Design and evaluation of bilayer sildenafil sublingual tablets combining fast-dispersible and mucoadhesive layers
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This study focused on the development and evaluation of a bilayer sildenafil tablet for sublingual administration. The aim was to design a sublingual tablet that provides both rapid onset and sustained drug delivery for treating erectile dysfunction. Bilayer tablets (total weight approximately 300 mg, containing 40 mg sildenafil citrate) were prepared by direct compression. The upper layer (200 mg) was designed as a fast-dispersible layer and a lower layer was a mucoadhesive layer (100 mg). The physical properties, in vitro drug release, and mucoadhesion of the formulations were evaluated. Mucoadhesion was tested on mucin-coated substrates using a modified falling liquid technique. The fast-dispersible layer disintegrated in 3.30 min. Among the evaluated polymers, HPMC showed the best adhesion and gel integrity for over 120 min compared with HPC-SL and Carbopol 940. Increasing concentration and the molecular weight of HPMC enhanced the structural durability of the mucoadhesive gel mass and effectively delayed drug release. The bilayer tablet design successfully pairs a quick-acting layer with a slow-releasing, adhesive layer. Based on these results, using an HPMC matrix is a practical approach to control sublingual sildenafil release for erectile dysfunction management.
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