Abstract
Fixed-dose combination formulations are multilayered platforms designed for solving complex medication regimens and overcoming polypharmacy problems especially in chronic diseases with geriatric patients. Multilayered tablets are considered promising avenues to combine different active pharmaceutical ingredients (APIs) for a synergic therapeutic effect, or different formulations of the same API in order to achieve a specific drug release profile. Besides, multilayered tablets can extensively help in avoiding possible interactions between different drugs, as well as optimizing each formulation individually in terms of pharmacokinetics and manufacturability. This review article discusses the most suitable materials used in the manufacturing of multilayered tablets, describes novel approaches to manufacturing improvement and process parameters, the influence of process parameters on layer adhesion, and the characterization tests of multilayered tablets.
Highlights
Food and Drug Administration (FDA) and European Medicine Agency (EMA) approved a record number of multilayered tablets as a combinatory multidrug therapeutic system, multilayered tablets possess some advantages over other solid dosage forms
Yamamura et al [42] studied the effect of external lubrication, where an external lubricant was sprayed onto the punches and dies and concluded that the external lubrication can increase the crushing strength of monolayer tablets by 40% without prolonging the corresponding tablet disintegration and dissolution
They prepared bilayer tablets containing microcrystalline cellulose in both layers and compacted with initial forces of 2 kN and 4 kN and observed that once the second layer compression force leveled up to 18 kN, tablets failed in the first layer rather than the interface, indicating a change in the mode of failure from the interlayer to intralayer
Summary
Alkseil et al [44] studied the effect of porosity on the bonding strength between the adjacent layers and concluded that when the first layer had low porosity, the bonding with the second layer became more difficult due to the tensile strength (σ) of the first layer was greater than the tensile strength of the interface (σlayer>σinterface) They prepared bilayer tablets containing microcrystalline cellulose (plastic material) in both layers and compacted with initial forces of 2 kN and 4 kN and observed that once the second layer compression force leveled up to 18 kN, tablets failed in the first layer rather than the interface (σlayer
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