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Escketamine hydrochloride tablet and preparation method thereof

A technology of esketamine hydrochloride tablets and esketamine hydrochloride, which is applied in the directions of pill delivery, pharmaceutical formulations, and medical preparations with non-active ingredients, etc., can solve the problems of poor powder fluidity, easy to cause splinter, large difference in tablet weight, etc. , to achieve the effect of low breakage rate, improved production efficiency and good dissolution rate

Pending Publication Date: 2022-03-18
BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The powder direct compression method omits the step of wet granulation, which has the advantages of saving time and energy, simple process, and fewer procedures. The direct compression of powder is easy to cause problems such as splits, which limits the application of this process to a certain extent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] It should be pointed out that the following detailed description is exemplary and intended to provide further explanation to the present application. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.

[0039] In order to enable those skilled in the art to understand the technical solution of the present application more clearly, the technical solution of the present application will be described in detail below in conjunction with specific embodiments.

[0040] The test materials used in the examples of the present invention are all conventional test materials in the field, and can be purchased through commercial channels.

[0041] Example 1:

[0042] 1. Raw material composition:

[0043] Esketamine hydrochloride 14.0 g, lactose 48.8 g, povidone K30 6 g, microcrystalline cellulose 20 g, mannitol 10 g, red iron oxide 0.14 g, yellow ...

Embodiment 2

[0049] 1. Raw material composition:

[0050]Esketamine hydrochloride 14.0g, lactose 40g, povidone K30 10g, microcrystalline cellulose 13.8g, mannitol 21g, red iron oxide 0.14g, yellow iron oxide 0.06g, magnesium stearate 1g.

[0051] 2. Preparation process:

[0052] The preparation process is the same as in Example 1.

Embodiment 3

[0054] 1. Raw material composition:

[0055] Esketamine hydrochloride 14.0 g, lactose 53.8 g, povidone K30 3 g, microcrystalline cellulose 23 g, mannitol 5 g, red iron oxide 0.14 g, yellow iron oxide 0.06 g, magnesium stearate 1 g.

[0056] 2. Preparation process:

[0057] The preparation process is the same as in Example 1.

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PUM

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Abstract

The invention relates to the technical field of medicine, in particular to an esketamine hydrochloride tablet and a preparation method thereof, and the esketamine hydrochloride tablet is prepared from the following components in percentage by weight: every 1000 esketamine hydrochloride tablets comprise 14 g of esketamine hydrochloride, 40-60 g of lactose, 10-30 g of microcrystalline cellulose, 2-10 g of povidone K30, 10-20 g of mannitol, 0.03-0.3 g of iron oxide and 0.3-10 g of lubricant. In addition, the invention discloses a preparation method of the esketamine hydrochloride tablet, a direct powder tabletting process is adopted, the technical process is simple and stable, equipment is simple, the esketamine hydrochloride tablet is suitable for industrial mass production, and the esketamine hydrochloride tablet has high dissolution rate.

Description

technical field [0001] The invention relates to the field of medicines and dosage forms thereof, in particular to an esketamine hydrochloride tablet and a preparation method thereof. Background technique [0002] Esketamine hydrochloride selectively inhibits the medial nucleus of the thalamus, blocks the ascending conduction from the spinal cord to the reticular formation, excites the limbic system, and has affinity for opioid receptors in the central nervous system and spinal cord. The anesthetic effect is mainly due to the inhibition of excitatory neurotransmitters (acetylcholine, L-glutamic acid) and N-methyl-D-aspartate receptors; the analgesic effect is mainly due to the blockade of the spinal cord to the reticular structure. Pain afferent signals and the combination with opioid receptors have no effect on spinothalamic conduction, so the improvement of visceral pain is limited. What has since been shown to be the first and only drug proven to reduce depressive symptom...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/137A61K47/38A61K47/32A61K47/26A61K47/02A61P25/24
CPCA61K31/137A61K9/2054A61K9/2027A61K9/2018A61K9/2009A61K9/2095A61P25/24
Inventor 吴霞王宇杰郭夏
Owner BEIJING WANQUAN SUNSHINE MEDICAL TECH CO LTD
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