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Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process
Direct compression and dry granulation processes for preparing carglumic acid tablets having less impurities than those produced by wet granulation process
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机译:直接压片法和干法制粒工艺可制备比湿法制粒工艺生产的杂质少的鹿角酸片
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摘要
The invention provides a process for preparing stable, high API content, solid pharmaceutical dosage forms by direct compression or dry granulation, characterized in that the pharmaceutical tablets rapidly disintegrate in water or other aqueous solutions to produce a clear or almost clear solution. Also provided is a pharmaceutical carglumic acid tablet, which has improved manufacturing, dissolution, and stability properties, and is less expensive to produce, compared to the equivalent commercial product.
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