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Acotiamide hydrochloride controlled release tablet and preparation method thereof

A technology of acotiamide hydrochloride and sustained-release tablets, applied in the field of medicine, can solve the problems of low release rate and poor stability in the early stage, and achieve the effects of improving the release rate, high product stability, and no solvent residue.

Inactive Publication Date: 2017-03-22
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The present invention aims at the problems of low initial release degree of acotiamide hydrochloride sustained-release drug, poor stability during process scale-up production, etc., and adopts the following technical scheme:

Method used

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  • Acotiamide hydrochloride controlled release tablet and preparation method thereof
  • Acotiamide hydrochloride controlled release tablet and preparation method thereof
  • Acotiamide hydrochloride controlled release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: Composition and preparation method of acotiamide hydrochloride sustained-release tablet

[0052] A, the composition of acotiamide hydrochloride sustained-release tablet

[0053]

[0054]

[0055] B, wherein each composition and corresponding weight percent in the acotiamide hydrochloride solid dispersion are as follows:

[0056]

[0057] C. Preparation method

[0058] (1) Acotiamide hydrochloride, xylitol, sorbitol, hypromellose, povidone K30, and poloxamer are pulverized respectively, and after crossing an 80 mesh sieve, they are mixed uniformly by weight percentage in B to prepare into a physical mixture;

[0059] (2) Set the extrusion temperature of the twin-screw hot-melt extruder to 80°C, start the screw when the preset temperature is reached, add the physical mixture in step (1) into the extruder, and extrude through the screw strips;

[0060] (3) Pulverizing the strip in step (2), crossing a 40-mesh sieve to obtain a solid dispersion wi...

Embodiment 2

[0064] Embodiment 2: Composition and preparation method of acotiamide hydrochloride sustained-release tablet

[0065] A, the composition of acotiamide hydrochloride sustained-release tablet

[0066]

[0067]

[0068] B, wherein each composition and corresponding weight percent in the acotiamide hydrochloride solid dispersion are as follows:

[0069]

[0070] C, preparation method: same as embodiment 1.

Embodiment 3

[0071] Embodiment 3: Composition and preparation method of acotiamide hydrochloride sustained-release tablet

[0072] A, the composition of acotiamide hydrochloride sustained-release tablet

[0073]

[0074] B, wherein each composition and corresponding weight percent in the acotiamide hydrochloride solid dispersion are as follows:

[0075]

[0076] C. Preparation method

[0077] (1) Acotiamide hydrochloride, poloxamer, crospovidone, povidone K30, and polyethylene glycol are pulverized respectively, and after passing through a 60-mesh sieve, they are uniformly mixed according to the weight percentage in B to prepare physical mixture;

[0078] (2) Set the extrusion temperature of the twin-screw hot-melt extruder to 130°C, start the screw when the preset temperature is reached, add the physical mixture in step (1) into the extruder, and extrude through the screw strips;

[0079] (3) Pulverizing the strip in step (2), crossing a 24-mesh sieve to obtain a solid dispersio...

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Abstract

The invention relates to an acotiamide hydrochloride controlled release tablet and a preparation method thereof, and belongs to the field of medical preparations. The controlled release tablet comprises an acotiamide hydrochloride solid dispersion and pharmaceutical excipients, wherein the acotiamide hydrochloride solid dispersion comprises acotiamide hydrochloride, a polymer, a plasticizer and a lubricant b; and the pharmaceutical excipients include a controlled release material, a stabilizer, a disintegrating agent, an adhesive, a lubricant a and a coating material. The preparation method comprises the steps of firstly performing hot-melt extrusion on acotiamide hydrochloride to obtain the acotiamide hydrochloride solid dispersion; secondly adding the solid dispersion to the pharmaceutical excipients to prepare a mixture; thirdly, preparing the mixture into a tablet; and finally preparing the tablet into a coated tablet by using the coating material. According to the scheme, the early release degree of acotiamide hydrochloride is increased, the controlled release effect can last for 24 hours, and the tablet has very high stability; and in addition, the preparation method is simple in process and free of solvent residues, and other impurities are not introduced in the whole process, so that the preparation method is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an acotiamide hydrochloride sustained-release tablet and a preparation method thereof, in particular to an acotiamide hydrochloride sustained-release tablet prepared by a hot-melt extrusion technology. Background technique [0002] Functional dyspepsia (FD) is the most common clinical functional gastrointestinal disease. The prevalence of FD in European countries is 20-30%. Domestic statistics show that FD patients account for about one-third of gastrointestinal specialist outpatients. The above is at a relatively high level, but there is no relevant specific drug on the market at present. [0003] Acotiamide is a new type of selective acetylcholinesterase inhibitor. Clinical trials have proven to be effective in the treatment of functional dyspepsia, and it is safe and effective. The drug can selectively block muscarinic M1 and M2 auto-receptors It works by promoting the release...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/426A61K47/36A61K47/32A61K47/38A61P1/14
CPCA61K9/0002A61K9/2027A61K9/205A61K9/2054A61K9/2866A61K31/426
Inventor 张颖彭艳丽杨江勇时耿青
Owner JINAN KANGHE MEDICAL TECH
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