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Intra-oral disintegration compositions and process for producing same

A technology of composition and disintegrant, which is applied in the field of oral disintegration composition, can solve the problems of high cost and slow dissolution, achieve the effect of skilled workers, improve curative effect, and save R&D and production costs

Inactive Publication Date: 2008-02-27
SHANGHAI INST OF PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by the present invention is to provide an orally disintegrating composition and its preparation method to solve the problems of high cost and slow dissolution in the above-mentioned prior art

Method used

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  • Intra-oral disintegration compositions and process for producing same
  • Intra-oral disintegration compositions and process for producing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Mirtazapine 15g

[0027] Aspartame 2g

[0028] Menthol 1g

[0029] Orange flavor 4g

[0030] Low-substituted hydroxypropyl cellulose 20g

[0031] Cross-linked polyvinylpyrrolidone 16g

[0032] Sodium carboxymethyl starch 32g

[0033] Microcrystalline Cellulose 80g

[0034] Mannitol 222g

[0035] Micronized silica gel 4g

[0036] Magnesium Stearate 4g

[0037] 0.2% Peppermint Oil 30% Ethanol Solution Appropriate amount

[0038]

[0039] Makes 1000 pieces

[0040] Preparation Process

[0041] Grind the raw material mirtazapine into fine powder, and pass through an 80-mesh sieve.

[0042] Grind the excipients aspartame, menthol, orange essence, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, microcrystalline cellulose, and mannitol into fine powder, and pass through a 80-mesh sieve .

[0043] Mix two-thirds of the total amount of low-substituted hydroxypropyl cel...

Embodiment 2

[0046] Mirtazapine 45g

[0047] Stevia 10g

[0048] Strawberry essence 4g

[0049] Sodium carboxymethyl starch 50g

[0050] Lactose 145g

[0051] Mannitol 180g

[0052] Micronized silica gel 8g

[0053] Magnesium stearate 8g

[0054] Appropriate amount of water

[0055]

[0056] Makes 1000 pieces

[0057] Preparation Process

[0058] Grind the raw material mirtazapine into fine powder, and pass through an 80-mesh sieve.

[0059] The auxiliary materials stevia, strawberry essence, sodium carboxymethyl starch, lactose, and mannitol are respectively ground into fine powder, and passed through a 80-mesh sieve.

[0060] The fine powder of raw and auxiliary materials is fully mixed according to the method of equal increase, passed through a 60-mesh sieve for 2-3 times, and an appropriate amount of water is added to make a soft material, passed through a 20-mesh sieve to granulate, and dried at 55°C±5°C.

[0061] After the dried gra...

Embodiment 3

[0063] Mirtazapine 3g

[0064] 12g powdered sugar

[0065] Lemon essence 5g

[0066] Croscarmellose Sodium 50g

[0067] Microcrystalline Cellulose 100g

[0068] Mannitol 105g

[0069] Micronized silica gel 12g

[0070] Macrogol 6000 6g

[0071] Magnesium Stearate 6g

[0072] 0.5%PVPk 30 50% ethanol solution appropriate amount

[0073]

[0074] Makes 1000 pieces

[0075] Preparation Process

[0076] Grind the raw material mirtazapine into fine powder, and pass through an 80-mesh sieve.

[0077] The auxiliary materials granulated sugar, croscarmellose sodium, microcrystalline cellulose, and mannitol are respectively ground into fine powder, and passed through a 80-mesh sieve.

[0078] Mix the fine powder of the raw and auxiliary materials according to the method of equal increments, pass through a 60-mesh sieve for 2-3 times, and add 0.5% PVPk 30 A proper amount of 50% ethanol solution is made into a soft material, granulated thro...

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Abstract

The invention relates to an orally disintegrating composition which comprises the following constituents (by weight percent): mirtazapine 1-10%, disintegrating agent 10-50%, filling agent 35-80%. The invention also relates to the process for preparing the orally disintegrating composition.

Description

technical field [0001] The invention relates to an orally disintegrating composition, in particular to an orally disintegrating composition with mirtazapine as an active substance. The invention also relates to a process for the preparation of the composition. Background technique [0002] Mirtazapine is a piperazine derivative, a tetracyclic antidepressant, and a norepinephrine and selective 5-HT reuptake inhibitor. It can promote NA and 5-HT by increasing the level of neurotransmitters in brain cells, blocking central NA-ergic neurons and terminal presynaptic membrane α2 autoreceptors and 5-HT-ergic nerve terminal presynaptic membrane α2 allogeneic receptors. release and exert an antidepressant effect. Mirtazapine can block various types of 5-HT receptors (5-HT2A, 5-HT2C, 5-HT3, etc.) The 5-HT1D receptor has a low affinity and basically does not affect the function of these receptors, so the incidence of adverse reactions such as insomnia, sexual dysfunction, and nausea...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/55A61K47/34A61K47/38A61P25/24A61K47/32A61K47/36
Inventor 吕峰孔德云陈瑞珠鲍珏琴
Owner SHANGHAI INST OF PHARMA IND
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