Sustained release composition and preparation method thereof

A technology of sustained release and composition, applied in the field of medicine, can solve problems such as insufficient dissolution, achieve the effects of reducing peak concentration, increasing drug loading, and increasing strength

Active Publication Date: 2021-01-12
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the solubility of ALTN or its salt is pH-dependent, and the solubility is the best under acidic conditions. According to this characteristic, the inventors combined gastric retention and slow-release technology to make ALTN or its salt stay in its dominant dissolution environment for a long time. More sufficient dissolution and release, which solves the problem of insufficient dissolution under high drug loading

Method used

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  • Sustained release composition and preparation method thereof
  • Sustained release composition and preparation method thereof
  • Sustained release composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～18

[0054] For Examples 1 to 18, ALTN hydrochloride, surfactants, and pharmaceutically acceptable carriers are mixed according to a certain ratio and then physically mixed to obtain various combinations of ALTN and surfactants shown in Table 1. mixture. Wherein the weight of ALTN hydrochloride is calculated as ALTN, and the weight of ALTN is used as a benchmark to count as 1 part.

[0055] Table 1

[0056]

Embodiment 19～22

[0058] For Examples 19-22, ALTN hydrochloride (2.5 g as ALTN) and the solid polymer material (5.60 g) shown in Table 2 were put in a container, the corresponding solvent was added, and the mixture was stirred until dissolved. The obtained solution is spray-dried at about 100° C., followed by drying under reduced pressure to obtain a solid dispersion of ALTN.

[0059] Table 2

[0060]

Embodiment 23～26

[0062] For Examples 23-26, different amounts of ALTN hydrochloride and solid polymer materials shown in Table 3 were placed in containers, corresponding solvents were added, and the mixture was stirred until dissolved. The obtained solution is spray-dried at about 100° C., followed by drying under reduced pressure to obtain the ALTN solid dispersion.

[0063] table 3

[0064]

[0065]

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Abstract

The present invention provides a sustained release composition which can maintain sustained release for 8 hours or more, reduces the peak concentration of the drug, reduces the side effects of the drug, reduces the number of times of daily administration, and even reduces the number of preparations administered each time. Meanwhile, the sustained-release composition has a gastric retention effect,is beneficial to improving the dissolution rate of weakly-alkaline indissolvable drugs, can keep sustained release for more than 8 hours, increases drug absorption by prolonging the retention time ofthe drugs in digestive tracts, and is beneficial to improving the bioavailability of the drugs.

Description

technical field [0001] The invention belongs to the field of medicine, in particular, the invention relates to a sustained-release composition and a preparation method, in particular to an oral administration preparation and a preparation method thereof. Background technique [0002] 9-Ethyl-6,6-dimethyl-8-(4-morpholin-4-yl-piperidin-1-yl)-11-oxo-6,11-dihydro-5H-benzo[ b] Carbazole-3-carbonitrile (abbreviated as ALTN in the present invention) or its salt is a poorly soluble drug and an inhibitor. Marketed capsule preparations (trade name ), developed by Roche for the treatment of anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer. The specification is 150mg, and the weight of the content of each capsule is about 330mg. You need to take 4 capsules each time, twice a day. The clinical dosage is large and the number of daily dosages is high. [0003] This product is formulated to contain lactose monohydrate, hydroxypropyl c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/32A61K47/20A61K47/38A61K31/5377A61P35/00
CPCA61K9/28A61K9/2054A61K9/2027A61K9/2013A61K31/5377A61P35/00
Inventor 谭晓峰梁文伟周伟杰赖树挺刘锋
Owner AC PHARMA CO LTD
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