Palonosetron solid medicine composition

A technology of palonosetron and composition, which is applied in the field of oral pharmaceutical composition containing 5-HT3 receptor antagonist and its preparation, can solve problems such as complicated prescription, and achieve fast dissolution rate, good curative effect and stability Good results

Inactive Publication Date: 2013-12-18
CHIA TAI TIANQING PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention solves the problems of uniformity of dispensing and dispersion, drug dissolution and bioavailability, but the prescription is complicated. Stable Palonosetron Solid Dosage Formulation with Dissolution Rate and High Bioavailability

Method used

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  • Palonosetron solid medicine composition
  • Palonosetron solid medicine composition
  • Palonosetron solid medicine composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The preparation of embodiment 1 palonosetron hard capsule

[0026]

[0027] Take the prescribed amount of palonosetron hydrochloride, add 5 times the amount of lactose and mix it, then carry out jet milling, then add 5 times the lactose to the obtained mixed powder and mix evenly, then add the remaining lactose and the prescribed amount of microcrystalline cellulose, carboxymethyl Add sodium starch and mix well, and finally add magnesium stearate and mix well. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.5 mg palonosetron) was weighed at each sampling point, and the moisture content was measured to determine the percentage content of each point. Capsule filling, inspection and packaging are carried out according to the detection results of the intermediate content, and the product is obtained.

Embodiment 2

[0028] The preparation of embodiment 2 palonosetron hard capsules

[0029]

[0030] Take the prescribed amount of palonosetron hydrochloride, add 5 times the amount of lactose and mix it, then carry out jet milling, then add 5 times the lactose to the obtained mixed powder and mix evenly, then add the remaining lactose and the prescribed amount of microcrystalline cellulose, carboxymethyl Add sodium starch and mix well, and finally add magnesium stearate and mix well. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.25 mg palonosetron) was weighed at each sampling point, and the moisture content was measured to determine the percentage content of each point. Capsule filling, inspection and packaging are carried out according to the detection results of the intermediate content, and the product is obtained.

Embodiment 3

[0031] The preparation of embodiment 3 palonosetron hard capsules

[0032]

[0033] Take the prescription amount of palonosetron hydrochloride, add 5 times the amount of lactose and mix it, then carry out jet milling, then add 5 times the lactose to the obtained mixed powder and mix evenly, then add the remaining lactose and the prescription amount of microcrystalline cellulose, carboxymethyl Add sodium starch and mix well, and finally add magnesium stearate and mix well. The obtained powder was sampled at 10 different positions, and an appropriate amount of powder (equivalent to 0.75 mg palonosetron) was weighed at each sampling point, and the moisture content was measured to determine the percentage content of each point. Capsule filling, inspection and packaging are carried out according to the detection results of the intermediate content, and the product is obtained.

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PUM

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Abstract

The invention relates to a palonosetron solid medicine composition. The palonosetron solid medicine composition comprises palonosetron or a pharmaceutically acceptable salt and a pharmaceutically acceptable excipient of the palonosetron, and the solid medicine composition does not contain an adhesion agent.

Description

technical field [0001] The present invention relates to a pharmaceutical composition, in particular, the present invention relates to a medicine containing 5-HT for the treatment of nausea and vomiting caused by cancer chemotherapeutic drugs 3 Oral pharmaceutical composition of receptor antagonist, its preparation method and its use in the field of medicine. Background technique [0002] Palonosetron (Palonos e tron) has a structural formula as shown in Formula I, and its chemical name is (3aS)-2-[(3s)-1-azabicyclo[2.2.2]octyl-2 , 3,3a,4,5,6-hexahydro-1-oxo-1H-benzo[de]isoquinoline, a selective 5-HT developed by Hels inn 3 receptor antagonists. Palonosetron hydrochloride injection was approved by the US Food and Drug Administration (FDA) in 2003 for the treatment of acute and delayed nausea and vomiting caused by moderately or highly emetogenic chemotherapy. [0003] [0004] Drugs for the treatment of nausea and vomiting need to take effect quickly and have high bioav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/20A61K9/16A61K31/473A61P1/08
CPCA61K9/4866A61K31/473
Inventor 晏彩霞张来芳吴秀兰吴蓓静隋姗姗万顺之周浩陈智林戴峻徐中南张喜全
Owner CHIA TAI TIANQING PHARMA GRP CO LTD
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