Scientific papers
INTRODUCTION: This investigation aimed to comprehend the behavior of poorly compressible paracetamol powder utilizing a compaction simulator (CS), an apparatus that records data during the compaction process. The primary objective was to explore the compressibility of paracetamol tablets produced through the dry granulation (slugging) process, employing different formulation compositions.
METHODS: Formulations were devised to observe the impact on compressibility using two distinct lactose-based fillers, Flowlac®100, Granulac®70, and the binder Kollidon® K90. Four formulations were prepared in each combination, maintaining a paracetamol to filler ratio of 1:1 and 0.8:1. Tablets were manufactured using a single punch (11.28 mm) compaction simulator at six varied pressures (152, 210, 263, 316, 400, 452 MPa). Throughout compression, the CS equipment recorded upper punch displacement and force data. The compressed tablets underwent testing for hardness, thickness, and weight variation, and comparisons were made between them.
RESULTS: Maximum tensile strength for all formulations was achieved at compaction pressures between 263-316 MPa. In formulations without a binder, those containing Granulac®70 exhibited higher tensile strength than those with Flowlac®100 at both filler ratios. The results suggested that the inclusion of a binder in formulations (F-45-1, F-45-2, F-50-3, and F-50-4) improved the compressibility of paracetamol. Formulation F-45-2, containing Flowlac®100 and binder, demonstrated superior compressibility with a tensile strength of 2.9 MPa. Data from the compaction simulator were utilized to compare Young’s Modulus and the work of compaction on selected formulations (F-45-1 and F-45-2).
DISCUSSION AND CONCLUSION: The proposed lactose-based filler, Flowlac®100, demonstrated successful applicability in enhancing the compressibility of paracetamol, particularly under low pressure conditions. Optimal formulations can be designed with reduced material quantities through the utilization of a compaction simulator.
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