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Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition

A technology of erlotinib hydrochloride and composition, which is applied in the field of pharmaceutical composition and preparation containing erlotinib hydrochloride, can solve problems such as flying dust, environmental pollution, and small bulk density, and achieve high process stability and dissolution Good performance and simple operation

Inactive Publication Date: 2016-03-02
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Commercially available pharmaceutical silica (such as colloidal silica and micropowder silica gel) has a small bulk density, usually in the range of 0.029 to 0.042g / cm 3 Between, if sieving treatment is carried out, it is easy to cause dust to fly, causing environmental pollution, and causing damage to the health of the staff
Separate sieving treatment will also make silica aggregate into spherical shape due to electrostatic effect, which is not conducive to achieving good mixing effect in subsequent processes
In addition, the dissolution curve of the pharmaceutical composition in other media (such as water) obtained according to the prescription and preparation method disclosed in the patent is not similar to that of the original commercially available product, and the corresponding bioequivalence results of the preparation may not be ideal

Method used

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  • Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition
  • Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition
  • Medicine composition containing erlotinib hydrochloride and preparation method of medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] type Quality (mg / tablet) parts by mass Erlotinib hydrochloride (calculated as Erlotinib) 100 1 lactose 70 0.7 microcrystalline cellulose 90 0.9 Sodium carboxymethyl starch 25 0.25 silica 10 0.1 Sodium dodecyl sulfate 3 0.03 Magnesium stearate 3 0.03

[0055] 1. Erlotinib hydrochloride and sodium lauryl sulfate are sieved for subsequent use;

[0056] 2. Mix the prescribed amount of raw materials, sodium carboxymethyl starch, and sodium lauryl sulfate for 5 minutes, add silicon dioxide and mix, and pass through a 40-mesh sieve to obtain mixed powder A;

[0057] 3. Then add the prescribed amount of lactose and microcrystalline cellulose and mix for 10 minutes to obtain the mixed powder B;

[0058] 4. Add the mixed powder B to the dry granulator for granulation, control the distance between the pressing wheels to 0.5mm, and the speed of the pressing wheels to 3r / min, to obtain a density of 1.03g / cm 3 The fl...

Embodiment 2

[0061] type Quality (mg / tablet) parts by mass Erlotinib hydrochloride (calculated as Erlotinib) 100 1 lactose 70 0.7 microcrystalline cellulose 100 1.0 Sodium carboxymethyl starch 27 0.27 silica 10 0.1 Sodium dodecyl sulfate 3 0.03 Magnesium stearate 2 0.02

[0062] 1. Erlotinib hydrochloride and sodium lauryl sulfate are sieved for subsequent use;

[0063] 2. Mix the prescribed amount of raw materials, sodium carboxymethyl starch, and sodium lauryl sulfate for 5 minutes, add silicon dioxide and mix, and pass through a 40-mesh sieve to obtain mixed powder A;

[0064] 3. Then add the prescribed amount of lactose and microcrystalline cellulose and mix for 10 minutes to obtain the mixed powder B;

[0065] 4. Add the mixed powder B to the dry granulator for granulation, control the distance between the pressing wheels to 0.5mm, and the speed of the pressing wheels to 2r / min, to obtain a density of 1.06g / cm 3 The f...

Embodiment 3

[0068] type Quality (mg / tablet) parts by mass Erlotinib hydrochloride (calculated as Erlotinib) 100 1 lactose 70 0.7 microcrystalline cellulose 100 1.0 Sodium carboxymethyl starch 25 0.25 silica 10 0.1 Sodium dodecyl sulfate 3 0.03 Magnesium stearate 2 0.02

[0069] 1. Erlotinib hydrochloride and sodium lauryl sulfate are sieved for subsequent use;

[0070] 2. Mix the prescribed amount of raw materials, sodium carboxymethyl starch, and sodium lauryl sulfate for 5 minutes, add silicon dioxide and mix, and pass through a 20-mesh sieve to obtain mixed powder A;

[0071] 3. Then add the prescribed amount of lactose and microcrystalline cellulose and mix for 10 minutes to obtain the mixed powder B;

[0072] 4. Add the mixed powder B to the dry granulator for granulation, control the spacing between the pressing wheels to 0.4mm, and the speed of the pressing wheels to 3r / min, to obtain a density of 1.18g / cm 3 The fl...

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Abstract

The invention provides a medicine composition containing erlotinib hydrochloride. The medicine composition has the advantages of being good in digestion performance, high in stability, low in clinical pharmacy risk and the like. In the production and preparation process, raw materials and auxiliary materials do not need to be specially treated, and the production process is simple.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing erlotinib hydrochloride and a preparation method. Background technique [0002] Erlotinib (CAS183321-74-6) is a small molecular compound that acts on the epidermal growth factor receptor (EGFR). EGFR is expressed on the surface of normal cells and tumor cells, and is overexpressed in specific tumor cells, especially non-small cell lung cancer (NSCLC) cells. Erlotinib can inhibit the intracellular casein related to epidermal growth factor receptor (EGFR). The phosphorylation of amino acid kinase can inhibit the growth of cancer cells by inhibiting the overexpression of EGFR in cancer cells. [0003] Erlotinib was developed by OSI Pharmaceuticals (now part of Astellas Pharmaceuticals), and its preparations were first launched in the United States in 2004 under the trade name Tarceva, which is clinically used for locally advanced or...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/517A61K47/38A61P35/00
Inventor 李凤陈豆
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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