Nilotinib tablet composition

Abstract

The invention relates to a nilotinib composition, belonging to the technical field of pharmacy. The nilotinib composition is characterized in that a unit dose of the composition is prepared from 200mgof nilotinib, 36-60mg of chitosan, 36-52mg of lactose, 7-10mg of crospovidone, 4-8mg of alginic acid, 1-3mg of fumed silica, 0.8-1.6mg of sodium dodecyl sulfate and 1.3-2.6mg of magnesium stearate. The stable nilotinib tablet composition with a high dissolution rate can be obtained.

Description

technical field [0001] The invention relates to a nilotinib composition and belongs to the technical field of pharmacy. Background technique [0002] Nilotinib is an antineoplastic drug, mainly used clinically to treat chronic myelogenous leukemia resistant to Gleevec (imatinib). It is a powerful and precise second-generation tyrosine kinase inhibitor, which can effectively treat patients with drug-resistant or intolerant chronic myeloid leukemia. [0003] Nilotinib is an insoluble drug, and its solubility in water is 0.2ug / ml. In order to ensure the bioavailability of the original Novartis, nilotinib was micronized and then added with solubilizer Poloxamer 188 to increase the drug’s solubility. Solubility. However, micronization is not suitable for operation, and the dust is too fine, which will have a certain impact on the environment, and a large amount of poloxamer added to the prescription has potential dangers to the safety of the drug. [0004] The commercially ava...

AI Technical Summary

Problems solved by technology

The added amount of cyclodextrin is too large, resulting in less added amount of the main drug, which is quite different from the commercially available specifications

[0005] If the tablet is prepared according to the common formula, the dissolution rate will decrease significantly during the storage process, and the dissolution rate will decrease by more than 10% after storage for about 8 months.