Development And Characterization Of Telmisartan Orodispersible Films: Overcoming Solubility Challenges For Enhanced Hypertensive Therapy

Abstract

This research conducted an in-depth analysis of the preformulation and formulation development of telmisartan, an antihypertensive medication that falls under the BCS Class II category and has a low solubility. Key physicochemical parameters, such as solubility (which was improved through the use of solid dispersions), partition coefficient (log P ~6.4), and λmax (296 nm in methanol), were characterised. Analytical procedures were validated through the use of a calibration curve in 0.1 N HCl (R2 ≥ 0.999), while FT-IR was utilised to check the compatibility of the medicine and the excipient. We optimised orodispersible films (ODFs), which exhibited rapid disintegration (within 60 seconds), high drug content (ranging from 95 to 105%), and stability under accelerated circumstances (40 degrees Celsius and 75% relative humidity). The results of the kinetic study showed that there was an abnormal transport (n = 0.62, Korsmeyer-Peppas model), which indicates that there are mechanisms that combine erosion and diffusion. The results of stability testing demonstrated that the product complied with the International Council for Harmonisation (ICH) criteria, with contaminants of less than or equal to 2% after a period of 12 months. The findings provide evidence of a robust formulation technique that can improve the bioavailability of telmisartan and the patient's compliance with the medication.