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Solid pharmaceutical composition for treating mental diseases

A material and high-speed mixing technology, applied in the field of medicine, can solve the problems of small interfering impurities, easy interference of impurity III, lack of accuracy of impurity IV, etc., and achieve the effect of excellent performance

Pending Publication Date: 2021-12-31
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] CN108828092A (Application No.: 201810653275.3, Guangdong, Yu Shaowen) discloses a method for determining the impurities in fluvoxamine maleate, the method can directional destroy impurity II, impurity III (i.e., dibutylene as described in the 2020 edition of the Chinese Pharmacopoeia) The impurity II) and impurity IV of the acid adduct, and the interference impurity is small, does not affect the positioning of each impurity, and solves the problem that impurity III is easily interfered and impurity IV lacks accuracy in USP41-NF36

Method used

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  • Solid pharmaceutical composition for treating mental diseases
  • Solid pharmaceutical composition for treating mental diseases
  • Solid pharmaceutical composition for treating mental diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095] Embodiment 1: prepare fluvoxamine maleate sheet (plain sheet)

[0096] prescription:

[0097] Fluvoxamine maleate (Lot01): 50 parts by weight,

[0098] Mannitol: 55 parts by weight,

[0099] Microcrystalline cellulose: 35 parts by weight,

[0100] Pregelatinized starch: 5 parts by weight,

[0101] Corn starch: 20 parts by weight,

[0102] Silica: 2 parts by weight,

[0103] Sodium stearyl fumarate: 5 parts by weight.

[0104] Preparation method:

[0105] (1) Each material is crushed in advance to pass through a 120-mesh sieve;

[0106] (2) Fluvoxamine maleate, mannitol, and microcrystalline cellulose are put in the pot of the high-speed mixing granulator, and mixed uniformly;

[0107] (3) Mix the pregelatinized starch with purified water (the amount of water is 15 times that of the pregelatinized starch) evenly, heat to 75-85°C under stirring and keep it warm for more than 30min to obtain a binder solution;

[0108] (4) Slowly add the binder solution to a hig...

Embodiment 2

[0112] Embodiment 2: preparation fluvoxamine maleate sheet (plain sheet)

[0113] prescription:

[0114] Fluvoxamine maleate (Lot01): 50 parts by weight,

[0115] Mannitol: 60 parts by weight

[0116] Microcrystalline cellulose: 30 parts by weight

[0117] Pregelatinized starch: 5.5 parts by weight,

[0118] Corn starch: 15 parts by weight,

[0119] Silica: 2.5 parts by weight,

[0120] Sodium stearyl fumarate: 4 parts by weight.

[0121] Preparation method:

[0122] (1) Each material is crushed in advance to pass through a 120-mesh sieve;

[0123] (2) Fluvoxamine maleate, mannitol, and microcrystalline cellulose are put in the pot of the high-speed mixing granulator, and mixed uniformly;

[0124] (3) Mix pregelatinized starch with purified water (the amount of water is 12 times the amount of pregelatinized starch), mix evenly, heat to 75-85°C under stirring and keep it warm for more than 30min to obtain a binder solution;

[0125](4) Slowly add the binder solution ...

Embodiment 3

[0129] Embodiment 3: preparation fluvoxamine maleate sheet (plain sheet)

[0130] prescription:

[0131] Fluvoxamine maleate (Lot01): 50 parts by weight,

[0132] Mannitol: 50 parts by weight

[0133] Microcrystalline cellulose: 40 parts by weight,

[0134] Pregelatinized starch: 4.5 parts by weight,

[0135] Corn starch: 25 parts by weight,

[0136] Silica: 1.5 parts by weight,

[0137] Sodium stearyl fumarate: 6 parts by weight.

[0138] Preparation method:

[0139] (1) Each material is crushed in advance to pass through a 120-mesh sieve;

[0140] (2) Fluvoxamine maleate, mannitol, and microcrystalline cellulose are put in the pot of the high-speed mixing granulator, and mixed uniformly;

[0141] (3) Mix the pregelatinized starch with purified water (the amount of water is 18 times the amount of pregelatinized starch), mix evenly, heat to 75-85°C under stirring and keep it warm for more than 30min to obtain a binder solution;

[0142] (4) Slowly add the binder sol...

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Abstract

The invention relates to a solid pharmaceutical composition for treating mental diseases, in particular to a method for preparing a fluvoxamine maleate tablet. The fluvoxamine maleate tablet is prepared from fluvoxamine maleate, mannitol, microcrystalline cellulose, pregelatinized starch, corn starch, silicon dioxide and sodium stearyl fumarate. The method comprises the following steps that the materials are mixed and granulated, and then pressed into tablets on a tablet press. The invention further relates to the tablets prepared by the method, the coated tablets prepared by taking the tablets as tablet cores, and application of the tablets and the coated tablets in preparation of medicines for treating mental diseases, such as depression and related symptoms, obsessive-compulsive disorder. The tablets have excellent performance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for treating mental diseases and a composition used in the treatment method. In particular, the present invention relates to a composition comprising fluvoxamine, a serotonin reuptake inhibitor, such as its maleic acid, and methods of using the composition for treating mental disorders, in particular to fluvoxamine containing maleate. A clear solid pharmaceutical composition, which is typically a tablet. Background technique [0002] Fluvoxamine Maleate (Fluvoxamine Maleate) is 2-[[[(1E)-5-methoxy-1-[4-(trifluoromethyl)phenyl]pentylidene]amino]oxy] Ethylamine maleate (1:1), CAS No. 61718-82-9, its chemical formula and molecular weight are as follows: [0003] [0004] Fluvoxamine was approved by SOLVAY Company in 1994 under the trade name LUVOX in the U.S. FDA as a selective serotonin reuptake inhibitor for the treatment of obsessive-compulsive neurosis. At present,...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/15A61K9/32A61K47/10A61K47/38A61K47/36A61K47/04A61K47/12A61P25/00A61P25/22A61P25/24
CPCA61K31/15A61K9/2059A61P25/24A61P25/00A61P25/22A61K9/2846A61K9/2095A61K9/2018A61K9/2054A61K9/2009A61K9/2013
Inventor 伍忆侯奇伟柳静汤芊袁亚丽蒋俊杰
Owner HUNAN DONGTING PHARMA
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