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Esketamine hydrochloride nasal spray and preparation method thereof

A technology of esketamine hydrochloride nasal and spray, applied in the directions of pharmaceutical formulations, aerosol delivery, medical preparations of inactive ingredients, etc.

Pending Publication Date: 2021-12-03
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In fact, the lag period of several weeks in the onset of traditional antidepressants has been identified as a major limiting factor, resulting in considerable morbidity and a high risk of suicidal behavior, especially during the first 9 days of starting an antidepressant

Method used

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  • Esketamine hydrochloride nasal spray and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] A kind of eschlorone hydrochloride nasal spray, its composition is as follows:

[0014] name Prescription (g) Eschlorone Hydrochloride 140.00 Disodium edetate 0 .8 glycerin 30.0 sodium hydroxide Appropriate amount Water for Injection add up to 1000

[0015] (1) Dissolve the prescribed amount of osmotic pressure regulator, chelating agent and raw material drug in sequence with water for injection, stir and mix evenly, pass 0.22 μm The sterilizing filter is sterilized;

[0016] (2) Add a sterile pH regulator to the sterile solution in step 1) to adjust it to 4, add sterile water for injection to make it 100%, and fill the obtained solution into a nasal spray bottle.

Embodiment 2

[0018] A kind of eschlorone hydrochloride nasal spray, its composition is as follows:

[0019] name Prescription (g) Eschlorone Hydrochloride 148.00 Disodium edetate 0. 9 glycerin 25.0 sodium hydroxide Appropriate amount Water for Injection add up to 1000

[0020] (1) Dissolve the prescribed amount of osmotic pressure regulator, chelating agent and raw material drug in sequence with water for injection, stir and mix evenly, pass 0.22 μm The sterilizing filter is sterilized;

[0021] (2) Add a sterile pH regulator to the sterile solution in step 1) to adjust it to 5, add sterile water for injection to make the volume 100%, and fill the obtained solution into a nasal spray bottle.

Embodiment 3

[0023] A kind of eschlorone hydrochloride nasal spray, its composition is as follows:

[0024] name Prescription (g) Eschlorone Hydrochloride 148.00 Disodium edetate 0. 9 glycerin 30.0 sodium hydroxide Appropriate amount Water for Injection add up to 1000

[0025] (1) Dissolve the prescribed amount of osmotic pressure regulator, chelating agent and raw material drug in sequence with water for injection, stir and mix evenly, pass 0.22 μm The sterilizing filter is sterilized;

[0026] (2) Add a sterile pH regulator to the sterile solution in step 1) to adjust it to 6, add sterile water for injection to make it up to 100%, and fill the obtained solution into a nasal spray bottle.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to an esketamine hydrochloride nasal spray and a preparation method thereof. In the preparation process of the preparation, esketamine hydrochloride, a chelating agent, a pH regulator and an osmotic pressure regulator are used, and an obtained sterile solution is filled into a nasal spray device. The preparation does not contain preservatives, damage to nasal mucosa and stimulation to nasal cilia are reduced, and the nasal cavity environment of a patient and the nasal mucosa cilia removing function are protected. The preparation is simple in prescription, easy to operate and convenient to use, and is a safe and effective preparation.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an esketamine hydrochloride nasal spray and a preparation method thereof. Background technique [0002] Ketamine (the racemic mixture of the corresponding S- and R-enantiomers) is an NMDA receptor antagonist with a wide range of effects in humans, including analgesia, anesthesia, hallucinations, dissociative effects, hypertension, and bronchial expansion. Ketamine is primarily used for the induction and maintenance of general anesthesia. Other uses include intensive care sedation, analgesia (especially in the emergency department and management of bronchospasm). Ketamine has also been shown to be effective in treating depression (especially in those who do not respond to current antidepressant medications). In patients with major depressive disorder, ketamine also produces a rapid antidepressant effect within a few hours. Ketamine and pharmaceutical compositions of ke...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/135A61K47/18A61P25/24
CPCA61K9/0043A61K31/135A61K47/183A61P25/24A61K9/12
Inventor 董玉娇宋雪梅
Owner BEIJING VENTUREPHARM BIOTECH
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