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Erlotinib hydrochloride tablets and preparation method thereof

An erlotinib hydrochloride tablet and a technology for erlotinib hydrochloride, which are applied in pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc., can solve the problem of dust flying, increase drug production costs, Problems such as adverse effects on the health of production workers

Active Publication Date: 2013-05-22
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD +1
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  • Abstract
  • Description
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AI Technical Summary

Problems solved by technology

[0007] In order to obtain sufficiently fine erlotinib hydrochloride, it is usually realized in the industry by means of jet milling, which will significantly increase the production cost of the drug, and at the same time increase the exposure probability of the drug. Since erlotinib hydrochloride is an antineoplastic drug, Has relatively large toxic and side effects, which will adversely affect the health of production workers
At the same time, extremely fine drug particles will also cause difficulties in industrial production, such as greater static electricity or more dust flying, and will also cause adverse effects such as poor mixing efficiency

Method used

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  • Erlotinib hydrochloride tablets and preparation method thereof
  • Erlotinib hydrochloride tablets and preparation method thereof
  • Erlotinib hydrochloride tablets and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1-4 and comparative Embodiment 5

[0026] Table 1

[0027]

[0028] Preparation Process:

[0029] 1. will RH40 (or Tween 20, Tween 40, SDS) mixed with lactose;

[0030] 2. Mix the materials except magnesium stearate with the mixture obtained in step "1";

[0031] 3. Carry out dry granulation of the material obtained in step "2";

[0032] 4. Add magnesium stearate to mix, and compress into tablets;

[0033] 5. The tablet is coated with a coating powder with the trade name of Opadry.

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Abstract

The invention discloses erlotinib hydrochloride tablets. The erlotinib hydrochloride tablets contain a surfactant with the HLB (hydrophile-lipophile balance) value of between 10 and 20 serving as a solubilizing agent which can effectively promote medicament dissolution. The invention also relates to a preparation method of the erlotinib hydrochloride tablets, which is simple in technological process, has no special requirement on granularity of raw materials, and is good in product dissolution.

Description

technical field [0001] The invention relates to a preparation method of a tablet containing erlotinib hydrochloride. Background technique [0002] Erlotinib Hydrochloride Tablets is a small molecule anticancer drug jointly developed by Genentech, Roche and OSI Pharmaceuticals, and its trade name is "Tarceva". In November 2004 and September 2005, it passed the approval of the US FDA and the European EMEA, and is now on the market in 70 to 80 countries around the world. It is an epidermal growth factor receptor-tyrosine kinase (EGFR-TK) inhibitor, a small molecule oral drug that prevents the EGFR-TK activity by inhibiting the tyrosine kinase activity of human epidermal growth factor receptor-1. Receptor-mediated intracellular signaling pathways, thereby preventing tumor cell growth and ultimately exhibiting anti-tumor effects. [0003] The molecular formula of erlotinib is C 22 h 23 N 3 o 4 , with a molecular weight of 589.7, has the following structural formula, and its...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/517A61K47/44A61K47/34A61P35/00
Inventor 彭俊清曹宇余慧张靖陆常辉
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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