Crizotinib capsule and preparation method thereof

A technology of crizotinib and scrizotinib, applied in the field of pharmaceutical manufacturing, can solve the problems of affecting product quality, poor fluidity, low dissolution rate of crizotinib and the like

Inactive Publication Date: 2015-10-14
刘小斌 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the research process of crizotinib capsules, we found that the raw materials of crizotinib are almost insoluble in water, resulting in a low dissolution rate of crizotinib, which affects the bioavailability and makes the drug curative effect poor. The specifications are large, the amount of auxiliary materials is relatively small, the fluidity of direct powder filling is poor, and the filling volume of capsules varies greatly, which affects product quality

Method used

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  • Crizotinib capsule and preparation method thereof
  • Crizotinib capsule and preparation method thereof
  • Crizotinib capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Crizotinib capsules (prescription quantity 1000 capsules)

[0019] Crizotinib capsules (prescription quantity 1000 capsules)

[0020]

[0021]

[0022] Preparation process: Weigh the prescribed amount of crizotinib, anhydrous calcium hydrogen phosphate, microcrystalline cellulose, and sodium starch glycolate, mix them evenly, prepare 80% ethanol solution as a wetting agent, and connect it to a fluidized bed. Add the mixture into the fluidized bed, turn on the fan to keep the mixture in suspension, add binder to make wet granules, and dry for 30 minutes. Take out the granules, add the prescribed amount of magnesium stearate and micropowder silica gel, mix evenly, measure the content of the granules, and fill the capsules according to the content of the granules. Finished product testing. The packaging is vested.

Embodiment 2

[0024] Crizotinib capsules (prescription quantity 1000 capsules)

[0025]

[0026] Preparation process: Weigh the prescribed amount of crizotinib, anhydrous calcium hydrogen phosphate, microcrystalline cellulose, and sodium starch glycolate, mix them evenly, prepare 80% ethanol solution as a wetting agent, and connect it to a fluidized bed. Add the mixture into the fluidized bed, turn on the fan to keep the mixture in suspension, add binder to make wet granules, and dry for 30 minutes. Take out the granules, add the prescribed amount of magnesium stearate and micropowder silica gel, mix evenly, measure the content of the granules, and fill the capsules according to the content of the granules. Finished product testing. The packaging is vested.

Embodiment 3

[0028] Crizotinib capsules (prescription quantity 1000 capsules)

[0029]

[0030] Preparation process: Weigh the prescribed amount of crizotinib, anhydrous calcium hydrogen phosphate, microcrystalline cellulose, and sodium starch glycolate, mix them evenly, prepare 80% ethanol solution as a wetting agent, and connect it to a fluidized bed. Add the mixture into the fluidized bed, turn on the fan to keep the mixture in suspension, add binder to make wet granules, and dry for 30 minutes. Take out the granules, add the prescribed amount of magnesium stearate and micropowder silica gel, mix evenly, measure the content of the granules, and fill the capsules according to the content of the granules. Finished product testing. The packaging is vested.

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Abstract

The invention provides crizotinib capsules and a preparation method thereof, wherein the specifications of the crizotinib capsules can be 200 mg and 250 mg, wherein the auxiliary materials in each capsule include 30-100 mg of microcrystalline cellulose, 50-200 mg of anhydrous calcium hydrophosphate, 20-50 mg of carboxymethyl starch sodium, 5-25 mg of silica gel micro powder and 1-10 mg of magnesium stearate. The preparation method includes following steps: one-step granulation in a fluidized bed, mixing and capsule filling, wherein an 80% ethanol solution is employed as a wetting agent. The preparation method solves the problems of poor flowability, high different of content quantity, low dissolution rate and poor stability of granules of the crizotinib capsules, improves the bioavailability and curative effects of the capsules and is better in curative effects.

Description

technical field [0001] The invention relates to a drug prescription and a preparation method for treating non-small cell lung cancer, belonging to the field of pharmaceutical manufacturing, and in particular to a crizotinib capsule and a preparation method. Background technique [0002] With the continuous improvement of medical diagnosis and the rapid popularization and use of high-end diagnostic imaging equipment, the number of patients who have been accurately diagnosed with breast cancer, lung cancer, gastric cancer and other common tumor diseases has skyrocketed. According to WHO statistics, in 2007, there were as many as 12 million newly diagnosed tumor patients in the world, and in the past few years, more than 7 million patients worldwide died of cancer every year. This figure is very close to the number of people who die from acute cardiovascular disease. In addition to the increasing incidence of cancer in developing countries and newly industrialized countries, t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/4545A61K47/38A61P35/00A61K47/04A61K47/36A61K47/12
Inventor 刘小斌吴鹏程
Owner 刘小斌
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