Background

The objective of this study was to design and assess the quality of PropoLid, a propolis-based, lidocaine-contained hydrophilic oromucosal film for the treatment of aphthous, ulcerative, and traumatic lesions in the oral cavity.

Methods

PropoLid oromucosal films containing Lidocaine (4%) and Propolis extract (1:10), known for its analgesic, antimicrobial, antifungal, and anti-inflammatory properties were obtained using solvent evaporation technique, with gelatin as the polymer and glycerin as the plasticizer (1:1.5). Rosehip syrup is added as a saliva-stimulating, flavoring and adhesive agent. The quality parameters of the PropoLid oral films, such as organoleptic properties, thickness, flexibility, dryness, surface pH, dissolution, and quantitative content of Lidocaine, were assessed.

Results

Yellow-brown translucent films with a smooth surface and an average thickness of 0.3 ± 0.03 mm were developed. The quality parameters of the obtained oral films meet the organoleptic requirements outlined in the Pharmacopoeia. The flexibility index of the films was >300 and the surface pH was 6.97. The quantitative content of lidocaine in the film was determined to be 2.5 mg/cm². Dissolution testing demonstrated that PropoLid oral films completely release active pharmaceutical substances responsible for the pharmacological effect.

Conclusion

The technology and composition developed to create mucoadhesive films that meet Pharmacopoeial requirements. The Lidocaine content per 1 cm² of the oral films is 2.5 mg, aligning with the previously calculated concentration of 4%. The PropoLid oral adhesive films can be used to treat oral ulcers with associated pain.

Search results

Development of New Combined PropoLid Oromucosal Films for the Treatment of Oral Ulcerative Lesions