ADVANCES IN FAST-DISSOLVING ORAL FILM FORMULATIONS OF TELMISARTAN: A SYSTEMATIC REVIEW OF POLYMER SELECTION, CHARACTERIZATION, AND CLINICAL RELEVANCE
Author
Rakesh Dhakad, Dr. Sandeep Mishra
Abstract
Telmisartan, a BCS Class II angiotensin II receptor blocker widely prescribed for hypertension management, suffers from poor aqueous solubility (~9 µg/mL), limited oral bioavailability (~42%), and a dissolution-rate-limited absorption profile that renders conventional dosage forms suboptimal for rapid therapeutic onset. Fast-dissolving oral films (FDOFs) — thin, water-soluble polymeric matrices designed to disintegrate within seconds upon contact with saliva — represent a transformative patient-centric strategy to overcome these biopharmaceutical limitations. This systematic review synthesizes peer-reviewed research published between 2022 and 2026 on the formulation, characterization, and pharmacodynamic evaluation of telmisartan fast-dissolving oral films and related oral disintegrating dosage forms. We analyze the selection and performance of film-forming polymers (HPMC, pullulan, PVA, sodium alginate), plasticizers (PEG 400, glycerol, sorbitol), superdisintegrants, and solubility-enhancing excipients (β-cyclodextrin complexes, solid dispersions). Critical evaluation parameters — thickness, folding endurance, tensile strength, surface pH, disintegration time, drug content uniformity, and in vitro dissolution — are discussed alongside Quality by Design (QbD) approaches, analytical characterization (FTIR, DSC), and ICH stability testing. Research gaps, including limited in vivo pharmacokinetic validation, scalability challenges, and absence of standardized regulatory frameworks, are identified and future directions outlined.
Keywords
telmisartan; fast-dissolving oral film; orodispersible film; HPMC; pullulan; solvent casting; BCS Class II; QbD; dissolution enhancement; hypertension; patient compliance
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References
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