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Olaparib pharmaceutical composition and preparation method thereof

A composition and drug technology, applied in the direction of drug combination, pharmaceutical formula, sugar-coated pills, etc., can solve problems such as poor stability, drug safety of patients affecting drug shelf life, stomach discomfort, etc.

Active Publication Date: 2016-11-23
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Copovidone is a linear copolymer of N-vinylpyrrolidone (VP) vinyl acetate (VA), which is widely used in pharmaceutical preparations, but clinical studies have shown that it can cause gastric discomfort after oral administration
[0005] According to the first edition of "Compendium of Pharmaceutical Excipients" (author Luo Mingsheng, etc.) and patent CN102238945, povidone is hygroscopic, and long-term storage can lead to product crystallization and poor stability, which will affect the shelf life of the drug or patients. drug safety

Method used

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  • Olaparib pharmaceutical composition and preparation method thereof
  • Olaparib pharmaceutical composition and preparation method thereof
  • Olaparib pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Table 1: Prescription Composition of Olaparib Tablets

[0050]

[0051] After olaparib, povidone 12PF and talcum powder are mixed evenly according to the prescription ratio, they are added into a drug hot-melt extruder to prepare a solid dispersion, which is cooled and crushed into suitable granules. Then the above-mentioned granules are evenly mixed with mannitol and remaining talcum powder, and magnesium stearate is added for total mixing. Then the mixed granules are pressed into tablets, and the hardness of the tablets is controlled to be ≥6kg / cm 2 . The tablet core is coated, and the weight of the coating is increased by 3%, and finally the finished product of the olaparib tablet is obtained after being packaged in aluminum-plastic blisters.

Embodiment 2

[0053] Table 2: Prescription Composition of Olaparib Tablets

[0054]

[0055] Using the above-mentioned prescription process, the tablet core is coated, and the weight of the coating is increased by 2%, and finally the finished product of olaparib tablet is obtained after being packaged in aluminum-plastic blisters.

Embodiment 3

[0057] Table 3: Prescription Composition of Olaparib Tablets

[0058]

[0059] Using the above-mentioned prescription process, the tablet core is coated, and the weight of the coating is increased by 3%, and finally the finished product of the olaparib tablet is obtained after being packed in aluminum-plastic blisters.

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Abstract

The invention discloses an olaparib pharmaceutical composition and a preparation method thereof, belongs to the field of pharmaceutical preparation, and particularly relates to the olaparib composition and the preparation method thereof. The composition comprises olaparib and a carrier. The olaparib composition provided by the invention has the advantages of safety, stability and excellent in-vitro dissolution effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an olaparib pharmaceutical composition and a preparation method thereof. Background technique [0002] Olaparib is an oral poly(ADP-ribosyltransferase) (PARP) inhibitor. It mainly blocks the repair of DNA damage, causes the accumulation of DNA damage, and finally kills tumor cells; in addition, it can also increase the sensitivity of cells to other endogenous DNA damage factors; inhibit angiogenesis; enhance the immunity of normal cells, thereby Resist the invasion of cancer cells. [0003] The therapeutic effect of olaparib on ovarian cancer has been highly recognized. EMEA and FDA successively granted orphan drug certification for olaparib for the treatment of ovarian cancer. Olaparib is currently undergoing clinical research in ovarian cancer, gastric cancer and non-small cell lung cancer with breast cancer susceptibility gene (BRCA) mutations. In the phase II ma...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K31/495A61K47/32A61K47/34A61K47/38A61P35/00
Inventor 王小雷曾金项文娟幸乔孙运栋
Owner JIANGSU HANSOH PHARMA CO LTD
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