Purpose:
Present study focused on formulation of mucoadhesive bilayer composite films for treatment of periodontitis and evaluation of its physicochemical properties.
Methods:
Solvent casting technique was used to prepare films. Primary layer (D) was prepared with flaxseed and HPMC composite to sustain release of doxycycline hyclate. Second layer (S) was comprised of sodium alginate and PVA composite for faster release of clove oil. Both layers were combined to generate bilayer film (B). All formulations were characterized further to get optimized formulation.
Results:
ATR-FTIR results showed intactness of drug and clove oil in presence of excipients. pH of films was compatible with periodontal cavity and thickness was suitable to insert into cavity. Immediate release layer showed faster disintegration and swelling. Content of clove oil was above 80%. Rate of swelling of a primary layer was slow and drug content complies with United States Pharmacopoeia. SEM analysis revealed intact, non-porous and smooth films. Films exhibited better mechanical strength and bio-adhesiveness. Clove oil was released from immediate release layer within 10 min and doxycycline hyclate release was retarded minimum of up to 8 h in primary layer as well as bilayer. Formulation also showed a significant effect on both E-coli and S. Aureus.
Conclusion:
In current study bilayer were successfully prepared and characterized. Optimized formulation be effectively used for treatment of periodontitis.
Keywords: Periodontitis, Flax seed mucilage, HPMC, Sodium alginate, Polyvinyl alcohol, Doxycycline hyclate, clove oil.