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Agomelatine tablet and preparation method thereof, as well as coated tablet of agomelatine tablet and preparation method thereof

A technology for agomelatine tablets and coated tablets, which is applied in the field of agomelatine tablets and its preparation, and can solve the problems of unfavorable drug stable release, unfavorable tablet storage, and fast dissolution of tablets, etc. Achieve the effects of strong industrial feasibility, reasonable selection, and stable preparation process

Active Publication Date: 2013-12-25
NEW FOUNDER HLDG DEV LLC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Chinese patent document CN03802710.0 discloses a composite made of cornstarch and lactose monohydrate through spray drying-coagulation as an excipient for agomelatine tablets. The preparation of the excipient is complicated, the cost is high, and it is difficult to control the quality
[0008] Chinese patent document CN200910244388.9 discloses a prescription and preparation method of agomelatine tablet, wherein, in this prescription, the addition amount of disintegrating agent carboxymethyl starch sodium is too large, can cause tablet to dissolve too fast, not Conducive to the stable release of drugs in the body, but also not conducive to tablet storage

Method used

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  • Agomelatine tablet and preparation method thereof, as well as coated tablet of agomelatine tablet and preparation method thereof
  • Agomelatine tablet and preparation method thereof, as well as coated tablet of agomelatine tablet and preparation method thereof
  • Agomelatine tablet and preparation method thereof, as well as coated tablet of agomelatine tablet and preparation method thereof

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preparation example Construction

[0056] The preparation method of agomelatine tablet of the present invention is preferably:

[0057] (1) The raw and auxiliary materials are crushed and sieved for later use;

[0058] (2) Povidone K30 is weighed to be mixed with a 10% by weight aqueous solution;

[0059] (3) Accurately weigh each raw and auxiliary material according to the prescription amount, mix agomelatine with lactose, starch, and sodium carboxymethyl starch, add an appropriate amount of 10% by weight of povidone K30 aqueous solution, and make a soft material;

[0060] (4) Soft materials are sieved to prepare wet granules and dried;

[0061] (5) granulate, add prescription amount magnesium stearate, silicon dioxide, mix evenly;

[0062] (6) Determination of main drug content, calculation of tablet weight;

[0063] (7) Tablets.

[0064] The standards and definitions of suitable soft materials can be defined in accordance with the 6th edition of "Pharmacy" published by People's Medical Publishing House i...

Embodiment 1

[0139] Embodiment 1: agomelatine tablet

[0140] prescription:

[0141] Raw material name Prescription dosage (g)

[0142] agomelatine 25

[0143] Lactose 70

[0144] starch 98

[0145] Sodium carboxymethyl starch 1

[0146] povidone k30 2

[0147] Silica 2

[0148] Magnesium Stearate 2

[0149] Makes 1000 pieces

[0150] Preparation:

[0151] (1) The raw and auxiliary materials are respectively pulverized and passed through a 100-mesh sieve for subsequent use;

[0152] (2) Take povidone K30, and be mixed with 10% by weight aqueous solution;

[0153] (3) Accurately weigh each raw and auxiliary material according to the prescription amount, mix agomelatine with lactose, starch, and sodium carboxymethyl starch, add an appropriate amount of 10% by weight of povidone K30 aqueous solution, and make a soft material;

[0154] (4) Soft materials are passed through a 20-mesh sieve to prepare wet granules, and dried at 60°C until the moisture content of the granules is 2-4%; ...

Embodiment 2

[0158] Embodiment 2: agomelatine film-coated tablet

[0159] Tablet prescription:

[0160] Raw material name Prescription dosage (g)

[0161] agomelatine 25

[0162] Lactose 70

[0163] starch 98

[0164] Sodium carboxymethyl starch 1

[0165] povidone k30 2

[0166] Silica 2

[0167] Magnesium Stearate 2

[0168] Makes 1000 pieces

[0169] Coating Solution Prescription:

[0170] Opadry II 45g

[0171] Add purified water to 300g

[0172] 1000g tablet core dosage

[0173] The weight gain of the coating is 2-4%.

[0174] Preparation:

[0175] Tablet preparation:

[0176] (1) The raw and auxiliary materials are respectively pulverized and passed through a 100-mesh sieve for subsequent use;

[0177] (2) Take povidone K30, and be mixed with 10% by weight aqueous solution;

[0178] (3) Accurately weigh each raw and auxiliary material according to the prescription amount, mix agomelatine with lactose, starch, and sodium carboxymethyl starch, add an appro...

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Abstract

The invention relates to an agomelatine tablet and a preparation method thereof, as well as a coated tablet of the agomelatine tablet and a preparation method thereof. The agomelatine tablet comprises the following components in percentage by weight: 10 to 15 percent of agomelatine, 80 to 89 percent of filler, 0.1 to 2 percent of sodium carboxymethyl starch serving as a disintegrating agent, 0.5 to 4 percent of lubricant, and 0.5 to 2 percent of adhesive. The agomelatine tablet has reasonable prescription and stable preparation process, good effects to auxiliary material selection and content selection of main drug and auxiliary materials, and low production cost.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an agomelatine tablet and a preparation method thereof. Background technique [0002] Agomelatine is a melatonin 1, 2 (MT1, MT2) receptor agonist and a 5-hydroxytryptamine 2c (5HT2C) receptor antagonist, which can directly bind to the 5HT2C receptor of the post-synaptic membrane , so as to exert its antidepressant effect, and does not increase the concentration of 5HT in the synapse, so there is no common side effect of serotonin reuptake inhibitor drugs and serotonin norepinephrine reuptake inhibitor drugs. Another unique target of the drug is the MT receptor. By stimulating the MT1 and MT2 receptors, it can adjust the patient's 24-hour rhythm and improve the patient's sleep quality, thereby promoting the improvement of the overall clinical condition of patients with depression. [0003] A large number of clinical studies have confirmed that: agomelatine has an ideal long-term and short...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/165A61P25/24
Inventor 易崇勤王振国
Owner NEW FOUNDER HLDG DEV LLC
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