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Oral disintegrated sertraline tablet and its prepn

The technology of oral disintegrating tablet and sertraline, which is applied in the field of medicine, can solve the problems that the medicine cannot be rapidly absorbed, is inconvenient to take, and has a slow onset of action, and achieves the advantages of improving bioavailability, convenient oral administration, and rapid onset of action. Effect

Inactive Publication Date: 2006-05-17
范敏华
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current sertraline is usually an oral gastric solution, the drug cannot be absorbed quickly, the onset of effect is slow, and it is inconvenient to take, especially for patients with poor swallowing function due to allergic diseases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: In this example, 1000 sertraline orally disintegrating tablets (specification: 0.25 g) were prepared, using the following ingredients:

[0024] Material name Feed amount

[0025] Sertraline 250g

[0026] Mannitol 420g

[0027] Microcrystalline Cellulose 150g

[0028] Crospovidone 70g

[0029] Aspartame 20g

[0030] Mint essence 10g

[0031] Silica 20g

[0032] Magnesium Stearate 5g

[0033] Process steps: raw materials, auxiliary material granules, adding aspartame, peppermint essence, silicon dioxide, and magnesium stearate, mixing evenly, compressing into tablets, and packaging.

[0034] The mouthfeel, oral disintegration time, disintegration time limit, and friability were measured for the samples of the above prescription.

[0035] Test items

[0036] great taste

[0037] Oral disintegration time limit 28 seconds

[0038] Disintegration time limit 19 seconds

[0039] Friability 0.5%

Embodiment 2

[0040] Example 2: In this example, 1000 sertraline orally disintegrating tablets (specification: 50 mg) were prepared using the following ingredients:

[0041] Material name Feed amount

[0042] Sertraline 250g

[0043] Sorbitol 400g

[0044] Glucose 80

[0045] Sucrose 70g

[0046] Croscarmellose Sodium 60g

[0047] Stevioside 25g

[0048] Sweet orange essence 10g

[0049] Silica 20g

[0050] Sodium Octadecyl Fumarate 5g

[0051] Process steps: raw materials, auxiliary material granules, adding stevioside, sweet orange essence, silicon dioxide, sodium stearyl fumarate, mixing evenly, compressing into tablets, and packaging.

[0052] The mouthfeel, oral disintegration time, disintegration time limit, and friability were measured for the samples of the above prescription.

[0053] Test items

[0054] great taste

[0055] Oral disintegration time limit 25 seconds

[0056] Disintegration time limit 16 seconds

[0057] Friability 0.6%

Embodiment 3

[0058] Example 3: In this example, 1000 sertraline orally disintegrating tablets (specification: 50 mg) were prepared using the following ingredients:

[0059] Material name Feed amount

[0060]Sertraline 250g

[0061] Mannitol 200g

[0062] Sucrose 220g

[0063] Gelatin 50g

[0064] Hydroxyethyl Cellulose 40g

[0065] Mint essence 10g

[0066] Process steps: raw materials and auxiliary materials are dissolved in water, fully mixed, added to the mold, placed in a freeze dryer to freeze at low temperature, vacuumed until the material is dry, and sealed for packaging.

[0067] The mouthfeel, oral disintegration time and disintegration time limit were measured for the samples of the above prescription.

[0068] Test items

[0069] great taste

[0070] Oral disintegration time limit 19 seconds

[0071] Disintegration time limit 14 seconds

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PUM

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Abstract

The present invention belongs to the field of medicine, and is especially one kind of oral disintegrated tablet of sertraline as depression treating medicine and its preparation process. The oral disintegrated tablet of sertraline includes sertraline as the effective medicine component and excipient mixture comprising disintegrating agent, stuffing, soluble polyol and penetrant. Specifically, the oral disintegrated tablet of sertraline contains sertraline 20-50 wt%, disintegrating agent 5-15 wt%, stuffing 10-30 wt%, soluble polyol 30-60 wt% and penetrant 1-5 wt%. Compared with other oral preparation forms, the present invention has wide covering of disintegrated medicine on gastrointestinal tract mucous membrane resulting in fast acting, no first pass effect, high bioavailability, less stimulation to gastrointestinal tract and easy taking.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to an antidepressant sertraline orally disintegrating tablet and a preparation method thereof. Background technique [0002] Depression, generally referring to mood disorders, is a syndrome characterized by low mood. This disorder can range from mild low mood to severe depression, which is different from normal low mood. The clinical features are: the most prominent clinical manifestation of depression is depression, accompanied by other clinical symptoms. [0003] Depression is often the result of a complex interaction of various genetic, psychological, and environmental factors. At present, there are many treatment methods for depression, such as psychotherapy, sleep deprivation therapy, phototherapy and electroconvulsive therapy, etc., but contemporary drug therapy is still the main treatment, supplemented by psychotherapy. [0004] Depressants are...

Claims

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Application Information

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IPC IPC(8): A61K31/136A61K9/20A61P25/24
Inventor 范敏华
Owner 范敏华
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