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A kind of palbociclib pharmaceutical composition and preparation method thereof

A technology of palbociclib and its composition, which is applied in the field of palbociclib pharmaceutical composition and its preparation, can solve the problems of poor dissolution stability, poor dissolution rate, and large influence, and achieve good stability and solve the problem of pH Sensitive and unstable, low loading effect

Active Publication Date: 2020-03-20
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its particle size is too large, which has a greater impact on its mixed materials, and its dissolution rate is not good, especially palbociclib is more sensitive to pH. When the pH is greater than 4, its dissolution rate is not good, and it is easy to cause dissolution stability. Difference

Method used

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  • A kind of palbociclib pharmaceutical composition and preparation method thereof
  • A kind of palbociclib pharmaceutical composition and preparation method thereof
  • A kind of palbociclib pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] composition The mass percentage of each component (%) Palbociclib (D90=35μm) 25％ Pregelatinized starch (D90=85μm) 35％ Lactitol (D90=140μm) 25％ Sodium starch glycolate (D90=140μm) 4％ Hydroxyethylmethylcellulose (D90=140μm) 5％ Hydroxyethylcellulose (D90=140μm) 4％ Citrate Fatty Acid Glycerides (D90=140μm) 2％

[0028] Separately pulverize the palbociclib raw material and auxiliary materials, control the particle size of the raw materials and auxiliary materials, mix the raw and auxiliary materials evenly, and directly fill the capsules.

Embodiment 2

[0030] composition The mass percentage of each component (%) Palbociclib (D90=30μm) 20％ Pregelatinized starch (D90=80μm) 35％ Lactitol (D90=130μm) 30％ Sodium starch glycolate (D90=130μm) 3％ Hydroxyethylmethylcellulose (D90=130μm) 6％ Hydroxyethylcellulose (D90=130μm) 5％ Citrate Fatty Acid Glycerides (D90=130μm) 1％

[0031] Separately pulverize the palbociclib raw material and auxiliary materials, control the particle size of the raw materials and auxiliary materials, mix the raw and auxiliary materials evenly, and directly fill the capsules.

Embodiment 3

[0033] composition The mass percentage of each component (%) Palbociclib (D90=40μm) 30％ Pregelatinized starch (D90=90μm) 35％ Lactitol (D90=150μm) 20％ Sodium starch glycolate (D90=150μm) 5％ Hydroxyethylmethylcellulose (D90=150μm) 4％ Hydroxyethylcellulose (D90=150μm) 4％ Citrate Fatty Acid Glycerides (D90=150μm) 2％

[0034] Separately pulverize the palbociclib raw material and auxiliary materials, control the particle size of the raw materials and auxiliary materials, mix the raw and auxiliary materials evenly, and directly fill the capsules.

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Abstract

The invention relates to the field of pharmaceutical preparations, and particularly discloses a palbociclib pharmaceutical composition and a method for preparing the same. The palbociclib pharmaceutical composition comprises, by weight, 20%-30% of palbociclib, 30%-40% of pregelatinized starch, 20%-30% of lactitol, 3%-5% of starch sodium glycollate, 4%-6% of hydroxyethyl methyl celluloses, 3%-5% ofhydroxyethyl celluloses and 1%-3% of citric acid fatty glyceride. The palbociclib pharmaceutical composition and the method have the advantages that excellent dissolution effects can be realized by the palbociclib pharmaceutical composition, the contents of related substances can be obviously reduced, the stability can be obviously enhanced, and clinical medicines can be advantageously safely used and can be advantageously stored for a long term; the particle sizes of raw auxiliary materials are controlled, accordingly, the palbociclib pharmaceutical composition is good in mixing property andflowability as discovered via experiments, and capsules can be directly filled with the palbociclib pharmaceutical composition by means of mixing.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a palbociclib pharmaceutical composition and a preparation method thereof. Background technique [0002] Statistics from the World Health Organization show that breast cancer is the second leading cause of cancer death among women worldwide. The incidence of breast cancer has been increasing over the past few decades. It is estimated that by 2020, there will be more than 1.7 million new cases of breast cancer each year. In 2012, there were 1.67 million new cases of breast cancer worldwide, accounting for 25% of all new cancer cases. Among them, there are 883,000 cases in developed countries and 794,000 cases in developing countries. New breast cancer cases are growing at a slightly higher rate in developing countries than in developed countries. The number of deaths from breast cancer was 522,000, ranking fifth in the death rate among all cancers; the number of fema...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/519A61P35/00A61P35/04
CPCA61K9/1652A61K31/519
Inventor 刘振腾李晓峰耿强袁雪
Owner SHANDONG YUXIN PHARMA CO LTD
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