A NOVEL DRUG DELIVERY SYSTEM OF INDIGENOUS HERBS FOR SUBLINGUAL IMMUNOTHERAPY IN COPD
DOI:
https://doi.org/10.22159/ijpps.2025v17i3.53317Keywords:
Bilayer tablet, Sublingual, Butterbur, Bee’s pollen, SLIT, COPD, Ex-vivo, In vitro, PermeabilityAbstract
Objective: To develop and evaluate bilayer sublingual tablets containing Butterbur and Bee’s Pollen extracts for the management of Chronic Obstructive Pulmonary Disease (COPD). The aim was to achieve anti-inflammatory, anti-allergic, and immune-modulatory effects via a non-invasive delivery system, improving patient compliance and therapeutic outcomes.
Methods: Bilayer tablets were formulated using direct compression, with Bee’s Pollen serving as the immune-modulatory layer and Butterbur as the anti-inflammatory layer. The tablets were evaluated for pre-and post-compression parameters, including flow properties, hardness, friability, disintegration, and dissolution. Fourier Transform Infrared (FTIR) spectroscopy confirmed drug-excipient compatibility. In vitro drug release studies were conducted, and ex vivo permeation studies using goat buccal mucosa simulated sublingual absorption. Stability tests followed ICH guidelines to ensure physical and chemical consistency under accelerated conditions.
Results: The bilayer tablets exhibited rapid disintegration (<3 min) and high drug release (>90%) during dissolution studies. FTIR analysis confirmed the absence of significant drug-excipient interactions. Ex vivo permeation studies demonstrated efficient drug absorption, supporting systemic delivery. Stability tests revealed no significant changes in parameters over 30 days. The best formulations, F8 and F9, showed superior dissolution and permeation profiles, with cumulative drug release reaching 94.91% (Butterbur) and 93.3% (Bee’s Pollen).
Conclusion: Bilayer sublingual tablets combining Butterbur and Bee’s Pollen extracts present a promising therapeutic strategy for COPD. The dual action of these herbal extracts offers enhanced anti-inflammatory and immune-modulating effects, potentially improving patient outcomes and compliance. Further clinical trials are recommended to validate these findings and explore the long-term therapeutic potential.
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