Floating Granules of Dicyclomine Hydrochloride: Formulation Approaches, Mechanisms, and Evaluation

Abstract Dicyclomine hydrochloride is an anticholinergic, antispasmodic agent widely used in the symptomatic management of irritable bowel syndrome and other functional gastrointestinal spasms. Its narrow absorption window in the proximal small intestine, short elimination half-life, and dose-dependent local site of action make it a rational candidate for gastroretentive drug delivery. Floating (buoyant) granules represent a multiple-unit, non-effervescent-or-effervescent gastroretentive approach that prolongs gastric residence time, improves local and systemic bioavailability, and permits sustained or controlled drug release while avoiding the all-or-nothing emptying behaviour associated with single-unit floating tablets. This review consolidates current understanding of gastroretentive drug delivery systems, the physicochemical and physiological basis of gastric floatation, the polymers and gas-generating agents used to formulate floating granules, and the evaluation parameters applied to such systems. Findings from experimental studies on structurally related floating granule and floating tablet systems for other actives are synthesised to identify formulation variables-polymer type and ratio, gas-generating agent concentration, and granulation technique-that govern buoyancy lag time, total floating duration, and drug release kinetics. The review concludes by outlining the formulation rationale, likely evaluation strategy, and translational prospects for a floating granule system of dicyclomine hydrochloride, and identifies gaps that future experimental work should address.