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Preparation method of escitalopram oxalate drop

A technology of escitalopram oxalate and drops, which can be applied to medical preparations without active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc. Problems such as slow performance

Pending Publication Date: 2021-07-02
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prevention and treatment of depression is urgent, but most patients are depressed and painful, have difficulty concentrating and thinking normally, and have resistance to taking medicine, which leads to aggravation of the disease
[0007] For mental patients, especially the elderly and children, the oral compliance of ordinary tablets is poor and the onset of action is slow

Method used

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  • Preparation method of escitalopram oxalate drop

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

[0034] The soda-lime glass molded pharmaceutical bottle used in the packaging complies with the regulations in "soda-lime glass molded pharmaceutical bottle" (YBB00272002-2015); 2016);

[0035] The filling volume difference index complies with the provisions of "oral solution, oral suspension, oral emulsion" and "general rule 0942 minimum filling volume inspection method" under the "general principles of preparations" in the Pharmacopoeia of the People's Republic of China.

[0036] Embodiment 1: the preparation of escitalopram oxal...

Embodiment 2

[0057] Embodiment 2: the preparation of escitalopram oxalate drops

[0058] Escitalopram Oxalate 1%

[0059] Xylitol 25.0%

[0060] Citric acid 0.4%

[0061] Sodium Citrate 1.0%

[0062] DL-malic acid 0.3%

[0063] Menthol 0.4%

[0064] Glycerin 10.0%

[0065] Propylene Glycol 30.0%

[0066] Methylparaben 0.8%

[0067] Propylparaben 0.4%

[0068] Appropriate amount of purified water

[0069] Preparation Process:

[0070] (1) Dissolution of API

[0071] The raw material drug is dissolved in an appropriate amount of purified water to obtain solution 1;

[0072] (2) Preparation of organic phase

[0073] Methylparaben, propylparaben and menthol were successively dissolved in a mixed solvent of glycerin and propylene glycol to obtain solution 2;

[0074] (3) Water phase preparation

[0075] Dissolve citric acid, sodium citrate, DL-malic acid, and xylitol in an appropriate amount of purified water to obtain solution 3;

[0076] (4) Mix solutions 1, 2, and 3 evenly, le...

Embodiment 3

[0078] Embodiment 3: the preparation of escitalopram oxalate drops

[0079] Escitalopram Oxalate 3%

[0080] Xylitol 25.0%

[0081] Citric acid 1%

[0082] Sodium Citrate 1.5%

[0083] DL-malic acid 0.6%

[0084] Menthol 0.2%

[0085] Glycerin 30.0%

[0086] Propylene Glycol 25.0%

[0087] Methylparaben 1.0%

[0088] Propylparaben 0.6%

[0089] Appropriate amount of purified water

[0090] Preparation Process:

[0091] (1) Dissolution of API

[0092] The raw material drug is dissolved in an appropriate amount of purified water to obtain solution 1;

[0093] (2) Preparation of organic phase

[0094] Methylparaben, propylparaben and menthol were successively dissolved in a mixed solvent of glycerin and propylene glycol to obtain solution 2;

[0095] (3) Water phase preparation

[0096] Dissolve citric acid, sodium citrate, DL-malic acid, and xylitol in an appropriate amount of purified water to obtain solution 3;

[0097] (4) Mix solutions 1, 2, and 3 evenly, let st...

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PUM

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Abstract

The invention relates to the technical field of medicine, in particular to a preparation method of an escitalopram oxalate drop. The escitalopram oxalate drop is composed of escitalopram oxalate, a pH buffer agent, a flavoring agent, a solvent and a preservative. The escitalopram oxalate contained in the drop prepared by the invention is racemic citalopram-S-enantiomer, and the action mechanism of the escitalopram oxalate may be related to the behavior of enhancing serotonin activation by inhibiting the 5-hydroxytryptamine reabsorption of neurons of a central nervous system. The escitalopram oxalate drop is clinically used for treating severe depression and general anxiety; compared with other dosage forms, the escitalopram oxalate drop has the advantages of being convenient to take, accurate in dosage, convenient to carry and transport and the like; and when the escitalopram oxalate drop is taken, a matched dropper is used for sucking liquid to a specified scale line, and the escitalopram oxalate drop is directly dropped into a mouth or added into other food to be taken.

Description

technical field [0001] The invention belongs to pharmaceutical preparations, and relates to a method for preparing drops of escitalopram oxalate. The preparation process of the preparation is simple and controllable. The preparation is clinically used for the treatment of depression. Background technique [0002] The American FOREST LABS company has already developed escitalopram oxalate oral solution, which is produced and marketed by ALLERGAN. The trade name is LEXAPRO ®. The dosage form is an oral solution with a specification of 1mg / ml. It is used for the treatment of depression, with or without agora syndrome Panic disorder, the original research and generic drugs currently on the market in China are in the form of tablets, and the drops are already on the market in the European Union, but not yet in China. [0003] The chemical name of escitalopram oxalate is S(+)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5 -eye oxalate, the chemical formu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/343A61P25/24
CPCA61K9/0053A61K9/08A61K31/343A61K47/10A61K47/12A61P25/24
Inventor 马艺腾王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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