Stable pharmaceutical composition of pregabalin and preparation method thereof

2013 
The invention relates to a stable pharmaceutical composition of pregabalin crystalline powder particles and a preparation method thereof. The composition is prepared from the pregabalin crystalline powder particles, magnesium stearate, and/or pharmaceutically acceptable other carriers through mixing. The composition contains 80-99 percent by weight of pregabalin and 0.1-5 percent by weight of magnesium stearate, wherein the total impurity content of the composition is smaller than 0.5 percent. The composition disclosed by the invention is simple in preparation process, high in production efficiency and easy for industrial production; especially, fewer related substance degradation products are generated, and the cost of commercialized production is greatly reduced.
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