Dual-Phase Extended-Release Tablets: A Comprehensive Review
DOI:
https://doi.org/10.69980/ajpr.v28i4.764Keywords:
Dual-phase drug delivery, Extended-release tablets, Immediate-release, Pharmacokinetics, Bilayer tablets, 3D printingAbstract
Dual-phase extended-release tablets represent a sophisticated oral drug delivery strategy, integrating the benefits of both immediate-release and sustained-release systems. These formulations, also known as biphasic or bilayer extended-release systems, are meticulously engineered to provide a rapid onset of therapeutic action via an initial drug burst, followed by prolonged drug release to maintain stable plasma concentrations over an extended period. This design addresses critical pharmacokinetic shortcomings of traditional immediate-release and single-phase extended-release formulations, such as fluctuating drug levels, sub-therapeutic troughs, and peak-related toxicities. The rationale for their development spans ensuring rapid relief, maintaining consistent therapeutic levels, reducing dosing frequency, and improving overall pharmacokinetic profiles, making them suitable for fixed-dose combinations. Various design and formulation approaches, including bilayer tablets, polymeric matrix systems, membrane-coated systems, multilayer tablets, and osmotic dual-release systems, are employed, each leveraging distinct mechanisms such as disintegration, dissolution, diffusion, erosion, and swelling. Rigorous evaluation through physical, mechanical, in vitro dissolution studies, IVIVC, and advanced analytical techniques like FT-IR and SEM, alongside stability studies, ensures their quality and performance. Dual-phase tablets find widespread applications in analgesics, antivirals, urologic, antidiabetic, cardiovascular, and antihistamine drugs. Despite challenges such as mechanical integrity issues, manufacturing complexity, and regulatory hurdles, ongoing advancements in smart polymers, in-silico modeling, and 3D printing are enhancing their feasibility. Poised to play a major role in future pharmacotherapy, these systems promise improved patient compliance, better therapeutic outcomes, and greater formulation flexibility
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