Preparation and Formulation Optimization of Acetylcysteine Tablets

OBJECTIVE To compare different preparation processes of acetylcysteine(N-acetyl-L-cysteine, NAC) tablets and optimize the formulation.

METHODS  Initial prescription was determined based on reference formulation information and prior knowledge. Then the optimal process was selected, the prescription was screened, and design of experiments was carried out to optimize the prescription, with dissolution, friability, and stability as the evaluation indexes.

RESULTS  Direct powder compression method was determined as the optimal process. The particle size distribution of NAC had a significant effect on product quality. The optimal particle size distribution range of NAC obtained from screening was 150–400 μm.

CONCLUSION The direct powder compression method is suitable for preparation of NAC tablets, which has good reproducibility and palatability, and meets the key quality requirements.