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Synergy of Excipient Selection and Mixing |
Homogeneity in Low-Dose Formulations

| Abstract: Achieving blend uniformity (BU) in low-dose formulations for direct compression (DC) is challenging. This study used Erythrosine as the model active pharmaceutical ingredient (API) to create blends with 3 % and 1 % API. Two blending methods were tested: Active Blends (single-step blending) and Triturations (two-step blending). BU was evaluated using UV/Vis-spectrometry, targeting relative standard deviations (RSD) below 5 %, ideally under 3 %. Blends were also tested for segregation-stability under stress.

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