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Solid medicine composition comprising palonosetron

The technology of palonosetron and composition is applied in the field of oral pharmaceutical composition containing 5-HT3 receptor antagonist and the field of preparation thereof, which can solve the problems of complicated prescription and the like, and achieves fast dissolution speed, good stability, and high performance. fast effect

Active Publication Date: 2017-09-08
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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  • Solid medicine composition comprising palonosetron
  • Solid medicine composition comprising palonosetron
  • Solid medicine composition comprising palonosetron

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The preparation of embodiment 1 palonosetron hard capsule

[0028]

[0029] 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

[0030] The preparation of embodiment 2 palonosetron hard capsules

[0031]

[0032] 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

[0033] The preparation of embodiment 3 palonosetron hard capsules

[0034]

[0035] 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 0.75 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 solid medicine composition comprising palonosetron. The solid medicine composition comprising the palonosetron comprises the palonosetron or pharmaceutical salt and a pharmaceutically acceptable excipient thereof, and does not contain an adhesive.

Description

[0001] This application is a divisional application with the application number 201210186522.6, the application date is June 2, 2012, and the invention name is "solid pharmaceutical composition of palonosetron". technical field [0002] 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 [0003] Palonosetron (Palonosetron) has the structural formula 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 Helsinn 3 receptor antagonists. Palonosetron hydrochloride injection was approved by the US Food and Drug Administration (FDA) in 2003 for the treatment of a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/473A61P1/08
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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