Purpose: Recurrent aphthous stomatitis (RAS) is the most common painful ulcerative
disease of oral mucosa happening in ~20% of people. Aimed to develop Myrtus communis
L. (Myrtle) containing oral patches, we applied box-behnken design to evaluate the effect of
polymers such as Polyvinyl pyrrolidone (PVP), Gelatin, Methylcellulose (MC) and Pectin.
Methods: The patches properties such as tensile strength, folding endurance, swelling
index, thickness, mucoadhesive strength and the pattern of myrtle release were evaluated as
dependent variables. Then, the model was adjusted according to the best fitted equation
with box behnken design.
Results: The results indicated that preparation of myrtle patch with hydrophilic polymers
showed the disintegration time up to 24h and more. Using of polyvinyl pyrrolidone as a
water soluble polymer and a pore-former polymer led to faster release of soluble materials
from the patch to 29 (min-1). Also it decreases swelling index by increasing the patch
disintegration. Gelatin and Pectin, with rigid matrix and water interaction properties,
decreased the swelling ratio. Pectin increased the tensile strength, but gelatin produced an
opposite effect. Thinner Myrtle patch (about 28μm) was obtained by formulation of methyl
cellulose with equal ratio with polyvinyl pyrrolidone or gelatin.
Conclusion: Altogether, the analysis showed that the optimal formulation was achieved
with of 35.04 mg of Gelatin, 7.22 mg of Pectin, 7.20 mg of polyvinyl pyrrolidone, 50.52 mg
of methyl cellulose and 20 mg of Myrtle extract
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