Alectinib composition

A technology of composition and tinib, which is applied in the direction of drug combination, medical preparations of non-active ingredients, inorganic non-active ingredients, etc., can solve the problems of easy hygroscopicity of capsules, caking of contents, and decrease of dissolution rate, etc., and achieve improvement Anti-hygroscopic performance, the effect of avoiding moisture absorption

Inactive Publication Date: 2019-02-26
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] During the storage of alectinib capsules, it was found that with the prolongation of storage time, the capsules tended to absorb moisture, causing the contents to agglomerate, and the dissolution rate decreased

Method used

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  • Alectinib composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Example 1.D 90 Alectinib 36 microns 150g, Tween 80 4g, fumed silica 26g, calcium sulfate 2g, hydroxypropyl cellulose 32g, anhydrous lactose 20g, edetate disodium 8g, magnesium stearate 1.0 g, prepare 1000 capsules according to the preparation method described in the specification technical scheme.

Embodiment 2

[0019] Example 2.D 90 Alectinib 55 microns 150g, Tween 80 8g, fumed silica 8g, calcium sulfate 8g, hydroxypropyl cellulose 18g, anhydrous lactose 46g, edetate disodium 4g, magnesium stearate 1.5g, prepare 1000 capsules according to the preparation method described in the specification technical scheme.

Embodiment 3

[0020] Example 3.D 90 Alectinib 45 microns 150g, Tween 80 6g, fumed silica 18g, calcium sulfate 6g, hydroxypropyl cellulose 28g, anhydrous lactose 30g, disodium edetate 6g, magnesium stearate 1.2g, prepare 1000 capsules according to the preparation method described in the technical scheme of the instructions.

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Abstract

The invention relates to an alectinib oral drug, and belongs to the technical field of pharmaceutic preparations. The alectinib composition, in every thousand unit doses, contains 150 g of alectinib with D90 being 36-55 micrometers, 4-8 g of tween 80, 8-26 g of fumed silica, 2-8 g of calcium sulfate, 18-32 g of hydroxy propyl celluloses, 20-46 g of lactose anhydrous, 4-8 g of ethylenediamine tetraacetic acid disodium salt and 1.0-1.5 g of magnesium stearate. According to the technical scheme, by reasonable combination of the several components, firstly, dissolution of a main drug is improved,and secondly, by combination effects of the fumed silica, the calcium sulfate and the ethylenediamine tetraacetic acid disodium salt, the moisture resisting and absorption performance in a storage process is improved.

Description

technical field [0001] The invention relates to an alectinib oral medicine, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Lung cancer is one of the most common malignant tumors in the world, and it has become the first cause of death from malignant tumors in urban population in my country. Non-small cell lung cancer includes squamous cell carcinoma (squamous cell carcinoma), adenocarcinoma, and large cell carcinoma. Compared with small cell carcinoma, its cancer cells grow and divide more slowly, and spread and metastasize relatively later. Non-small cell lung cancer accounts for about 80% of all lung cancers, and about 75% of the patients are found in the middle and advanced stages, and the 5-year survival rate is very low. [0003] Alectinib (also known as alectinib, alectinib,) is FDA-approved for the first-line treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC). The drug was develop...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K47/18A61K47/02A61K47/04A61K31/5377A61P35/00
CPCA61K9/485A61K9/4858A61K31/5377A61P35/00
Inventor不公告发明人
OwnerWEIHAI GUANBIAO INFORMATION TECH