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Mirogabalin Besilate orally disintegrating tablet

A technology of orally disintegrating tablets and disintegrating agents, which is applied in the direction of medical preparations of non-active ingredients, pill delivery, metabolic diseases, etc., to achieve the effect of good taste, small stimulation and fast release

Inactive Publication Date: 2020-02-04
合肥拓锐生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] So far, there is no report on the development of an orally disintegrating tablet containing Mirogabalin Besilate

Method used

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  • Mirogabalin Besilate orally disintegrating tablet
  • Mirogabalin Besilate orally disintegrating tablet
  • Mirogabalin Besilate orally disintegrating tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] A prescription for Mirogabalin Besilate orally disintegrating tablets:

[0037]

[0038]

[0039] The preparation method of above-mentioned Mirogabalin Besilate orally disintegrating tablet, comprises the steps:

[0040] According to the D-mannitol of prescription quantity, take half D-mannitol and be mixed with the D-mannitol aqueous solution that mass fraction is 10wt%, in fluidized bed granulator, spray granulation to obtain particle diameter and be 150-250 μm D-mannitol granules;

[0041] Mix Mirogabalin Besilate with D-mannitol granules, corn starch, crystalline cellulose, and the remaining D-mannitol in a column mixer for 5 minutes, add hydroxypropyl cellulose, sucralose, aspartame, L- Menthol and the magnesium stearate mixing of 80wt% prescription quantity, add remaining magnesium stearate mixing again, then flow into the mold of tablet press by the bucket of column mixer under stirring, control environment relative humidity is not More than 60%, compress...

Embodiment 2

[0043] A prescription for Mirogabalin Besilate orally disintegrating tablets:

[0044]

[0045]

[0046] The preparation method of the above-mentioned Mirogabalin Besilate orally disintegrating tablet is the same as that in Example 1, and its specification is 5 mg (in base) / tablet, with a diameter of 7.1 mm, a thickness of 2.6 mm, and a hardness of 30N.

Embodiment 3

[0048] A prescription for Mirogabalin Besilate orally disintegrating tablets:

[0049]

[0050] The preparation method of above-mentioned Mirogabalin Besilate orally disintegrating tablet, comprises the steps:

[0051] According to the D-mannitol of prescription quantity, take half D-mannitol and be mixed with the D-mannitol aqueous solution that mass fraction is 10wt%, in fluidized bed granulator, spray granulation to obtain particle diameter and be 150-250 μm D-mannitol granules;

[0052] Mix Mirogabalin Besilate with D-mannitol granules, crystalline cellulose, and remaining D-mannitol in a column mixer for 5 minutes, add crospovidone, sucralose, acesulfame potassium, L-menthol and 80wt% Mix the prescribed amount of sodium stearyl fumarate, then add the remaining sodium stearyl fumarate and mix evenly, then flow into the mold of the tablet press through the barrel of the column mixer under stirring, and control the relative humidity of the environment The content is not...

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Abstract

The invention discloses a Mirogabalin Besilate orally disintegrating tablet. The Mirogabalin Besilate orally disintegrating tablet comprises the following raw materials in percentages by weight: 5% to6.5% of Mirogabalin Besilate, 70% to 87% of a filler, 2.5% to 15% of a disintegrant, 0% to 2.18% of lubricant, 0% to 10% of a high molecular coating agent, 0% to 5% of a colorant, 0% to 10% of a binder, 0.5% to 2% of a flavoring agent and 0.2% to 2% of a perfume, wherein the sum of the weight percentage of each raw material is 100%, and the filler is at least one of D-mannitol, crystalline cellulose, corn starch, trehalose and hypromellose. The Mirogabalin Besilate orally disintegrating tablet has the same tablet hardness and moderate mechanical strength as common tablets, and the disintegration time in the oral cavity can be shortened.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a Mirogabalin Besilate orally disintegrating tablet. Background technique [0002] Diabetic neuropathic pain is the most common chronic complication of diabetes, which seriously affects people's quality of life. Studies have shown that ion channels play a very important role in the occurrence of diabetic neuropathic pain. On January 8, 2019, Japan's PMDA approved Daiichi Sankyo's Tarlige tablets (mirogabalin besylate, 2.5mg, 5mg, 10mg, 15mg) for the treatment of peripheral neuropathic pain (PNP). In general, the initial dose for adult patients is 5 mg, taken orally twice a day, and then gradually increased by 5 mg at intervals of at least one week, up to 15 mg. The dose can be appropriately adjusted between 10mg and 15mg according to age and symptoms, orally 2 times a day. Mirogabalin (DS-5565) is a ligand of α2δ-1. When they bind, they can reduce the influx of calcium ions ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/195A61K47/10A61P3/10A61P25/00A61P25/02
CPCA61K9/0056A61K9/2018A61K31/195A61P3/10A61P25/00A61P25/02
Inventor 戴德标陆文通裴九宏吴丽萍
Owner 合肥拓锐生物科技有限公司
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