Formulations and Evaluation of Fast Disintegrating Tablets of Amlodipine Besylate: A Comprehensive Review

Fast disintegrating tablets (FDTs) have revolutionized oral drug delivery by offering rapid disintegration and dissolution in the oral cavity without the need for water, thus enhancing patient compliance and convenience, especially in pediatric, geriatric, and dysphagic populations. Amlodipine Besylate, a widely used calcium channel blocker for hypertension and angina, often encounters challenges related to bitter taste, poor aqueous solubility, and delayed onset of action in conventional dosage forms. Formulating Amlodipine Besylate as an FDT can overcome these issues by enabling faster disintegration, improved palatability, and potentially enhanced bioavailability. This review comprehensively examines various formulation strategies, including the selection of superdisintegrants, binders, fillers, and taste masking techniques, alongside different preparation methods such as direct compression, wet granulation, and sublimation. The evaluation parameters critical for FDTs such as disintegration time, hardness, friability, dissolution profile, and stability are discussed in detail. Additionally, recent advancements like the use of natural superdisintegrants, nanoparticle incorporation, and 3D printing technology are highlighted for their potential to further optimize Amlodipine Besylate FDTs. The article also addresses formulation challenges and future perspectives, emphasizing the role of innovative excipients and technologies in the development of effective, patient-friendly fast disintegrating tablets for cardiovascular therapy.