Abstract
Tablets used for extended drug release commonly contain large amounts of drugs. The corresponding drug release mechanism thus has to be well-known and invariable under numerous conditions in order to prevent any uncontrolled drug release. Particularly important is the stability and invariability of the release mechanism in the presence of alcohol due to the possible occurrence of the dose dumping effect. The effect of 3D printing (3DP) coating on the drug release mechanism and the drug release rate was studied as a possible tool for the prevention of the alcohol-induced dose dumping effect. Three types of matrix tablets (hydrophilic, lipophilic, and hydrophilic-lipophilic) were prepared by the direct compression method and coated using 3DP. The commercial filament of polyvinyl alcohol (PVA) and the filament prepared from hypromellose by hot melt extrusion (HME) were used as coating materials. Both coating materials were characterized by SEM, DSC, Raman spectroscopy, and PXRD during particular stages of the processing/coating procedure. The dissolution behavior of the uncoated and coated tablets was studied in the strongly acidic (pH 1.2) and alcoholic (40% of ethanol) dissolution media. The dissolution tests in the alcoholic medium showed that the Affinisol coating was effective in preventing the dose dumping incidence. The dissolution tests in the acidic dissolution media showed that the Affinisol coating can also be useful for the delayed release of active substances.
Highlights
In recent years, the technology of 3D printing (3DP) has significantly affected development in many areas of science and research
This study focused on using the 3DP for the coating of tablets with extended drug release to reduce the alcohol-induced dose dumping (ADD) effect
The tablets used for the extended drug release formulations commonly contain a large amount of drug and their release mechanism must be invariable to prevent any possibility of uncontrolled drug release, which can give rise to the dose dumping effect
Summary
The technology of 3D printing (3DP) has significantly affected development in many areas of science and research. For the pharmaceutical research and industry, the method of 3DP represents a challenge for an individualized therapy, as is frequently discussed, and for an improvement of the properties of some types of the solid dosage forms. It is generally known that alcohol can change or totally destroy the drug release mechanism, which can result in an immediate and uncontrolled release of the active pharmaceutical substance (API) from the dosage form [2,3,4]. This process is called the alcohol-induced dose dumping (ADD) effect.
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