Development and optimization Ambroxol Raft forming suspensions
This study focuses on the formulation, optimization, and evaluation of ambroxol hydrochloride in a novel raft-forming oral suspension aimed at enhancing gastric retention and controlled drug release. The formulation utilizes polymeric complexation and pH-responsive gelation to form a floating in-situ gel upon contact with gastric fluids. Using design of experiments (DoE), critical parameters such as polymer concentration, viscosity enhancers, and gelation agents were optimized to achieve desired raft strength, floating lag time, and drug release profile. The optimized formulation demonstrated prolonged gastric residence time, enhanced mucosal adhesion, and sustained drug release for up to 12 hours.
In vitro and in vivo assessments confirmed the formulation’s potential in reducing dosing frequency and improving local therapeutic efficacy, particularly for pulmonary conditions. The platform also offers broad applicability for other gastric-retentive therapies.