Medicinal composition of agomelatine-containing enteric capsule

A technology of enteric-coated capsules and compositions, applied in the treatment of depression, the field of enteric-coated capsules containing the active ingredient agomelatine, can solve the problems of low bioavailability and the like

Inactive Publication Date: 2013-03-06
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The inventor thinks that it is because of the first-pass effect that its bioavailability is low, and this method alone cannot solve the fundamental problem

Method used

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  • Medicinal composition of agomelatine-containing enteric capsule
  • Medicinal composition of agomelatine-containing enteric capsule
  • Medicinal composition of agomelatine-containing enteric capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Enteric-coated pellets containing 2mg agomelatine

[0037] agomelatine 2.6g

[0038] 2% hypromellose (70% ethanol) 150g

[0039] Blank pellets 120g

[0040] Process: a, the agomelatine of prescription quantity is dissolved in the 2% hypromellose (50% ethanol) of prescription quantity;

[0041] b. Preheat the blank pellets in a fluidized bed to make the material temperature 40°C;

[0042] c. Attach the medicinal solution to the pellets at a speed of 3ml / min until the end.

[0043] Isolation gown

[0044] Hypromellose 2g

[0045] water 100g

[0046] Process: a, the hypromellose of prescription quantity is dissolved in the water of prescription quantity;

[0047] b. Place 100 g of drug-containing pellets in a fluidized bed for preheating, so that the material temperature is 40°C;

[0048] c. Coating is completed at a speed of 3ml / min.

[0049] Enteric coating layer

[0050]

[0051] Process: a. Disperse the Eudragit S of the prescribed amount in 30g of...

Embodiment 2

[0054] d. Coating at a speed of 4ml / min, sampling an appropriate amount when the weight of the tablet increases by 6% and 8%; spraying the rest of the coating liquid, and curing in a ventilated oven at 40°C for 4 hours. Then fill the ordinary capsules according to the intermediate content. Example 2 Enteric-coated pellets containing 3 mg agomelatine

[0055] Agomelatine 4.5g

[0056] 10% povidone (70% ethanol) 250g

[0057] Blank pellets 180g

[0058] Isolation gown

[0059] Povidone 3g

[0060] water 100g

[0061] Process: a, the povidone of prescription quantity is dissolved in the water of prescription quantity;

[0062] b. Preheat 150 g of drug-containing pellets in a fluidized bed so that the material temperature is 40°C;

[0063] c. Coating is completed at a speed of 3ml / min.

[0064] Enteric coating layer

[0065]

[0066] Process: a. Mix each component in the prescription according to the prescription amount and set aside;

[0067] b. Preheating the above ...

Embodiment 3

[0069] Example 3 Enteric-coated capsules containing 5 mg agomelatine

[0070] Mix the raw and auxiliary materials evenly, and pack enteric-coated capsules with 200 mg per can.

[0071]

[0072]

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PUM

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Abstract

The invention relates to a medicinal composition of an agomelatine-containing enteric capsule. The medicinal composition is characterized in that the composition is mainly composed of a medicine-containing part and an enteric material part. 1mg-100mg of the active component agomelatine is contained. The enteric preparation provided in the invention is used for treating depression and anxiety, adjusting sleep rhythm and regulating biological clock, and has the advantages of small main drug content and high bioavailability.

Description

technical field [0001] The invention belongs to the technical field of drug sustained-release preparations, and more specifically relates to an enteric-coated capsule containing agomelatine as an active ingredient, which is mainly used for the treatment of depression. Background technique [0002] Drug name: agomelatine [0003] English name: Agomelatine [0004] Chemical name: N-[2-(7-methoxy-1-naphthyl)ethyl]acetamide [0005] Structural formula: [0006] [0007] Molecular formula: C 15 h 17 NO 2 [0008] Molecular weight: 243.30 [0009] According to statistics, the global annual medical expenses for depression total about 60 billion U.S. dollars. The current prevalence of depression in China is about 3% to 5%, and it is estimated that there are 36 million people with depression. The direct economic burden caused by depression in my country is about 14.1 billion yuan, and the indirect economic loss is about 48.1 billion yuan. The burden reached 62.1 billion yu...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/165A61K47/38A61K47/32A61P25/24A61P25/22A61P25/20
Inventor 王博李洪起任晓文连潇嫣
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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