Palbociclib pharmaceutical composition and preparation method thereof

A composition and drug technology, applied in the direction of drug combination, pharmaceutical formulation, antineoplastic drugs, etc., can solve the problems of reduced solubility, large dust production, and reduced curative effect

Active Publication Date: 2016-07-13
河北泽运生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many shortcomings in the current dry granulation process: First, there are many dry granulation machine manufacturers in my country, but the stability of the equipment is relatively poor, and the failure rate is high. The main problems include roll damage, water leakage, roll misalignment, and dust production. Large, low yield, difficult to clean, unstable pressure, etc.; secondly, the equipment is expensive; the important thing is that the production volume is small, the first-pass rate is low, and the obtained particles are irregular,

Method used

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  • Palbociclib pharmaceutical composition and preparation method thereof
  • Palbociclib pharmaceutical composition and preparation method thereof
  • Palbociclib pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Example 1 (1000 formulation units)

[0033]

[0034] Add palbociclib free base, colloidal silicon dioxide, microcrystalline cellulose, carboxymethyl starch sodium, and lactose into the mixer for pre-mixing for 10 minutes, add magnesium stearate for total mixing for 4 minutes, discharge, and add to Capsule filling is performed in a capsule filling machine.

Embodiment 2

[0035] Example 2 (1000 formulation units)

[0036]

[0037]Add palbociclib free base, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, and lactose into the mixer for pre-mixing for 12 minutes, add magnesium stearate for total mixing for 5 minutes, discharge, and add to Capsule filling is performed in a capsule filling machine.

Embodiment 3

[0038] Example 3 (1000 formulation units)

[0039]

[0040] Add palbociclib free base, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, and lactose into the mixer for pre-mixing for 12 minutes, add magnesium stearate for total mixing for 6 minutes, discharge, and add to Capsule filling is performed in a capsule filling machine.

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PUM

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Abstract

The invention discloses a palbociclib pharmaceutical composition, comprising palbociclib or its medicinal salt and a pharmaceutically acceptable auxiliary material, wherein the palbociclib or its medicinal salt is 50-150 Mum, and the medicinal salt includes isethionates, hydrochlorides, sulfates or benzene sulfonates.Direct mixing and capsuling process of raw and auxiliary materials is used for the pharmaceutical composition provided herein, the biological availability is high, product quality stability is good, the technical process is easy to control, inter-batch reproducibility is good, and the composition is easy to industrialize.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a pharmaceutical composition of palbociclib, in particular to a pharmaceutical composition of palbociclib prepared by a direct mixing process and a preparation method thereof. Background technique [0002] Breast cancer is one of the most common malignant tumors in women. The incidence rate accounts for 7% to 10% of all kinds of malignant tumors in the whole body. It is second only to uterine cancer and has become the main cause of threat to women's health. Its incidence is often related to heredity, and the incidence rate is higher in women around the age of 40 to 60 before and after menopause. It is one of the malignant tumors that usually occurs in the glandular epithelial tissue of the breast, seriously affecting the physical and mental health of women and even threatening their lives. The incidence rate has been higher than the world average. [0003] Aro...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/519A61P35/00
CPCA61K9/4866A61K31/519
Inventor 武倩倩潘晓凯
Owner 河北泽运生物医药科技有限公司
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