Abstract
The effect of sodium lauryl sulfate on the drug-excipient interactions resulting from prolonged powder mixing with magnesium stearate was evaluated. Two formulations, identical in their composition, with and without 0.1% sodium lauryl sulfate were compared under identical mixing conditions to study the drug-excipient interaction on prolonged mixing and its effect on in vitro dissolution from hand-filled, uncompacted capsules. The results of this study reveal that the addition of sodium lauryl sulfate in the solid state to magnesium stearate in 1: 5 ratio can offset the deleterious effects, such as the decrease in dissolution rate, associated with prolonged mixing of magnesium stearate. The results suggest that there is a strong physical interaction between the magnesium stearate flakes and sodium lauryl sulfate during the solid-state powder mixing process. The interaction between magnesium stearate and sodium lauryl sulfate frees the magnesium stearate flakes from the drug-excipient agglomerates. As a result, the capsule disintegration time and the drug dissolution rate are not adversely affected.
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