IR) layer formulated with HPMC K-100LV and a sustained-release (SR) layer of Kollicoat SR 30-D, a film-forming polymer. The novelty of the system resides in employing Kollicoat SR 30-D, typically utilized as a coating polymer, as a matrix-forming polymer to regulate the release of a highly soluble drug. The use of hydrophilic and hydrophobic polymers for this purpose has had limited success because of burst releases or poor film formation. Both the IR layer and the SR layer were statistically optimized using Design-Expert®. In the optimized formulation, the IR layer exhibited rapid drug release with a t90 value of 5.18 minutes and the SR layer maintained sustained release for up to 12 hours (t₉₀ = 688.71 minutes). The release followed Korsmeyer–Peppas kinetics (n = 0.483), which confirms a diffusion-controlled mechanism through the Kollicoat matrix. Scanning electron microscopy revealed a uniform, dense film of Kollicoat SR 30-D with microchannels after dissolution, which supports the idea that the film acts as a diffusion barrier. The bilayer film showed good folding endurance, low moisture absorption, and minimal water vapour transmission rates, indicating mechanical and physicochemical stability. This study demonstrates that Kollicoat SR 30-D can be successfully used as a sustained-release film-forming polymer for highly water-soluble drugs, offering a scalable, solvent-free, and commercially viable platform for gastroretentive formulations.

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