Pregabalin capsule and preparation method thereof

Abstract

The invention discloses a pregabalin capsule and a preparation method thereof. The content is composed of pregabalin and silicified microcrystalline cellulose, wherein the silicified microcrystallinecellulose is prepared by blending microcrystalline cellulose and micro-powder silica gel in water and performing drying. In the pregabalin capsule, a weight percentage of pregabalin is 25-75%, D90 is100-250 [mu]m, and D50 is 35-75 [mu]m; and D90 of the excipient silicified microcrystalline cellulose is 200-350 [mu]m, and D50 is 90-130 [mu]m. The production process is simple, the product is stable, and the pregabalin capsule is suitable for large-scale industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pregabalin capsule and a preparation method thereof. Background technique [0002] Pregabalin is a new type of antiepileptic drug. Its molecular structure has γ-aminobutyric acid structure, so it has anticonvulsant effect. [0003] Pregabalin is a class I drug in the BCS classification system. Pregabalin reaches its peak concentration after 1.5 hours of oral administration, and its relative bioavailability is ≥90%, and C max And AUC has a linear relationship with the dose, it is not combined with plasma protein in vivo, and has almost no metabolism. [0004] Pregabalin was successfully developed by Pfizer Europe MA EEIG. It was first approved for marketing by the European Medicines Agency (EMA) on July 6, 2004. 100mg, 150mg, 200mg, 225mg, 300mg), oral liquid (specification: 20mg / ml). [0005] The EMA review report shows that the pregabalin capsules (trade name ...

AI Technical Summary

Problems solved by technology

Therefore, wet granulation (especially wet granulation with lactose as filler) is not suitable for the preparation of pregabalin capsules

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